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Chris focuses on digital diagnostic, therapeutic, and remote patient monitoring technologies and their impact on personalized medicine and population health. Chris has led market analysis and strategy engagements across the diagnostics and health tech spaces. Connect with him on LinkedIn or reach out at [email protected]
Fanny Anderson is a Senior Associate at DeciBio, with experience in strategy development across the healthcare IT space, including clinical decision support, real-world evidence and digital health. Connect with her on LinkedIn to learn more about her expertise in health technology consulting.
Digital health newsletter
TLDR: Apple launched its Women’s Health Study in 2019 alongside parallel studies in hearing health and heart health. Apple just released preliminary results from the women’s health study, which includes over 10,000 participants and intends to better understand menstrual cycles and gynecological conditions. The study collects self-reported data around menstrual cycles through surveys or the cycle-tracking feature on iPhones and Apple Watches. Initial results suggest that over 6,000 participants tracked at least one menstrual symptom, with abdominal cramps experienced by nearly 90% of symptomatic participants. Preliminary analysis suggests similar symptom prevalence rates across races, though it excludes detail on symptom severity or symptom duration by race.
So what? Apple’s study is one of the largest longitudinal studies in women’s health and is expected to continue through 2029 as it aims to narrow the medical research gap between men and women. Further data collection and analysis of symptom prevalence and severity may elucidate connections between self-reported data (e.g., cycle length, menstrual flow rate, pain level) and women’s health conditions like PCOS, infertility and menopause. Composite digital biomarkers could potentially be used for digital screening or diagnostics in the future, especially for conditions causing longer cycles, heavier blood flow and/or severe pain (e.g., PCOS, endometriosis). However, Apple’s study will likely be limited to discovering composite digital biomarkers, as its study protocol does not mention collection of biospecimens (e.g., peripheral blood, menstrual blood) needed for multi-omic data analysis (e.g., genomic, proteomic). Alternatively, Google Verily’s Project Baseline is an example of a longitudinal study collecting both digital and physiological biomarkers (e.g., continuous wearable use paired with genetic testing and routine bloodwork), though their research is not yet focused in women’s health.
TLDR: Women’s health represents a fairly nascent but rapidly growing segment within the digital biomarker and therapeutics space. The digital contraceptives market was incepted in 2018, when Natural Cycles became the first to officially garner FDA approval as a software application for contraception based on its smartphone app and thermometer. Clue, a period-tracking app with 13 million users worldwide, recently received FDA approval as the second digital contraceptive cleared in the U.S. Unlike Natural Cycles, Clue Birth Control is a completely digital product (e.g., app-only, no thermometer), with only slightly lower efficacy. Under ‘typical use,’ Clue is ~92% effective while Natural Cycles is ~93% effective, on par with oral contraceptives. Clue’s ovulation prediction algorithm is based on an initial questionnaire and uses Bayesian modeling to personalize predictions over time, narrowing a user’s “high risk” window. Despite clinical utility and efficacy data, Natural Cycles and Clue Birth Control both rely on direct-to-consumer business models with premium, subscription-based pricing for users. Digital contraceptives have yet to gain payor coverage beyond FSA/HSA eligibility, though Natural Cycles is aiming toward reimbursement in the future.
So what? Digital contraceptives represent just one of several potential applications for digital biomarkers in women’s health. Digital biomarkers that are passively collected (e.g., heart rate, body temperature, activity level) and actively self-reported (e.g., cycle length, flow rate, pain level) could potentially be used to develop screening tools for conditions like PCOS and endometriosis . These conditions are linked to infertility in up to 30% and 40% of cases, respectively, and timely diagnosis is a major unmet need that could be improved by digital screening tools in the future. Pharma-digital partnerships in fertility demonstrate the value that pharma sees in leveraging digital biomarkers related to fertility. For example, Myovant Sciences and Flo also recently established a partnership aimed toward generating a digital screening tool for heavy menstrual bleeding, which afflicts 25% of women and often indicates uterine fibroids.
TLDR: Text-based virtual primary care provider 98point6 is partnering with Quest Diagnostics to integrate patient labs into telehealth visits. The partnership will allow patients to access text-based consultations from 98point6 following lab work conducted by Quest Diagnostics. 98point6 currently focuses on self-insured employers as a key customer segment, with the Quest partnership bolstering their value proposition as an increasingly convenient, integrated solution for employees.
So what? 98point6 is certainly not the first telemedicine player to integrate lab work on its platform. For example, Teledoc and Doctor on Demand both have long-standing partnerships with Quest and LabCorp to integrate lab services. CommonHealth also has partnerships with Quest and LabCorp to allow patients to view lab results through the CommonHealth app. For 98point6, integrating lab results into its text-based platform is key to improving its value as a primary care solution, especially as the pandemic continues to drive COVID-19 testing. Lab integration is also key for chronic disease management which often requires frequent lab work (e.g., heart disease, hypertension, diabetes, inflammatory disorders).
TLDR: Led by former Microsoft executive, Truveta is a start-up that plans to combine and curate real-world data from ~13% of hospitals in the U.S. Fourteen large health systems, including Providence, Northwell Health, Trinity Health and CommonSpirit, have formed this startup to aggregate data from their respective patient populations. The startup will collect and anonymize this data in compliance with HIPAA and their own ethical guidelines, then monetize this data by selling access to life sciences companies and payors. Truveta’s mission is to enable contributing health systems and customers alike to improve patient care, accelerate drug discovery and advance access for underserved populations. However, the value to patients remains abstract as their business model does not appear to include any tangible compensation, incentive or opportunities for patients in exchange for their data.
So what? Truveta joins a growing marketplace of real-world data companies that are collecting, linking and monetizing patient data. This marketplace includes several types of companies, such as giant aggregators (e.g., IQVIA, Optum, HealthVerity), oncology software providers (e.g., Flatiron, Syapse, ConcertAI), molecular labs (e.g., Tempus, Guardant Health, Foundation Medicine), tissue banks (e.g., M2GEN) and data integrators (e.g., Datavant, Seqster). Truveta will enter the market as the first health system-driven company, with arguably the highest-volume longitudinal data access of any existing player (e.g., EMR and claims data for patients across 13% of U.S. hospitals). While existing datasets are often fragmented, with limited size and longitudinal reach, Truveta is positioned to deliver a statistically significant, longitudinal dataset that could allow RWD customers to consolidate disparate data purchases over time. Competitors will likely watch closely to see whether Truveta will join the crowded oncology space or carve out its own niche in a different therapeutic area (e.g., neurodegenerative disorders, chronic disease, rare disease, immune diseases). Truveta’s data cleaning, standardization and analysis efforts will likely require multiple years due to different EMR systems, data ontologies and unstructured text, though the timeline will depend on the therapeutic areas they choose to pursue (e.g., rare disease vs. general oncology vs. chronic disease).
TLDR: Yesterday, molecular diagnostics giant, Becton Dickinson, announced a commercial partnership with home-test kit provider, Scanwell Health, to develop an at-home COVID-19 antigen test. Scanwell, initially focused on providing solutions for smartphone-based UTI testing, will leverage its computer vision technology and smartphone app for patient engagement (e.g., test administration, results, education), while BD will contribute its expertise in antigen diagnostics, leveraging its existing EUA-approved BD Veritor COVID-19 antigen test.
So what? Over the last year, we’ve highlighted the diagnostics industry’s relative sluggishness to develop digital transformation strategies and strategic partnerships in the way that both pharma giants and small biotechs have. Though Roche Diagnostics was arguably the market pioneer for articulating and executing a digital strategy, similar investments from Roche Diagnostics’ competitors have been few and far between. After partnering with Babson last year to develop a “needle-free” blood collection device for future retail pharmacy diagnostics and releasing promising initial clinical data last month, BD appears to be positioning itself as a leader in digital transformation among diagnostics incumbents. Hologic recently jumped in the game, partnering with Google Cloud to leverage the tech company’s AI/ML and cloud infrastructure capabilities to turbocharge computer vision-based image analysis for its cervical cancer screening assays. We believe COVID will continue acting as a strong driving force for digitization of diagnostics, prompting diagnostics behemoths to tune-up their digital strategies and partner to harness valuable data from wearables and biosensors, remote primary care and chronic condition monitoring devices, AI chatbots, RWD sets, and more.
TLDR: Pharma giant AstraZeneca has enlisted AliveCor as a research partner, hoping to leverage the cardiac health-focused RPM company’s devices and SaMD algorithms with a broad mission of improving real-world disease management and identifying other applications. The primary near-term objective of the partnership will focus on using AliveCor’s Kardia-K AI to measure real-world blood potassium concentration from ECGs as a biomarker for kidney disease.
So what? Contrary to the situation in diagnostics, biopharmas were quicker to capitalize on the promise of wearable / sensor-generated digital biomarkers, RWD, and digital therapeutics through aggressive partnership activity over the last few years, perhaps due to clearer and nearer-term commercial opportunities accessible through digital partnerships. While the open-ended objectives of the partnership are unclear, the capabilities of the two companies point toward a potential patient monitoring and engagement platform for chronic kidney disease patients on AZ medications.
TLDR: Hologic, a leader in molecular diagnostics and women’s health, has inked a partnership with Google Cloud. As part of the collaboration, Google will lend its deep learning expertise to support further development of Hologic’s Genius AI technology for digital cytology image analysis for cervical cancer screening. Hologic will also benefit from migrating its data management architecture to the Google Cloud.
So what? As a diagnostics-focused consulting firm, we were early to highlight the lack of investment in digital development from the diagnostics world, particularly in contrast with the early and abundant investments made by pharma in digital therapeutics. Over the last year, the FDA has issued a handful of clearances suggesting that AI-guided diagnostic image analysis is poised for take-off in women’s health. In November, Hologic’s Genius AI was FDA-cleared for supporting digital breast tomosynthesis (DBT) analysis. In June, Zebra Medical netted FDA clearance for HealthMammo, which helps prioritize mammograms with suspicious characteristics. Other notable start-ups to score AI wins last year include White Rabbit AI, Densitas, Therapixel, and Screenpoint Medical. These algorithms all take an augmentative approach to supporting — not replacing — pathologists’ and radiologists’ roles in diagnostic image analysis. Hologic’s play to keep pace with the “AI-ification” of a core therapeutic area is a theme we expect to see first in areas with heavy diagnostic imaging reliance (e.g., oncology, neurology, dermatology, ophthalmology), and soon from other MDx players in less expected applications (e.g., real-time infectious disease outbreak tracking, analytics surrounding at-home testing).
TLDR: In an attempt to bring continuous health monitoring to non-wearables users, Google is launching heart and respiratory rate monitoring on its Pixel smartphones via optical (i.e., camera-based) analysis. While Google boast’s medical-grade accuracy of readings, the features are not approved as diagnostic tools.
So what? After a year’s wait, Google recently finalized its acquisition of Fitbit, formally launching the tech giant into the smartwatch race with Apple and Samsung. While Apple has continued to prioritize new features via the Apple Watch franchise, Samsung similarly integrated a heart rate monitor in its new Galaxy devices. Smartphone-based digital biomarker monitoring can be fertile grounds for refining digital biomarker signatures and algorithms while catering to a larger addressable patient base than smartwatches. Though smartphone-based digital biomarker tools are typically positioned as non-diagnostic tools and thus bypass FDA clearance, it’s not difficult to imagine a future in which smartphones employ libraries of digital biomarker apps that harvest and commercialize health data for R&D purposes, or that seek FDA clearance down the line. As each player continues building out their health hub (e.g., Apple Health, Google Fit, Samsung Health), we expect to see an evolution of digital biomarker capabilities and integration of smartphone-smartwatch metrics that enable holistic, patient-centric health tracking that increasingly migrates toward FDA-cleared / medical-grade status.
TLDR: Nuance, a leader in healthcare conversational AI and natural language processing (NLP), announced plans to acquire start-up Saykara, who is focused on understanding and structuring ambient conversation.
So what? It’s no surprise that Becker’s Hospital Review profiled voice-enabled EHRs as a top-10 trend for digital health in 2021. Last year, Nuance partnered its Dragon Medical Virtual Assistant to EHR leaders Epic and Cerner, who commercialized “Hey Epic!” and “Cerner Nuance Virtual Assistant” to enable voice-based query of medical records to reduce administrative / workflow burden for physicians. Amazon has plans of its own in the space, where Amazon Transcribe Medical is leveraging the company’s AI/ML capabilities and Alexa voice tech. Google’s Medical Digital Assist is similarly looking to fuse those assets to make a play in the space. Nuance’s acquisition of “cousin company” Saykara (founded by a former Nuance exec) will bolster its ambient capture capabilities, parsing information spoken between patient and doctor into relevant EHR fields and notes. Though these tools offer exciting potential to improve accuracy and efficiency of data capture and retrieval, they likely have a long road ahead before seeing widespread adoption and use in the clinic.
Remote cardiology monitoring heats up early in 2021
TLDR: As highlighted in many prior issues, remote monitoring devices entering routine clinical care for patients living with chronic conditions — particularly cardiac disease — is a key expected digital health trend for 2021. Philips made the first big splash with its $2.8B acquisition of BioTelemetry (~6x revenues), quickly followed by a $635M buy of Capsule Technologies (~6x revenues), which is focused on EMR integration of medical device data (e.g., RPM / IoT devices). Philips has now been joined by Boston Scientific, who made its own splash with a $925M acquisition of Preventice Solutions (~6x revenues) with up to ~$300M more in milestone payments. Third to the party is Hillrom, a hospital bed and cardiac device manufacturer, who snatched up cardiac wearable developer BardyDx for $375M (~12x revenues) plus an undisclosed upside from commercial milestones.
So what? While virtual visits captured the bulk of attention from investors and digital health industry onlookers during the early phases of the pandemic, remote patient monitoring (RPM) devices have begun to dominate the conversation since. A key inflection point in this industry arc was Teladoc’s $18.5B Q3 acquisition of Livongo, which legitimized the notion of a telehealth platform strategy leveraging virtual visits in tandem with RPM devices and data solutions to establish a “closed loop” ecosystem. While Livongo is focused on diabetes, a key synergy driver for the merger was potential service expansion for the ~40% of Teladoc visits attributed to a broader array of chronic conditions, including cardiac disease. While this is likely to translate in the near-term to support for Teladoc’s diabetes patients, we expect platform innovations will seek to extend Livongo’s “AI+AI” approach to cardiac health in parallel. Similarly, the cardio-RPM acquisitions we’re now seeing are likely to follow similar trajectories that look to downstream EMR and virtual visit integration to plug into clinical workflows. While early commercial successes in the digital biomarker RPM space are likely to be in cardiology, we expect near-term expansion into other indications and novel combinatorial digital biomarkers for RPM that incorporate wholly novel biometric markers and / or digital behavioral markers.
TLDR: BabsonDx, a medtech start-up with automated sample handling and proprietary analytics platforms, partnered with Becton Dickinson last February, with the goal of leveraging BD’s novel capillary blood collection device to develop clinical diagnostics fit for retail pharmacies without requiring venipuncture or a phlebotomist. This week, BabsonDx published results from its initial clinical study (N=81), finding strong concordance between its capillary draw and standard venipuncture on results from two routine blood testing panels.
So what? While the BD-Babson partnership certainly smells a bit like Theranos in its approach of decentralizing diagnostics to retail settings using “just a drop” of blood (Babson’s is “pea-sized”), a key Theranos failing was its accompanying goal of massive multiplexing. Babson-BD, on the other hand, are well-positioned to capitalize on the COVID-driven increase in patient, provider, and payor comfort with point-of-care, and now at-home / self-sampled diagnostics (e.g., EverlyWell, LetsGetChecked, Hims & Hers, LabCorp). Prior to COVID, few companies had seen substantial uptake of at-home tests outside of health & wellness (i.e., non-medical) testing. In our own research and casework, we’ve seen clients increasingly invest in developing strategies for decentralized testing and digital tool incorporation. In the wake of COVID, we forecast spillover effects causing some shifting of other clinical diagnostics to increasingly patient-centric, convenience-driven, and digitally enhanced approaches.
TLDR: This week, Israeli digital therapeutics (DTx) start-up Theranica received FDA 510(k) clearance for its Nerivio remote neuromodulation wearable and companion analytics app for managing episodic and chronic migraine in patients 12 and older. In 2019, Nerivio obtained de novo FDA clearance for use in treating adult episodic migraine.
So what? Though Theranica’s newest approval isn’t a unique “win” for the DTx space in terms of expanding the types of solutions legitimized by FDA clearance, the label expansion will significantly increase Theranica’s addressable patient population. Nerivio’s clearance does, however, favor greater awareness and demonstrated value of DTx solutions that leverage their digital modality to collect high-frequency, longitudinal DTx utilization data and their patient engagement interfaces to collect patient reported symptoms and outcomes data. For example, Akili Interactive Labs’ EndeavorRx FDA-cleared DTx video game for ADHD monitors patients’ performance and utilization behaviors second-by-second, which can be fed into dynamic algorithms to personalize the treatment / gaming experience to maximize efficacy and adherence for each patient. As the DTx space develops, we expect to see continued emphasis on leveraging real-time analytics to drive transformative, personalized approaches — rather than substitutive approaches — to individual patient treatment.
DeciBio’s FDA SaMD Reg Framework for Dummies: FDA’s action plan for regulating AI/ML-based SaMD medical devices
TLDR: In April 2019, FDA published its “Proposed Regulatory Framework” for a total product lifecycle (TPLC) approach to regulating AI/ML-based Software as a Medical Device (AI/ML-SaMD). Last week, FDA released a 5-pronged action plan for furthering progress on this framework in 2021:
So what? SaMD manufacturers have long criticized the FDA’s traditional regulatory framework as “misfitted-for-purpose” and antagonistic to innovation. AI/ML-SaMD’s unique ability to learn and improve as more data is fed through it merits a novel — agile, TPLC-based — approach to regulation that primarily clears an organization’s infrastructure and change management plan rather than the SaMD itself as a finished product. While FDA’s venture into uncharted territory is likely to come with some choppy waters and detours, this action plan marks a deviation from healthcare’s oft-criticized resistance to change and a welcomed application of broader technology principles (e.g., agile development, human-centered design) to healthcare innovation.
Digital Biomarkers Steal the Show @ CES 2021: 432 companies showcase digital health solutions at CES 2021
TLDR: Amid the sea of tech launches at CES 2021, sensors, wearables, and SaMD enabling remote patient monitoring stole the show. We’ve picked out a few that caught our eye (links to device details below):
So what? While launches of new remote patient monitoring (RPM) and digital diagnostic technologies at CES is by no means a first, “forced” utilization by clinicians and patients attempting to minimize in-person care during the pandemic has dramatically accelerated their adoption. More broadly, COVID has accelerated and (to a relatively limited extent) validated the clinical use of digital biomarkers. Last year’s $18.5B Teladoc-Livongo merger exemplifies this trend — Teladoc’s virtual visit platform paired with Livongo’s IoT of wearables, sensors, and RPM tools positions “Teladongo” to create a closed-loop ecosystem that leverages passive, longitudinal digital biomarker data to inform routine clinical care. While the pandemic’s urgency has most notably catalyzed digital biomarker use for RPM, we expect early disease detection and real-time treatment selection / optimization applications to follow close behind.
On the heels of disappointing schizophrenia trial readout,
Pear Therapeutics inks deal with digital pill company etectRx
TLDR: Last week, Novartis read out results from its trial evaluating efficacy of Pear Therapeutics’ PEAR-004 DTx as an adjunct to pharmacotherapy for N=112 schizophrenia patients (NCT03751280). Despite high patient engagement rates with the DTx, the readout showed no statistically significant difference for any primary or secondary outcome measures — e.g., reduced severity of schizophrenia symptoms. This week, Pear has announced a partnership with etectRx — a Proteus-esque company who has developed a digital pill and paired sensor for monitoring medication adherence.
So what? Pear’s unfavorable PEAR-004 readouts are first for digital health — and perhaps healthcare at-large. In April of last year, Pear commercialized PEAR-004 under the FDA’s temporary 510(k) exemption for digital cognitive behavioral therapies (iCBT). While PEAR-004’s readout is no cause for alarm (the DTx still shows no safety risk or adverse effects on outcomes), its readout marks the first significant setback for Pear after a string of splashy headlines. To make matters more awkward, the Pear-Novartis PEAR-004 partnership marks the second joint disappointment for the two (recall their high-profile “break-up” over co-commercializing Pear’s flagship reSET and reSET-O DTx for substance use disorders). That said, we’re intrigued to see Pear join the race against Otsuka (who acquired the salvaged pieces of Proteus post-bankruptcy) in integrating digital pill sensing / monitoring, DTx, and pharmacotherapy.
TLDR: Massachusetts governor Charlie Baker signed bill S.2984, establishing indefinite payor requirements for reimbursement parity for telemental health services and 2 years of extended parity for virtual primary care and chronic care management. The 2-year extension will allow the state and payors to negotiate more permanent reimbursement guidelines for virtual primary and chronic care.
So what? While likely to be extended given continued upticks in U.S. COVID cases, impending end of the public health emergency (PHE) on Jan 31 threatens the security of telehealth reimbursement in states without legislation requiring payors to extend parity. While some payors have more progressively issued voluntary extensions, Anthem and UnitedHealth Group (collectively covering ~90M U.S. lives) previously announced plans to stop covering at-parity. Massachusetts’ new bill will hopefully “prime the pump” for states who have yet to enact similar extensions. While virtual mental health services will now permanently be reimbursed at-parity, primary and chronic care are likely being phased in more incrementally due to lingering uncertainties / criticisms of parity in care quality or costs compared to brick-and-mortar care (e.g., due to overutilization or lacking physical patient observation, respectively). While parity reimbursement is a significant interim win, significant innovation in value-based care (VBC) models expected under Biden’s CMS and CMMI may force near-term facelifts for these policies. Such facelifts will likely incorporate principles like value-based insurance design (VBID) to toggle cost-sharing based on physician-guided essentiality of services, and digital quality metrics (e.g., for access, utilization, per-clinical case presentation costs, aggregate costs) that drive HEOR to inform data-driven reimbursement models.
For a full reference of state modifications to telehealth requirements (as of Jan 1, 2021), see here.
TLDR: Haven, the Amazon-Berkshire Hathaway-JPM Chase joint venture that shocked the industry in 2018 due to its unlikely suspects, will cease operations in February. This announcement was largely expected by most due to limited progress in concerted / synergistic market offerings, individual company strategies (we’re looking at you, Amazon), and constant flux in leadership.
So what? While the joint venture may be dissolving, there’s no doubt that the insights gained throughout its short life will (continue to) be leveraged in the respective individual businesses — especially for Amazon. In 2020, Amazon launched its Amazon Care telehealth service for employees, Amazon Pharmacy via Amazon Prime (thanks, PillPack), and its first 5 Amazon Care “neighborhood health centers”, with another 20+ planned for this year. It’s no secret Amazon is planning to take off the “employees only” training wheels to transform the primary care ecosystem akin to its disruption of e-commerce, and we’re excited to see what 2021 holds for Amazon.
TLDR: As we highlighted quarter-by-quarter throughout the year, 2020 was a quantum leap in funding for digital health, tallying a year-end $13.8B, nearly double 2019’s $7.2B and 2018’s $7.7B*. Despite Q3 reports that Q4 funding was on-track for a dip from 2020’s red-hot deal surge, investors doled out $3.8B in 92 funding rounds in Q4. Unsurprisingly, 2020 was also a landmark year for digital health M&A, with a whomping 64 deals* (20 in Q4), excluding 6 big SPAC “IPOs” (compare to 2019’s 53 deals).
* Note: According to MobiHealthNews. Differing scopes / definitions of “digital health” drives slight differences in MobiHealthNews and Rock Health data — e.g., Rock Health estimated funding of $7.4B (2019), $8.2B (2018) and ~$12B (preliminary 2020). CB Insights estimates total 2020 digital health funding of ~$32B due to a far broader scope.
So what? Despite early whispers that COVID would dry up investor funding in digital health for the year, the pandemic has since been labeled a “black swan” that set some digital health companies’ timelines back and drastically launched others into mainstream clinical care. While the latter are primarily responsible for 2020’s funding boom, companies facing COVID headwinds still benefited from resurgent and novel enthusiasm for digital health at-large. Temporary regulatory and reimbursement waivers drove first-time use of many digital tools by providers and patients alike, providing empirical basis for recognizing their relative value and combating some fears and perceptions previously gating significant adoption. These approvals also provided “natural experimental” data to regulatory agencies and payors. Increased federal and state funding and innovation initiatives for digital health, as well as voluntary payor coverage expansions (though more modest in scale) suggest some “success” of the COVID experiment from a value-based care standpoint. Investors expect companies riding COVID’s tailwinds — telehealth, remote monitoring, decentralized clinical trial solutions, interoperability tools, patient engagement tools, symptom chatbots, among others — to continue or accelerate this trend in 2021, while global vaccination efforts will hopefully provide a boost for others, contributing to overall growth for 2021 funding.
TLDR: In August, Abbott received EUA for its BinaxNOW COVID-19 Ag Card rapid test for use in schools, workplaces and other sites. This point-of-care test required a nasal swab to be taken by a health professional. Abbott has now secured an EUA for the latest iteration of its BinaxNOW test to be used at home, with virtual guidance and results given through Abbott’s NAVICA app. Abbott has partnered with telehealth service eMed to roll out the test and support patients with additional information. Abbott expects to roll out 30M tests in Q1 and 90M tests in Q2 next year. Patients must be prescribed the test ($25) by a clinician, at which point they can download Abbott’s NAVICA app, access the eMed telehealth service and receive the testing kit by mail.
So what? Abbott marks the first diagnostics giant to receive an EUA for an all-in-one, at-home COVID-19 test solution. Abbott’s EUA follows recent approvals granted to at-home tests developed by Ellume Health and Lucira Health, though it’s the first to offer an integrated telehealth service with the test. Ellume Health remains the only over-the-counter, at-home test, with Abbott and Lucira Health both requiring prescriptions to access tests. However, Abbott’s manufacturing capabilities are likely to trump smaller at-home test players, especially in the near term. In Q1 2021, Ellume Health is expected to manufacture ~9M tests (~100k tests per day) compared to Abbott’s ~30M tests (~330k+ tests per day). Abbott’s NAVICA app is also expected to drive “digital health passport” activity, with increasing potential to scale across the BINAX portfolio of point-of-care and (now) at-home testing options.
TLDR: Starting in 2018, Kaiser Permanente has built an ecosystem of 6 digital mental health apps that clinicians could recommend for patients. Kaiser trained clinicians on how to incorporate these apps in their workflows, typically as an adjunct to treatment or therapy, while also allowing patients to self-refer. Data privacy considerations were crucial to selecting the included apps, which were Headspace, Calm, Whil, myStrength, SilverCloud and Thrive. Initial data from a cohort of ~560 clinicians yielded ~16,000 patient referrals to mental health apps, with 58% downloading an app, 40% using it at least once, and 27% using an app 3+ times.
So what? Kaiser’s data indicates that app downloading remains a key barrier to patient adoption, despite clinician referral. Though nearly ~75% of patients who opened an app reported sustained engagement (i.e., 3+ uses), ~60% of patients referred to an app never used it. This app utilization data is similar to that seen in other digital health prescription platforms, like Xealth’s partnership with UPMC where it integrated with Epic’s EMR and MyChart solutions. Xealth’s platform facilitated 1.1M digital health prescriptions (not specific to mental health) and ~40% of patients engaged with a digital health solution at least once. The similar adoption data seen between Kaiser’s ecosystem (requires app downloads) and Xealth’s integrated solution (apps accessible through patient EMR portal) may point to patient willingness to use digital health apps, rather than workflow burdens, as the primary barrier to adoption. A recent survey conducted by Accenture found that data privacy and efficacy remain key concerns gating patient adoption of digital health, despite increased adoption during the pandemic. Persistent provider recommendation and education around key concerns will likely be crucial to driving adoption of digital health tools in the future.
TLDR: The FDA granted EUA to the first over-the-counter at-home COVID-19 diagnostic test, developed by Australian digital diagnostics company Ellume Health. The Ellume COVID-19 Home Test kit consists of a sterile nasal swab, processing fluid, a dropper, a Bluetooth-connected sample analyzer, and instructions to download the Ellume COVID-19 Home Test App app. The app walks users through how to connect the app to the analyzer, collect a sample, and conduct the test. The test is a rapid, lateral flow antigen test that returns results in 15-20 minutes. The test has a sensitivity of 96% and specificity of 100% in symptomatic patients, though performance falls in asymptomatic patients to a sensitivity of 91% and specificity of 96%.
So what? Ellume’s test approval comes on the heels of the FDA’s first EUA for an at-home test kit granted to Lucira Health last month. However, Lucira Health’s test requires a prescription, has only been studied in symptomatic patients, and will not be marketed nationally until spring 2021. Ellume’s test can be purchased for ~$30, does not require a prescription, and can be used in individuals with or without symptoms. Ellume plans to manufacture 100K tests per day starting in January, with the goal of reaching 1M tests per day by mid 2021. The Ellume app requires users to provide their ZIP code and DOB so that the results are automatically pushed to public health authorities. Though the FDA has approved 25 home sample collection kits to-date, Ellume’s is the first to connect with an app for automated results reporting.
TLDR: After investing $6M in Xealth earlier this year, Cerner and Xealth built a digital health prescribing platform, to allow physicians to prescribe and monitor digital health tools. Cerner’s customer Banner Health is the first to roll out the solution. Physicians recommending digital health tools typically give patients brochures or ask them to make a download from the app store. Though some apps have a clinician portal, this data is often siloed and providers do not have a centralized view of prescribing patterns and patient utilization data.
So what? Xealth provides the centralized, interoperable infrastructure that is key to lowering barriers to adoption for digital health tools in a clinical setting. Xealth works with 30+ digital health solutions, including Omada, SilverCloud, ResMed and Healthwise. By providing direct integration with medical record systems like Cerner and Epic, Xealth maximizes efficiency for providers interested in prescribing digital health solutions to patients. Xealth also lowers barriers for patients to find and use their doctor-recommended digital health tool by sending prescription information directly to patients’ smartphones. With a major health system roll-out already under its belt at UPMC (e.g., facilitated 1.1M digital health prescriptions to-date), Xealth is likely to find similar success at Banner Health and beyond.
TLDR: With a total of $1.05B in funding and a $8.1B valuation, precision medicine and data company Tempus is broadening its reach outside of oncology, into infectious disease, depression, cardiology, and diabetes. In May, Tempus launched a PCR diagnostic test for COVID-19 run at its labs in Chicago and Atlanta, and has since conducted 1 million tests. Tempus has also collected RNA-seq transcriptome data for 10,000 patients through academic partnerships. The company also launched a service earlier this year enabling psychiatrists to order Tempus’ xG test and receive a molecular report that may inform treatments for major depressive disorder based on patients’ genetic information.
So what? Primarily focused in oncology, Tempus claims to have collected and analyzed clinical and molecular data for nearly 1 in 3 cancer patients in the U.S. Tempus leverages its multi-omic data to fuel its AI-driven precision medicine software and real-world evidence offerings, which support pharma research and therapeutics development. As Tempus expands molecular test offerings into other disease areas, its clinical-molecular real world database is likely to follow suit. Molecular data collection is increasingly routine in oncology care, making the real-world data space increasingly crowded there. Disease areas that remain on the cusp of precision medicine revolutions, like cardiology and mental health, offer attractive opportunities for Tempus to build highly unique and differentiated multi-omic datasets.
TLDR: After announcing joint development of their COVID “digital contact tracing” API in April, our team published an article covering its technical details, pros and cons, and potential post-COVID applications in the digital biomarker space. Following widespread criticism ranging from technical inaccuracies (i.e., poor sensitivity and specificity) to Orwellian privacy concerns, Google and Apple have scored their biggest win, with the CA Notify app leveraging its API to go live tomorrow.
So what? Since April, the remote monitoring space has seen a steady stream of VC funding, acquisitions, regulatory approvals, CPT code and reimbursement expansions. While these solutions primarily focus on monitoring chronic disease patients, they continue to set the stage for upstream use of digital biomarker surveillance for screening and diagnostic applications. Furthermore, digital biomarkers provide speed, continuity, and cost benefits that instrument-and-reagent solutions cannot accomplish, providing improved overall diagnostic value. However, repurposing these solutions as long-term epidemiological or public health surveillance tools is less certain. One could easily envision smartphone manufacturers adding a “Public Health Alert” feature, similar to the Public Safety and AMBER Alert notifications, that could be used to issue heightened vigilance notices or health recommendations for at a sub-local level for budding outbreak clusters for seasonal pathogens like influenza, future epidemics (e.g., SARS, H1N1, MERS, Zika, Ebola), or even pandemics. Digital surveillance tools could also be leveraged for basic epidemiological research to better estimate disease incidence and prevalence, characterize transmission rates and patterns, and refine disease models. While we’re likely to see fluctuations in reported accuracy and public acceptance of digital surveillance tools in the near-term, we strongly believe they hold long-term potential for transforming preventive care.
TLDR: Ro is a telehealth company that began as a digital pharmacy called Roman (now a subsidiary) focused on expanding access to men’s health treatments (e.g., ED, hair loss). Ro has since expanded to offer wraparound teleconsultation services and solutions for women’s health (Rory), smoking cessation (Zero), and weight loss (Plenity), as well as a subscription-based digital pharmacy for generics. Ro’s acquisition of Workpath, a technology platform for coordinating at-home phlebotomy visits, marks a milestone in its strategy to create a vertically integrated telehealth platform.
So what? COVID’s acceleration of telehealth adoption by patients, providers, and payors has made for a record-breaking year of 24 telehealth deals for a total of $1.5B (compare to 2019’s 12 deals at $384M). Amid a landscape of telehealth giants making big moves (e.g., Teladoc’s $18.8B acquisition of Livongo, Amwell’s IPO [now valued at $6.8B], Hims & Hers SPAC merger [valued at $1.6B]), Ro’s CEO, Zachariah Reitano, has said the company is setting its own sights on a public offering. Ro’s angling toward vertical integration is not unlike Teladoc’s strategy with Livongo, which augmented the company’s virtual visit platform with an AI platform with at-home diagnostic and therapeutic applications. We maintain that the rapidly maturing telehealth space continues to be ripe for consolidation, particularly via vertical integration plays that shift perception from telehealth being substitutive for in-person care to telehealth expanding the scope and possibilities of care (e.g., through a feedback loop of real-time, continuous data collection, AI or physician-based interpretation, and digital therapeutics).
TLDR: It’s no secret that 2020 has been a record-shattering year for digital health — by Q3, Rock Health had cataloged ~$9.4B in venture capital funding, already squashing 2018’s full-year ~$8.2B record. While a new report from CB Insights forecasts a ~35% deceleration in Q4 funding compared to Q3, analysts still forecast Q4 2020 funding will edge out Q4 2019’s by ~10%.
So what? While funding may be decelerating, total 2020 funding is expected to beat 2018’s record-high ~$8.2B by a whomping ~50% and average deal size to-date (~$30M) marks a notable uptick from 2019’s (~$20M). Deal activity has continued to skew later-stage and Q4 IPOs show no signs of slowing, keeping investor enthusiasm hot (e.g., Hims & Hers’ SPAC merger, Butterfly Network’s SPAC merger, Cloudbreak Health’s SPAC merger, Livongo execs’ stealth SPAC launch set for $500M IPO). We see no reason to believe that Q4’s “contraction” in VC funding foreshadows any bending of the overarching funding trendline moving into 2021. We maintain that the take-off for telehealth propelled by COVID is likely to continue translating into expanded opportunities for adjacent technologies (e.g., remote patient monitoring, patient engagement, virtual clinical trials) with (slightly) derisked prospects for investors.
TLDR: Last week, CommonPass, an app enabling digital documentation and sharing of individuals’ COVID status (i.e., test results and vaccination status), signed on the Airport Council International, a group representing almost 2,000 airports around the world, and JetBlue, Lufthansa, Swiss International Airlines, and Virgin Atlantic. This move follows CommonPass’ successful pilot with United Airlines.
So what? With Pfizer / BioNTech and Moderna’s vaccines now under EUA, digital health organizations are preparing to hit the market with “digital passports” in hopes of reopening domestic and international economies and travel. Key players joining the World Economic Forum’s CommonPass in the space include IBM Watson (Digital Health Pass), International Chamber of Commerce (AOKpass), Mayo Clinic & Safe Health (HealthCheck), with some like Mayo Clinic’s already indicating plans to expand the passport more broadly to infectious disease diagnostics (e.g., STI testing). In a recent interview, IBM’s healthcare blockchain solutions lead emphasized the importance of leveraging open standards (e.g., W3C) and public-private collaboration to avoid locking the world into any single proprietary “passport”. Thus, while CommonPass has seen early adoption by major organizations, we anticipate broad uptake of other leading and local solutions that prioritize interoperability and help normalize it in the lexicon and expectations of patients, providers, and governments globally.
TLDR: Formed from a merger of CenseoHealth and Advance Health, Signify Health is a technology company that provides care integration and management solutions. Iowa Department of Public Health inked a partnership with Signify Health in 2017 to integrate its siloed data systems for care management across obstetrical care, early development and child care. Signify Health has built a shared technology platform for Iowa DPH’s statewide network of community providers to coordinate services, share information and point patients to local community resources for social care / non-medical needs (e.g., housing, transportation, mental health). To date, approximately 400k individuals in Iowa have had a social care need met using the Signify platform.
So what? Over the past two years, Iowa has seen a jump from 67% to 97% of women receiving a regular source of obstetrical care, representing a significant increase for women insured by Medicaid and/or supported by Title V funding. Medicaid pays for >40% of births across the U.S., and access to obstetrics care is crucial to improving maternal health outcomes in this population. Iowa’s partnership with Signify demonstrates the importance of SDOH data collection and resource distribution (e.g., housing, transportation) in lowering barriers to accessing medical care. Last week, Signify Health acquired PatientBlox, a healthcare payment blockchain company. The acquisition positions Signify Health to better take on value-based care by supporting novel payment models and risk arrangements, increasing the scalability of Signify’s existing medical-social data integration and care management platform.
TLDR: After acquiring PillPack in 2018, the online storefront for Amazon Pharmacy is finally live. The website allows shoppers to order prescriptions directly through Amazon and pay with their health insurance or out-of-pocket. Amazon Prime members are eligible for free two-day shipping on any prescription, as well as discounts on generic and brand-name drugs when paying without insurance. Incumbent retail pharmacies, like Walgreens, CVS and Riteaid, saw their stocks fall after Amazon’s announcement last Tuesday. However, the jury is still out on the extent of Amazon’s ability to steal patient volumes from major pharmacy retailers. Most notably, patients will have to transfer existing prescriptions over to Amazon Pharmacy, requiring them to contact their prescriber and potentially schedule a visit.
So what? Beyond traditional retail pharmacies, Amazon also poses a competitive threat to prescription discount solutions and digital pharmacies. Amazon is not only making a play toward convenience, but also toward price transparency. Amazon will facilitate price comparisons for prescriptions through its Prime Rx tool, allowing Prime members to evaluate costs when using insurance vs. paying out-of-pocket with discounts. Prime Rx will likely compete directly with prescription discount and price comparison providers like GoodRx, which just went public a few months ago. While Amazon Pharmacy is available at ~50k pharmacies, GoodRx has a lead with ~70k pharmacies available to consumers and several key partnerships (e.g., Kroger Rx Savings, Walmart’s Prescription Savings Program). Amazon is also driving competition in the online pharmacy space more broadly, particularly with UnitedHealth Group and Walmart who both acquired digital pharmacies earlier this year (Walmart-CareZone, UnitedHealth-DivvyDose).
TLDR: Last week, Lucira Health became the first to clinch FDA authorization for an entirely at-home test for COVID-19, called the “All-In-One Test Kit”. The single-use home test kit requires a doctor’s prescription and is expected to cost less than $50. Based on LAMP technology, the test requires a nasal swab, which is swirled into a solution and inserted into a portable device that reads out a light-up result within 30 minutes. The test will soon become available to patients of Sutter Health and South Florida’s Cleveland Clinic, but will not be marketed nationally until spring 2021.
So what? Lucira Health joins nearly 300 COVID-19 tests authorized by the FDA as the first true at-home test. However, at-home testing could distance patients from the reporting process, which requires a chain of communication from patients to healthcare providers to public health officials. This is undoubtedly part of the FDA’s rationale for making the Lucira test prescription-only, such that patients must report their results back to the prescribing physician. Though the test has only been studied in symptomatic patients so far, one could imagine this at-home test being extremely attractive for the routine testing that will likely be required for a transition into a “new normal” in 2021. At-home test providers like Lucira Health are well positioned to integrate with the rising wave of digital passport solutions (e.g., IBM Health Pass app, CommonPass app) that help to verify an individual’s COVID status ahead of entering public spaces (e.g., work, travel).
TLDR: According to a recent survey of >1,500 physicians by the COVID-19 Healthcare Coalition, key challenges to sustained telehealth adoption include reimbursement, EHR integration and patient access to technology. The survey identified a consensus among providers that telehealth has a positive impact on patient outcomes, experience and cost of care. However, >70% of respondents said the potential roll-back of reimbursement coverage would be a major challenge to sustained adoption. More surprisingly, ~60% of clinicians reported that they still cannot access telehealth interfaces directly through their EHR systems. Synchronous video calls remain the dominant telehealth modality (~80% use interactive video visits) with very few using RPM tech (~11%).
So what? Looking ahead to a post-pandemic era, reimbursement for telehealth visits will likely be the primary lever of sustained adoption. Just last month, CMS added reimbursement for 11 new telehealth services during the public health emergency. Though Medicare leaders have called for continued access to telehealth, further evidence around cost effectiveness and patient outcomes will likely be crucial to driving sustained uptake by private payers. Initial data suggests cost-savings, especially in chronic disease care, and improved patient experience. Younger generations are also expected to act as champions of telemedicine, driving continued adoption in the future. Millennials and Gen Z are willing to pay a “convenience premium” for telehealth services and are more comfortable with technology, while older participants tend to prefer traditional care.
TLDR: In Amwell’s (AMWL) first public earnings call, co-CEO brothers Roy and Ido Schoenberg reported total Q3 revenues of $62.6M (vs. ~$35M in 2019), projecting FY 2020 total revenues of ~$240M (vs. $149M in 2019, or ~60% growth YoY). While it’s no surprise that Amwell and its virtual visit competitors are on-track for a record-setting growth year, interesting highlights of the earnings call include:
Inversion of mix of AMG (Amwell providers) vs. non-AMG (health system / health plan providers compared to last year — now ~75% non-AMG, reflecting a shift toward hybrid / “virtual first” + brick-and-mortar care models
~30% decrease in visit volume (1.4M in Q3 vs. 2M in Q2) compared to Q2’s peak volumes associated with COVID, with a shift toward lower-margin visits
Margins improvements expected in the mid-term (Amwell’s long-term GM target is ~50%) as new telehealth experiences translate into sustained post-pandemic use and expanded use of specialty care visits
So what? While Amwell lags its primary competitor Teladoc (TDOC) in scale of revenues (~75% less expected in 2020) and visits (40-50% less expected in 2020), the newly public company has experienced massive growth during the pandemic. Teladoc has long enjoyed the scarcity premium of being first-to-market, with much skepticism over newer competitors’ ability to achieve comparable scale. One such concern has been ability to scale an external network of providers (e.g., Amwell’s non-AMGs) to provide patients with a unified virtual + brick-and-mortar care experience (i.e., being able to see your PCP or specialist rather than a separate virtual provider, or worse, a new virtual provider each time). In the last year, Amwell has expanded its provider network tenfold from just 6,000 (Q3 2019) to 62,000 (Q3 2020). Another concern has been the ability of competitors to scale globally. While Amwell has work cut out for itself in this domain, the company expects its recent Google Cloud partnership to be a major driver for global expansion. As Amwell continues to scale on the back of the pandemic, we expect Amwell to call Teladoc’s raise in the chronic disease management space (i.e., creation of a unified care platform via merger with Livongo).
TLDR: Last week, Google pulled back the curtains on its two latest healthcare tools: Healthcare Natural Language API and AutoML Entity Extraction for Healthcare. Both tools can be used to mine, extract, and organize data from unstructured clinical records, a major pain point for providers looking to more effectively leverage their clinical data and for pharma and RWD players hoping to gain insights from deeper clinical information that typically requires time-intensive manual curation. The NLP API will be available for free through Dec. 10 while AutoML will be free for the first 5,000 text records and 1,000 document pages imported.
So what? In its announcement, Google Cloud highlighted a few key use cases it sees as strong fits for the technology — telehealth visit transcript mining and documentation, more effective pharma patient-to-trial matching, and provider reporting requirements (e.g., HEDIS, disease registries). We additionally see strong fit for this technology for:
Improved clinical decision support, value-based care, and population health management tools providers may develop internally
Potential revenue diversification for providers via enhanced partnerships with RWD aggregators or outright development of proprietary RWD offerings
TLDR: UK-based fertility company Apricity has built an algorithm to predict female fertility based on lifestyle factors. The company serves as a virtual fertility clinic, offering tele-consultations and AI-driven personalized treatments (e.g., IVF, FET, IUI, egg freezing). It just launched an online tool that analyzes lifestyle factors to predict a woman’s chances of conceiving naturally. Its predictions are based on age, BMI, weekly alcohol intake and smoking habits. The key value of the tool appears to be allowing users to adjust their inputs and see how their fertility predictions may change over time, showing individuals the impact lifestyle changes may have on improving fertility (e.g., healthy BMI, reduced alcohol consumption, smoking cessation).
So what? Though this tool focuses on lifestyle factors, predictive algorithms may eventually incorporate both self-reported and biometric data to identify digital biomarkers in fertility. Metrics like body temperature, heart rate, menstrual cycle length, flow rate and pain level may be combined to develop digital screening or diagnostic tools for key conditions related to infertility (e.g., endometriosis, PCOS) that are often misdiagnosed. With over 3,000 women’s health apps available today, there are a myriad of players collecting key metrics that could be predictive of fertility. The Apple Women’s Health Study is particularly promising for digital biomarker discovery, given its massive scale (500,000 participants) and longitudinal approach (10 years) to collecting digital metrics linked to phenotypic data about key conditions.
TLDR: Key changes: (1) sweeping reform of appointed health agency officials, with a focus on scientists and doctors, pandemic specialists, and Obama-era ACA champions, (2) generally speaking, reinvigoration of the ACA, though potentially limited by SCOTUS’ imminent hearing on the constitutionality of the individual mandate and potential Republican control of the Senate; (3) rollbacks of Trump’s executive orders and administrative actions limiting state Medicare and Medicaid access (e.g., slashed marketplace advertising budgets, work eligibility requirements, premium cost-sharing), (4) reversal of Trump’s Title X reforms banning funding recipients from performing or referring abortions.
So what? The political philosophies underlying Biden-Harris’ anticipated healthcare changes should come as no surprise. While Harris was an early “Medicare for All” champion and Biden a more moderate “public option” proponent, both plans for restructuring America’s coverage will be challenging without a decisive Democratic Senate majority. More myopically, we expect a Biden administration to usher in a decisive, top-down strategy for halting and reversing record-breaking COVID infection rates, and ultimately, implement coordinated federal-state plans for safe re-openings and vaccine rollout. At a high-level, Biden’s administration is expected to contrast the Trump administration’s tone with respect to social determinants of health (SDOH) and equity of healthcare access and outcomes, with expected investments in virtual care and revitalized emphasis on value-based care and alternative payment models via CMMI. While agency deregulation and unique emergency / pandemic-driven authorizations during Trump’s term have seemingly set the stage for a digital health “boom”, we expect the next 4 years under Biden to bring structured investments, industry expertise, and emphasized goals of equity and access that will allow the digital health sector to leverage built momentum and thrive.
TLDR: The program aims to leverage the nearly century-old technology of EEG and advancements in machine learning to discover composite biomarkers for depression, anxiety, and other mental health conditions. While the program’s scope is broad, its initial focus appears to be on development of compound subjective-objective biomarkers (i.e., objective digital biomarkers that complement subjective patient experience and clinician observations) with highest initial uptake for patient monitoring and prognostic applications.
So what? Project Amber signals a tonal change from “big tech”, which to-date has largely safeguarded in-house development for leading digital biomarkers (e.g., Apple & Google / Fitbit’s Heart studies). While Alphabet will still pursue independent development, this open-source call for collaboration invites leading researchers and digital health experts to leverage Project Amber’s portable EEG hardware design, machine learning techniques, and data visualization and stimulus software to derive their own insights. While EEG biomarkers are largely perceived as non-novel and lab-based (i.e., requiring presentation to a traditional healthcare setting), Alphabet’s prototype adds to a growing cohort of portable EEG devices aimed at virtual / remote use. Outside of EEG, other companies are pursuing smart device-based digital biomarkers for mental health (e.g., Mindstrong Health, Ellipsis Health, BrainCheck, CompanionMx).
TLDR: Founded in 2015, NightWare built an app to help individuals suffering from PTSD-related nightmares to improve restful sleep, and it has just been FDA approved for use on Apple Watch. The app monitors sleep patterns through heart rate and movement, and builds a customized treatment in the form of vibration patterns that interrupt nightmares without fully awakening the user. The NightWare device is prescription-only and intended as a combination therapy alongside prescribed medications and other therapies for PTSD. The prescribed NightWare kit includes an Apple Watch, which should only be worn during sleep due to false alerts and battery life (i.e., needs to charge during the day). Given recent FDA approval, it remains to be seen how payers will navigate coverage for NightWare as a companion therapy, including the AppleWatch hardware.
So what? NightWare joins a growing list of FDA approved digital therapeutics in mental health. In PTSD, the commercial DTx landscape is relatively nascent, with Freespira as the key FDA-approved solution and other products still in development (e.g., Pear Therapeutics). Since its FDA approval, Freespira appears to have garnered insurance coverage by some private payers including Highmark and Anthem. Payer coverage of FDA-approved DTx is improving, but remains spotty across payers. Long-term evidence generation around care outcomes and cost appears to be crucial for more robust payer coverage. Pear Therapeutics just released analysis of real-world claims data, suggesting reduced payer spending of ~$2,150 per patient over six months with its reSET-O product for opioid use disorder. Though Pear’s data suggests near-term costs savings, ICER experts call for additional evidence to compare the long-term clinical and economic value of DTx companion therapies, like reSET-O and NightWare, relative to standalone medication.
TLDR: In this updated readout from the Fitbit / Scripps DETECT study (Digital Engagement and Tracking for Early Control and Treatment), researchers used a “triad” of resting heart rate, sleep quality, physical activity data from 3,800 symptomatic patients (of the 30,000+ total patients enrolled) along with patient-reported symptom data to improve diagnostic accuracy to 0.80 (from 0.77). Notably, while sleep and physical activity were significant predictors (AUC of 0.68 and 0.69, respectively), resting heart rate was not (AUC of 0.52).
So what? In an August readout from Fitbit, researchers reported diagnostic accuracy of AUC 0.77 in detecting COVID across 1,100+ patients using the same digital biomarker triad with 4 days of prior symptom history. This updated readout not only validates the initial findings among a much larger study group, but shows slight improvement in overall diagnostic performance by layering patient-reported symptom data into the “triad” as a fourth digital biomarker. While still in its infancy, the digital biomarker space is showing early promise as a complementary (and in the distant future, perhaps substitutive) approach to traditional biomarkers for detecting disease. The overwhelming trend toward multi-omic signatures in the “traditional” biomarker space is already coming to bear in digital biomarkers, which we expect will explode in complexity, diversity of biometrics and behavioral markers, and patient-reported data in the years to come. In addition to the Fitbit DETECT study, other major COVID-focused digital biomarker development programs underway include Huami’s ~1.3M-user study in China and the Robert Koch Institute’s study in Germany with 500,000+ enrolled.
TLDR: After investing in Seqster in February, Takeda has now announced an extended partnership with the RWD start-up dubbed the “mint.com” of health data by its CEO, Ardy Arianpour. Under the partnership, Takeda will gain access to the Seqster Research Portal (SRP) which matches patient-level clinical data from 3,000 hospitals / health systems and 150,000 doctor’s offices with patients’ molecular and wearables-generated data. Takeda plans to leverage the portal to launch 12 distinct use cases across the organization in the next few weeks.
So what? Takeda’s announcement comes on the heels of its recent partnership with Amazon Web Services and Accenture aimed at cloud-driven organizational infrastructure transformation. Other global pharma giants have inked similar partnerships (e.g., Merck-AWS, Google-Pfizer, Google-GSK, Google-Bayer) establishing the infrastructure to support larger, more real-time use of RWD. The Takeda-Seqster partnership also follows a trend of pharma companies partnering with RWD aggregators (e.g., Roche / Genentech-PicnicHealth) to tap into larger, more multi-omic datasets with potential for massive scale, automated data linkage (e.g., Datavant), and near real-time reporting. Stay tuned for our interview next week with Seqster CEO, Ardy Arianpour, and Takeda Head of Emerging Technologies & Digital Partnerships, Emir Roach!
TLDR: The partnership will link real-world data collected on new therapies to generate more robust safety and efficacy profiles. The companies each play distinct roles in the engagement, with Medidata’s clinical research platform, TriNetX’s real-world data from a global network of HCOs, and Datavan’ts token-based data ecosystem. They aim to link relevant data for new therapies before trials, during clinical trials and after approval, with the ultimate goal of optimizing capture for safety and surveillance data.
So what? Each player in this partnership arguably has the resources and runway to roll-out directly competitive offerings on real-world data for new therapies. However, perhaps the most differentiating aspect of their joint offering is one that these players could not build alone. This is the opportunity for seamless, longitudinal visibility on the performance of newly approved therapies, which would appeal to pharma and payers alike. Longitudinal data capture is one of the key pain points observed with disparate RWD offerings available today, because patient data is so often siloed across disparate institutions and IT systems (e.g., EMR, LIS, EDC, etc.). Datavant’s market-leading “patient key” tokenization technology is particularly crucial to building longitudinal, patient-level datasets spanning data sources, as evidenced by its growing number of data partnerships (e.g., Parexel-TriNetX, Takeda-Seqster, Blue Health Intelligence, Medable, Precision Digital Health, Prognos, Symphony Health, Trialbee, Castor). Given Medidata’s entrenchment in clinical trials, Datavant’s open data ecosystem and TriNetX global reach across ~170 HCOs, these companies are incredibly well-positioned to facilitate longitudinal data capture that could offset the need for post-market studies requiring active patient follow-up.
TLDR: Medidata offers end-to-end software solutions for clinical trials through its Rave Platform, including trial planning, data management and analytics. Medidata’s market-leading Rave EDC solution offers integration with the Rave Patient Cloud, a suite of patient-centric tools including eConsent, eCOA, and wearable sensors. Medidata’s acquisition of MC10 will bolster its Patient Cloud platform through MC10’s BioStamp sensors and analytics capabilities. Medidata will leverage MC10’s biosensors to expand its portfolio of patient-facing tech, better enabling decentralized clinical trials and biomarker discovery efforts.
So what? Digitization and decentralization of clinical trials has become increasingly important during the COVID-19 pandemic. Researchers also estimate that ~70% of clinical trials will likely include wearable sensors by 2025. Medidata’s acquisition of MC10’s biomarker business will allow the software giant to expand its decentralized trial capabilities toward remote, continuous biometric measurement. MC10’s BioStamp nPoint sensor captures 44 standard metrics around activity, posture, sleep, sEMG and vital signs (e.g, continuous HR and HRV, respiration rate). MC10’s digital biomarker capabilities will allow Medidata’s industry customers to innovate in remote biometric data capture, analysis and integration with other data capture mechanisms used in trials.
TLDR: LabCorp announced a new technology platform that facilitates interoperability across disparate tools deployed in clinical trials. LabCorp’s drug development business, Covance, aims to leverage this integrated platform to reduce administrative tasks for patients and sites while achieving operational efficiencies for study sites. The need for interoperability is rooted in LabCorp’s recent acquisitions of GlobalCare (global mobile nursing and ambulant care organization) and snapIoT (global med tech company with digitized clinical trial platform). Integration with snapIoT’s platform will significantly bolster Covance’s decentralized trial technology through eConsent, ePRO, eCOA, telemedicine and connected device integration.
So what? Earlier this year, LabCorp inked a deal with digital trial software company Medable to integrate its patient and site interfaces. LabCorp’s latest acquisitions and integrated tech platform indicate a sustained effort toward decentralized trial capabilities embedded in Covance’s own offering. A recent PharmaIntelligence survey suggests that ~90% of experts anticipate sustained adoption of decentralized trials in the near term. However, data protection and privacy remains a key obstacle in implementation for decentralized trials. This challenge is evidenced by a recent ransomware attack on global software company eResearchTechnology, which was facilitating ePRO for several COVID-19 trials at the time. Data security concerns will likely remain paramount to industry stakeholders decision-making around decentralization of endpoint data collection (e.g., ePRO) to decentralize in the future.
TLDR: CEOs and leaders of digital health think tanks, venture capital funds, and start-ups believe a Trump victory in next week’s election could hold detrimental consequences for the digital health space. Among these are: (1) dismantling of the Affordable Care Act, which could threaten ~30M Americans’ coverage, valuable contracts with health plans on individual exchanges, and more broadly, innovation in a potentially unstable regulatory and payment landscape; (2) concomitant dismantling of the Center for Medicare & Medicaid Innovation (CMMI), which could be detrimental efforts to reform payment mechanisms (e.g., value-based care models); (3) threats to patient privacy and protection under policies resembling “consumer protection” rather than “patient protection”; (4) despite existence of bipartisan support for telehealth (most notably from Trump’s CMS Administrator Seema Verma), rollbacks on payment parity for virtual care in favor of treating the “patient as consumer” under a “free market” that relies on digital health companies to cut costs to remain competitive (proponents of this argument believe that a Biden administration’s public option could be used to exert competitive pressure on commercial payors to maintain parity coverage); and (5) continued failure to address systemic access and equity issues in connectivity, digital infrastructure, and social determinants of health, which drive up to 80-90% of clinical outcomes.
So what? Market mechanics and policies aside, fundamental differences in the two candidates’ political philosophies create two diverging paths into healthcare’s digital future. While Trump’s HHS, CMS, and FCC appointees have pushed innovation in telehealth and information blocking — two significant and welcomed changes in the space — his administration largely stands for deregulation and the “status quo” of healthcare in terms of how equitably it distributes. Biden’s nomination, on the other hand, was won on the back of promises of healthcare reform that stresses improved access for low-income and rural Americans, key populations for which digital modalities offer such advantages and potential to improve and equalize clinical outcomes. It’s for this reason that we have chosen not to remove “politics” from business and remind our readers to vote, and to vote for a future that brings the digital health space closer to improving outcomes for all.
TLDR: CMS has added 11 new codes to the list of ~135 reimbursable Medicare telehealth services the agency has brought online for the duration of the public health emergency. These new codes largely focus on rehabilitation and chronic care, including cardiac and respiratory monitoring and analysis of implanted neurostimulator patient data.
So what? While private payors appear likely to cease parity reimbursement for telehealth, which has largely contributed to this year’s telehealth boom, CMS is doubling down to expand its suite of covered telehealth procedures. Though coverage is currently only approved for the duration of the public health emergency, CMS Administrator Seema Verma has continued to describe CMS’ foray into telehealth as a “genie” that is “not going back in the bottle”. In addition the the Medicare code expansion, CMS plans to provide additional support to state Medicaid and CHIP programs, which saw a 2,600% spike in utilization of telehealth services from March to June. CMS’ code additions for chronic care data analysis and patient management align well with market activity (e.g., TDOC’s acquisition of LVGO) and early data demonstrating potential cost- and time-savings, as well as improved patient experience and interest in continued telehealth-based management. However, if the telehealth boom is to extend beyond the pandemic, commercial payors will need to follow suit.
TLDR: Formed in 2018 as a joint venture between Comcast and Independence Blue Cross, Quil Health aims to provide healthcare assistance through consumer tech (e.g., laptops, smartphones, TVs). Its first product, Quil Engage, helps patients prepare and recover from surgery through an engagement app with educational content, paired with in-home motion sensors and smart devices to monitor patients post-op. Its newest platform, Quil Assure, offers an integrated sensor-based technology platform that allows users to connect with their clinical care team and caregivers from home. The platform leverages a smart network of in-home, ambient sensors that monitor movement and send real-time alerts, while a voice-enabled speaker allows caregivers to check in.
So what? Dubbed the “silver tsunami,” the growing population of seniors in the U.S. (currently >55M) drives increasing demand for remote monitoring solutions that support aging-in-place. Just this week, Deloitte announced plans to roll out a new Hospital at Home platform focused on remote care for seniors and patients with chronic disease. Merely a year after launching, Quil has already demonstrated value with its Engage platform, which has driven a 14% reduction in length of stay and 26% reduction in readmission rates for users. The remote monitoring market provides an attractive opportunity for digital health companies to align incentives and demonstrate value across key stakeholders (e.g., payers as customers, providers and patients as end-users).
TLDR: Twentyeight Health, named after the average length of a menstrual cycle, just raised $5.1M in seed funding last week. Founded in 2018, Twentyeight Health aims to enable women who are underinsured or on Medicaid to access birth control (though they accept all major insurance plans). Its service facilitates teleconsultations with physicians, access to over 100 FDA-approved birth control options, and rapid shipment of products with $0 copay for insured women. For women who are uninsured and not able to pay OOP, the startup struck up a partnership with Bedsider’s Contraceptive Access Fund to provide free birth control. Twentyeight Health is currently available in 6 states (NY, FL, MD, NJ, NC, PA), where it is the first and only tele-reproductive health company to accept Medicaid.
So what? The telemedicine market continues to see players specializing in therapeutic areas. Twentyeight Health joins a growing list of players focused on reproductive health (e.g., Hims and Hers, Nurx, PillClub). In the U.S.,~60% of reproductive-aged women (i.e., 40M women) are covered by Medicaid, underinsured or uninsured, yet Twentyeight Health is the first to focus its services on these populations. Founder Amy Fan notes that Twentyeight Health’s Medicaid-driven business model brought scrutiny from potential investors who view the Medicaid and underserved populations as the domain of non-profit organizations rather than for-profit companies. Twentyeight Health combats these challenges by tapping into the existing funding for preventative care services already offered under the ACA. Their recent seed funding is evidence of initial success, as the startup aims to use the funds to expand their services across the U.S.
TLDR: Yesterday, IBM unveiled its digital blockchain-based platform for patient-driven health data management and sharing. Digital Health Pass’ initial use case will be COVID health status (e.g., test results, vaccine status, temperature scans, other related health data). Patients will be able to import new results via QR code onto their encrypted digital wallet and share their information without exposing their underlying data.
So what? IBM isn’t the first to target the “digital passport” — CommonPass, backed by the World Economic Forum and now U.S. Customs & Border Protection, is the leading solution that has now entered real-world “trials” by United Airlines and Cathay Pacific. Preceding CommonPass, the International Chamber of Commerce (ICC) debuted its AOK Pass platform in June. And at HLTH this morning, Mayo Clinic also launched its HealthCheck “digital health passport” platform in collaboration with Safe Health, which will additionally target STI health status as a key market application. “The future of virtual care includes on-demand diagnostic testing, including the tracking of lab results and proof of vaccine administration in support of the post-COVID-19 “new normal,” said John Halamka, president of Mayo Clinic Platform. Considering the controversial reception of Apple & Google’s API exposure notification platform, digital passports should expect to be met with adoption challenges and sharp scrutiny over data management and privacy practices. However, they stand to pave the path forward for interoperable, patient-owned health data solutions that may radically transform healthcare.
TLDR: Rideshare giant Lyft has teamed up with EHR giant Epic to integrate non-emergency medical transport (NEMT) ordering into healthcare providers’ Epic systems. NEMT programs are designed to improve healthcare access (esp. for preventive care) and follow-up with patients for whom transportation to and from visits poses a financial or physical barrier. In the last 2 years, Lyft has grown its footprint in NEMT, striking contracts with Medicaid to cover ~20% of its beneficiaries and publishing outcomes on reduced ER and ambulance utilization and improved HEDIS measures for health plans.
So what? Prior to this deal, clinicians would typically need to sign into a separate IT system to order patients a rideshare. While perhaps seemingly trivial, the added efficiency of in-EHR, “one-click” ordering may drive significant behavior change — both in utilization frequency for existing Lyft-ordering clinicians and new utilization among (perhaps older) doctors still ordering alternative modes of transportation (e.g., taxi) for their patients (by analogy, consider how integrated EHR ordering of genomic hereditary cancer tests has driven increased awareness and ordering among PCPs). Unsurprisingly, rideshare competitor Uber has also made moves to capture some of Medicaid’s $2B+ annual spending on NEMT. Although acknowledged by CMS as part of an important strategy to address social determinants of health (SDOH), the NEMT program has drawn criticism over fraudulent and wasteful spending, perhaps unsurprisingly from the Trump administration.
TLDR: Cigna’s relatively new subsidiary for health services, Evernorth, took over management of Cigna’s Express Scripts’ digital health formulary, and has added 8 new digital health solutions onto its 2021 formulary — (1) Wildflower Health (women’s health), (2) Quit Genius (smoking cessation), (3,4,5) Hinge Health, Omada MSK by Physera, and RecoveryOne (in-home physical / musculoskeletal therapy), (6) Prevail Health (caregiver support), and (7) Buoy Health (COVID symptom AI chatbot).
So what? Digital health formularies are growing in number and breadth of indications addressed, helping legitimize clinically validated digital health solutions and drive their adoption among large, self-insured employers and care management programs. These solutions add to Evernorth’s 5 existing solutions (Livongo, Omada, Propeller Health, SilverCloud Health, and Lifescan). Formularies can serve as an effective channel for evidence-based digital solutions to drive adoption at-scale while steering clear of the complicated CMS and commercial payor reimbursement pathways. Take Livongo for example, whose record-setting ~$100M Q2 2020 revenues (up 125% YoY), was largely driven by 4 new contracts with Fortune 100 companies. Livongo, included on the Evernorth formulary, reported in Q2 that ~20% of clients now utilize more than one Livongo solution (diabetes, hypertension, weight management). While previously focused on diabetes and cardiovascular disease solutions, Evernorth’s formulary now stretches into new therapeutic areas with high clinical need that have seen less flashy success to-date.
TLDR: Telehealth and pharmacy services startup Hims & Hers joins the growing list of digital health companies going public this year. Hims & Hers is set to merge with Oaktree Acquisition Corp. in a blank check deal that will bring the combined company an estimated $330M upon closing. This nontraditional approach to going public by merging with a special purpose acquisition company (SPAC) allows Hims & Hers to mitigate volatility with the IPO market.
So what? Hims & Hers offers a subscription-based platform directly to customers, with an estimated subscriber base of 260,000 as of June 2020. Hims & Hers positions itself as an increasingly end-to-end solution for telemedicine and pharmacy fulfillment services. Last year, the startup launched an in-house pharmacy fulfillment center in Ohio. Earlier this year, the startup accelerated time from medication order to delivery through partnership with digital pharmacy Alto. Hims & Hers has conducted 2 million telehealth consultations and provides access to more than 50 health and wellness products. With its blank check deal, Hims & Hers aims to expand into new product areas and serve as a “the digital front door” to the healthcare system.
TLDR: Founded in 2015, DivvyDose is a home-delivery pharmacy focused on patients with multiple chronic diseases. Though the finances have not been released, the deal is estimated to be worth $300M. Similar to competitor PillPack, DivvyDose ships medication to customers in easy-to-use packages organized by day with dosage details and timing instructions. The acquisition will allow UnitedHealth members to access DivvyDose’s virtual pharmacy and prescription delivery services. DivvyDose is not UnitedHealth’s first digital health acquisition, after scooping up online patient engagement platform PatientsLikeMe last year and virtual behavioral health company AbleTo earlier this year.
So what? The digital pharmacy space has seen growing acquisitions and funding activity over the past few years. While health plans eye digital pharmacies to improve chronic disease management and lower costs, retail giants aim to grow their customer base and increase stickiness. Amazon acquired PillPack in 2018, which has since partnered with Blue Cross Blue Shield of Massachusetts. Earlier this year, Walmart followed suit in acquiring prescription management tech startup CareZone. Digital pharmacy startups with growing funding include Alto Pharmacy (~$350M), Capsule
(~$270M), Truepill (~$115M), Genius Rx (~$70M) and NimbleRx (~$60M). Several are partnering or expanding telemedicine capabilities to round out end-to-end solutions for prescription access and medication delivery.
TLDR: As of October 1, the U.S.’ two largest private insurers, United and Anthem (collectively cover ~90M lives), have ended full coverage of (i.e., copay-free) non-COVID virtual visits. Neither company has provided clear guidance on their updated cost-sharing structure, although United has mentioned on its website that patients can expect to pay ~$50 or less for a virtual visit.
So what? There’s no doubt that COVID has revolutionized the way payors, patients, and providers think about telemedicine. As of August, 36% of Americans have had a virtual visit, up from just 11% in January. And at the peak of the public health emergency in April, Epic reported that telemedicine comprised ~70% of all ambulatory care visits, up from <0.01% pre-pandemic. However, as pandemic management has improved, we’ve begun to see a snap-back in the telehealth boom as some visits converted back to traditional, in-person ones (also likely due to an increase in top-line visit volume from suspected COVID cases). Layered onto this snap-back is the risk that reimbursement rollbacks exacerbate patient confusion and concerns over out-of-pocket costs for telehealth visits, a key barrier to patient utilization. While enthusiasts have harkened the arrival of the “age of telemedicine”, coverage rollbacks at United and Anthem’s scale could significantly lengthen the timeline to “crossing the chasm” to sustained widespread adoption. Meanwhile, CMS and several private insurers including Aetna / CVS Health and the Blue Cross Blue Shield Association (collectively, >200M lives covered) have extended waived coverage through the end of the year, after which policy modifications may be reassessed.
TLDR: After filing to go public at the end of August, GoodRx’s IPO began trading last week. GoodRx sold 34.6 million shares at $33 each, exceeding its target range of $24-$28 per share. Founded in 2011, the startup is rooted in price transparency for prescriptions and enables consumers to access their medication at the lowest prices. As opposed to most digital health companies that have entered the public market, GoodRx has been profitable since 2016 and continues to report strong revenue growth through 2020. GoodRx’s prescription offering generates the vast majority of its revenue, drawing fees from pharmacy benefit managers (PBMs) when individuals submit GoodRx codes to fill prescriptions.
So what? GoodRx joins a growing list of digital health IPOs this year, including One Medical, Accolade, Schrodinger, GoHealth, Amwell and Outset Medical. GoodRx’s IPO is further evidence of a sustained digital health IPO boom, as numbers for 2020 catch up to those seen in 2019. Looking ahead, GoodRx sees telemedicine as a key growth driver. Last year, GoodRx acquired telemedicine company HeyDoctor to expand into virtual care services. This acquisition pushed GoodRx upstream in consumers’ prescription medication journey, facilitating virtual consultations for diagnosis and prescribing therapy. GoodRx now competes more directly with companies merging virtual care and pharmacy services, including Hims, which is allegedly eyeing IPO prospects as well.
TLDR: Last week, Best Buy announced Lively Flip, a flip phone for seniors to connect with loved ones and healthcare services alike. The Lively Flip offers voice capabilities enabled by Amazon Alexa, including telehealth access. Best Buy Health plans to offer several pricing models for its add-on health and safety packages, with the most basic starting at $19.99 per month. The Urgent Response feature, for example, provides 24/7 access to doctors and nurses and is included in preferred or ultimate health and safety packages.
So what? Best Buy set its sights on healthcare as key to its growth strategy last year, when their CEO announced plans to reach 5 million seniors through in-home health monitoring by 2025. Best Buy joins the ranks of retail giants edging into the healthcare space, following suit to Walmart and Amazon in telehealth services. Last week, Walmart’s Sam’s Club announced plans to offer $1 telehealth visits to members through a partnership with virtual primary care provider 98point6. Amazon Care continues to push into telemedicine as it rolls out virtual care for employees in Washington state over the coming months.
TLDR: Google implemented a COVID-19 filter for its maps application, which has billions of users worldwide. The filter provides seven-day averages of new cases per 100,000 population and key trends around infection rates. Several key sources will provide data to fuel the app at the city, state and provincial levels, including The New York Times, Johns Hopkins and Wikipedia. Google will offer this feature across all countries and territories supported by Google Maps.
So what? The Google Maps update comes amid Google’s continued efforts to deploy its contact tracing system, developed in partnership with Apple. Earlier this month, Google and Apple attempted to streamline user enrollment through recent software updates to Apple and Android smartphones. The update provides “Exposure Notifications Express” capabilities, which sends notifications to device users in participating states with the option to opt into the contact tracing system. Consenting users are then enrolled in the feature without needing to download any app developed by public health agencies, which intends to significantly lower barriers to participation. Virginia was the first state to roll out a contact tracing app based on the Apple-Google framework. Since launching the app in August, nearly half a million people (~6% of the state’s 8M population) have downloaded the app. Research on adoption rates needed for contact tracing to be effective range from 10% to 60% of the population, though continued adoption and impact in the U.S. remains to be seen.
TLDR: Apple debuted its Series 6 watch last week, which comes with a blood oxygenation sensor. The sensor uses LED light and photodiodes to analyze the light reflected from blood, then its algorithms determine a blood oxygen level within 15 seconds. The watch can measure levels on demand by users, and also capture routine measurements passively in the background. Experts speculate that daily measurement of blood oxygen levels may not be actionable for healthy people, whose levels are typically in the 90-100% range. However, blood oxygen levels are particularly relevant for individuals with chronic conditions like asthma, heart disease and COPD, or with acute respiratory infections, where blood oxygen levels may fall to 60%.
So what? In contrast to its early incorporation of ECG capabilities, Apple is a fast-follower to Fitbit and Withings when it comes to blood oxygen sensors. Apple adds blood oxygen to a growing list of healthcare features offered by the watch, including the ECG app and fall detection feature. Apple has launched three clinical studies to validate its latest feature. The studies span relevant therapeutic areas, from asthma to heart failure to early detection of infectious respiratory conditions (e.g., flu, COVID-19). The asthma study even involves a collaboration with Anthem, and aims to determine if the Apple Watch could improve disease management and reduce emergency hospitalizations. In addition to the watch, Apple continues to make headlines with its increasing healthcare activity, including a national health initiative partnership with Singapore and an expanded partnership with the VA to increase telehealth access for veterans.
TLDR: Sharecare’s virtual health platform allows its users to manage their healthcare and digital health tools from one place. Sharecare has developed content on many health topics, curated in collaboration with leading healthcare providers and academic institutions. Through its latest partnership with Amazon, Sharecare will integrate its library of over 80,000 health Q&As into the Alexa voice service, adding to the repertoire of health information offered by the virtual assistant.
So what? Amazon Alexa has been launching medical skills since it gained HIPAA compliance last year, allowing the voice assistant to securely transmit and receive health data. Experts estimate that >19 million people in the U.S. use voice assistants to answer questions related to their health, and >25% of Americans (~80 million people) own a smart speaker. Amazon Alexa offers the installed base to distribute health information while also capturing de-identified data around users’ health journeys, potentially leading to the discovery of vocal biomarkers for disease detection. Looking forward, Amazon’s potential to discover vocal or combined vocal-digital biomarkers is further bolstered by its Halo wearable and service, announced last month.
TLDR: Last week brought IPOs from two digital health companies, telemedicine provider Amwell and at-home hemodialysis company Outset Medical. Amwell raised $742M for ~40 million shares, with unexpectedly high pricing of ~$18 per share, while Outset Medical raised $278M for ~10 million shares, closing at ~$58 per share. Amwell and Outset Medical join a growing list of public offerings in digital health this year, including One Medical, Accolade, Schrodinger and GoHealth.
So what? This year’s numbers are quickly catching up to 2019’s digital health IPO boom, in which five companies went public. A few notable digital health players are also preparing for IPOs in the coming months, including GoodRx, Hims & Hers, MDLive and Oscar Health. Among them, GoodRx is uniquely positioned as one of the only digital health companies going public that is currently profitable, with some IPO estimates near $1B. The sustained wave of digital health startups seeking IPOs suggests a maturing marketplace in the midst of a pandemic that continues to expose flaws in the healthcare system.
TLDR: The pharma giant and prescription DTx company plan to jointly develop and commercialize a digital therapeutic for schizophrenia. The DTx will take the form of a mobile app built on Click’s platform, using cognitive mechanisms to drive behavioral changes. Boehringer Ingelheim will gain exclusive global rights to the novel treatment through payments for upfront R&D, led by Click, and later regulatory and commercial applications. The companies aim to validate the app-based DTx through clinical trials and eventually gain regulatory approval, either as a standalone treatment or combination therapy, potentially even paired with BI’s own pipeline compounds for schizophrenia.
So what? The deal comes on the heels of an up-and-down year for digital therapeutics. Several pharma-digital partnerships ended (e.g., Novartis/Pear, Sanofi/Onduo), while DTx pioneer Proteus filed for bankrupcy and was acquired by Otsuka for $15M, despite a former valuation of $1.5B. Despite these key failures, recent acquisitions (e.g., Novartis/Amblyotech,
Biofourmis/Gaido) and FDA approvals (e.g., Akili, etectRx) have bolstered the DTx space. Last year, Click Therapeutics landed a ~$300M deal with Otsuka, aimed toward developing a DTx for major depressive disorder. Structured similarly to its new partnership with BI, this deal is still ongoing and includes $10M in payments from Otsuka to support Click’s upfront R&D and regulatory efforts, though the DTx does not yet appear to have entered clinical trials.
TLDR: Fitbit’s latest generation Sense smartwatch has gained FDA and CE approval for its ECG app, ahead of launch in the U.S. and EU next month. The ECG app will allow users to take a 30-second, single-lead ECG reading, which can help to detect cases of atrial fibrillation. Fitbit initiated a large-scale heart health study earlier this year, aimed toward detecting irregular heart rhythms with its more basic PPG heart rate tracking technology, used across Fitbit wearables. Fitbit’s study comes four years after Apple launched its Heart Study, which enrolled almost 420,000 participants. Fitbit’s study has already enrolled 400,000 participants since May, and has the potential to unlock a-fib detection across Fitbit’s smartwatch product line in the future.
So what? Fitbit follows Apple and Samsung as the third smartwatch in the U.S. with an FDA-cleared ECG app. Fitbit’s Sense smartwatch also includes sensors for skin temperature and electrical conductivity, which help to measure stress levels. In conjunction with activity and heart rate data, temperature data may pose an opportunity for Fitbit to build algorithms for screening conditions beyond heart arrhythmia. Fitbit launched a study with 100,000 participants earlier this year, looking toward early detection of symptoms associated with COVID-19 and flu. Fitbit may eventually follow suit to Apple in launching a women’s health study, leveraging new temperature sensors and its existing ovulation tracking platform.
TLDR: Digital pharmacy and API startup Truepill just landed $75M in Series C funding, merely two months after closing its $25M Series B round. Truepill’s B2B business model focuses on health plans, pharma companies, and DTC health brands as customers for its patient-facing platform and pharmacy fulfillment services. Truepill’s API-connected infrastructure provides patients with access to telehealth services, pharmacy fulfillment, and a custom-built EMR. With its latest funding, Truepill plans to expand this ecosystem by launching an at-home lab testing service this fall. This service will include hundreds of at-home lab tests focused in diagnosing and managing chronic disease (e.g., diabetes, heart disease, kidney disease), leveraging third-party lab partners for testing.
So what? Combining at-home lab testing with telehealth and digital pharmacy services will allow Truepill’s customers to serve their patients with an end-to-end chronic disease management solution. As the COVID-19 pandemic continues to push the boundaries of traditional in-person care, at-home testing has become an increasingly important trend in the digital health space. A few of Truepill’s customers have already launched at-home test kits for infectious diseases, including Nurx STI tests and Hims & Hers COVID-19 Test. Key companies offering at-home testing for chronic diseases currently focus on risk factors, such as Everlywell’s Heart Health Test or LabCorp’s Lipid Panel and Diabetes Risk Test. Truepill is well positioned to differentiate its at-home test offering by facilitating routine testing for disease management, while addressing adjacent care and prescription needs.
TLDR: GoodRx, a patient-facing solution for prescription drug price transparency and discounts, has filed for IPO following its third consecutive year of profitability, a rarity among prior exits in digital health. GoodRx’s H1 2020 profits ($55M on ~$260M total H1 2020 revenues) are up ~75% YoY, which is no anomaly for the company who has been “on and off profitable” since 2013. GoodRx’s monetization strategy involves collecting fees from pharmacy benefits managers when its ~17M patient users purchase drugs using GoodRx discount codes, and the company is now exploring opportunities to play in telehealth. On the telehealth side, Amwell (formerly American Well) has also filed for IPO following a $100M raise from Google (bringing total funding over $900M) and Teladoc’s (TDOC) recent $18.5B buy of “AI+AI” chronic care company Livongo. Considered Teladoc’s biggest competitor, Amwell works with 55 health plans to cover 80M lives.
So what? We expect GoodRx’s IPO to serve as a launching point for deeper strategic expansion into telehealth and secondary revenue opportunities (e.g., the $30B TAM for pharmaceutical manufacturer solutions). GoodRx’s 2019 acquisition of HeyDoctor began enabling virtual consultations, prescription refills and patient self-education regarding medications. We expect GoodRx to use its IPO tailwinds to continue carving out its lane in telehealth. The Google and IPO cash infusions for Amwell are expected to fuel strategic development and help remain competitive with Teladoc’s rapidly evolving platform, with Amwell’s recent Google Cloud partnership perhaps offering a glimpse into the company’s nearest-term goals. The partnership aims to migrate video capabilities and leverage Google’s AI/ML and natural language processing capabilities to transform patient intake / management and patient experience. For reference, we’ve summarized Amwell vs. Teladoc head-to-head below.
TLDR: Last week, Amazon unveiled its multi-sensor, screenless Halo Band wearable, set to enter the market at ~$70 including a 6-month subscription to Amazon Halo services. Halo Band is currently a consumer-grade wearable, as opposed to Apple and Samsung’s watches with FDA-cleared ECG capabilities (Fitbit still awaiting clearance). While Halo Band will incorporate core existing wearables features like activity and sleep tracking, Amazon consciously sought out a few points of differentiation. Halo Band will uniquely feature body fat percentage (BFP) scanning, vocal tone analysis for emotional health monitoring, and intensity and duration-weighted activity goals (e.g. compare to other wearables’ step-counting).
So what? The historically consumer health-oriented wearables space has transformed into an arms race between tech giants aiming to offer medical-grade wearables. In the past year, Apple and Samsung successfully received clearance for the space’s “foothold” medical application — passive ECG monitoring for a-fib detection. While Fitbit awaits clearance and Amazon is newly entering the space, it’s undeniably that all of these giants have their sights set well beyond ECGs, including digital biomarker signatures for presymptomatic and asymptomatic SARS-CoV-2 diagnosis, passive mental health monitoring a la Mindstrong Health (e.g., Amazon Halo tone analysis + activity / sleep monitoring), and pre- / post-surgical behavior monitoring and modification. These applications may represent just the tip of the iceberg for what we may see roll out in the coming years, catalyzed by heightened firsthand consumer experience and adoption of digital health technologies during COVID.
TLDR: After Pear’s landmark FDA pre-cert clearance in March, the company launched an open-label clinical trial for patients with insomnia and comorbid insomnia-depression, along with two studies on the precursor solution before Somryst’s clearance. New data from one study (N=1,149) on that precursor shows validating efficacy after 9-week treatment, including improvement in sleep-onset latency, wake after sleep onset, total times woken, sleep efficiency, sleep quality, and total sleep time. The second study (N=151) focused on measuring longitudinal patient engagement, from which researchers were able to develop an algorithm for predicting treatment dropout with an AUC of up to 0.9.
So what? The post-clearance (technically, “post-certification”) validation data corroborating Somryst’s efficacy and safety serves as a positive initial indicator for the FDA’s pre-cert program, which has drawn a fair deal of skepticism. Pear’s continued prospective data collection and validation additionally shows commitment to agile development / iteration of its “cleared” therapeutic based on novel patient-level data. Researchers identified several key indicators of intervention dropout, including average time to complete a treatment module, number of email support messages sent, and time to get out of bed after waking. These type of proactive, post-clearance real-world data studies focused on efficacy, safety, and engagement / utilization are key success factors for the FDA’s pre-cert program that may continue generating confidence in fast-tracked SaMD solutions.
TLDR: In a merger of two digital health industry veterans, Teladoc will acquire 58% of Livongo in Teladoc shares, plus $11.33 cash per share. The new giant, colloquially dubbed “Telavongo”, set a record high for digital health valuations, comprising over 40% of total VC funding in digital health since 2011 and dwarfing the ~$375M average M&A price for acquisitions made by digital health companies. The combined company’s telemedicine virtual visit and applied health signals patient engagement platforms are expected to bring in $1.3B in total revenues this year.
So what? The deal has clear benefits for both parties. For Teladoc, the deal offers potential differentiation from other leading virtual visit providers (e.g., AmWell, Doctor on Demand) and the tidal wave of “novel” (yet fairly commoditized) market entrants. Connection to Livongo’s AI+AI chronic disease management solution may provide added sticking points for patient retention, a key challenge for virtual visit companies. For Livongo, incorporation into Teladoc’s network offers an opportunity of enormous scale to distribute its solution with Teladoc’s massive registry of virtual providers and to more readily expand into new disease areas. As Livongo Founder Glen Tullman puts it, “One of the really exciting synergies is to go after the 70 million people that Teladoc already has a relationship with, and have our collective doctors now say to people: ‘You’re having this issue? Here — we have a great solution for you.” The merged company’s end-to-end virtual visit and remote engagement solution is well-positioned to evolve into a digital care ecosystem of its own that extends beyond chronic care. One thing is for certain — virtual visit and chronic care management competitors have their work cut out for them, and the largest of them will likely be looking for opportunistic acquisition opportunities of their own to keep pace with “Telavongo”.
TLDR: Virginia Department of Health launched COVIDWISE last week, the first contact tracing app built upon Apple and Google’s Exposure Notifications API. The free app leverages Bluetooth technology to trace exposure to individuals with positive COVID-19 test results. Bluetooth tracing aims to mitigate privacy concerns by not collecting actual GPS data, but is fraught with potential inaccuracies to COVID exposure assessments. The Department of Health must confirm positive test results for users through a PIN, which allows the notification system to ping users who may have been exposed to infected individuals. Success of the app in reducing COVID infection rates primarily hinges on downloads and use by Virginia’s population, which remains to be seen over the coming weeks.
So what? Six months and nearly 5 million cases into the COVID pandemic, the need for tools to reduce infection rates is increasingly dire. Other states have released contact tracing apps outside of the Apple-Google API system, which have been met with varying degrees of success. In May, Utah launched the Healthy Together app which combines GPS and Bluetooth data and allows public health workers to access location tracking data and contact exposed individuals. North Dakota also launched its Care19 app in May, but only saw 4% adoption by the end of June due to privacy issues with real-time GPS tracking. Virginia marks the first state to adopt the Apple-Google Bluetooth-only system, and will likely be a key litmus test for the privacy-conserving design, informing other states’ decisions to follow suit in the future. Adoption of contact tracing will likely continue to unfold at the state level, as there do not appear to be any plans for a nation-wide government-sponsored tracing and notification system.
TLDR: Cerner’s ~$6M investment in Providence-St. Joseph Health spinout Xealth comes with plans to bring their digital health prescription platform to Cerner’s EHR and patient portal. Xealth’s platform supports 30+ digital health programs, with applications spanning from chronic disease to behavioral health support to maternal care. Clinicians can use Xealth to seamlessly integrate, prescribe and monitor digital health tools used by patients through their EHR. With an EHR market share of ~25% in the U.S., Cerner is an ideal partner for Xealth to scale their platform and lower barriers to digital health adoption through centralized, easy access to key solutions.
So what? As the digital heatlh field a growing pool of digital health players attempt to address care gaps in the pandemic era, scalability is more important than ever. Cerner’s investment points to the importance of scalability, as Xealth’s platform provides digital health at scale through its centralized, pre-vetted library of digital health tools. Xealth is among a few key players in the digital health prescription space, including Mount Sinai spinoff Rx.Health, Kaiser Permanente’s Project Chamai for mental health, and UK NHS Apps Library. These players are well positioned to improve adoption of digital therapeutics and remote monitoring tools by reducing barriers to clinician prescription or recommended adoption by patients.
TLDR: A key trend before the pandemic, remote patient monitoring in oncology is more crucial now than ever to minimize in-person visits and help patients navigate treatment at home. Based in the UK, Careology offers patients and caregivers a mobile app to visualize their care plan, manage medication, record side-effects and keep track of key vitals through integration with health-tracking devices. Their latest product, Careology Professional, allows clinicians to monitor patients’ vitals (e.g., temperature, heart rate, blood pressure, weight, activity), therapy toxicities and medication adherence in real time. The tool also enables the care team to view patients at the cohort-level, in order to triage patient needs and reduce unnecessary adverse events.
So what? Careology’s product launch comes in the wake of Biofourmis’ acquisition of Gaido Health, Takeda’s AI-based RPM oncology solution, in April. Oncology RPM players are seeing emerging partnership interest from pharma (e.g., BMS-Voluntis, Merck-uMotif) and EMR providers (e.g., Varian-Noona, Cerner-Carevive, McKesson-Navigating Cancer, Elekta-Kaiku Health). Partnership activity revolves around collection of patient-reported outcomes (PROs), which are gaining traction as endpoints in clinical trials (e.g., quality of life), an emerging real-world data type, and a key trend in value-based care. Research increasingly suggests that symptom tracking and reporting can reduce ER visits and hospitalizations for oncology patients, resulting in improved outcomes and reduced costs to healthcare systems. In the UK and across Europe, value-based care is inherently incentivized based on national health systems. In the U.S., the CMS Oncology Care Model offers value-based payment for oncology practices based on improving outcomes relative to costs. The latest draft measures for the Oncology Care First Model would require implementation of electronic PRO capture under value-based payment contracts.
TLDR: Microsoft researchers developed a machine learning (ML)-based approach to defining cohorts of patients based on sustained engagement with digital cognitive behavioral therapy (CBT). Roughly 55,000 patients using SilverCloud Health’s 8-module CBT program for depression and anxiety were longitudinally assessed (~14 weeks) for level of engagement (i.e., use of any therapy module and use of each specific module in a given week) and clinical outcomes (e.g., PHQ-9 for depression, GAD-7 for anxiety). Researchers identified 5 cohorts:
So what? Digital health tools, and mental health ones in particular, have suffered from high user attrition and low levels of engagement (or consider the ~85% of patients in Classes 1-3). While the ultimate goal of these tools is to create added value that non-digital interventions inherently cannot achieve (e.g., continuous outcomes and engagement monitoring, dynamic therapies that adjust in real-time using monitoring data), the more immediate goal is to establish substantial equivalence to traditional interventions like in-person CBT. But successful outcomes evidence requires understanding user behaviors, drivers of patient disengagement, and how “Class 1-4” patients can be kept on-track so that they too demonstrate improved clinical outcomes. Deep characterization of these behaviors can inform development of CDx / CoDx-esque patient stratification and corresponding strategies for dynamically tailoring DTx content, logic, and engagement points (e.g., notifications, clinician outreach).
TLDR: Proteus recently declared bankruptcy after a failed partnership with Otsuka to expand Proteus’ ABILIFY MYCITE medication adherence-tracking solution, among other challenges (see Vol. 23). Former partner, Otsuka, has now placed a $15M “stalking horse” acquisition bid that will set a valuation floor for other bidders interested in scooping up the fallen unicorn. Bidding will close on Aug 4, with an auction on Aug 6.
So what? After over 20 years of pioneering the digital health space, Proteus developed a wide portfolio of research and technologies extending beyond medication adherence tracking — one of the key reasons we believe they failed. That being said, there appears to be an interesting potential acquisition opportunity for other pharma or DTx companies looking to expand their digital capabilities who are willing to pick up and repurpose Proteus’ many pieces. In any case, we’d be surprised if no challengers emerged for a >$50M bid and are anxious to see how the incorporation of Proteus’ tech assets unfolds in the coming year.
TLDR: Conceived as a health record concierge service, PicnicHealth collects and aggregates health record data on behalf of individuals looking to track down their past records, stored in siloed EMR systems across disparate care sites. PicnicHealth leverages ML algorithms trained by manual curation to structure medical record data across unstructured notes and reports, including MRI images. After collecting retrospective medical record data, PicnicHealth sustains patient utilization and data capture as a medical record management platform. Picnic’s partnership with Roche and Genentech aims to support accelerated R&D efforts for MS treatments based on real-world data for 5,000 MS patients, including 7 years of retrospective data and 5 years of prospective data. The partnership is set to scale toward neurology, hematology and rare disease (e.g., Huntington’s disease) in the future.
So what? The Roche-PicnicHealth partnership is one of a growing string of investments by pharma in the real-world data space, and aligns with Roche / Genentech’s first digital health moves in multiple sclerosis with Floodlight Open. Roche’s $2B acquisition of Flatiron in 2018 set an industry standard for the tremendous value associated with real-world data in the eyes of big pharma. Several pharma partnerships (e.g., Amgen-Syapse, Novartis-Cota, Sanofi-Aetion, BMS-Concerto HealthAI) have emerged over the past few years, aiming to leverage real-world data across the drug lifecycle, from discovery to clinical trials to label expansion. Existing partnerships and the Roche-PicnicHealth engagement point to longitudinal data capture and analysis of unstructured data fields as key differentiators of RWE players. These differentiators will likely continue to drive pharma partnerships, based on pharma’s vested interest in discovering valuable insights around disease progression, treatment history and clinical outcomes.
TLDR: Vitls, a Houston-based start-up launched by a husband-wife duo looking for an improved RPM solution for their son with febrile seizures, received FDA approval for its Tégo vitals monitoring patch. The disposable adhesive patch measures heart and respiration rates, heart rate variability, body temperature, and blood oxygenation (SpO2) and has a 6-day battery life. Vitls plans to commercialize their technology in Q3.
So what? A growing number of RPM players are riding the wave of attention, funding, and eased regulatory scrutiny for RPM technologies to meet the COVID-generated need. As simple digitized / remote reporting of biometrics has won trust and broader acceptance from the public, RPM players have begun increasingly looking to incorporate multiple RPM / wearables-based biomarkers into digital signatures that may also be able to predict or detect early disease or add prognostic or monitoring value beyond simply enabling remote measurement of markers that could be read non-digitally. Accordingly, the RPM space, traditionally dominated by device manufacturers, has begun evolving to require applied analytics and multi-source integration capabilities to capture the larger share of the total addressable market. Among these emerging innovators are “integrated signals” companies like VivifyHealth, Validic, and Human API, which may look to bring device companies like Vitls into their platforms.
TLDR: Leveraging technology partner CloudMedx’s AI capabilities, Anthem has launched its C19 Explorer, C19 Privileged, and C19 Navigator COVID tracking and decision-making solutions for the public, government policy-makers, and Anthem employer groups, respectively. The solutions leverage aggregated public data (e.g., cases, test volumes, hospital bed / ICU utilization, economic performance) and proprietary data (e.g., Anthem claims / member data, level of “social mobility” / adherence to stay-at-home orders, scenario-based modeling outputs for staff and public testing thresholds required for public or workplace re-opening). See here for Anthem’s full webinar walkthrough of the tool.
So what? As COVID cases rapidly climb in states and locales attempting soft re-openings, local and state governments and employers have expressed urgent need for a broad toolkit of solutions that help aggregate, predictively model, and support decision-making for best-practices in managing future attempts at public and workplace re-openings. The Anthem tool provides open-source public information and education while opening a commercial revenue stream for the payor and opportunity to harvest utilization data to prospectively monitor government and employer decision-making.
TLDR: Last week, Rock Health published its midyear digital health funding report, tallying a record-setting $5.4B in funding and 51 M&As for the sector, despite the pandemic and expectations of an economic recession. This week, MobiHealthNews published its midyear summary of deals, profiling 35 M&As (note the discrepancy due to differing definitions of “digital health”). The list ranges from Teladoc’s $600M buy of InTouch Health to Healthy.io’s recent $9M acquisition of competitor Inui Health, and a handful of deals with undisclosed financials.
So what? Rock Health and MobiHealthNews’ funding and M&A data reinforces the now-hardly novel narrative that COVID was the catalyst for the revolution that digital health has been waiting for. Despite a gloomy macroeconomic outlook, record-setting exits continue to fuel investor optimism, which will hopefully bring novel solutions into the fray and provide existing start-ups with the starting capital they need to evolve product concepts and prototypes into MVPs. We’re optimistic that early successes for telehealth and remote monitoring solutions will translate into greater patient, provider, regulator, and payor awareness, trust, and support for other segments of digital health solutions.
TLDR: In mid-April, we wrote a blog post covering Apple & Google’s partnership to develop a “universal smartphone” COVID contact tracing API. The announcement was surrounded by hype and cynicism, and months later, governments worldwide have failed to implement digital contact tracing effectively. Oxford researchers have estimated that ~60% of a region’s population must enable a contact tracing app in order for it to be effective. In comparison, France and Italy’s nationally sponsored apps have drawn 3-6% uptake, and U.S. states like North and South Dakota who are leading digital tracing efforts have similarly accumulated low-single digit user bases. By contrast, South Korea and China have seen relative success bringing case counts down with digital tracing programs in-place, at the cost of reduced personal privacy. This leaves us wondering — what is the outlook for population-scale digital health solutions?
So what? Key adoption hurdles that digital contact tracing faces include privacy concerns, understanding of technology, and technology flaws. In the U.S., rising non-cooperation sentiment, ranging from indifference and fatigue to Trumpian “anti-mask”, “anti-social distancing” outcries have shot digital tracing apps dead in the water. Even among the rational, cooperating majority, fears and misinformation persist about what data is collected, how it can be used, and what the real privacy risks are. Of those that are aware of digital tracing apps and have a smartphone to enable access, a recent survey found that only ~40% support their use. The survey findings also suggested that respondents perceived no difference between Bluetooth and GPS-based approaches, despite explanation of the difference in data collected. Furthermore, ~30% of respondents believed that the app would identify and share infected individuals’ names with other users, even after receiving a “consumer-friendly” explanation of anonymized tokens. To make matters worse, studies have shown certain apps (e.g., Australia’s, UK’s) only work ~25% of the time, eroding trust in their efficacy. All this considered, our outlook is that digital tracing, while in its infancy, can be technically effective with multi-modal supplementation (e.g,. South Korea’s video surveillance and financial transaction tracking) and perhaps as a standalone approach in the mid-term future; however, greater public education and innovation of novel “trustable” approaches is needed for effective public uptake and buy-in in geographies with strong personal privacy fears.
TLDR: Evidation’s direct-to-patient, virtual research platform currently has 4 million users across the U.S. With its most recent funding, Evidation looks towards offering digital interventions and treatments through its virtual research app. Digital interventions will guide patients through care regiments and generate actionable insights that may be shared with providers. Though specifics around their “virtual therapy” play and target therapeutic areas remain unknown, Evidation notes that virtual health programs are set to launch later this year. Evidation also intends to expand its usership base across the U.S., particularly to capture at-risk or disease-specific populations.
So what? Evidation’s research platform aims to characterize the “behaviorome” by analyzing behavioral data in the context of health. Evidation has conducted over 50 studies to-date across chronic diseases, with a focus on neurodegenerative disorders and mental health conditions. Based on its existing data assets and research studies, Evidation is positioned to launch virtual interventions rooted in behavioral health. Recent FDA approvals in the DTx space attest to the opportunity for behavior-driven digital interventions, including Akili’s EndeavorRx for ADHD and Pear Therapeutics’ Somryst for chronic insomnia.
TLDR: The $1.3M deal aims to provide military couples with free access to MFB Fertility’s Proov at-home fertility tests. Earlier this year, MFB Fertility cinched FDA approval for Proov as the first at-home ovulation test that measures progesterone alongside LH levels. While other rapid test strip solutions historically rely on LH alone to predict ovulation, Proov’s tests are proven to confirm ovulation based on the urine metabolite of progesterone (PdG). Proov’s tests are accompanied by a mobile app, which tracks hormone levels longitudinally.
So what? Infertility affects >10% of couples in the U.S., and disproportionately impacts military families. The fertility space is becoming increasingly saturated with apps, wearables and biosensors aimed to equip women with information about their fertility and menstrual cycles. Key conditions that are linked to infertility (e.g., PCOS, endometriosis) currently have poor screening tools and high rates of misdiagnosis. Digital tools like Proov are well positioned to capture the longitudinal data necessary to develop digital biomarkers in women’s health, based on relevant metrics like cycle length, flow rate, body temperature, and hormone levels.
TLDR: The pandemic has spurred rapid adoption of telehealth and digital tools to meet healthcare demands under an extremely strained system. Pravene Nath outlines three key strategies for digital health companies to sustain success in a post-COVID world. Firstly, target underserved populations who truly need telehealth to access care, not out of convenience, but due to challenges like age, disability or remoteness. Secondly, measure and publish improvements in care quality achieved by digital tools like remote patient monitoring and chat-bots in order to drive recognition by payers and the government. Thirdly, prioritize patient needs and protect patient data, especially under currently relaxed HIPAA rules.
So what? In light of unprecedented growth, the digital health sector is in its best position yet to generate meaningful data and demonstrate value to the healthcare system. Sustained adoption of digital health solutions relies on continued uptake by payors, providers and ultimately patients. Pravene’s calls to action allude to the importance of addressing patient needs and demonstrating value beyond convenience in the post-COVID world. Digital health companies should continue to drive their value by addressing key weaknesses in the healthcare system, including efficiently collecting data and drawing actionable insights for customers across the ecosystem (e.g., patients, providers, payers, pharma, diagnostics, etc.).
TLDR: After spending nearly 20 years establishing the digital health market, with ~500 patents and a ~$1.5B valuation, Proteus Digital Health filed for Chapter 11 bankruptcy last week. In this podcast, HIMSS’ editors argue that Proteus’ major downfalls were: (1) overambitious scoping and pursuit of products across multiple digital health categories and therapeutic areas, (2) misaligned incentives and goals with former pharma partner Otsuka, (3) poor timing of leadership transitions, and (4) perhaps an inherent shortcoming of a medical device-based adherence tracking solution with high associated costs. With IP that may be worth more than any of Preotus’ pre-commercial products, it’s unlikely that the company draws a partner or cash to make a comeback. See last week’s newsletter for some context.
So what? Proteus’ major downfalls offer valuable “lessons learned” for other digital health start-ups. First, the old-school approach of constraining product development to solution segments or indications that can demonstrably generate revenue before expanding a portfolio should not be dismissed. Proteus had virtually no partnerships with other digital health companies because Proteus had aspirations to become an end-to-end solution provider and viewed others in digital health as competitors. Second, while digital health start-up / pharma partnerships have increasingly been criticized as “doomed to fail” mismatches, careful communication and alignment of goals and expectations and consideration of leadership transitions can help avoid partnership busts. Friction between Proteus’ need for rapid, large-scale revenue generation after spending nearly two decades as a “pre-revenue” company and a pharma partner’s typical metered, stepwise approach to product launches likely played a role in the partnership’s demise. Deal insiders have speculated that the coincidental timing of Otsuka’s U.S. R&D lead leaving the company may have also had a hand in the failure, similar to how Sanofi’s CEO change was a key piece in the Onduo partnership dissolution. Lastly, digital health innovators should work under the assumption that other modalities may be advantaged approaches to solving the same problem. In Proteus’ case, perhaps a pivot from the ~$1,600 Abilify MyCite sensing device (which could cost more than the drug itself) to include video- or AI-based adherence tracking (e.g., a la Wellth) could have been more successful. Despite its failures, it’s undeniable that Proteus’ early and sustained efforts in digital health played a key role in bringing digital health concepts and solutions into the lexicon of legislators and regulators.
TLDR: With more than 1,100 clinical trials disrupted as a result of COVID, biopharma companies have turned to virtual methods of recruiting, consenting, and monitoring trial participants to minimize derailed trials. Leading companies supporting this virtualization of trials are Evidation, Science 37, Medable, and Unlearn.AI. Similar to telehealth, digital health industry leaders and biopharma R&D directors believe virtual trial solutions will continue to play a significant role post-pandemic as patients and innovators reap the benefits of virtualized care and previously pie-in-the-sky digital “alternatives” enter mainstream healthcare conversations.
So what? The clinical trial engine has been notoriously slow to innovate. Biopharma companies have, somewhat sensibly, adopted an “if it ain’t broke, don’t fix it” mentality, avoiding the potential loss of time and R&D spend by disrupting the status quo of typical clinical trial formats. However, the system is broken. About 90% of clinical trials fail, with patient attrition due to scheduling and financial challenges cited as leading causes. The time and travel barriers gating clinical trial participation disproportionately affect working parents, Medicaid patients, and communities of color. Here, digital health again offers an accessibility advantage to traditional modalities of healthcare. While digital device access and literacy are by no means perfectly equitable, gaps are being closed by increasing smartphone ownership and connectivity in low-income populations globally and device subsidy programs (e.g., Apple Watch via trials). Thoughtful innovation that furthers virtualization of formerly in-person clinical trial procedures alongside advances in equitability of access to digital health tools is well-positioned to disrupt the age-old clinical trial paradigm.
TLDR: Since early March, 911 calls for emergency medical services (EMS) have dropped ~25% in the U.S., according to an Academic Emergency Medicine study that surveyed ~10,000 EMS agencies across ~45 states. However, EMS units reported increases in severe emergency events (e.g., cardiac arrests), as seen through the doubling of EMS-attended deaths in the period.
So what? These findings have a number of potential implications: (1) that sharply reduced strain on EMS agencies amid a pandemic, sustained even after Phase 4 re-openings of most states, may suggest efficacy of conversational AI / digital triaging, telemedicine / virtual visits, and remote patient monitoring (RPM) solutions in preventing unnecessary emergency calls and visits, (2) that concerns of contracting COVID while visiting a healthcare facility or concerns of burdening the system with non-COVID emergencies is resulting in discerning use of emergency services, (3) that avoidance of accessing emergency services is resulting in delayed, worse outcomes for patients who actually needed them. All three of these implications likely hold some truth, suggesting that any early progress we’ve made in innovation and adoption of “digital front door” solutions is not enough. Digital infrastructures must be simultaneously effective in reducing unnecessary healthcare costs / critical encounters and lowering barriers to basic assessment and effective (i.e., sufficiently “sensitive”, in diagnostic terms) triaging services. We’re optimistic that this is possible through built experience with virtual visits as a new norm, and continued innovation in RPM technologies that leverage patient behavior as a focal point for human-centered design.
TLDR: Two years and 10 clinical trials since its FDA submission, Akili Interactive earned the FDA’s first approval for a video game digital therapeutic (DTx). Akili’s EndeavorRx is a prescription-only DTx intended for children ages 8-12 with attention deficit hyperactivity disorder (ADHD) and has shown clinically meaningful improvement in gold-standard measurements of impairment severity, both as a standalone therapy and as an adjunct to traditional stimulant therapy. No significant adverse events have been reported to-date.
So what? Unprecedented adoption of telemedicine solutions during COVID has enabled remote consultations and biometric patient monitoring, whose impacts have been most notable in primary, chronic, and mental health care. The FDA’s first video game DTx approval expands the scope of current DTx formularies, helping close the digital loop between virtual doctor visits, diagnoses, treatment, and monitoring. Skepticism remains over digital therapeutics, particularly around their poor user engagement and attrition rates; however, developers like Akili, whose design team is headed by an ex-Star Wars art director and stacked with consumer gaming experts, believe that gamified treatment approaches that leverage psychology may help address these problems. Akili’s pipeline of future video game therapies focuses on autism, depression, Alzheimer’s (in partnership with Pfizer), and multiple sclerosis.
TLDR: Following $500+ million in funding, unicorn valuation, and FDA approval for its medication embedded sensor-patch device, DTx unicorn Proteus Digital Health filed for bankruptcy. Proteus and Otsuka garnered FDA approval for their jointly developed Abilify MyCite system, which combines Otsuka’s drug with Proteus’ ingestible sensor and wearable to treat schizophrenia. Earlier this year, Proteus and Otsuka terminated the partnership due to limited uptake by clinicians and patients with mental illness. Experts estimate the price of the generic drug itself was merely ~1% of the list price for the drug-device combination system (e.g., ~$20 for the generic vs. ~$1,650 for the system). Though drug adherence is a key unmet need in the mental health space, high prices without clear clinical outcomes and limited consumer interest have severely gated adoption by payers and clinicians, ultimately driving the bankruptcy filing.
So what? Proteus’ bankruptcy comes in the wake of an up-and-down year for digital therapeutics. Despite buzz of a pharma “DTxit” amid break-ups of key pharma-digital partnership (e.g., Novartis/Pear, Sanofi/Onduo), recent acquisitions (e.g., Novartis/Amblyotech, Biofourmis/Gaido) and FDA approvals (e.g., Akili, etectRx) have restored confidence in the DTx space. As a pioneer in DTx, Proteus’ initial success and recent burnout serves as a warning to all DTx players eager to convert funding hype into sustained clinical adoption. In developing and scaling their products, DTx players should look to demonstrate value to payers and prioritize the patient experience. Proteus has announced plans to shift toward oncology and infectious disease, where they hope to appeal to payers and deliver clinical outcomes. Meanwhile, Otsuka has acquired the license to use Proteus’ tech in developing mental health treatments and will continue to sell the Abilify MyCite system.
TLDR: Last week, the retail giant scooped up CareZone’s technology for medication management, including features that allow patients to scan insurance cards and drug labels to check coverage and set up home delivery. CareZone’s pharmacy logistics business was excluded from the deal, likely due to ongoing litigation with Cigna’s Express Scripts PBM. An insider to the deal suggested that Walmart paid $200 million.
So what? It’s no secret that Walmart has been closely watching Amazon, CVS, and Walgreens’ strategies in the retail primary care space. In 2018, Amazon acquired PillPack ($753 million) to build out its digital “Amazon Pharmacy”, and has since piloted telehealth primary care and digital symptom checking offerings to its employees. CVS is on-target to open 1,500 HealthHUB primary care centers by the end of 2021, and Walgreens is rapidly ramping up primary care infrastructure via its partnership with VillageMD. In the past couple years, Walmart inked a deal with Anthem to lower OTC drug prices and basic medical supplies for its customers, entered acquisition talks with Humana (a la CVS-Aetna), and cut the ribbon on its first 2 standalone primary clinics. Now in talks with Verizon to equip its retail and medical operations with 5G, Walmart’s president of health claims that these initiatives are “just the start” of their strategy to revolutionize primary care by prioritizing low prices and convenience, analogous to their strategy in the retail space. Analysts estimate that 90% of Americans live within 10 miles of a Walmart store, positioning Walmart as a formidable primary care competitor.
TLDR: CMS head, Seema Verma, reaffirmed telehealth industry optimism last week, contending that she “can’t imagine going back” to pre-COVID telehealth restrictions. “People recognize the value of this, so it seems like it would not be a good thing to force our beneficiaries to go back to in-person visits,” Verma said during a virtual event hosted by STAT News. Payors and legislators, however, will need to align on best practices and allowable reimbursement amounts relative to traditional in-person visits, which have been at parity during COVID.
So what? Hospital margins have been squeezed by COVID, with healthcare administrators speculating that independent health systems will be swallowed up in post-pandemic M&As. While recouping these losses in the aftermath, hospitals may fight to maximize in-person visits, which have associated facility fees and allow for additional procedures (e.g., labs, imaging). However, mounting pressure from patients in a reimbursement-friendly environment may leave providers no choice but continue supporting significant virtual visit volumes. Virtual visits for Medicare patients have soared from a few thousand per week to over 1.3M per week since COVID’s onset, while private payor claims for virtual visits skyrocketed nearly 45x year-over-year. The momentum from both public and private payors has pushed a bipartisan coalition of 30 senators to release a letter urging Senate leadership to make current telehealth policies permanent. Though reimbursement for virtual visits is unlikely to remain at parity with in-person visits following the pandemic, evolution of a broader suite of remote care technologies are likely to support expansion of virtual care beyond collection of a consultation fee, providing opportunity for hospitals to drive up margins and increase total patient populations.
TLDR: Last week, telemedicine virtual visit and chatbot company Babylon Health experienced a data breach that resulted in three patients mistakenly receiving recordings of other patients’ consultations. The company reported that a software issue caused the breach and ensured no external security threats were at play.
So what? This incident doesn’t come as a first for Babylon, and follows a trend of growing cynicism around telehealth risks, including privacy and security, malpractice claims, health disparities and equity of access. Although telehealth platforms are presumably more vulnerable to software issues in these early days of scaling, they may increase vulnerability to malicious attacks and security breaches, as they expose specific vendors’ weaknesses, and diminish patient confidence and trust in telehealth solutions, which already stand at a tipping point for sustained adoption. Other telehealth and remote monitoring companies would do well to use Babylon’s mishap as an opportunity to re-evaluate the robustness of internal and external privacy protections.
TLDR: Using real-world data from a French national claims database, Abbott analyzed ~75K FreeStyle Libre CGM users’ HbA1C levels, and diabetes- and general acute events over the course of a year. The study found average HbA1C reductions of 0.9 and 0.6 percentage points among non-insulin users and long-term insulin users, respectively, over a 6-month window. Additionally, Abbott demonstrated a ~30% drop in diabetes-related acute events among FreeStyle Libre users and a 13% drop in all-cause hospitalizations.
So what? Continuous glucose monitors (CGMs) are an essential hardware component of remote diabetes patient management, a ~$6B market. Digital diabetes management remains one of the best-established, well-funded segments of the digital health market with perhaps the nearest-term path to at-scale revenue realization. Recent partnerships in the space aim to create an end-to-end solution leveraging CGM hardware and software solutions for trends monitoring, live coaching, and insights delivery (e.g., Dexcom-Livongo, Dexcom-Onduo, Abbott-Omada). This end-to-end digital patient management approach has led to robust funding, valuation, and revenue realization (see Livongo’s Q1 earnings call) for “software” companies in the space, providing a model for other therapeutic areas to follow.
[Forbes Featured Article] — Digital Biomarkers Supersede Theranos: No Blood, No Jokes by Stephane Budel & Chris Lew
In our most recent Forbes article, we break down the 3 key ways in which digital biomarkers are poised to disrupt “traditional” genomic and proteomic biomarkers, and what a fully-digital 22nd century might look like.
TLDR: RWD and clinical trial solutions provider, Evidation Health, will use the funding to track medical first responders’ self-reported symptoms, behavior, and sleep and activity patterns using wearable devices. Evidation’s COVID-19 Pulse study has already enrolled ~185,000 participants to use wearables and self-reported survey data to characterize healthcare system responses to COVID and digital biomarkers. This new study aims to further drive development of digital biomarker-based predictive algorithms for COVID early detection and prevention.
So what? As COVID continues to highlight the importance of real-time, remote, population-scale infectious disease monitoring, wearable and smart device companies like Fitbit, Oura, Apple & Google, Kinsa Health, and Medopad (now Huma) and data-focused companies like Evidation Health and AiCure are using digital-behavioral biomarker signatures to drive earlier detection and prevention of new COVID cases, likely with the aim of launching post-pandemic monitoring solutions or data that helps economies safely reopen while minimizing “aftershock” outbreaks.
TLDR: McKinsey distinguishes five segments of virtual care (see image above) and, using claims data, estimates a share of each care model that could be delivered virtually. While on-demand urgent care has historically represented the largest segment of the telehealth market, McKinsey projects that the largest opportunity (~$125B) lies in the virtual office visit segment (i.e., physician consults without need for physical exam or concurrent procedures), for which ~25% of all visits may be virtualized.
So what? Forcing cancelation of ~70% of all in-person visits, COVID has increased telehealth use from ~10% to ~50% of all consumers. Nearly 60% of providers view telehealth more favorably than they did pre-COVID. Last week, UnitedHealth’s CMO claimed that the telehealth “genie is out of the bottle,” suggesting a path to expanded post-COVID reimbursement for virtual services. With the holy grail trio of stakeholders aligned, telehealth is paving the way for other digital health solutions to ride telehealth’s coattails and augment the scope of virtual visits (e.g., wearables and digital diagnostics, digital therapeutics, remote monitoring solutions). Translating current patient and provider behaviors into long-term care and market preferences will be critical in driving McKinsey’s modeled conversion of the existing market; however, a still larger market can be captured through market expansion — i.e., additional visit volume driven or enabled by improved digital offerings.
TLDR: Last Thursday, Singapore announced that it will outfit each of its 5.7 million residents with a “small wearable device” that can be worn on a lanyard or carried in a bag to enable Bluetooth-based digital contact tracing. It remains unclear whether device use will be legally mandated and what additional digital data or biomarkers the devices will collect.
So what? Singapore’s decision to launch nationwide wearables-based tracking follows weeks of criticism of efficacy and privacy issues with smartphone and app-based contact tracing like Singapore’s TraceTogether app and Google & Apple’s contact tracing API. Wearables leaders in Asia expect “multiple, if not all” governments in Asia to follow suit with aggressive digital surveillance programs. These initiatives, if implemented, will represent the largest real-world clinical use of digital biomarkers. Clear articulation of digital biomarkers’ nascency, current and expected shortcomings, and plans for refinement following these vanguard initiatives will be pivotal in driving success of future digital biomarker programs.
[Podcast] The Outcomes Rocket: The Digital Biomarker Revolution by Chris Lew
Hear DeciBio Senior Associate Chris Lew’s take on how digital biomarkers are revolutionizing care and how DeciBio offers unique value as a data-driven and precision-medicine focused consultancy in the space.
strategic guidance that DeciBio possesses.
strategic guidance that DeciBio possesses.
strategic guidance that DeciBio possesses.
TLDR: Starting in Q3 2020, Samsung Galaxy Watch Active2 devices will include ECG-based atrial fibrillation (a-fib) and cardiac arrhythmia detection capabilities. This comes on the heels of the South Korean FDA’s (MFDS) April approval of the watch’s cuffless blood pressure monitoring feature. South Korean watch users will now be able to push digital ECG and blood pressure readings to their physicians.
So what? While Apple far and away leads the smartwatch market (~50% market share), Samsung (~15%) and Fitbit (~10%) continue to add health-focused features that position their devices as direct medical device competitors. While Fitbit’s ECG function has not yet been FDA-approved, the company has completed 3 clinical trials and launched the Fitbit Heart Study, their analog of Apple’s ~420K participant Heart Study. We expect heart rate-tracking smartwatches to increasingly expand clinical use cases and adoption, and believe Samsung is a player to watch, with its strong foothold in the ~$28 billion APAC smartwatch market.
TLDR: In a recent Nature publication, researchers used a symptom checking app to track patient-reported symptoms for ~2.7 million users in the UK and U.S., which were linked to their SARS-CoV-2 RT-PCR test results. The study found that ~65% of COVID-positive patients experienced loss of smell and taste in addition to well-documented symptoms of the virus (e.g., persistent cough, fever, shortness of breath). Additional symptoms among positive patients included fatigue, skipped meals, diarrhea, delirium, and hoarse voice. Based on symptom combinations and reported test results, the researchers developed a predictive model that they applied to untested patients in the cohort (N~800K), concluding that >5% of the entire cohort had been SARS-CoV-2 positive.
So what? While virtual visit telemedicine solutions have received the bulk of funding and media attention among digital technologies deployed in the fight against COVID, symptom checkers have gained awareness and utilization amid mounting clinical evidence aiming to support their utility. Symptom checkers or “chatbots” can leverage AI-ML on massively scaled real-world symptom data to predict diagnoses and inform clinical decision-making. Governments and leading health systems have recognized the value of chatbots in the fight against COVID; however, decentralized development of bespoke solutions lacking the AI-ML capabilities, experience, and scale that commercial players have (e.g., Babylon, Ada, K Health, Buoy), is likely to continue producing inconsistent and inaccurate results. We anticipate the post-pandemic symptom chatbot market may shift back to leading commercial players with possible entries from tech giants with AI-ML / neural network and voice tech capabilities (e.g., Google, Amazon, Apple).
TLDR: Higi, who has placed >10,000 FDA-cleared primary care kiosks used by ~62M patients in pharmacies, grocery stores, and retail locations throughout the U.S., added Babylon Health as a strategic investor and partner. Babylon led the $30M Series B, and appears to have its eyes set on Higi’s “anonymized and aggregated” patient data, while augmenting kiosks with “end-to-end” digital assessments and programs that leverage Babylon’s symptom checking and telemedicine capabilities.
So what? Prior to Babylon’s U.S. market launch in Q1 2020, the company announced that it would be unveiling 2 “very large” strategic partners with plans to add up to 3 more by the end of the year. Based on company announcements, it appears Higi is the first of these, and that a Medicaid-targeted partnership is next. In May, Babylon inked a partnership with Mount Sinai to roll out its symptom chatbot and virtual visit and monitoring app to millions of insured New Yorkers. We expect that Babylon has a couple more strategy plays in store for this year that will also focus on rapidly growing its U.S. patient base and payor relationships via well-distributed solutions, and leading providers and brands.
TLDR: Everlywell initially announced plans to commercialize at-home COVID-19 sample collection kits paired with telediagnostics services in March. Soon after, the FDA issued a statement clarifying that no at-home tests were yet approved and that additional oversight was underway to evaluate at-home kits. Everlywell marks the first at-home COVID sample collection kit to garner Emergency Use Authorization (EUA), and will allow customers to send nasal swab samples to a variety of third party labs for analysis. The FDA claims that Everlywell’s data demonstrating sample stability of its nasal swab collection method was crucial to its success in achieving EUA status.
So what? Everlywell’s EUA approval may be the first, but it is unlikely to be the last. Before the FDA barred at-home testing, several telediagnostics players had announced plans to commercialize COVID-19 test offerings similar to Everlywell, including Nurx, Carbon Health, and myLAB Box. In the UK, Babylon Health is giving at-home COVID-19 antibody tests at-cost (£69) to anyone in the UK, allowing individuals to collect samples at-home and send them to an accredited Eurofins laboratory for analysis. Similarly, Scanwell Health has developed at-home COVID-19 antibody tests in partnership with Lemonaid Health and appears to be awaiting FDA approval to officially distribute the test. The FDA expects that Everlywell’s study data will support other inbound EUA requests, which will likely lower barriers to entry for other telediagnostics players hoping to launch at-home testing products.
TLDR: As a major payor in the Pacific Northwest, Premera Blue Cross covers 2 million individuals. Their first-ever virtual primary care plan, Premera NOW, will become available for employers to purchase in October 2020. The Premera NOW app will run on 98point6’s text-based primary care platform, allowing customers to access a board-certified 98point6 virtual provider on-demand without a copay. The app allows customers to submit information and photos regarding their symptoms, followed by a text-based appointment with a physician through in-app messaging. Patients may be referred for an in-person appointment with a specialist in their network if needed.
So what? Beyond its partnership with 98point6, Premera previously announced expanded telehealth offerings through Doctor on Demand for video-based virtual care. Premera also temporarily waived costs for virtual visits supporting patients with mental health and substance use disorders during the pandemic. Premera is one of several payors partnering directly with telemedicine providers and incentivizing customer adoption. In March, Blue Shield of California opted to waive out-of-pocket costs for members using Teladoc’s telehealth services. Last month, Humana launched On Hand, a virtual care health plan powered by Doctor on Demand that offers virtual primary care visits with no copay. Though copay suspensions will likely be temporary, increasing normalization of telemedicine solutions among payors is likely to result in sustained adoption by customers after the pandemic has receded.
TLDR: Fitbit looks to enroll 200-250K device owners in its new study, which aims to produce clinical and regulatory data validating its PPG a-fib detection algorithm for FDA submissions.
So what? Fitbit continues to close its competitive gap with Apple and expand medical (i.e., non-general health and wellness) use cases. Fitbit began collaborating with BMS and Pfizer last year to bring cardiac arrhythmia detection online, and has completed a clinical trial intended to earn FDA clearance for its ECG capabilities (which Apple earned in September 2018). Fitbit has also picked up mindshare among researchers looking to expand use cases for digital biomarkers, including notable projects to detect and track influenza and COVID-19 symptoms. This new study seeks to enlist all heart-tracking enabled Fitbit devices, including some of its exercise trackers, which start as low as ~$100. If successful, Fitbit could drive further penetration of the general cardiac health screening population Apple has primed with its ~$200+ smartwatches. While Apple had success with enrollment for its ~420K-patient Heart Study, researchers reported nearly 60% attrition of patients notified of an irregular heart rhythm who failed to follow nudges to consult with an HCP. Fitbit will need to harness learnings from Apple’s foray into the space to maximize potential for success.
See our “In other news” section at the end of this digest for leaks on upcoming Apple Watch digital biomarker features.
TLDR: Reception of Apple & Google’s contact tracing tool among state governments and public health agencies has been cold, with key states now planning to ramp up traditional contact tracing workforces to help reopen businesses. California and New York announced plans to each hire ~20,000 contact tracers, while leading public health figures have called on Congress to allot $12B to hire 180,000 contact tracers nationwide.
So what? Public health officials fear the blind optimism of deploying untested technology designed by Silicon Valley “techies” with limited healthcare experience presents undue health, safety, and privacy risks. Instead, they are urging states to evaluate tech-enabled solutions that complement the work of traditional contact tracers (e.g., Utah’s “Healthy Together” app, developed by social app company Twenty, which relays symptom and location history data to contact tracing professionals when a user opts in). Similar in nature, a public safety app, Citizen, which already has an installed base of ~4M in major metro areas, is attracting the attention of major employers looking to use tech-augmented approaches to reopen their offices. These solutions, along with less privacy-minded ones rolled out in China, South Korea, and Singapore, highlight that digital solutions’ adoption and potential to drive positive outcomes are fragile and highly dependent on identity and perceptions of the manufacturer and local sociopolitical and cultural attitudes.
TLDR: Alveo Technologies’ be.well platform, originally outfitted for at-home influenza and respiratory syncytial virus (RSV) testing, is now preparing for clinical trials with the force of pharma giant J&J behind it. The be.well platform uses an inexpensive reader and cartridges that can be loaded with user-taken samples, and links to a mobile app that can record and relay results to HCPs. The start-up will leverage J&J’s clinical development expertise to push its platform through human trials this month, with hopes of receiving EUA to bring its first test to market.
So what? This comes on the heels of recent FDA emergency approvals of at-home molecular and serology tests for COVID-19 from LabCorp and Quest, respectively, a regulatory milestone for at-home and digitally-enabled diagnostic testing. Although a temporary emergency measure, we believe this could translate to broader acceptance and intensified advocacy for at-home testing of seasonal respiratory viruses or other infectious diseases (e.g., STIs) as stringent public health policies strive to keep patients out of crowded brick-and-mortar testing centers for the reminder of the year. Sustained “pilot” use of these remote testing solutions may drive greater consumer and HCP acceptance that survive the pandemic, as we’ve seen with telehealth.
TLDR: A new poll conducted by the Washington Post and University of Maryland suggests that ~50% of U.S. smartphone users are unlikely to use Google & Apple’s contact tracing app, slated for a mid-May rollout. Oxford estimates ~60% of a country’s population needs to use a contact tracing tool for it to be effective. A recent Kaiser Family Foundation poll, however, found a higher rate of acceptance — nearly ⅔ — “once people heard the argument that this could allow for many schools and businesses to reopen”.
So what? A mounting number of reports posit that Apple and Google’s contact tracing app is doomed to fail. However, CDC experts estimate that 300,000 contact tracers would be required to safely re-open the country, a feat operationally and financially unlikely without the support of digital contact tracers. However, raw poll data suggests a familiar pre-pandemic take-home message for digital health players — anxieties around data privacy and security extend beyond consumer tech giants and governments, and the personal benefits of using digital health tools are not well understood. While the headline-grabber was that ~55% of polled U.S. smartphone users do not trust Apple or Google to keep data anonymous, ~45% of respondents also do not trust universities or public health agencies to do so. These polls serve as yet another signal of the urgent and severe need for technology developers to improve transparency and patient literacy with digital tools, establish assurances for data protection, and prioritize features that benefit users at the individual level to incentivize use and develop trust. While cited barriers to adoption of telehealth / RPM tools are distinct, some principles at play are conserved. Consumers’ low risk tolerance and disincentive to disrupt the status quo require demonstration of clear personal gain (e.g., for telehealth and RPM, added convenience without sacrificing quality) and real-world utilization before large-scale buy-in. For contact tracing, potential analogous solutions include returning micro-, community-level disease surveillance insights to users or tying local business re-openings to community-specific performance to demonstrate the real-world benefits of supporting these solutions. Additionally, tech companies and governments may be expected to outline clear limitations for data use and offer legal recourse and resolution should those limitations or data security be compromised.
TLDR: Last week, clinicians at a leading academic medical center in Germany used the Apple Watch to diagnose severe cardiac ischemia and prevent myocardial infarction in an 80-year old Apple Watch enthusiast. After presenting to the hospital with chest pain, but normal ECG readings and bloodwork, the physicians cracked open her Apple Watch ECG readings and found repeated patterns of ST segment depression, a strong indicator of severe cardiac ischemia. Immediate surgical response confirmed the watch’s diagnosis and led to successful treatment.
So what? While currently only indicated for detecting cardiac arrhythmias, this success story sheds light on the trajectory for Apple Watch and similar medical-grade wearables expanding into new indications, and in the longer-term, into new therapeutic areas. By passively collecting digital biomarker data, these devices can enable more real-time diagnosis, or as in the recent case, prevention of acute disease incidents before otherwise clinically detectable. This encouraging story also highlights increasing clinician adoption of digital technologies, with practitioners now stepping outside of indicated FDA use guidelines to apply these technologies practically and in novel ways to meet the moment.
TLDR: In the face of unprecedented demand for telemedicine, EHR giant Epic is rolling out telehealth services in partnership with software provider Twilio. Twilio’s Programmable Video API will fuel Epic’s telehealth services app by allowing providers to initiate televisits. The app offers a solution for providers to hold remote video visits with patients while viewing and updating their medical record within Epic’s interface. Epic contains health record data for over 60% of Americans in its software systems, positioning its telemedicine services for widespread impact across ~250 million potential patients.
So what? The COVID pandemic continues to drive infrastructural changes that support uptake of telemedicine by healthcare providers. From CMS boosting telehealth reimbursement to the FCC devoting $200M to the COVID-19 Telehealth Program, healthcare providers across the U.S. are increasingly incentivized to adopt telemedicine solutions. With improved reimbursement and funding available, Epic’s app will become another telemedicine solution for health systems to choose from. However, Epic’s app will likely offer a workflow edge over its competitors. DrChrono appears to be similarly angled toward workflow advantages with its recent launch of telehealth services integrated with its mobile EHR, including streamlined post-visit billing processes for video consultations. Epic has the opportunity to differentiate by capturing televisit transcription data, facilitating pre-consultation prep, or supporting post-consultation workup, all within the health record software.
Forbes Featured Article — The Precision Medicine Revolution Will Be Driven By Diagnostic Technologies by Stephane Budel
TLDR: After over a year of closed-door collaborations with health systems like Mayo Clinic, Ascension Health, and UCSF, Google Cloud has launched its Healthcare API solution, now available to all HCOs. Healthcare API centralizes clinical data from disparate sources (e.g., different EHR systems, lab and imaging software) and harmonizes it into a universal or “interoperable” format that can be shared with authorized third parties, like other providers, digital health apps a patient has consented to sharing data with, or the patient herself. The solution also enables HCOs to perform de-identified analytics and develop machine learning models to run on their patient populations (e.g., for outcomes and quality assessment and predictive analytics, operations, revenue cycle management).
So what? After announcing a March 2022 deadline for health systems to comply with the new interop rules published in March, ONC announced discretionary relaxations to that timeline and others last week as HCOs prioritize their COVID response. As HCOs adopt API solutions to earn compliance, Google Cloud’s Healthcare API will compete with Amazon’s AWS and Microsoft’s Azure, both of which are leveraging partnerships with Cerner and Epic after their Google collabs crumbled. After a rough Q4 2019 battling public outcry from its “Project Nightingale” collaboration with Ascension Health, Google Cloud is now making its Healthcare API available, hoping to reverse bad optics and regain provider trust while helping HCOs work towards true interoperability.
TLDR: Earlier this month, the FCC proposed the COVID-19 Telehealth Program, which aims to provide $200M in funding for eligible healthcare providers to invest in telehealth equipment. Telehealth funding intends to allow health systems to better serve low-income and underserved patient populations. Last week, the FCC selected 6 initial health systems and approved a total of $3.2M to be distributed across these first round picks. Individual funding allotment ranges from ~$240k for Neighborhood Health Care in Cleveland to ~$1M for Ochsner Clinic Foundation in New Orleans. A combined ~$1M was also allotted in New York to Hudson River HealthCare and Mount Sinai Health System. The health systems specify the key-use cases for telehealth funding in their applications to the FCC, and many cite remote patient monitoring and tele-visits as crucial to reduce strain on the severely limited PPE supply.
So what? With over $195M remaining in the fund, these initial winning health systems represent only the tip of the iceberg for the many health systems expected to gain funding in the coming weeks. FCC Commissioner Brendan Carr expects the fund to have a lasting impact as the healthcare system realizes the increased savings and improved outcomes that result from telehealth. COVID aside, Carr highlights the long-term opportunity for connected care technologies to alleviate the burden of chronic disease on the healthcare system by reducing emergency visits and improving therapy adherence. This FCC fund is one of the many recent boosts to telehealth infrastructure expected to drive sustained adoption of telehealth after the COVID pandemic. Beyond funding, expanded reimbursement and regulatory decisions have lowered barriers to telemedicine adoption for patients and providers alike.
TLDR: FDA guidance on regulation of AI technologies (published April 2019) has failed to keep pace with the agency’s thinking, creating an opportunity for digital diagnostics, remote patient monitoring, and telehealth players to learn from the FDA’s public meeting notes and approaches of successful initial AI innovators. Patient-facing applications of AI largely focus on video / imaging guidance, at-home IVDs, and digital therapeutics leveraging AI capabilities, while provider-facing applications center around diagnostic imaging and interpretation support, CDS, and patient triaging solutions. While provider-facing guidance has been fairly clear (e.g., act as a support, not substitute for clinician interpretation, avoid “black box” algorithms), patient-facing ones are left more to infer key considerations from pioneers in the space like Butterfly Network, Caption Health, and Ultromics. A common thread seems to be focusing on simplicity, clarity, and “fool-proofing” AI-based user guidance.
So what? As adoption of telehealth and remote patient monitoring solutions continues to accelerate, features that leverage AI will become increasingly relevant. Remote diagnostic technologies will require AI features that guide patients to capture a cardiac ultrasound or retinal image correctly, to accurately detect a signal in at-home IVD tests using their smartphone, or to position themselves in front of a smartphone camera to enable appropriate real-time modification of interactive digital therapeutics. The COVID pandemic is making it increasingly clear that remote care solutions offer many advantages over brick-and-mortar care and are here to stay. While implementation of AI can help bridge some of the shortcomings of contact-free care, effective guardrails must be established that minimize patient user error and simplify the patient experience.
‘Digital Contact Tracing’ — Advantages, Risks, & Post-COVID Applications by Chris Lew & Fanny Anderson
While Apple & Google’s technology holds promise over traditional contact tracing and other, less privacy-friendly methods of digital surveillance being used across the globe, perceived data privacy and security risks remain hurdles to individual and collective adoption.
On the Brink of a “Digital Health Revolution” by Chris Lew
Telehealth optimism spills over into new therapeutic areas and adjacent digital solutions, following strong financial performance and positive patient and provider experiences
Temporary relaxations in FDA regulations and CMS reimbursement for virtual visits and remote patient monitoring (RPM) has created a “domino effect”, triggering a cascade of acceptance of adjacent digital health solutions by patients, providers, and (at least temporarily) payors. Solutions in specialty telehealth, digital diagnostics, at-home biometric monitoring, provider digital workflow management, and IT integration have seen increased interest, investment, and utilization.
TLDR: After terminating its commercialization partnership with Pear Therapeutics last fall, Novartis is re-entering the digital therapeutics space. Novartis plans to acquire Amblyotech, the U.S. software start-up developing digital therapeutics for amblyopia, or lazy eye, which affects ~3% of the population globally. Amblyotech’s “Dig Rush” app leverages 3D glasses and video game technology on a tablet device to attempt to treat patients with lazy eye. Through the acquisition, Novartis will continue Amblyotech’s existing collaborations with McGill University and Ubisoft gaming studio, aiming to gain regulatory approvals and commercialize games in development.
So what? Novartis’ acquisition marks a deviation from its partnership strategy with Pear Therapeutics, which aimed to commercialize DTx solutions for substance use disorder and chronic insomnia. Its acquisition reaffirms pharma’s interest in DTx being a mainstay for the space, contrary to buzz about pharma’s “DTxit” following a string of break-ups between Novartis/Pear, Otsuka/Proteus and Sanofi/Onduo. Novartis’ acquisition confirms that DTx will likely be a critical strategy for pharma to address needs that existing standards of care have failed to meet. Acquiring digital solutions like Amblyotech may also hold less risk than investing in the costly and lengthy R&D to develop a new biologic. DTx certainly hold promise for pharmas as a way to scale access and improve outcomes while remaining competitive as low-cost digital solutions continue to emerge. For Novartis, Amblyotech represents an opportunity to improve adherence and address unmet needs in amblyopia, where there are few approved therapies for adults and existing treatments have low success rates.
TLDR: RPM startup Biofourmis expands its reach into oncology with its acquisition of Gaido Health. Originally focused in cardiovascular disease, Biofourmis built its FDA-cleared Biovitals platform to integrate wearable technology and AI-driven analytics. Spun out of Takeda Digital Ventures, Gaido’s oncology tool leverages RPM technology and patient surveys to facilitate remote care for patients at home. Gaido’s predictive analytics also detect early signs of complications in patients recently discharged from the hospital. Integration with Biofourmis’ Biovitals platform will allow Gaido to be used commercially, as utilization to-date has been limited to clinical trials.
So what? Biofourmis’ investment in oncology-specific RPM technology points to a broader trend of value-based care models emerging in oncology. The Oncology Care Model offers value-based payment for oncology practices providing improving outcomes and reducing costs for patients receiving chemotherapy, while also providing patients with access to health record information, care plans, and a care coordinator. CMS released the latest draft measures for the Oncology Care First Model earlier this year, which would require one additional measure: implementation of electronic patient-reported outcomes (ePROs). Symptom management is not only a key pain point for cancer patients, but may also result in unnecessary, costly hospital visits. ePROs have the potential to facilitate real-time symptom tracking and predict adverse events or hospitalizations. By integrating Gaido’s oncology technology into the Biovitals RPM platform, Biofourmis is positioned to offer an ePROs and symptom tracking solution to oncology practices participating in value-based care.
TLDR: Luminostics will leverage Sanofi’s clinical development expertise to adapt its novel fluorescent nanoparticle diagnostic technology to COVID-19. The companies aim to roll out their over-the-counter, diagnostic test utilizing smartphones as a “reader” by the end of the year.
So what? While Sanofi has inked partnerships focused on developing COVID-19 therapeutics with BARDA, Translate Bio, and GSK, this pharma-digital diagnostics collaboration is a fairly unconventional one in the digital health space. To-date, industry buzz has focused on pharma-digital therapeutics partnerships (see the story above); however, we expect pharmas to increasingly look to digital early detection and diagnostics technologies that complement their existing therapeutic pipelines or developing digital therapeutic pipelines. Preparing for a future of digital diagnostics can help pharmas expand their serviceable patient populations and identify digital biomarkers with implications on clinical outcomes (i.e., “digital CDx”). While this early pharma-digital diagnostics partnership likely has less of a Dx / Tx synergy strategy, we expect to see more that do as digital diagnostics solutions gain traction in oncology, cardiovascular disease, neurological disease, and mental health.
TLDR: Historic competitors Apple and Google have announced plans to develop a contact tracing system over the coming months, initially relying on official public health apps and eventually building the functionality directly into iOS and Android software. In May, the tech giants will launch two APIs, for iOS and Android, which facilitates interoperability and allows users to voluntarily share data through approved apps. Bluetooth contact tracing capabilities will then be built into the system, which will leverage Bluetooth transmissions to collect data on proximity between smartphones without using physical location data. If a user reports infection with COVID-19 through the app, the system will push alerts to any other phones that have been in close proximity with the infected user’s phone. Eventually, Apple and Google plan to incorporate these functionalities directly into iOS and Android software so that individuals can opt in without downloading an app.
So what? Apple and Google are not alone in leveraging Bluetooth technology for COVID-19 contact tracing. Existing apps have primarily been launched by academic research institutions, including MIT’s SafeWatch, Stanford’s COVID Watch and the multi-organizational Pan-European Privacy-Preserving Proximity Tracing. Apple and Google have the potential for population-level adoption than existing tools given their massive customer base. Google’s COVID-19 Community Mobility Reports have already begun to demonstrate the value of population-level mobility data for public health officials. However, patient privacy concerns are paramount in tech giants’ efforts to enter the healthcare space, COVID included. Beyond the underlying opt-in nature of the tool, Apple and Google aim to maintain privacy and security through several underlying mechanisms, including anonymous ID keys that change every ~15 mins per individual to prevent traceable static ID numbers or a master list of phone IDs. Beyond privacy concerns, critics point to other potential weaknesses in the system — namely duration of exposure to infected individuals which may or may not be accurately captured. Mitigating privacy concerns and unnecessary panic will likely be crucial to inspiring adoption of the new system, whose impact relies heavily on population-level adoption to drive accurate behavioral change.
TLDR: Science 37, an industry leader in decentralized clinical trials, has partnered with Innovo Research, a national leader in trial site networks, on a rapid-start solution to accelerate the start-up time needed for COVID-19-related clinical trials for vaccines, drugs, and diagnostics. Innovo plans to utilize their network of sites and patients for recruitment and screening, while Science 37 plans to leverage their telemedicine platform and at-home nursing capabilities for virtual and at-home clinical trial check-points and visits.
So what? Science 37 and Innovo Research’s partnership comes at a time when the virtual research model is much needed due to worldwide quarantine measures, and when trials related to COVID-19 require rapid starts. As the use of digital products in clinical trials has continued to increase in recent years, Science 37 has seen growing success in the virtual clinical trial space with an FDA endorsement of the idea following Science 37’s recent publication of a white paper on the subject. Additionally, Science 37 has “penned a pact” with PPD, a leading clinical trial CRO, to help run its trials remotely. Just as virtual visit and remote patient monitoring solutions have ridden adoption and utilization tailwinds ushered in by COVID, virtual clinical trial solutions appear to be on the cusp of inflection, driven by utility in high-urgency applications while eliminating risks associated with in-person interactions.
TLDR: In this podcast from Andreessen Horowitz, Dr. Bobby Green (Community Oncologist, Chief Medical Officer of Flatiron Health) and Dr. Sumit Shah (Stanford Cancer Center) discuss how COVID is catalyzing digital transformation in the patient and physician oncology workflow. As with primary care, virtual visits have had enormous value in maintaining care while minimizing risk of viral exposure. In the past 2 weeks, Stanford’s Cancer Center has seen virtual visits grow from 5-10% to >60% of total visit volume, with routine follow-ups, patient symptom discussions, and test results (e.g., blood counts) as primary use cases. Meanwhile, Flatiron’s network of community oncology centers has seen in-person office visits drop by 22% as non-essential appointments are conducted virtually or postponed. Both oncologists noted the significance of virtual tumor boards and online crowdsourcing (via Twitter) to supplement ASCO’s guidance for using cost-benefit analyses and relevant data to support treatment decision-making during the crisis. Lastly, the need to minimize or virtualize non-essential clinical trial check-points is driving value-based, patient-centric care, where patients may have needed to travel and wait for 6+ hours to comply with trial protocols. While certainly not stand-ins for physical care (e.g., therapy administration, human touch), these digital transformations across the cancer care pathway seem to be positively received by patients and clinicians alike.
So what? Industry experts see telehealth solutions improving patient journeys, clinician workflows, and value-based care at-large in primary care and oncology care, and see this lasting beyond the pandemic. However, growing pains exist — virtual delivery of significant diagnostic / prognostic news lacks the humanity of an in-person conversation, screen-sharing and store-and-forward image / video capabilities within telehealth solutions are often not supported, and real-time communication between providers has not fully capitalized on the digital opportunity at-hand. Despite this, oncologists envision a future in which some in-person visits are replaced by virtual follow-ups and at-home therapy administration (e.g., for subcutaneous IVs) overseen via virtual consultation. Oncologists envision a broader network of virtual clinical trials reducing unnecessary travel burden and procedures on the patient as the crisis highlights procedures with dubious value to outcomes. And oncologists envision a future in which virtual care expands clinicians’ insight into who a patient is in their day-to-day environment — home.
Here we make sense of the fragmented landscape of coronavirus testing options currently available and examine which tests will likely most easily enter hospital laboratories, based on insights from DeciBio’s Emmes Infectious Disease database.
Why COVID Telehealth Surges Might Survive the Pandemic by Chris Lew
Temporary reimbursement expansion for virtual visits is eroding key barriers to adoption and driving infrastructural change
2020 Vision: 3 Advancements in Computer Vision for Health by Julia Daniel
Here we highlight three creative ways computer vision is entering the medical sphere, and the pertinent questions facing this rapidly-moving field
TLDR: Digital health saw its second-most funded quarter in Q1 2020, with $3.1B invested across 107 deals, according to Rock Health’s quarterly update. Late-stage funding constituted nearly one third of deals last quarter, indicating a maturing digital health market. COVID-19 poses an economic threat even to the healthcare sector, as evidenced by hospital closures linked to Coronavirus panic. However, digital health may be positioned to address COVID-related challenges faced by the broader healthcare industry. As individuals continue to forgo traditional routes to care under shelter-in-place orders across the nation, they may increasingly rely on digital health tools to address medical needs.
So what? Though the economic impacts of COVID-19 are still unfolding, the pandemic poses a unique opportunity for digital health startups to scale their capabilities. Digital health sectors like telemedicine, RPM and digital diagnostics are positioned to see sustained adoption post-pandemic due to infrastructural changes and accelerated adoption curves. Coming off a record-breaking quarter in funding, digital health startups are also protected by their access to private capital. Rock Health points out that deal structures in venture fund partnership agreements are designed to prevent limited partners to withdraw capital. Though both private and public capital will become constrained, venture firms will likely invest funds raised before the pandemic and continue to support growth in digital health.
TLDR: Last Monday, FCC Commissioner Ajit Pai proposed earmarking $200 million of the $2 trillion CARES Act for healthcare providers to purchase telecom and broadband devices and services and hire any personnel needed to support telehealth services. On Thursday, the commission approved the program, which will enable organizations to apply for up to $1 million and will prioritize those in areas hardest hit by COVID and that treat traditionally underserved populations. The FCC earmarked another $100 million from its budget to facilitate broader telehealth adoption over the next two years. “I’m hard-pressed these days to think of any better use case for the agency’s mission of advancing connectivity than telemedicine,” said Pai.
So what? This telehealth stimulus comes on the heels of CMS and private payors relaxing reimbursement restrictions for virtual visits and remote patient monitoring to slow the spread of COVID-19 in healthcare facilities. Since temporarily lifting telehealth’s major barrier to adoption, companies like Teladoc, Amwell, and Doctor on Demand have seen astronomical spikes in virtual visit volume and IT loads from providers and patients who have quickly adopted telehealth solutions out of the urgency and necessity of the crisis. While some skeptics argue that these “band-aid” solutions will not survive the pandemic, most signs point toward this being an inflection point for broad telehealth adoption, including this new FCC fund to support infrastructure adoption. Commissioner Jessica Rosenworcel added, “The toll this pandemic is taking on our healthcare system is clear. To the extent that connectivity solutions can provide immediate assistance with remote care and monitoring, we should use them. There is already evidence across the country that this works.”
Nationwide “stay-at-home” prompts digital mental health stakeholders to band together to address growing concerns
TLDR: Following initiatives from mental health DTx, telehealth, and wellness companies like Happify Health, Talkspace, and Headspace to provide free or discounted programs during the COVID pandemic, chronic disease management companies are working with employers and payors to broaden access to mental health programs. Yesterday, Omada Health began offering its stress, anxiety, and depression management platform for free to all U.S. employers and commercial payors. Livongo teamed up with Kaiser Permanente to offer all members free access to its myStrength program. SilverCloud Health and Express Scripts similarly inked a deal to offer members free access to SilverCloud’s mental and behavioral health coaching programs.
So what? In the wake of a national lockdown to halt the virus’ accelerating death toll, experts expect social distancing to have serious implications on suicide rates, depression, and anxiety, as well as chronic conditions like heart disease, diabetes, and dementia. Following the trend in telehealth at-large, the urgency and necessity COVID has created for virtual mental health solutions has triggered temporary reimbursement / payment solutions that are causing massive spikes in utilization and eroding longstanding barriers to adoption (e.g., available reimbursement, patient and provider awareness, lack of trust and experience) . Mounting political pressure and fear of a post-COVID global depression has caused employers (e.g., Starbucks, PwC) and payors (e.g., Aetna) to expand their virtual mental health benefits. These temporary relaxations in reimbursement could lead to lasting impact for tele-mental health, as we are seeing in the telehealth primary care arena.
TLDR: Last week, several telemedicine providers launched direct-to-consumer COVID-19 tests to meet rising demand for diagnostics. FDA initially warned consumers to be wary of “unauthorized tests” sold online. Now, FDA’s Emergency Use Authorization guidelines are completely halting at-home sample collection for tests sent to private labs for analysis. In the UK, finger-prick at-home test kits are expected to become available to the NHS Staff, not to diagnose COVID-19 but to test whether someone has already recovered from the virus. This test intends to allow health professionals to confidently return to work while generating more accurate incidence numbers for COVID-19 in the UK.
So what? Telemedicine providers like Nurx, EverlyWell and Carbon Health are now forced to destroy samples already collected and halt test ordering. However, there may be a window of opportunity for direct-to-consumer tests that pair at-home sample collection with at-home analysis, and thus do not require sending samples to private labs. Scanwell Health is currently on the hunt for FDA approval of their serology-based point-of-care diagnostic test that may be conducted at home in 15 minutes. Meanwhile, diagnostic behemoths continue to work towards meeting demand for diagnostic testing. Abbott just gained FDA Emergency Use Authorization for its point-of-care test, expanding their diagnostic production capabilities to ~5M tests per month.
Spotlight on COVID-19 — As more tests win FDA emergency use authorization, weekly commercial production capacity is expected to hit 6.5M+ tests; telehealth providers jump into the fray, but are subjected to additional FDA oversight
TLDR: Recognizing that software as a medical device (SaMD) requires a regulatory framework as lean and agile as software development, the FDA launched v1.0 of its “pre-cert” program last year. The program allows streamlined premarket review and commercialization of SaMD solutions for companies able to demonstrate a culture and infrastructure suited to prospective real-world evaluation of efficacy and safety, and prompt agile refinement of solutions. Pear Therapeutics, who has undergone FDA clearance for its reSET and reSET-O digital therapeutics, is now the first company to complete pre-cert, using its digital cognitive behavioral therapy for insomnia (CBTi). To help the FDA pressure-test this new framework, Pear pursued and received traditional 510(k) clearance for Somryst in parallel.
So what? While early days for pre-cert, this win for Pear reaffirms the FDA’s commitment to modernizing and tailoring premarket review appropriately for certain digital health solutions. Highlighted by Pear’s CMO in a recent interview about details of the pre-cert process, “organizational excellence” (i.e., ability to identify and promptly respond to real-world performance data) is key to success, but will mean something slightly different for the myriad of companies that may pursue pre-cert. While still restricted to 9 companies helping pilot the program (including Apple, J&J, Fitbit, Verily, and Roche), pre-cert offers a promising and unprecedented way of regulating digital health solutions.
TLDR: Two studies emerged last week to evaluate if wearables can detect COVID-19. Both studies attempt to link device-collected physiological data with user-reported symptoms data. UCSF’s TeamPredict Study aims to collect data from Oura Ring users, including physiological data generated by the smart ring and daily self-reported surveys. Scripps’ DETECT Study will collect data from users of several wearables, including Apple Watch, Fitbit, Oura Ring and Garmin. The study focuses on heart-rate, activity and sleep data, which it will attempt to link with user-reported symptom data.
So what? Wearables represent the next frontier of digital health combatting COVID-19, following in the footsteps of telemedicine, digital screening, symptom-checking and remote monitoring tools. Wearables pose a unique opportunity to generate digital biomarkers for COVID-19 by linking physiological metrics with user-reported data. Given that body temperature is a closed-loop metric (e.g., physiological metric and symptom), digital tools with temperature sensors are well-positioned to participate in research efforts. Fertility start-up Ava Women is seeking research partners in COVID-19 because their ovulation-tracking wearable is already designed to collect COVID-related data, including basal body temperature and respiratory rate. Researchers at Kinsa Health are investigating data collected through their digital thermometer to identify surges in infection across the U.S.
TLDR: Apple has released a COVID-19 website and app in partnership with the CDC, White House Coronavirus Task Force, and FEMA. The platform serves as a screening tool and information platform, where users can answer a series of questions about their symptoms, risk factors, and exposure to receive recommendations on next steps (i.e., self-isolate, seek care).
So what? Apple follows in the path of other digital health / telehealth providers to democratize COVID-19 information for consumers (Bouy Health’s Symptom Checker, Ro COVID-19 screening, Clearstep chat bot). However, questions have been raised about the efficacy of AI-driven chatbots aimed to help users evaluate their symptoms and COVID-19 risk. Additionally, beyond patient-facing avenues, healthcare software companies such as Alcidion are incorporating COVID-19 screening tools to help hospitals identify cases sooner.