Subscribe to our weekly Digital Health Digest to receive our latest insights directly to your inbox. Each issue of our digest profiles 3 key stories of the week with deep-dive commentary on broader implications for the industry, as well as M&A and funding activity. See our archive of past issues and connect with our digital health team below:
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: 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.