Digital Health Newsletter & Insights

DeciBio’s Weekly Digital Health Digest

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:

 

SUBSCRIBE

 

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

  • Vol. 40 (11/24/2020) — Amazon Pharmacy goes live | FDA authorizes first at-home COVID test

    Amazon Pharmacy goes live, making waves across pharmacy ecosystem

    TLDR: After acquiring PillPack in 2018, the online storefront for Amazon Pharmacy is finally live. The website allows shoppers to order prescriptions directly through Amazon and pay with their health insurance or out-of-pocket. Amazon Prime members are eligible for free two-day shipping on any prescription, as well as discounts on generic and brand-name drugs when paying without insurance. Incumbent retail pharmacies, like Walgreens, CVS and Riteaid, saw their stocks fall after Amazon’s announcement last Tuesday. However, the jury is still out on the extent of Amazon’s ability to steal patient volumes from major pharmacy retailers. Most notably, patients will have to transfer existing prescriptions over to Amazon Pharmacy, requiring them to contact their prescriber and potentially schedule a visit.

    So what? Beyond traditional retail pharmacies, Amazon also poses a competitive threat to prescription discount solutions and digital pharmacies. Amazon is not only making a play toward convenience, but also toward price transparency. Amazon will facilitate price comparisons for prescriptions through its Prime Rx tool, allowing Prime members to evaluate costs when using insurance vs. paying out-of-pocket with discounts. Prime Rx will likely compete directly with prescription discount and price comparison providers like GoodRx, which just went public a few months ago. While Amazon Pharmacy is available at ~50k pharmacies, GoodRx has a lead with ~70k pharmacies available to consumers and several key partnerships (e.g., Kroger Rx SavingsWalmart’s Prescription Savings Program). Amazon is also driving competition in the online pharmacy space more broadly, particularly with UnitedHealth Group and Walmart who both acquired digital pharmacies earlier this year (Walmart-CareZoneUnitedHealth-DivvyDose).

    FDA authorizes first rapid at-home COVID-19 test as prescription-only

    TLDR: Last week, Lucira Health became the first to clinch FDA authorization for an entirely at-home test for COVID-19, called the “All-In-One Test Kit”. The single-use home test kit requires a doctor’s prescription and is expected to cost less than $50. Based on LAMP technology, the test requires a nasal swab, which is swirled into a solution and inserted into a portable device that reads out a light-up result within 30 minutes. The test will soon become available to patients of Sutter Health and South Florida’s Cleveland Clinic, but will not be marketed nationally until spring 2021.

    So what? Lucira Health joins nearly 300 COVID-19 tests authorized by the FDA as the first true at-home test. However, at-home testing could distance patients from the reporting process, which requires a chain of communication from patients to healthcare providers to public health officials. This is undoubtedly part of the FDA’s rationale for making the Lucira test prescription-only, such that patients must report their results back to the prescribing physician. Though the test has only been studied in symptomatic patients so far, one could imagine this at-home test being extremely attractive for the routine testing that will likely be required for a transition into a “new normal” in 2021. At-home test providers like Lucira Health are well positioned to integrate with the rising wave of digital passport solutions (e.g., IBM Health Pass appCommonPass app) that help to verify an individual’s COVID status ahead of entering public spaces (e.g., work, travel).

    EHR integration and reimbursement challenges remain crucial to teleheatlh’s impact

    TLDR: According to a recent survey of >1,500 physicians by the COVID-19 Healthcare Coalition, key challenges to sustained telehealth adoption include reimbursement, EHR integration and patient access to technology. The survey identified a consensus among providers that telehealth has a positive impact on patient outcomes, experience and cost of care. However, >70% of respondents said the potential roll-back of reimbursement coverage would be a major challenge to sustained adoption. More surprisingly, ~60% of clinicians reported that they still cannot access telehealth interfaces directly through their EHR systems. Synchronous video calls remain the dominant telehealth modality (~80% use interactive video visits) with very few using RPM tech (~11%).

    So what? Looking ahead to a post-pandemic era, reimbursement for telehealth visits will likely be the primary lever of sustained adoption. Just last month, CMS added reimbursement for 11 new telehealth services during the public health emergency. Though Medicare leaders have called for continued access to telehealth, further evidence around cost effectiveness and patient outcomes will likely be crucial to driving sustained uptake by private payers. Initial data suggests cost-savings, especially in chronic disease care, and improved patient experience. Younger generations are also expected to act as champions of telemedicine, driving continued adoption in the future. Millennials and Gen Z are willing to pay a “convenience premium” for telehealth services and are more comfortable with technology, while older participants tend to prefer traditional care.

  • Vol. 39 (11/17/2020) — Amwell's Q3 revenue jump | Google's new AI tool for medical records

    Amwell’s Q3 revenues jump 80% heading into a new COVID “peak”

    TLDR: In Amwell’s (AMWL) first public earnings call, co-CEO brothers Roy and Ido Schoenberg reported total Q3 revenues of $62.6M (vs. ~$35M in 2019), projecting FY 2020 total revenues of ~$240M (vs. $149M in 2019, or ~60% growth YoY). While it’s no surprise that Amwell and its virtual visit competitors are on-track for a record-setting growth year, interesting highlights of the earnings call include:

    • Inversion of mix of AMG (Amwell providers) vs. non-AMG  (health system / health plan providers compared to last year — now ~75% non-AMG, reflecting a shift toward hybrid / “virtual first” + brick-and-mortar care models

    • ~30% decrease in visit volume (1.4M in Q3 vs. 2M in Q2) compared to Q2’s peak volumes associated with COVID, with a shift toward lower-margin visits

    • Margins improvements expected in the mid-term (Amwell’s long-term GM target is ~50%) as new telehealth experiences translate into sustained post-pandemic use and expanded use of specialty care visits

    So what? While Amwell lags its primary competitor Teladoc (TDOC) in scale of revenues (~75% less expected in 2020) and visits (40-50% less expected in 2020), the newly public company has experienced massive growth during the pandemic. Teladoc has long enjoyed the scarcity premium of being first-to-market, with much skepticism over newer competitors’ ability to achieve comparable scale. One such concern has been ability to scale an external network of providers (e.g., Amwell’s non-AMGs) to provide patients with a unified virtual + brick-and-mortar care experience (i.e., being able to see your PCP or specialist rather than a separate virtual provider, or worse, a new virtual provider each time). In the last year, Amwell has expanded its provider network tenfold from just 6,000 (Q3 2019) to 62,000 (Q3 2020). Another concern has been the ability of competitors to scale globally. While Amwell has work cut out for itself in this domain, the company expects its recent Google Cloud partnership to be a major driver for global expansion. As Amwell continues to scale on the back of the pandemic, we expect Amwell to call Teladoc’s raise in the chronic disease management space (i.e., creation of a unified care platform via merger with Livongo).

    Google Cloud launches AI tools for mining unstructured medical text

    TLDR: Last week, Google pulled back the curtains on its two latest healthcare tools: Healthcare Natural Language API and AutoML Entity Extraction for Healthcare. Both tools can be used to mine, extract, and organize data from unstructured clinical records, a major pain point for providers looking to more effectively leverage their clinical data and for pharma and RWD players hoping to gain insights from deeper clinical information that typically requires time-intensive manual curation. The  NLP API will be available for free through Dec. 10 while AutoML will be free for the first 5,000 text records and 1,000 document pages imported.

    So what? In its announcement, Google Cloud highlighted a few key use cases it sees as strong fits for the technology — telehealth visit transcript mining and documentation, more effective pharma patient-to-trial matching, and provider reporting requirements (e.g., HEDIS, disease registries). We additionally see strong fit for this technology for:

    • Improved clinical decision support, value-based care, and population health management tools providers may develop internally

    • Potential revenue diversification for providers via enhanced partnerships with RWD aggregators or outright development of proprietary RWD offerings

    • Enriched utility of interoperable clinical records shared between providers (i.e., reduced “missing” fields and errors)

    Virtual fertility clinic launches AI tool to predict probability of natural conception

    TLDR: UK-based fertility company Apricity has built an algorithm to predict female fertility based on lifestyle factors. The company serves as a virtual fertility clinic, offering tele-consultations and AI-driven personalized treatments (e.g., IVF, FET, IUI, egg freezing). It just launched an online tool that analyzes lifestyle factors to predict a woman’s chances of conceiving naturally.  Its predictions are based on age, BMI, weekly alcohol intake and smoking habits. The key value of the tool appears to be allowing users to adjust their inputs and see how their fertility predictions may change over time, showing individuals the impact lifestyle changes may have on improving fertility (e.g., healthy BMI, reduced alcohol consumption, smoking cessation).

    So what? Though this tool focuses on lifestyle factors, predictive algorithms may eventually incorporate both self-reported and biometric data to identify digital biomarkers in fertility. Metrics like body temperature, heart rate, menstrual cycle length, flow rate and pain level may be combined to develop digital screening or diagnostic tools for key conditions related to infertility (e.g., endometriosis, PCOS) that are often misdiagnosed. With over 3,000 women’s health apps available today, there are a myriad of players collecting key metrics that could be predictive of fertility. The Apple Women’s Health Study is particularly promising for digital biomarker discovery, given its massive scale (500,000 participants) and longitudinal approach (10 years) to collecting digital metrics linked to phenotypic data about key conditions.

  • Vol. 38 (11/10/2020) — Unpacking Takeda & Seqster's RWD Partnership

    How Biden is expected to unwind dozens of Trump-era health-care changes

    TLDR: Key changes: (1) sweeping reform of appointed health agency officials, with a focus on scientists and doctors, pandemic specialists, and Obama-era ACA champions, (2) generally speaking, reinvigoration of the ACA, though potentially limited by SCOTUS’ imminent hearing on the constitutionality of the individual mandate and potential Republican control of the Senate; (3) rollbacks of Trump’s executive orders and administrative actions limiting state Medicare and Medicaid access (e.g., slashed marketplace advertising budgets, work eligibility requirements, premium cost-sharing), (4) reversal of Trump’s Title X reforms banning funding recipients from performing or referring abortions.

    So what? The political philosophies underlying Biden-Harris’ anticipated healthcare changes should come as no surprise. While Harris was an early “Medicare for All” champion and Biden a more moderate “public option” proponent, both plans for restructuring America’s coverage will be challenging without a decisive Democratic Senate majority. More myopically, we expect a Biden administration to usher in a decisive, top-down strategy for halting and reversing record-breaking COVID infection rates, and ultimately, implement coordinated federal-state plans for safe re-openings and vaccine rollout. At a high-level, Biden’s administration is expected to contrast the Trump administration’s tone with respect to social determinants of health (SDOH) and equity of healthcare access and outcomes, with expected investments in virtual care and revitalized emphasis on value-based care and alternative payment models via CMMI. While agency deregulation and unique emergency / pandemic-driven authorizations during Trump’s term have seemingly set the stage for a digital health “boom”, we expect the next 4 years under Biden to bring structured investments, industry expertise, and emphasized goals of equity and access that will allow the digital health sector to leverage built momentum and thrive.

    Alphabet unveils open-source “Project Amber” for digital mental health biomarker discovery, invites collaboration

    TLDR: The program aims to leverage the nearly century-old technology of EEG and advancements in machine learning to discover composite biomarkers for depression, anxiety, and other mental health conditions. While the program’s scope is broad, its initial focus appears to be on development of compound subjective-objective biomarkers (i.e., objective digital biomarkers that complement subjective patient experience and clinician observations) with highest initial uptake for patient monitoring and prognostic applications.

    So what? Project Amber signals a tonal change from “big tech”, which to-date has largely safeguarded in-house development for leading digital biomarkers (e.g., Apple & Google / Fitbit’s Heart studies). While Alphabet will still pursue independent development, this open-source call for collaboration invites leading researchers and digital health experts to leverage Project Amber’s portable EEG hardware design, machine learning techniques, and data visualization and stimulus software to derive their own insights. While EEG biomarkers are largely perceived as non-novel and lab-based (i.e., requiring presentation to a traditional healthcare setting), Alphabet’s prototype adds to a growing cohort of portable EEG devices aimed at virtual / remote use. Outside of EEG, other companies are pursuing smart device-based digital biomarkers for mental health (e.g., Mindstrong HealthEllipsis HealthBrainCheckCompanionMx).

    FDA approves Apple Watch app for treatment of PTSD-related nightmares

    TLDR: Founded in 2015, NightWare built an app to help individuals suffering from PTSD-related nightmares to improve restful sleep, and it has just been FDA approved for use on Apple Watch. The app monitors sleep patterns through heart rate and movement, and builds a customized treatment in the form of vibration patterns that interrupt nightmares without fully awakening the user. The NightWare device is prescription-only and intended as a combination therapy alongside prescribed medications and other therapies for PTSD. The prescribed NightWare kit includes an Apple Watch, which should only be worn during sleep due to false alerts and battery life (i.e., needs to charge during the day). Given recent FDA approval, it remains to be seen how payers will navigate coverage for NightWare as a companion therapy, including the AppleWatch hardware.

    So what? NightWare joins a growing list of FDA approved digital therapeutics in mental health. In PTSD, the commercial DTx landscape is relatively nascent, with Freespira as the key FDA-approved solution and other products still in development (e.g., Pear Therapeutics). Since its FDA approval, Freespira appears to have garnered insurance coverage by some private payers including Highmark and Anthem. Payer coverage of FDA-approved DTx is improving, but remains spotty across payers. Long-term evidence generation around care outcomes and cost appears to be crucial for more robust payer coverage. Pear Therapeutics just released analysis of real-world claims data, suggesting reduced payer spending of ~$2,150 per patient over six months with its reSET-O product for opioid use disorder. Though Pear’s data suggests near-term costs savings, ICER experts call for additional evidence to compare the long-term clinical and economic value of DTx companion therapies, like reSET-O and NightWare, relative to standalone medication.

  • Vol. 37 (11/4/2020) — A big week for RWD

    Pairing wearables data with self-reported symptoms could improve COVID-19 prediction

    TLDR: In this updated readout from the Fitbit / Scripps DETECT study (Digital Engagement and Tracking for Early Control and Treatment), researchers used a “triad” of resting heart rate, sleep quality, physical activity data from 3,800 symptomatic patients (of the 30,000+ total patients enrolled) along with patient-reported symptom data to improve diagnostic accuracy to 0.80 (from 0.77). Notably, while sleep and physical activity were significant predictors (AUC of 0.68 and 0.69, respectively), resting heart rate was not (AUC of 0.52).

    So what? In an August readout from Fitbit, researchers reported diagnostic accuracy of AUC 0.77 in detecting COVID across 1,100+ patients using the same digital biomarker triad with 4 days of prior symptom history. This updated readout not only validates the initial findings among a much larger study group, but shows slight improvement in overall diagnostic performance by layering patient-reported symptom data into the “triad” as a fourth digital biomarker. While still in its infancy, the digital biomarker space is showing early promise as a complementary (and in the distant future, perhaps substitutive) approach to traditional biomarkers for detecting disease. The overwhelming trend toward multi-omic signatures in the “traditional” biomarker space is already coming to bear in digital biomarkers, which we expect will explode in complexity, diversity of biometrics and behavioral markers, and patient-reported data in the years to come. In addition to the Fitbit DETECT study, other major COVID-focused digital biomarker development programs underway include Huami’s ~1.3M-user study in China and the Robert Koch Institute’s study in Germany with 500,000+ enrolled.

    Takeda extends RWD partnership with patient-centric data aggregator Seqster 

    TLDR: After investing in Seqster in February, Takeda has now announced an extended partnership with the RWD start-up dubbed the “mint.com” of health data by its CEO, Ardy Arianpour. Under the partnership, Takeda will gain access to the Seqster Research Portal (SRP) which matches patient-level clinical data from 3,000 hospitals / health systems and 150,000 doctor’s offices with patients’ molecular and wearables-generated data. Takeda plans to leverage the portal to launch 12 distinct use cases across the organization in the next few weeks.

    So what? Takeda’s announcement comes on the heels of its recent partnership with Amazon Web Services and Accenture aimed at cloud-driven organizational infrastructure transformation. Other global pharma giants have inked similar partnerships (e.g., Merck-AWSGoogle-PfizerGoogle-GSKGoogle-Bayer) establishing the infrastructure to support larger, more real-time use of RWD. The Takeda-Seqster partnership also follows a trend of pharma companies partnering with RWD aggregators (e.g., Roche / Genentech-PicnicHealth) to tap into larger, more multi-omic datasets with potential for massive scale, automated data linkage (e.g., Datavant), and near real-time reporting. Stay tuned for our interview next week with Seqster CEO, Ardy Arianpour, and Takeda Head of Emerging Technologies & Digital Partnerships, Emir Roach!

    Medidata, TriNetX and Datavant join forces for real-world data pact

    TLDR: The partnership will link real-world data collected on new therapies to generate more robust safety and efficacy profiles. The companies each play distinct roles in the engagement, with Medidata’s clinical research platform, TriNetX’s real-world data from a global network of HCOs, and Datavan’ts token-based data ecosystem. They aim to link relevant data for new therapies before trials, during clinical trials and after approval, with the ultimate goal of optimizing capture for safety and surveillance data.

    So what? Each player in this partnership arguably has the resources and runway to roll-out directly competitive offerings on real-world data for new therapies. However, perhaps the most differentiating aspect of their joint offering is one that these players could not build alone. This is the opportunity for seamless, longitudinal visibility on the  performance of newly approved therapies, which would appeal to pharma and payers alike. Longitudinal data capture is one of the key pain points observed with disparate RWD offerings available today, because patient data is so often siloed across disparate institutions and IT systems (e.g., EMR, LIS, EDC, etc.). Datavant’s market-leading “patient key” tokenization technology is particularly crucial to building longitudinal, patient-level datasets spanning data sources, as evidenced by its growing number of data partnerships (e.g., Parexel-TriNetXTakeda-SeqsterBlue Health IntelligenceMedablePrecision Digital HealthPrognosSymphony HealthTrialbeeCastor). Given Medidata’s entrenchment in clinical trials, Datavant’s open data ecosystem and TriNetX global reach across ~170 HCOs, these companies are incredibly well-positioned to facilitate longitudinal data capture that could offset the need for post-market studies requiring active patient follow-up.

  • Vol. 36 (10/28/2020) — 5 ways the election could impact digital health

    Medidata acquires MC10’s digital biomarker business

    TLDR: Medidata  offers end-to-end software solutions for clinical trials through its Rave Platform, including trial planning, data management and analytics. Medidata’s market-leading Rave EDC solution offers integration with the Rave Patient Cloud, a suite of patient-centric tools including eConsent, eCOA, and wearable sensors. Medidata’s acquisition of MC10 will bolster its Patient Cloud platform through MC10’s BioStamp sensors and analytics capabilities. Medidata will leverage MC10’s biosensors to expand its portfolio of patient-facing tech, better enabling decentralized clinical trials and biomarker discovery efforts.

    So what? Digitization and decentralization of clinical trials has become increasingly important during the COVID-19 pandemic. Researchers also estimate that ~70% of clinical trials will likely include wearable sensors by 2025. Medidata’s acquisition of MC10’s biomarker business will allow the software giant to expand its decentralized trial capabilities toward remote, continuous biometric measurement. MC10’s BioStamp nPoint sensor captures 44 standard metrics around activity, posture, sleep, sEMG and vital signs (e.g, continuous HR and HRV, respiration rate). MC10’s digital biomarker capabilities will allow Medidata’s industry customers to innovate in remote biometric data capture, analysis and integration with other data capture mechanisms used in trials.

    LabCorp enhances decentralized clinical trial offering with integrated platform

    TLDR: LabCorp announced a new technology platform that facilitates interoperability across disparate tools deployed in clinical trials. LabCorp’s drug development business, Covance, aims to leverage this integrated platform to reduce administrative tasks for patients and sites while achieving operational efficiencies for study sites. The need for interoperability is rooted in LabCorp’s recent acquisitions of GlobalCare (global mobile nursing and ambulant care organization) and snapIoT (global med tech company with digitized clinical trial platform). Integration with snapIoT’s platform will significantly bolster Covance’s decentralized trial technology through eConsent, ePRO, eCOA, telemedicine and connected device integration.

    So what? Earlier this year, LabCorp inked a deal with digital trial software company Medable to integrate its patient and site interfaces. LabCorp’s latest acquisitions and integrated tech platform indicate a sustained effort toward decentralized trial capabilities embedded in Covance’s own offering. A recent PharmaIntelligence survey suggests that ~90% of experts anticipate sustained adoption of decentralized trials in the near term. However, data protection and privacy remains a key obstacle in implementation for decentralized trials. This challenge is evidenced by a recent ransomware attack on global software company eResearchTechnology, which was facilitating ePRO for several COVID-19 trials at the time. Data security concerns will likely remain paramount to industry stakeholders decision-making around decentralization of endpoint data collection (e.g., ePRO) to decentralize in the future.

    5 ways the election could upend digital health, according to 14 healthcare CEOs, investors, and policy experts

    TLDR: CEOs and leaders of digital health think tanks, venture capital funds, and start-ups believe a Trump victory in next week’s election could hold detrimental consequences for the digital health space. Among these are: (1) dismantling of the Affordable Care Act, which could threaten ~30M Americans’ coverage, valuable contracts with health plans on individual exchanges, and more broadly, innovation in a potentially unstable regulatory and payment landscape; (2) concomitant dismantling of the Center for Medicare & Medicaid Innovation (CMMI), which could be detrimental efforts to reform payment mechanisms (e.g., value-based care models); (3) threats to patient privacy and protection under policies resembling “consumer protection” rather than “patient protection”; (4) despite existence of bipartisan support for telehealth (most notably from Trump’s CMS Administrator Seema Verma), rollbacks on payment parity for virtual care in favor of treating the “patient as consumer” under a “free market” that relies on digital health companies to cut costs to remain competitive (proponents of this argument believe that a Biden administration’s public option could be used to exert competitive pressure on commercial payors to maintain parity coverage); and (5) continued failure to address systemic access and equity issues in connectivity, digital infrastructure, and social determinants of health, which drive up to 80-90% of clinical outcomes.

    So what? Market mechanics and policies aside, fundamental differences in the two candidates’ political philosophies create two diverging paths into healthcare’s digital future. While Trump’s HHS, CMS, and FCC appointees have pushed innovation in telehealth and information blocking — two significant and welcomed changes in the space — his administration largely stands for deregulation and the “status quo” of healthcare in terms of how equitably it distributes. Biden’s nomination, on the other hand, was won on the back of promises of healthcare reform that stresses improved access for low-income and rural Americans, key populations for which digital modalities offer such advantages and potential to improve and equalize clinical outcomes. It’s for this reason that we have chosen not to remove “politics” from business and remind our readers to vote, and to vote for a future that brings the digital health space closer to improving outcomes for all.

DeciBio’s Q&A with Ramon Felciano, Ph.D., CTO & VP of Strategy for QIAGEN Digital Insights

strategic guidance that DeciBio possesses.

‘Digital Contact Tracing’ — Advantages, Risks, & Post-COVID Applications

strategic guidance that DeciBio possesses.

How Consumerization is Driving Evolution of Digital Health through Strategic Partnerships

strategic guidance that DeciBio possesses.