This is the thirty sixth issue of Things & Thinks. The research brief summarizes two important issues in digital health-outcome measures and patient rights. The monthly sections with a Longread, Tweet and Chart o the Month, follows included the newly started section-Mental Model of the Month. Happy to hear your thoughts and feedback…
Robustness of Digital Health Claims
Researchers at Rock Health and Johns Hopkins University analyzed the activity of 224 companies that have collectively raised $8.2 billion since 2011. Their findings are quite interesting-
- Digital health companies typically make 3 types of claims- Engagement (how engaged users are with the technology), Economic (a product’s impact on health-related expenses or revenue for the buyer or end user of the product) and Clinical (a product’s impact on patient health or well-being).
Many companies (43%) made zero claims.
- The median number of claims of any type was zero for companies that sold to consumers and providers. The median number of economic and engagement claims for companies that sold to payers was also zero. Companies that sold to employers made more clinical, economic, and engagement claims than companies that sold to all other customer types.
- The researchers also calculated ‘clinical robustness’ score-defined as the sum of the number of regulatory filings and clinical trials.
- The average clinical robustness score for all companies was 2.5 (clinical trials: 1.8; regulatory filings: 0.8). The median clinical robustness score was 1, with 98 companies (44%) having a score of 0 and 34 companies (15%) having a score of 1. Diagnosis companies had the highest average clinical robustness scores (2.8), followed by treatment companies (2.2), and then prevention companies (1.9).
- Finally, the researchers also did not find any correlation between funding and its clinical robustness score!
The lack of overall correlation between a company’s total venture funding and its clinical robustness score similarly highlighted a significant asymmetry in how companies are potentially valued in today’s marketplace
Beyond traditional privacy definitions
Duke University’s Eric Perakslis wrote an insightful commentary about prioritizing privacy principles for digitzed trial participants. He proposes a basic set of practices that ‘should be considered when applying digitization opportunities to clinical trials. Anything else, is the equivalent of setting patients adrift in stormy seas.’
- Construct studies that minimize the creation of new patient accounts
- Ensure all BAA agreements prohibit further use of patient data
- Understand that gaps in patient protections are now major health tech business models & select partners accordingly
- Apply critical judgement to all uses of patient data
- Ensure patient personas are unbiased, accurate and vetted with (uncompensated) patients
- Ensure algorithms are independently evaluated for precision and bias
- Ensure cybersecurity expertise is directly available to all trial design teams
- Utilize experts to understand the gaps between regulatory compliance and patient protections
- Minimize use of patient-owned devices and patient home networks for remote monitoring
- Have an explicit cyber incident response plan for each trial
Digital Healthcare News
Tech in Digital Health
Apple revealed several new features in its latest watchOS9 including new medication tracking tool, receive alerts about possible drug interactions, a new atrial fibrillation history feature and more tools for sleep tracking as well as features for home workout at its Worldwide Developers Conference Monday previewing its watchOS 9 and iOS 16.
Sesame, a direct-pay digital healthcare marketplace, has raised $27 million in series B funding led by GV, Alphabet’s venture capital arm.
US Supreme Court overturned Roe v Wade, thereby jeopardizing right for abortion. There is a lot of pressure on tech firms-health and non-health both-about protecting data privacy.
Auckland-based health technology startup Alimetry has received clearance from the US FDA for its wearable device for diagnosing gastric disorders.
Rune Labs received FDA 510(k) clearance to use its StrivePD app to monitor Parkinson’s disease patients’ symptoms through the Apple Watch.
EarliTec Diagnostics received FDA 510(k) clearance for EarliPoint Evaluation, that helps clinicians identify autism spectrum disorder for children between the ages of 16 and 30 months old.
Schrödinger, that provides its machine-learning-powered drug discovery platform to big pharma, will kick off its own clinical development program for a candidate molecule for non-Hodgkin lymphomas.
Digital therapeutic maker Happify Health is partnering with Biogen on a digital engagement and education platform for multiple sclerosis.
Sidekick Health and Lilly will collaborate to support breast cancer patients; patients will be given access to a tailored digital treatment plan to promote behaviour modification and overcome barriers to change. Patients will also be able to access educational content on living with cancer.
Funding, Deals, Mergers & acquisitions
Bristol Myers Squibb is buying lung cancer biotech Turning Point Therapeutics, for $4.1 billion.
Optum, a UnitedHealth Group company, will acquire EMIS Group for $1.5 billion. EMIS is a UK based provider for healthcare software, information technology and other services.
CareBridge received $140 million in a new funding round; the company focuses on Medicaid and dual eligible patients with disabilities using at-home care.
Aidoc raised $110 million in Series D investment. Aidoc is a AI enabled care platform.
Diabeloop, a closed-loop insulin delivery system start-up using AI, received $75 million in Series C funding.
Insilico, AI drug discovery start-up, received $60 million in Series D funding.
Bicycle Health, the virtual provider of treatment for opioid use disorder (OUD), received $50 million in Series B funding.
Direct primary care startup Hint Health raised $45 million in a funding round. Hint offers a platform where providers can enroll patients as members and directly bill for services.
Indian health tech company Pristyn Care bought Lybrate, a mobile health platform.
Wearables shipments worldwide declined 3% year-over-year in the first quarter, marking the industry’s first-ever decline.
Karkinos Healthcare, a technology-driven cancer care platform in India, has entered into a strategic partnership with American oncology diagnostics firm C2i Genomics to promote AI-enabled cancer monitoring in the country.
Two million patients in New England who received care at almost 60 healthcare facilities affiliated with Shields Health Care Group, a medical imaging and outpatient surgical services provider, may have had their personal data exposed in a cyberattack earlier this year.
Mental Model of the Month
For this month, I have chosen a well-known mental model — Law of Diminishing Returns. It is also somewhat related to last month’s model- Brook’s Law. As the name suggests, sometimes doing more leads to less results! this sketchplanation really captures the gist of the model-
This is proving to be true for a lot of consumer focused digital health, which want to collect every data points, send tons of notifications and gamify every step of the intervention. But sometimes this can prove counterproductive, confuse/fatigue end users and collecting data that may not be used may lead to wastage/burden on healthcare resources.
Longread of the Month
NHS recently released a report providing insights into ‘Using Health Data for Research and Analysis’, proposing an approach called a “trusted research environment” or TRE. Using this approach, the report suggest, will help build trust in patients, ease data access for researchers, enabling checking and sharing of analytical tools in the design and help build health data science community. Here is the link to the report.
Tweet of the Month
Oracle’s Larry Ellison, after completing the acquisition of Cerner, set out a vision to use the power of Cerner to build a national health records database. This vision, not surprisingly, received lot of feedback and this tweet has some interesting commentary on it.
Chart of the Month
This month, instead of a chart, I have a schematic figure from NEJM Catalyst, that captures the innovation in the primary care space in the US.