Move fast, but don’t break things

Despite adjacency to the tech industry and the oft-cited motto to “move fast and break things,” success in digital health instead requires adherence to the regulations of the healthcare industry. Certain digital health solutions and tools require FDA oversight—last week saw Lensar’s FDA clearance of its AR-assisted cataract surgery system and EarliTec Diagnostics’ FDA clearance for its autism diagnosis support tool, plus Rune Labs get an FDA nod to translate Apple Watch data into insights about Parkinson’s. While some startups are steeped in the regulatory terrain, achieving regulatory approval is not always straightforward or well-understood; a recent survey by the nonprofit Digital Medicine Society (DiME) reported that 25% of digital health developers didn't know whether their product should be regulated; of those who did know regulation was needed, 75% didn’t know the optimal pathway. A new initiative by DiME, FDA, Consumer Technology Association, Google, Abbott, yours truly at Rock Health, and additional partners aims to change that. The collaboration will develop a new tool to help digital health innovators build regulatory considerations into their strategy from the outset—a potential differentiator from competitors and with investors, especially important at a time when belts are expected to tighten.

Rock Health will be in Boston on July 19, and we are hosting a digital health community happy hour from 5-7:30 pm. If you’re interested in joining and connecting with local innovators, please fill out this form.


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Initial clinical trial locations include Austin, SF, and LA Forbes

Facebook Is Receiving Sensitive Medical Information From Hospital Websites
Probably a HIPAA violation, definitely a little creepy STAT

Digital Mental Health's Crowded Market Means Startups Must Show Outcomes
+ Why digital mental health investment may shift toward severe illness Behavioral Health Business

Why Rural Americans Keep Waiting for Fast Internet, Despite Billions Spent
Reliable access is still a problem in 2022 The Wall Street Journal

VA Offers Up To $650M To Test Health Tech
$20M innovation challenge to help prevent veteran suicide Becker's Hospital Review

How Apple's Approach Is Building A Revolution In Health
Enhancing the provider-patient relationship with wearables TechCrunch

Oracle Thinks It Can Fix Healthcare's Biggest Tech Issue
But some health IT experts are skeptical The Verge

Should you build or buy the provider data platform for your company? Check out this helpful resource created by Ribbon Health, a Rock Health portfolio company, to evaluate the key considerations. Ribbon is an API data platform that provides a range of real-time data insights including provider demographics, insurance, cost, and quality.

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