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Thursday, 8 January 2026 |
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Deregulating a rapidly evolving industry |
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| If today’s newsletter is any indication, AI in healthcare is going to be unavoidable this year. |
| In the last few days: |
- OpenAI announced ChatGPT Health, a new product where users can input health information to make sense of it, “while supporting, not replacing, care from clinicians”
- That came just days after OpenAI released a report about the staggering extent to which consumers are turning to ChatGPT for healthcare questions
- Startup Doctronic made waves with a new pilot in Utah in which AI is handling prescription renewals
- … and FDA Commissioner Marty Makary shared new digital health guidance, saying in an interview that the agency isn’t anticipating regulating tools like ChatGPT and Google that provide health information
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| Makary’s remarks came as the FDA put out two updated pieces of guidance on Tuesday: One on clinical decision-making tools and another on how it plans to regulate consumer wellness devices, redrawing the line between what’s considered wellness and what’s medical. |
| When it comes to healthcare, AI is here, and consumers and providers are involving it in the decisions they make about their health. And self-collected data is becoming a bigger piece of that. |
| The FDA guidance around devices and wellness in particular, seems to provide clarity to wearable makers about what the agency considers information shared as a wellness product, versus what veers into a medical grade output at a time when things are changing fast. My colleague Nicole Wetsman did some digging and saw that in that guidance, examples around blood pressure and continuous glucose monitors had been added, as well as a new section around what types of sensing can be used for wellness — and what becomes medical grade. |
| The question we have now is: How much does the updated guidance change what device makers do with their products? |
| One hint: Tom Hale, CEO of Oura, a company that’s been pushing for less regulation of wearables, said in a LinkedIn post that the guidance was “a great step in the right direction.” |
| - Lydia |
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Ask AI |
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In a report released this week, OpenAI shared that 40 million people use ChatGPT daily to ask healthcare questions. A survey included in the report found that three in five US adults reported using AI tools for health or healthcare in the last three months, including to check symptoms and talk through treatment options. The report came shortly before OpenAI announced ChatGPT Health on Wednesday, expanding the
work it’s doing in healthcare. |
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This week in health Тech |
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Tivara raised $3.6 million for AI agents to answer patient calls. Mischief VC, Y Combinator and Day One Ventures led the seed round. Its customers include the Los Angeles Cancer Network. |
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Worldwide made. Thanks for reading.
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