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The FDA just unleashed thousands of AI health tools overnight.
On January 6, Commissioner Marty Makary announced sweeping deregulation that exempts wellness apps, wearables, and certain clinical decision support tools from FDA oversight.
This isn’t a minor adjustment, it’s a seismic shift.
What changed:
• Single-recommendation AI tools can skip FDA review if deemed “informational”
• Long-term risk predictors (like cardiovascular risk) are now exempt
• Wellness and fitness wearables face minimal oversight
• Digital health companies can access Medicare patients through the new TEMPO pilot
The dividing line? Time sensitivity and data complexity.
AI that predicts your 10-year heart disease risk? No FDA review needed.
AI that predicts risk within 24 hours or uses genomics? Still regulated.
This creates an interesting paradox: the same algorithm could be regulated or unregulated based solely on its output timeframe.
📊 Consider the scale: Over 1,357 AI medical devices were already FDA-cleared. Now thousands more can bypass that process entirely.
For innovators, this is liberation. Silicon Valley speed meets healthcare.
For patients, it’s complicated. More access to AI tools, but less regulatory validation.
For health systems? They’re now the de facto gatekeepers, deciding which unregulated AI tools are safe enough for their patients.
The real question isn’t whether this accelerates innovation (it will), but whether health systems are ready to become the primary safety validators for consumer AI.
We’re entering uncharted territory where your fitness tracker might diagnose conditions your doctor hasn’t considered, and there’s no FDA in between.
This could democratize healthcare AI or create a wild west of unvalidated algorithms. Probably both.
♻️ Repost if healthcare AI needs smart guardrails, not red tape
👉 Follow me, Jonathan Govette, for real-time updates on healthcare technology and business news. LinkedIn Profile: https://www.linkedin.com/in/jonathangovette/
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Author:
CEO/Co-Founder @ Oatmeal Health | AI Lung Cancer Screening | Almost Became a Doctor | Engineer | Follow to Share What I’ve Learned Along the Way
I help patients get the care they need earlier, preventing late-stage cancer.
That’s been the throughline across three companies and almost 20 years in healthcare. At ReferralMD, we fixed broken referral networks so patients didn’t fall through the cracks. At Oatmeal Health, it’s lung cancer: building the diagnostic and screening infrastructure so the 85% of cases caught too late get caught early instead.
Today as CEO of Oatmeal Health, I lead a team embedding AI into radiology workflows to turn routine lung CT scans into reimbursable cancer risk assessments. We partner with FQHCs to reach underserved communities, and with health systems and payers to make early detection economically sustainable. Think HeartFlow or Cleerly, but for lungs.
Between companies, I advised at Techstars and Plug and Play, mentoring founders building in digital health. That experience shaped how I think about what separates companies that ship from companies that stall: distribution, reimbursement, and clinical trust, not just technology.
I’m a CancerX alumnus, a 3x healthcare founder, and someone who believes the biggest problems in cancer aren’t scientific. They’re operational.
We’re hiring mission-driven builders at Oatmeal Health. If you want to work on something that matters, reach out.
When I’m not working, I’m traveling, mentoring, and keeping up with one very energetic husky. 🐾
Substack – The Oatmeal Bite:
Millions of patients get less care because of who they are, where they live, or how they look. I’m fighting to change that. CEO @OatmealHealth, a startup built for the underserved. The Oatmeal Bite: intel for clinicians, investors, and advocates.
Jonathan Govette
CEO of Oatmeal Health
Substack:
https://oatmealhealthjonathangovette.substack.com/
