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The FDA just flipped the script on digital health regulation.
Starting January 2, 2026, the TEMPO pilot program allows digital health companies to skip premarket approvals, investigational device exemptions, and certain clinical trial requirements.
Think about that for a second.
The same agency that takes years to approve devices is now saying: “Go ahead, treat Medicare patients first, show us the data later.”
This isn’t just regulatory flexibility, it’s a complete paradigm shift.
Up to 40 companies can participate across four areas:
• Cardio-kidney-metabolic conditions
• Musculoskeletal disorders
• Behavioral health
• One more to be determined
Here’s where it gets interesting:
This aligns with CMS’s ACCESS Model launching July 1, 2026, which reimburses providers for using digital tools with chronic disease patients. For the first time, we have regulatory flexibility AND payment incentives aligned.
The implications are massive:
✓ Startups can reach Medicare beneficiaries without spending millions on regulatory approval
✓ Patients get faster access to innovative digital therapeutics
✓ Real-world data drives future regulation instead of controlled trials
But here’s my concern:
We’re essentially beta testing on our most vulnerable population, Medicare beneficiaries with chronic conditions. Yes, there’s clinician supervision and consent requirements, but are we comfortable with this trade-off?
The traditional FDA approval process exists for a reason. It’s slow, expensive, and frustrating, but it catches problems before they scale.
Now we’re inverting that model entirely.
This could be the breakthrough digital health has been waiting for, or it could expose millions of seniors to unproven technologies.
My prediction: Within 18 months, we’ll see either a massive expansion of this program or a high-profile failure that sets digital health back years.
The FDA is betting big on real-world evidence over controlled trials. CMS is betting Medicare dollars on digital therapeutics. And 40 companies are about to test whether Silicon Valley’s “move fast and break things” mentality works in healthcare.
What could possibly go wrong? 🎯
♻️ Repost if you think digital health regulation needs radical reform
👉 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/
