FDA taps radiologist Rick Abramson, MD, to lead its Digital Health Center of Excellence
The FDA has selected radiologist Rick Abramson, MD, as director of the Digital Health Center of Excellence (DHCoE), according to a Feb. 19 report from STAT citing anonymous sources. As of late Monday, the agency had not issued a formal announcement, but Abramson's LinkedIn profile was updated in February to reflect the new title.
"My colleagues and I [at the FDA] focus on advancing scientifically coherent, ethically grounded and risk-proportionate regulatory approaches for digital health technologies," Abramson notes on LinkedIn. His stated goal: ensure regulatory science keeps pace with innovation while protecting patients, empowering consumers and preserving public trust.
Why this matters for healthcare leaders
FDA policy is signaling a lighter premarket touch for certain digital health products, with more tools reaching the market without traditional premarket review. In January, the agency outlined a more hands-off stance for segments of digital health-consistent with efforts to accelerate AI-enabled solutions, as summarized by McDermott Will & Schulte.
For providers, payers, and health tech teams, this shifts the pressure to internal validation, procurement diligence and postmarket monitoring. Expect faster product cycles, more frequent updates and greater responsibility to prove real-world safety and performance inside your own systems.
What the DHCoE does
Launched in 2020 within the Center for Devices and Radiological Health, the DHCoE supports the FDA's digital health oversight and innovation agenda. It provides expertise on medical device cybersecurity, AI/ML, regulatory science, and strategic partnerships-but it does not make market authorization decisions.
Primary stakeholders include patients, developers, radiologists and other clinicians, researchers, payers and government agencies. For context, see the FDA's overview of the Digital Health Center of Excellence.
Abramson's background
A Harvard-trained radiologist and Fellow of the American College of Radiology, Abramson previously served as chief medical officer at Annalise.ai (now Harrison.ai) and remains an adjoint associate professor of biomedical engineering at Vanderbilt University. Earlier, he was corporate VP over the radiology service line at HCA Healthcare, leading enterprise strategy for radiology and AI across nearly 200 hospitals.
He credits his work with aligning clinicians, engineers, policymakers and operators around clear standards of evidence, performance and accountability. "I am motivated by a simple North Star: ensuring that regulatory science remains rigorous, ethically grounded and firmly anchored to public health impact-while evolving thoughtfully as digital technologies continue to transform how we promote, maintain and restore health," he writes.
Recent policy moves to watch
Abramson joined the FDA last June as a senior consultant to the Office of the Commissioner before stepping into this leadership role. Earlier this month, the center launched a Digital Health Devices Pilot with the Centers for Medicare & Medicaid Services to encourage technology use in chronic care while maintaining patient safety.
Practical steps for hospitals, health systems and payers
- Tighten governance: Refresh your digital health and AI oversight committee charters, roles and escalation paths. Make sure clinical safety, IT security and legal have shared accountability.
- Vet updates like new devices: Treat algorithm updates and model re-trains as change-controlled events. Require vendor transparency on data, performance, bias and monitoring plans.
- Stand up postmarket surveillance: Use registries, QA workflows and incident reporting to monitor real-world performance and drift. Close the loop with vendors on fixes.
- Map your portfolio to FDA policy: Classify apps and devices against current guidance to understand which products bypass premarket review and where you need stronger internal evidence.
- Prepare for payer scrutiny: Build economic and outcomes dossiers early. CMS pilots and coverage decisions will reward solutions that show measurable, sustained benefit in chronic care.
If you're responsible for compliance or regulatory strategy, this learning path can help you operationalize current expectations: AI for Regulatory Affairs Specialists.
Another radiologist in a federal tech role
Abramson is the second radiologist to step into a high-impact federal position during President Donald Trump's second term. Last summer, Health and Human Services named Florida interventional radiologist Thomas Keane, MD, MBA, as the ninth National Coordinator for Health IT, overseeing policy for interoperability, EHRs and related technologies at the Office of the National Coordinator for Health IT.
Bottom line: Expect faster market entry for select digital health and AI tools-and more responsibility on healthcare organizations to validate, monitor and prove value. With Abramson at DHCoE, the FDA's posture looks set to emphasize practical, risk-proportionate oversight while keeping patient safety and public trust at the center.
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