FDA picks radiologist to fill key AI-related role
The U.S. Food and Drug Administration recently picked a noted radiologist to fill a key role in the agency.
Rick Abramson, MD, has been selected to serve as director of the Digital Health Center of Excellence, STAT first reported Feb. 19, citing anonymous sources. The FDA had not issued an official announcement about the appointment as of late Monday and would not comment on the hire, only confirming on background he was hired to fill the role.
Abramson—who previously served as chief medical officer for radiology vendor Annalise.ai (now Harrison.ai)—also has updated his LinkedIn profile as of 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 said in his bio for the social media site. “Our goal is to ensure that regulatory science keeps pace with innovation while protecting patients, empowering consumers and preserving public trust.”
Abramson, Harrison.ai and Vanderbilt University—where he still serves as an adjoint associate professor of biomedical engineering—also did not immediately respond to requests for comment Monday. The Harvard-trained radiologist is a Fellow of the American College of Radiology and served as keynote speaker at ACR's Quality and Safety and Informatics Conference in 2024. ACR declined to comment about the appointment Monday.
The FDA first established its Digital Health Center of Excellence in September 2020 as part of the Center for Devices and Radiological Health. DHCoE was created to provide advice and support during the agency’s regulatory review of digital health technology, according to the original announcement. However, it is not responsible for making market authorization decisions.
It aims to foster digital health innovation, providing services related to medical device cybersecurity, AI, regulatory science advancement and strategic partnerships. The center’s primary customers include patients, developers, radiologists and other healthcare providers, researchers, industry payers and government agencies.
Abramson’s appointment comes as the FDA wrestles with the future regulation of AI, STAT noted Thursday. He first came aboard as a senior consultant to the Office of the Commissioner last June, LinkedIn confirms. Subsequently, the agency announced in January it would implement a more hands-off approach to digital health product regulation. This will allow for more technologies to be commercialized without FDA premarket review and aligns with efforts to promote deployment of AI-enabled products, McDermott Will & Schulte reported.
Earlier this month, Abramson’s center launched a “Digital Health Devices Pilot” in connection with the Centers for Medicare & Medicaid Services. The move is aimed at promoting greater use of technology to advance chronic care while safeguarding patient safety.
Abramson first joined the radiology vendor in summer 2022, tasked with guiding Annalise.ai’s clinical roadmap for international expansion. He holds over 25 years of experience in healthcare including roles in clinical practice, academic research, policy development and management. Abramson previously served as corporate VP over the radiology service line at Nashville-based HCA Healthcare, the nation’s largest hospital system. There, he led enterprise strategic development for radiology and AI across HCA’s network of nearly 200 hospitals, Annalise.ai noted at the time. With the vendor, he worked to advance partnerships with providers, tech developers and regulatory bodies globally.
“Across these roles, I have helped align clinicians, engineers, policymakers and operators around clear standards of evidence, performance and accountability,” Abramson says on LinkedIn. “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 added later.
Abramson is the second radiologist to fill a key regulatory role 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 of health IT. In the role, he oversees federal policy related to interoperability, electronic health records and other medtech issues.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.