FDA appoints former AI exec Rick Abramson to lead digital health center

FDA names former AI executive to lead digital health

The Food and Drug Administration has appointed Rick Abramson, a former executive from an artificial intelligence health company, as the new director of its Digital Health Center of Excellence. Abramson was most recently the chief medical officer at a subsidiary of Harrison.ai, a company that develops AI for interpreting radiological images.

Two people familiar with the appointment confirmed the move to STAT. Abramson has been serving as a senior adviser in the FDA commissioner’s office since last summer.

Appointment follows push for AI deregulation

The leadership change comes as the FDA grapples with how to regulate a rapidly expanding field of AI-enabled medical software. In January, the agency announced a significant policy shift to soften its oversight of certain AI products.

That shift, which allows more wellness products and AI tools that support clinician decisions to avoid full FDA review, was reportedly led by Abramson and two other officials. Three agency employees told STAT the push was driven by Abramson, Jared Seehafer, and Shantanu Nundy from the commissioner's office.

New director's background in clinical AI

Abramson's background is firmly in the world of commercial health AI. His former company, Harrison.ai, focuses on creating AI assistants for use in radiology and pathology, areas where the FDA has previously cleared several products.

This industry experience is now being applied directly to regulatory policy. His appointment signals the agency's focus on integrating industry expertise as it shapes new digital health frameworks.

The FDA's evolving stance on software

The FDA's Digital Health Center of Excellence was established to provide specialized review and policy for software-based medical devices. Abramson's arrival follows a period of notable deregulation for lower-risk digital tools.

The agency's recent actions highlight a strategic pivot. Key elements of the new approach include:

• Reduced oversight for AI that supports, but does not replace, clinical decision-making.
• Allowing more general wellness products to come to market without FDA review.
• Creating clearer pathways for software-as-a-medical-device (SaMD) updates.

The long-term impact of this lighter-touch regulatory stance on patient safety and innovation remains a central question. Abramson will now be the official leading the center tasked with navigating these complex trade-offs.