Drugs

Industry Vet Named Head of FDA Digital Health Center

FDA has appointed a veteran artificial intelligence executive to lead its digital health policy unit, signaling a sharper regulatory focus on AI-driven medical technologies. Rick Abramson, who previously served as chief medical officer at a subsidiary of Harrison.ai, an Australian firm known for developing advanced AI systems designed to interpret radiological images, has been named director of the FDA’s Digital Health Center of Excellence, a key office responsible for shaping oversight of software-based medical devices, artificial intelligence tools, and other emerging digital health technologies, according to a report by DistilInfo.

The move reflects a broader trend of federal agencies recruiting leaders from industry to help navigate technically complex domains. In Abramson’s case, his experience building and deploying medical AI systems provides firsthand insight into algorithm development, validation, clinical integration, and lifecycle management — issues central to the FDA’s evolving regulatory framework, the report says.

The Digital Health Center of Excellence serves as a hub within FDA for digital health expertise. It coordinates policy development, supports review teams evaluating digital products, and engages with external stakeholders across the healthcare and technology sectors. The Center plays an increasingly prominent role as AI-enabled software becomes embedded in diagnostics, treatment planning, remote monitoring, and clinical decision support. Regulators must assess not only safety and effectiveness at launch, but also how adaptive algorithms perform post-market.

Abramson’s appointment comes amid intensifying scrutiny over how artificial intelligence should be regulated in healthcare. FDA has issued discussion papers and proposed frameworks addressing AI and machine learning–based software as a medical device, including approaches for handling algorithm updates and continuous learning systems.

Yet stakeholders across industry and academia have urged the agency to provide clearer guidance and more predictable pathways, arguing that regulatory uncertainty can slow innovation. At the same time, patient safety advocates have called for stronger guardrails to address bias, transparency, and real-world performance monitoring.

By naming a leader with direct AI product development experience, the FDA appears to be prioritizing technical fluency in shaping policy. Observers expect Abramson to influence not only premarket review standards, but also post-market surveillance requirements and engagement models with developers.

The appointment may also signal a more collaborative posture between regulators and AI innovators. An industry veteran at the helm of the DHCoE could facilitate more structured dialogue on validation standards, real-world evidence generation, and adaptive regulatory mechanisms, according to the report.

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