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# Regulating AI in Healthcare: Paragon White Paper
- URL: https://www.fdaweb.com/regulating-ai-in-healthcare-paragon-white-paper/
- Published: 2024-12-11T12:00:00.000Z
- Updated: 2026-09-14T14:49:05.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5158348

A Paragon Health Institute white paper presents guidelines that it says will protect the many benefits of artificial intelligence (AI) in healthcare without increasing risks to public health. “Patient safety is an overarching concern throughout,” the [paper](https://paragoninstitute.org/private-health/healthcare-AI-regulation/?ref=fdaweb.com) says, “as injury can be caused not only by faulty AI products but also by superior AI products not securing market access in a timely fashion. Closely related to safety concerns is the evaluation of AI risk and its contextualization within individual AI technologies and their specific medical applications.”

The paper outlines problems facing AI regulation in healthcare and then proposes the guidelines it says can mitigate the problems.

“Previous regulation by FDA of healthcare software has a significant influence on the guidance provided,” Paragon says. “The agency’s basic model for a software’s rigor of inspection and evaluation remains unrevised…. The major departures in approach are not from agencies like FDA but from an emerging sentiment that believes government should implement expansive preemptive rules on AI healthcare, rules that generalize the diverse technologies categorized under the singular term AI and ignore the role of existing patient safeguards for medical device safety and health information.”

Paragon says its proposed approach is an effective and non-disruptive model for crafting AI healthcare regulation. Above all, it says, the guidelines seek to maintain regulatory governance in existing agencies with historical experience in healthcare matters, albeit with recommendations reflecting the new realities specific to AI technologies. It says the approach has the advantage of not expanding the federal bureaucracy and avoiding a regulatory framework that favors established companies in the AI market.

Paragon’s president, **Brian Blase**, worked on healthcare economic policy in the first Trump administration. FDA commissioner nominee **Marty Makary** is listed as one of Paragon’s Public Advisors.