Regulation of AI in Healthcare

WASHINGTON, Dec. 11, 2024 /PRNewswire/ — Paragon Health Institute, a leader in healthcare research and market-based policy proposals, has released today a significant report on artificial intelligence in healthcare, Healthcare AI Regulation: Guidelines for Maintaining Public Protections & Innovation. This paper comes at the end of a year when hundreds of AI-related bills have been proposed across state legislatures and the federal government has been promoting expansive cross-agency AI regulation. The central concern of Paragon’s paper is the prevention of AI misregulation that fails to improve public protections while increasing costs and reducing the medical advances policymakers desire most from AI.

The paper illuminates the complexities of AI regulation in healthcare and then proposes guidelines that balance public protections with the need for healthcare innovation. Among the more noteworthy proposals is the recommendation that AI regulation must specify both the type of AI technology and the healthcare context to which each rule applies. In other words, rules would use granular descriptions like “artificial neural networks in medical image analysis” instead of vague language like “healthcare AI.” This emphasis on the combination of technology definition and medical context recognizes that AI risk is closely tied to these two factors.

The paper also recommends that policymakers use existing regulatory agencies — which already have industry experience — to govern AI in healthcare instead of a centralized AI office or AI czar. The paper argues such centralization would decrease regulatory awareness of industry-specific considerations and risk duplicative rulemaking between the AI office and other government agencies. Instead, the guidelines advocate for regulatory agencies having the personnel, internal AI expertise, and resources necessary to perform their duties properly.

The report’s guidelines also touch on matters such as:

• aligning regulatory efforts with the FDA’s historic work of evaluating software as a medical device;
• handling scenarios where AI-enabled devices have empirically confirmed benefits but whose mechanism of effect is hard to explain; and
• concerns around algorithmic discrimination and data privacy in AI-enabled systems.

Report author and Visiting Research Fellow Kev Coleman observed, “AI is poised to make remarkable contributions to American healthcare, but these contributions can be jeopardized by a suboptimal regulatory framework. What we need is an approach that preserves safety standards while discouraging rules that benefit the biggest AI vendors while impeding innovative startups from entering the market.”

Launched in late 2021 by Brian Blase, Paragon Health Institute provides health policy research as well as market-based policy proposals for improved outcomes in the public and private sectors. Journalists and healthcare analysts can review Paragon’s latest studies and commentary at paragoninstitute.org/research/.

Contact:

Anthony Wojtkowiak
media@paragoninstitute.org
703.527.2734

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SOURCE Paragon Health Institute