The Trump administration has promised to reduce the barriers between health artificial intelligence developers and patients. With a provocative new proposal, an AI company has offered regulators a way to let a broad swath of potentially risky AI devices flood the market.
AI developer Harrison.ai last October petitioned the Food and Drug Administration to allow manufacturers to release certain new AI products radiologists use to analyze medical images without review, provided the FDA has previously cleared a relevant product from a company. AI developers would also need to follow certain technical standards and offer a plan for how to keep tabs on the product’s performance.
The FDA allows anyone to submit a petition asking for devices to be exempted from review, but it happens rarely. The agency must respond within 180 days, and if it does not deny Harrison.ai’s proposal by mid-April, it will go into effect. At the same time it’s considering the petition, the FDA announced that it had appointed a former senior executive from a Harrison.ai subsidiary to direct the office that informs agency policy on AI.
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