Revenue Cycle Insider

Question: Technology and artificial intelligence (AI) advance incredibly quickly, but have developers thought about what happens when healthcare technology systems or AI-enabled devices require updates or become obsolete? Are there regulations to guide manufacturers through the life of the devices?

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Answer: On Jan. 7, 2025, the U.S. Food and Drug Administration (FDA) published draft guidance that offered recommendations for companies developing and marketing AI-enabled devices throughout the device’s total product life cycle (TPLC). The guidance, titled “Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” still needs to be finalized, but is the first document of its kind to offer comprehensive proposals for AI devices from development to product decommission.

“The FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways. As we continue to see exciting developments in this field, it’s important to recognize that there are specific considerations unique to AI-enabled devices,” said Troy Tazbaz, director of the Digital Health Center of Excellence for the Center for Devices and Radiological Health at the FDA in a press release.

Among the recommendations proposed by the agency is a broad approach to risk management during the device’s life cycle and suggestions on how and when companies should explain the AI device management and postmarket performance monitoring. The FDA also recommends companies to use the finalized guidance to steer their decision-making throughout a device’s life cycle.

The FDA is seeking public comments on the proposed guidance by April 7, 2025.

Resource: Review the draft guidance here.

Mike Shaughnessy, BA, CPC, Development Editor, AAPC