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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: The FDA released a discussion paper detailing a conceptual framework for regulation of medical devices with generative AI features. Feedback on the framework is due by Oct. 19. The FDA is seeking feedback on a potential way of regulating medical devices equipped with generative AI features, informed by the process of training human clinicians. Described as a \u201ccompetency-based approach,\u201d the process would evaluate AI-equipped devices in increasingly clinical scenarios, including potentially with real patients.
The FDA is seeking feedback on a potential way of regulating medical devices equipped with generative AI features, informed by the process of training human clinicians.
It is \u201cinspired, at a high level, by how human clinicians are evaluated and credentialed,\u201d according to an FDA discussion paper. The paper also discussed ongoing evaluation of AI devices after they come to market, noting that the FDA is \u201cconsidering whether it is appropriate to accept greater premarket uncertainty … through greater reliance on postmarket monitoring.\u201d The paper said it is intended \u201cfor discussion purposes only\u201d and is \u201cmeant to seek early input\u201d from outside the FDA. In a statement to Healio, the agency said it intends to work collaboratively on \u201cefficient, scientifically sound and least burdensome approaches\u201d to evaluating generative AI-enabled medical devices \u201cacross the total product life cycle.\u201d \u201cBy inviting input from the public, we are launching a transparent process to inform the development of an approach that safeguards patients and consumers, advances innovation and serves as a potential model for regulators around the world,\u201d the agency stated. The deadline to submit feedback is Oct. 19. In the paper, the FDA outlined a potential \u201ccompetency-based approach\u201d for premarket evaluation consisting of two parts: nonclinical benchmarking and clinical confirmation. Benchmarking would assess the safety, clinical proficiency, generalizability and agentic AI capabilities of the devices \u2014 but not necessarily all four elements for each device. This could potentially be done using \u201csynthetic data generation and simulation tools, including virtual patient avatars,\u201d the FDA wrote. Clinical confirmation would evaluate how AI-enabled devices perform \u201cunder real-world or clinically representative conditions.\u201d Aside from prospective clinical studies, the FDA suggested this could be done through retrospective analysis of real patient data; \u201cshadow deployment\u201d in a live clinical workflow without affecting actual care; the use of patient actors; or clinician review of real patient-device encounters. The FDA cited several research papers that informed these ideas. A coauthor of one of these, David Blumenthal, MD, MPP, professor at the Harvard T.H. Chan School of Public Health, told Healio the FDA had offered \u201ca thoughtful and useful beginning of a conversation.\u201d David Blumenthal \u201cIt\u2019s not settled policy, and the framework could evolve considerably during the process of collecting information,\u201d he said. \u201cThere\u2019s a lot of work that needs to be done on the clinical confirmation side and that needs to be piloted and worked out in collaboration between healthcare professionals and AI developers.\u201d While commending the FDA for having \u201can open mind and seeking broad input,\u201d he added it may be \u201coperating in areas where they don\u2019t yet have authority.\u201d \u201cIt\u2019s not clear whether FDA will actually be an agency that implements the process they have outlined because it\u2019s not always clear that generative AI used in healthcare is actually a medical device,\u201d he said. \u201cWhat they understandably didn\u2019t address, because they are part of a government that has complicated processes, is the need for new legislation, if any; for new agencies, if any; for private sector capabilities, if any.\u201d For more information: David Blumenthal, MD, MPP, can be reached at dablumenthal@hsph.harvard.edu. Published by: Sources\/Disclosures Source:
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References:
Disclosures:
Blumenthal reports being on the board of directors for Aledade.
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