ARTICLE SUMMARY:
In this week’s Pathways Picks: AdvaMed provides detailed input to Capitol Hill on AI policy priorities; the UK launches an AI medical device sandbox; EU’s device policy group meets; notified body resources increase; China updates risk classification procedures; FDA joins reimbursement panels, and addresses device remanufacturing; and more.
AI Picks
Artificial intelligence advocacy, authorizations, and Airlocks:
AdvaMed’s AI takes. In March, a US lawmaker issued a “request for information” about gaps and opportunities regarding the use of artificial intelligence in healthcare, and dozens of organizations, including the American Hospital Association and an array of clinical groups, responded last week before the May 6 deadline. Among the most detailed responses to Rep. Ami Bera’s (D-CA) request, however, came from AdvaMed, which submitted a 22-page set of recommendations for AI. The trade group gave the most detailed attention to reimbursement issues. In particular, it emphasized areas where Congress can encourage CMS to modernize its regulatory structure for AI, including by aligning Medicare benefit categories with AI/machine learning technologies and rethinking the assumptions of its payments systems (Physician Fee Schedule, outpatient, etc.) in the context of AI.
AdvaMed also used its response to press FDA to allow more flexibility in how it applies predetermined change control plans for AI/ML devices. Further, it pushed for a more cohesive, national approach to balancing the use of health data to support AI and ensuring patient protections. “Current laws, policies, and regulations do not adequately address privacy and ethical risks and allow for the best use of patient health data,” the group wrote. “Assembling an optimal framework for the regulation and oversight of data used in AI models for healthcare needs true innovation, boldness, and originality.” Some other specific proposals included in AdvaMed’s letter:
