AdvaMed Plans AI Regulation Recommendations for Medtech Sector

The Advanced Medical Technology Association (AdvaMed) and its Digital Health Tech division have released a new AI Policy Roadmap, urging U.S. policymakers to clarify and streamline federal oversight of AI-enabled medical devices. The roadmap recommends maintaining the FDA as the primary regulator, expanding access to high-quality health data while safeguarding patient privacy, and formalizing Medicare reimbursement structures for digital health technologies. Industry leaders stress the need for updated federal health privacy laws, clear patient data guidelines, and international regulatory cooperation to ensure equitable access, particularly for underserved communities. AdvaMed also supports refining the FDA’s Predetermined Change Control Plan to keep pace with rapid AI advancements while cautioning against third-party oversight that could duplicate or complicate existing processes. These recommendations reflect a broader push to balance innovation, patient safety, and access as AI tools become more prevalent in healthcare. The medtech industry underscores that effective regulation is crucial for fostering both innovation and patient trust in AI-powered health solutions.