April 25, 2025- AdvaMed released its “AI Policy Roadmap,” a detailed policy outline for Congress and the federal agencies with jurisdiction over medtech to consider in promoting the next era of artificial intelligence-enabled medical and digital health technologies to provide patients and clinicians transformative new tools to aid in diagnosis and treatment.
The policy proposal outlines the background of FDA-authorized AI-enabled medical devices – more than 1,000 over the last 25 years – and includes numerous examples of the real-life instances in which AI-enabled health tech is serving patients, including software analyzing digital images to detect prostate cancer, cuffless blood pressure monitoring at home, and insertable cardiac monitors with algorithms to improve diagnoses of abnormal events. The policy recommendations cover ensuring patient privacy and data protection without stifling innovation, preserving FDA’s role as the lead regulator for AI-enabled health tech, and updating options for reimbursement and coverage of proven AI-authorized options to serve patients and clinicians. Coverage and reimbursement are critical to patient access.