AdvaMed Releases “AI Policy Roadmap” to Guide Congress and Federal Agencies

AdvaMed, the Medtech Association, today 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 future of AI applications in medtech is vast and bright. It’s also mostly to be determined. We’re in an era of discovery,” said Scott Whitaker, AdvaMed president and CEO. “While none of us can anticipate all the game-changing applications of AI in medtech to come, we can confidently predict that transformation will continue at a rapid pace—and the policy environment absolutely must keep up. This is the right time to promote the development of AI-enabled medtech to its fullest potential to serve all patients, regardless of zip code or circumstance. Our industry looks forward to continuing to work with Congress on these exciting advancements.” 

“Recent breakthroughs in machine learning and AI are already transforming health care—streamlining administrative workflows, minimizing scan times, monitoring patient health both in and out of clinical settings, and significantly reducing wait times. This is just the beginning. We see tremendous potential to harness AI not only to automate routine tasks, but also to deliver deeply personalized care and treatment,” said Dr. Taha Kass-Hout, global chief science and technology officer, GE HealthCare, and chair of AdvaMed’s Digital Health Tech division board. “The continued support of Congress and the Administration will be important in creating policies necessary to help further ensure as many patients as possible have access to AI-enabled innovations to speed diagnosis, promote the right treatment, and increase access to high quality and affordable care.”

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. 

Congress already has been thoughtful on considerations to serve patients with AI-enabled health tech, setting the stage for future policymaking. Last year, the House of Representatives’ bipartisan Task Force on Artificial Intelligence urged the Centers for Medicare and Medicaid Services (CMS) to develop a formalized payment pathway for AI-enabled medical devices. Kass-Hout contributed to a task force panel. The bipartisan Senate Artificial Intelligence Caucus has hosted sessions on Capitol Hill including an AI demonstration day to show lawmakers and their staff the latest AI-enabled health tech. 

AdvaMed’s recently released Medical Innovation Agenda for the 119^th Congress includes recommendations on harnessing the power of AI to improve patient outcomes and access to innovative medtech.