AdvaMed has released a policy roadmap intended to guide Congress and regulatory agencies on fostering responsible growth of AI in medical technology.

The Washington, D.C.-based trade association says its recommendations are aimed at aligning federal oversight with the increasing deployment of AI-enabled tools across healthcare settings.

“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 AdvaMed president and CEO Scott Whitaker. “The policy environment absolutely must keep up.”
The document lays out several recommendations, including maintaining the FDA as the primary regulator for AI-based medical tools and expanding access to high-quality health data while safeguarding patient privacy. AdvaMed stresses the need for policies that ensure equitable access, particularly in underserved communities, and highlights the role of AI in extending diagnostic and treatment capabilities beyond traditional clinical settings.

Reimbursement challenges are also central to the roadmap. AdvaMed calls on the Centers for Medicare & Medicaid Services to formalize payment structures for algorithm-based health services and digital therapeutics, citing current ambiguity as a barrier to adoption.

Additionally, the roadmap supports the FDA’s Predetermined Change Control Plan (PCCP), which allows for streamlined modifications to AI-based devices. AdvaMed recommends further refinement of this framework to keep regulatory processes in step with rapid AI advancements.

While recognizing the promise of generative AI, AdvaMed urges a cautious, risk-based approach to future regulation. The group also raises concerns about proposals to introduce third-party labs for AI oversight, warning that they could duplicate existing processes and introduce unnecessary risks.

AdvaMed reports that more than 1,000 AI-enabled medical devices have been authorized by the FDA over the past 25 years. Cited examples include software used to detect prostate cancer in imaging studies, insertable cardiac monitors that apply algorithms to identify abnormal events, and cuffless blood pressure monitoring tools for home use.

Dr. Taha Kass-Hout, GE HealthCare’s global chief science and technology officer and chair of AdvaMed’s Digital Health Tech division board, underscored the importance of government engagement. “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,” he said.

Federal policymakers have shown growing interest in the space. A bipartisan House task force last year encouraged the Centers for Medicare and Medicaid Services to establish a payment framework for AI medical devices, and the Senate’s AI Caucus has hosted demonstrations to familiarize lawmakers with current technologies.

The policy roadmap builds on AdvaMed’s broader Medical Innovation Agenda for the 119th Congress, which includes a focus on AI's potential to expand access and improve outcomes.

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