AdvaMed® Comment Letter to ASTP/ONC: Removing Barriers to AI-Enabled Medical Technologies in Clinical Care
In this AdvaMed® Comment Letter to ASTP/ONC — submitted in response to the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) Request for Information on accelerating AI adoption in clinical care — AdvaMed® outlines the policy reforms needed to unlock the full potential of AI-enabled medical devices for patients and clinicians.
AdvaMed’s member companies have been developing and deploying AI-enabled medical devices in clinical settings for more than 25 years. With FDA having authorized over 1,300 AI-enabled medical devices as of December 2025, the medtech industry has a proven track record of bringing safe, effective AI-powered innovations to patients. But regulatory, coverage, and data privacy barriers continue to slow adoption and limit patient access.
In this comment letter, AdvaMed® urges HHS to prioritize reforms in three key areas:
1. FDA Regulation of AI-Enabled Medical Devices AdvaMed® recommends improving transparency and consistency in the De Novo premarket pathway, expanding use of Predetermined Change Control Plans (PCCPs) to keep pace with rapid AI innovation, and ensuring FDA guidance distinguishes between complex AI systems and more traditional machine learning approaches to avoid unnecessary regulatory burden.
2. CMS Coverage and Payment for AI Technologies Outdated Medicare payment frameworks are creating significant barriers to patient access. AdvaMed® calls on CMS to modernize the Hospital Outpatient Prospective Payment System (OPPS) and New Technology APC program for Software as a Medical Device (SaMD), update the Transitional Pass-Through Payment criteria to include AI technologies that do not require direct patient contact, and implement payment policies under the Physician Fee Schedule that reflect the unique value and costs of SaMD across diverse care settings.
3. HIPAA Data Privacy Reforms Access to high-quality health data is essential for AI development and validation. AdvaMed recommends amending HIPAA’s definition of “health care operations” to explicitly include AI model development, enhancing Safe Harbor de-identification flexibility for AI use cases, and issuing guidance to clarify the permissibility of using generative AI tools to process protected health information (PHI) for treatment, payment, and health care operations purposes.
AdvaMed® also underscores the importance of maintaining FDA as the sole federal regulator of AI-enabled medical devices, supporting consensus-based standards over new third-party evaluation frameworks, and advancing interoperability to unlock richer datasets for AI model training and validation.