On March 14, 2025, AdvaMed, the MedTech Association, released its AI Policy Roadmap (the Roadmap) outlining policy priorities for Congress and the U.S. Food and Drug Administration (FDA). The impetus for the Roadmap was the recognition of the important role that AI-enabled devices will play in improving the accuracy and efficiency of disease diagnosis, enabling higher quality treatments, and expanding access to health care and to innovative technologies. The Roadmap is broken down into three main policy priority areas: privacy and data access, FDA AI regulatory framework, and reimbursement and coverage.
Privacy and Data Access
The Roadmap contends that one component of AI-enabled devices that sets them apart from traditional technology is the need for large datasets to train and validate the algorithms underlying the devices. The need for large datasets creates two distinct challenges.
- First, health care data is highly fragmented and generally stored in non-standardized formats. Health care data is not frequently shared across health systems, and there are very few commercial vendors that provide the services necessary to link and standardize this data.
- The second significant challenge is the need to protect patient privacy and ensure that data security is prioritized. To this end, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires protection of certain types of personal health information, consent to use and/or disclose data, and strict deidentification requirements when personal health information is used. The need for high quality data measured against the need to protect patient privacy creates an inherent tension in policy priorities.
To mitigate this tension, the Roadmap provides three recommendations:
- Congress and regulatory agencies such as the FDA should ensure data protection without stifling innovation.
- Congress should evaluate the need to update HIPAA for the AI era and create clear guidelines specifically for data use in AI development.
- Congress and regulatory agencies should develop appropriate guidelines around patient notice and authorization for the data used to develop AI.
The Roadmap strives to balance the need for a high volume of high quality standardized data with patient privacy by placing modernized consent and notification requirements at the center of the policy priorities. Recognizing the need for large datasets, the Roadmap emphasizes modernizing traditional privacy policies, such as HIPAA, to accommodate data use and collection for AI models.
FDA AI Regulatory Framework
The FDA regulates certain AI-enabled devices for safety and efficacy. However, AI-enabled devices require a different approach than FDA’s “traditional” medical device review model for those devices that undergo changes in an iterative fashion. For approved medical devices that evolve continuously, e.g., AI-enabled devices, developers must submit for FDA review any modification that could significantly affect the product’s safety or effectiveness, consistent with FDA-drafted guidance on the preapproval process for post-market changes – referred to as predetermined change control plans (PCCP). These post-market changes occur as algorithms continue to learn and validate against the data of the populations using the technology. The algorithms then adjust based on continued learning. While Congress passed legislation authorizing PCCP approval in 2022, comprehensive FDA PCCP guidance was only released in December of 2024. The complete pre- and post-market processes for AI-enabled devices are outlined in the FDA’s “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.”
The Roadmap’s recommendations suggest that FDA modernize regulations to align with the increasing shift from traditional medical devices to AI-enabled devices. Specifically, the Roadmap recommends that:
- The FDA should remain the lead regulator responsible for overseeing the safety and effectiveness of AI-enabled medical devices.
- The FDA should implement the existing PCCP authority to ensure it achieves its intended purpose of ensuring patients have timely access to positive product updates.
- The FDA should issue timely and current AI guidance documents related to AI-enabled devices and to prioritize the development and recognition of voluntary international consensus standards.
- The FDA should establish a globally harmonized approach to regulatory oversight of AI-enabled devices.
The Roadmap commends progress made by Congress and the FDA to modernize legislative and regulatory processes applicable to AI-enabled devices but urges continued focus on keeping pace with technological innovation. The focus of the policy recommendations is on streamlined, uniform regulations that are not overly burdensome and will not stifle innovation.
Reimbursement and Coverage
Finally, the third policy area addressed in the Roadmap is reimbursement and coverage as a critical component of increasing access to digital health technologies. Currently, reimbursement for AI-enabled devices has been considered on a device-specific basis, leading to incremental policy changes. The Roadmap suggests that Medicare, as the country’s largest health care payor supporting the medical needs of millions of Americans, could be instrumental in shifting this policy position. Further, Medicare policy initiatives heavily influence the coverage policies of private payors and state Medicaid plans. While the Roadmap acknowledges that there is no one single policy solution to increase accessibility to digital health technology through reimbursement, “accurately capturing the cost and value of [AI-enabled devices] is critical to ensuring appropriate reimbursement.”
Toward this end, the Roadmap provides five policy suggestions:
- Congress should consider legislative solutions to address the impact of budget neutrality constraints, or restraining Medicare spending to a certain defined threshold, on the coverage and adoption of AI technologies.
- The Centers for Medicare & Medicaid Services (CMS) should develop a formalized payment pathway for algorithm-based health care services to ensure future innovation and to protect access to this subset of AI technologies for Medicare beneficiaries.
- To ensure future innovation and to protect access to algorithm-based health care services for Medicare beneficiaries, CMS should develop a formalized payment pathway for algorithm-based health care services.
- Congress and the FDA should facilitate the adoption and reimbursement of digital therapeutics through legislation and regulation.
- CMS should leverage its authority to test innovative alternative payment models to promote the ability of AI technologies to improve patient care and/or lower costs.
The development and adoption of AI-enabled devices to improve diagnosis, treatment, and patient care will be amplified by the adoption of appropriate reimbursement policies as health care providers and practitioners will be more readily able to learn about and use these health care tools. Sound reimbursement and coverage policies are an integral part of supporting innovation and development of AI-enabled health care devices.
Conclusion
In a recent press release, Scott Whitaker, AdvaMed CEO and President said about the release of the Roadmap, “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… 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.” It is from this position of promoting new technology that AdvaMed urges Congress and the Food and Drug Administration to act in support of the development of AI-enabled medical technology.
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