ATA ACTION URGES FDA TO BUILD A RISK-BASED, FUNCTION-FOCUSED FRAMEWORK FOR GENERATIVE AI-ENABLED MEDICAL DEVICES

WASHINGTON, DC, OCTOBER 20, 2026 – ATA Action: Advocacy Shaping Virtual Care, the advocacy-focused affiliate of the American Telemedicine Association (ATA), today submitted comments to the U.S. Food and Drug Administration (FDA) in response to its discussion paper, Considerations for the Regulation of Generative AI-Enabled Medical Devices. ATA Action commended the agency for seeking public input before drafting guidance and expressed its eagerness to work with FDA on crafting future policy.

ATA Action’s comments express support for the risk-based direction of the discussion paper, including its two-axis risk framework, competency-based approach to premarket review, and greater reliance on post market monitoring. The comments draw from ATA’s Policy Principles on Artificial Intelligence and are organized around those principles.

“AI has enormous potential to expand access to high-quality virtual care, but only if the regulatory framework is clear, proportionate, and built to last,” said Joe Nye, Head of Federal Government Relations for ATA Action. “FDA’s discussion paper is a strong start. We look forward to working with the agency to turn it into guidance that protects patients, gives developers and clinicians predictability, and gets safe, effective tools to the people who need them, especially in rural and underserved communities.”

Key recommendations in ATA Action’s comments include:

• Keep accountability with manufacturers. Manufacturers should remain responsible for the safety and performance of the devices they sell, including those built on third-party foundation models. FDA should avoid shifting monitoring duties to the small, rural, and safety-net practices that lack the staff to take them on and should instead give clinicians simple ways to report problems.
• Clear disclosure that is reasonable and proportionate. FDA labeling should explain in plain language what a device does, who it is for, and its known limitations, make clear the user is interacting with AI, and offer a clear path to a human clinician or emergency service, as appropriate.
• Regulate by function and risk, not by technology. Oversight should rest on what a tool does and risk, not on the fact that it uses generative AI. The FDA’s two-axis framework for AI systems that serve multiple clinical functions within a single interaction supports unified, harmonized, and risk-based regulation, with federal leadership to promote national consistency and without general prohibitions or broad pre-authorization schemes.
• Create a voluntary federal-state clinical AI sandbox. As states adopt differing approaches to clinical AI, ATA Action proposed a voluntary federal-state AI sandbox, built on the TEMPO pilot and developed with the Department of Health & Human Services (HHS) and participating states, and work alongside FDA’s existing authorization pathways. It would generate real-world evidence and phased clinician oversight, while FDA exercises conditional, time-limited enforcement discretion. This would give real-world evidence and direct insight into how these tools perform once deployed, and can inform a durable, nationally consistent framework.
• Scale validation to risk. ATA Action supports pairing benchmark testing with clinical confirmation scaled to risk, agrees that a prospective clinical study should not be required in every case, and strongly supports FDA’s openness to accepting more uncertainty at authorization when paired with strong post market monitoring and flexible predetermined change control plans.
• Evaluate Performance Across Patient Subgroups. Manufacturers should test devices with people who reflect intended users.
• Weigh the real-world alternative. In evaluating risk, FDA should consider the care a patient would realistically receive without an AI-supported service. In many rural communities and areas with clinician shortages, that alternative is a long wait or no care at all. ATA Action also encourages FDA to keep coordinating with the Centers for Medicare & Medicaid (CMS) to ensure safe and effective devices reach patients who need them.
• Rely on existing privacy and security rules. FDA should rely on established privacy and cybersecurity requirements rather than create new ones specific to generative AI and should protect the proprietary and confidential information developers share with the agency.

ATA Action’s AI in Virtual Care Policy Initiative

The comment letter reflects the broader work of the ATA’s AI in Virtual Care Policy Initiative, to advance policy frameworks that support the safe, effective, and accessible use of AI in virtual care. The initiative’s three working groups focus on state frameworks, federal legislative frameworks, and federal agency frameworks, to help ensure a consistent, informed approach to AI policy at every level of government.

ATA Action’s full comment letter is available here.

About the ATA

The American Telemedicine Association (ATA), the definitive voice for virtual care, is the industry’s trusted community focused on expanding access to healthcare through innovation by advancing education, resources, and policy. Founded in 1993, the ATA represents the most diverse ecosystem in healthcare – including leading health systems, academic medical centers, payers, technology innovators, life sciences companies, and clinician leaders – the ATA delivers clinical standards, policy leadership, education, and evidence frameworks that accelerate high-quality, technology-enabled care.

About ATA Action

ATA Action expands and protects how virtual care is legislated and regulated at all levels of government. Founded in 2022, ATA Action works collaboratively with federal and state legislators and policymakers to influence legislative and regulatory developments in virtual care, digital health, remote patient monitoring, AI in healthcare, health data privacy, private sector healthcare investment, and more. ATA Action represents hospital systems, technology companies, professional associations, direct-to-consumer digital health providers, payers, pharmaceutical manufacturers, digital therapeutics developers, and remote monitoring organizations, and facilitates member-led coalitions focused on initiatives to advance AI in Virtual Care Policy and Cross State Care. ATA Action is a registered 501(c)(6) nonprofit trade organization engaged in lobbying efforts to shape industry-related legislation and serves as an affiliated trade association of the ATA, a 501(c)(3) entity recognized for its leadership in advancing innovation and leading transformation in virtual care.