Central to ATA Action’s argument is an urgent call for the FDA to recalibrate how it conceptualizes clinical risk. In standard regulatory reviews, an investigational device is traditionally evaluated against an idealized clinical encounter led by an attentive physician.

In modern virtual care, however, that baseline is often a fiction. Across thousands of rural zip codes and underserved inner-city neighborhoods, the realistic alternative to an AI-supported screening or triage tool is not a prompt, high-touch consultation with a top academic specialist; it is a six-month waiting list, hours of travel, or no clinical care at all.

Joe Nye, Head of Federal Government Relations for ATA Action, stressed that regulatory evaluations must weigh this access vacuum: “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. 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.”

To prevent algorithmic tools from perpetuating healthcare disparities, the group urged the agency to mandate that manufacturers validate models across real-world patient subgroups—explicitly testing for performance variations across rural populations, individuals with limited health literacy, and non-English-speaking patients, rather than relying exclusively on synthetic datasets.

The trade group strongly endorsed the FDA’s proposed two-axis risk matrix, which evaluates systems based on two independent vectors: the degree of clinical autonomy the tool exercises and the potential severity of harm if an output is flawed.

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