The Trump Administration’s FY2027 FDA request contains a proposed Clinical Trial Notification Pathway, described as a risk-based, expedited alternative for some early-stage studies. FDA says the current process is duplicative and time-consuming, and has helped push early-stage preclinical and Phase 1 work to China and Australia. The proposal reflects concern that outdated regulation can weaken U.S. competitiveness in strategically important areas, a concern also applied to clinical Artificial Intelligence.
Clinical Artificial Intelligence is presented as a tool that could expand access and reduce costs in routine care. Utah this year launched a first-of-its-kind partnership with Doctronic allowing an autonomous Artificial Intelligence system to participate in prescription renewals for chronic conditions. That may sound minor in a doctor-rich ZIP Code, but it matters when more than 40 million rural Americans live in areas with too few primary care providers. For many patients, clinical Artificial Intelligence could mean a working parent getting a refill approved without missing half a day of work, an ER patient getting a scan interpreted faster at 2 a.m., and a small-town clinic gaining specialist-level support it otherwise would not have.
Before his resignation, Marty Makary announced revised FDA guidance on low-risk general-wellness products and clinical decision support software, along with promises of a new regulatory framework for Artificial Intelligence that would modernize the agency and support investment. The follow-through has drawn criticism after FDA rejected a citizen petition from Harrison.ai proposing an alternative pathway for certain radiology Artificial Intelligence devices. The petition, drafted with help from former senior FDA officials, described current U.S. pathways as burdensome and ill-suited to the rapid evolution of Artificial Intelligence and pointed to a gap between the U.S. and markets in the U.K., Europe and Asia.
The evidence cited is striking. One review found that 97% of ophthalmology Artificial Intelligence devices were available in the European Union, compared with only 8% in the U.S. A separate review found that just one of 26 digital pathology Artificial Intelligence devices available in Europe and Britain had been authorized by FDA. DermaSensor, the first FDA-authorized Artificial Intelligence for skin-cancer detection in primary care, received authorization in Europe and Australia three years before FDA gave the go-ahead. The Harrison.ai chest X-ray Artificial Intelligence algorithm can identify 124 findings abroad but is authorized for only five in the U.S.
The central concern is that FDA still regulates many Artificial Intelligence systems as traditional medical devices, even as newer systems can be retrained, updated and deployed with more varied outputs. A better-calibrated model would combine premarket review with postmarket monitoring, similar to how physicians are licensed, credentialed and reevaluated over time. Senate appropriators last year asked FDA to assess whether it has the statutory tools needed to regulate clinical Artificial Intelligence, underscoring the mismatch between existing oversight and fast-moving medical software.
