Draft guidance signals FDA seeks to foster innovation in digital health sector

The FDA’s new guidance on digital health paves way for more tools that aim to support physicians and patients.

Expect to see a slew of new software programs and tools aimed to support clinicians and patients to make informed treatment decisions, after the Food and Drug Administration released its long-awaited draft rule last week on clinical decision support (CDS) systems.

A clinical decision support system is health information technology software designed for clinicians and patients to assist in a course of treatment. These decisions could include diagnoses, medication recommendations and diagnostic tests to determine root causes of symptoms.

Most hospitals and physician offices today use some form of CDS. The upside to CDS is it can help providers achieve quality improvement goals by reducing unnecessary tests and by following established care practice guidelines. For instance, some hospitals have started using CDS systems to discourage providers from ordering unnecessary high-cost images for routine problems such as headaches and lower back pain.

FDA Commissioner Scott Gottlieb, M.D., on Dec. 7 outlined the agency’s approach to CDS software in draft guidance to clarify what CDS products would be subject to FDA regulation. Comments on the draft guidance are open for 60 days.

Essentially, the FDA is recommending no regulatory oversight of CDS products where physicians can independently review the software’s decision and make an informed decision based on that information. The FDA guidance states, “The intended user should be able to reach the same recommendation on his or her own without relying primarily on the software function.”

Similarly, the FDA won’t regulate a category of products called “patient decision support software,” where the patient or caregiver can review the recommendation and then decide a course of action. An example of this is a pre-set prompt that reminds a patient when to take a drug and at what dose.

The FDA will continue to oversee CDS tools that “are intended to process or analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations,“ the agency said in a statement. Under the 21st Century Cures Act these are considered medical devices and subject to greater oversight.

The FDA made several other announcements related to digital health, including one on 3D printing, that make clear it seeks to foster innovation in the fast-developing digital health sector.

The latest moves by the FDA will likely clear some doubt among start ups as well as tech giants such as Apple and Google that many CDS products in development won’t have to go through the same rigorous approval process that medical devices endure, experts said.

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