FDA releases long-awaited clinical decision support guidance, clarifies oversight of mobile apps

The Food and Drug Administration released three new guidance documents on Thursday with implications for the digital health industry, including one highly anticipated guideline on how the agency plans to regulate clinical decision support tools.

The draft guidance covers decision support technology for both clinicians and patients and builds on several notable exemptions outlined in the 21st Century Cures Act. According to the guidance, analytics technology intended to support clinical diagnoses that provides room for a physician to independently review the basis of the software’s recommendations would not be regulated by the FDA. That includes software that provides current treatment guidelines based on patient information or tools that offer recommendations for a certain intervention, test or drug consistent with clinical guidelines.

However, software that analyzes medical images or laboratory or medical tests would remain under FDA oversight. For example, a device that analyzes breathing patterns for sleep apnea or collects physiological data to monitor whether a person is having a heart attack would also be regulated as a medical device by the FDA. In statement, FDA Commissioner Scott Gottlieb, M.D., specifically referenced software programs that use electrocardiograms or data from a spinal fluid test to diagnose tuberculosis or viral meningitis.

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“These are areas in which the information provided in the clinical decision software, if not accurate, has the potential for significant patient harm, and the FDA plays an important role in ensuring the safety and effectiveness of these products,” he said.

Morgan Reed, executive director of ACT | The App Association’s Connected Health Initiative, called the CDS guidance an “important first step” in providing a pathway for innovative tools to assist physicians.

“For years, our members have developed clinical and patient decision support software, but their solutions will not be adopted, nor their benefits felt, absent a clear regulatory framework,” Reed said in an emailed statement. “Today’s guidance focuses regulatory intent on the safety and effectiveness of software that independently analyzes patient data, rather than on software that supports doctors’ ability to use data to make treatment decisions."

The FDA also made several notable changes to the way it regulates mobile applications, as required under the 21st Century Cures Act. Through draft guidance, the agency proposed changes to previously published regulatory guidelines covering general wellness and mobile medical apps that pose a low risk for patients. The FDA also elected to move apps that allow patients to interact with ONC-certified EHRs out of its initial list of apps that require enforcement. 

“Many of these products no longer qualify as medical devices that would be subject to the FDA’s oversight,” Gottlieb said.

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Finally, the FDA finalized guidance issued last year establishing a common framework for regulators to evaluate software as a medical device based on the overall risk of the product.  

Thursday’s document release continues the FDA’s ongoing effort to reform its approach to digital health regulation, which includes the launch of a precertification pilot program stocked with companies like Apple, Fitbit and Verily.