FDA Commissioner Scott Gottlieb, MD, released three policy guidelines Dec. 7 outlining the agency's approach to digital health oversight.
Here are the three policies the FDA released.
1. "Clinical and Patient Decision Support Software." The draft guidance clarifies which types of CDS and PDS software the FDA defines as a "medical device" in need of agency oversight. Software that allows a user to "independently review" the basis for its recommendations are excluded from FDA regulation, such as CDS that suggests clinicians order particular tests consistent with existing guidelines. The FDA will continue to oversee software programs that analyze data to make treatment recommendations or diagnoses.
"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," Dr. Gottlieb said.
2. "Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act." The draft guidance outlines digital health technologies — such as mobile health and lifestyle apps — that FDA officials have determined fall outside of the agency's purview. These technologies "no longer qualify as medical devices that would be subject to the FDA’s oversight," according to Dr. Gottlieb.
"Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the healthcare system," he said.
3. "Software as a Medical Device: Clinical Evaluation." The final guidance establishes common principles for regulators to use when evaluating the safety and performance of Software-as-a-Medical-Device services, with an emphasis on analyzing the overall risk the product poses to a patient or user. The guidance builds on a draft guidance issued in October 2016, informed by the FDA's work with national and international regulatory authorities.
"We believe the FDA must, whenever possible, encourage the development of tools that can help people be more informed about their health," Dr. Gottlieb said. "We must always lean in the direction of enhancing access to more information — not restricting information flow — given the ability of reliable information to positively impact daily life."