On December 7, 2017, the FDA announced three new policy documents geared toward advancing and properly overseeing innovative new digital health tools. The documents mark an acute recognition by the FDA that as consumers and health care providers increasingly use digital technologies as health tools to acquire information, the FDA’s policies must continue to encourage the development of such technologies.
Of the three new guidance documents, two are drafts and one is final. The guidances address the provisions of the 21st Century Cures Act and clarify where the FDA has a role in the promotion of digital health care.
The first guidance is titled “Clinical and Patient Decision Support Software” and addresses clinical decision support software (CDS). CDS technology assists health care providers in making decisions as to the course of treatment for a patient’s disease or condition. The FDA seeks to encourage software developers to create and expand CDS functionality in treating old and new diseases. The guidance identifies which types of CDS do not qualify as a “medical device” and thus do not require FDA regulation, namely, CDS that permits the health care provider to independently review the basis of the recommendation for treatment.
The second guidance addresses the FDA’s interpretation of other types of software that are similarly no longer considered medical devices, titled “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.” In particular, this guidance sets out that digital health technologies such as mobile apps that are used by consumers to log, record, track, evaluate and make decisions on a healthy lifestyle, like dietary logs, meal planners, or activity trackers, fall outside the scope of FDA regulations.
Lastly, the FDA issued a final guidance, “Software as a Medical Device: Clinical Evaluation,” expanding the draft issued in October 2016. The guidance establishes and harmonizes global principles for evaluating the safety, efficacy and performance of Software as a Medical Device, based upon the overall risk of the product.
The three guidances issued last week seek to continue to clarify the FDA’s role and oversight in digital health technologies. As the ever-changing field of digital health technology expands, so too will the FDA’s efforts to encourage innovators to create and expand such technology.