Opportunity for Stakeholders to Impact FDA’s “Non-Device” Software Report

There is still time for stakeholders to impact FDA’s 2020 update to its congressionally mandated report on best practices for “non-device” software, i.e., software functions excluded from the definition of medical device by the 21st Century Cures Act. Stakeholder comments, which can provide further evidence of improved patient safety through the application and use of non-device software, best practices to promote patient safety associated with the application and use of non-device software, and accomplishments related to education and competency associated with these software functions, are due by July 30, 2020.

Stakeholders should take this opportunity to comment because the historical record should continue to reflect why non-device software should be afforded regulatory flexibility under the Cures Act exclusion. Section 3060 of the Cures Act excluded five software functions from being defined as devices under the Food, Drug, and Cosmetic Act. These are software intended: (1) for administrative support of a health care facility; (2) to encourage or maintain a healthy lifestyle; (3) to serve as electronic patient records; (4) to transfer, store, convert formats, or display data; or (5) to provide limited clinical decision support.

Under the Cures Act, the Secretary of Health and Human Services (HHS), in consultation with FDA, is required to evaluate and report the risks and benefits to health associated with these non-device software functions every two years. This report must include input from stakeholders, such as patients, consumers, healthcare providers, startup companies, health plans, other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small business purchasers, employers, and other experts.

The Cures Act was enacted in December 2016, and HHS and FDA released the first report, Report on Non-Device Software Functions: Impact to Health and Best Practices, in December 2018 (FDA, December 2018 Report). For the 2020 update, FDA is requesting stakeholder comments regarding patient safety, specifically best practices to promote patient safety, and education and competency associated with these software functions. FDA is required to incorporate stakeholder input in the development of the 2020 risk and benefit report update.

The December 2018 Report, which heavily cited “outside experts,” i.e., stakeholders, concluded that non-device software functions presented more benefits than risks to patient safety. FDA, December 2018 Report, at ii. For example, HHS and FDA identified “no direct impacts to patient safety” from software intended to encourage or maintain a healthy lifestyle. Id. at 7.

The December 2018 Report described evidence from studies with mindfulness smartphone applications, daily activity trackers for monitoring physical activity, and a smartphone-based smoking cessation application. All of these software applications demonstrated positive benefits. Id.

Software applications intended to encourage or maintain a healthy lifestyle have only proliferated since 2018. The same is true for the other non-device software functions, including software intended to provide limited clinical decision support. In the December 2018 Report, HHS and FDA concluded that use of such software “could positively impact patient safety” and “showed a positive impact on standard of care guideline discussions during clinical care rounds.” Id. at 11. The examples of limited clinical decision support software provided in the report included software intended to identify drug-drug interaction-induced adverse drug reactions. The December 2018 Report noted, however, that FDA received one adverse event related to a “software bug” in a clinical decision support software function that could lead to a patient receiving the wrong dose. Id. at 11-12.

By submitting comments, stakeholders have the opportunity to provide additional evidence of improved patient safety; examples of patient benefits that non-device software can provide; and the standards that are necessary for best practices to promote safety, education, and competency. For example, the December 2018 Report stated that “outside experts” suggested best practices for software intended to provide limited clinical decision support take into consideration the timing of presenting information, monitor and document the quality of the information, and account for variations in processes. Id. at 12. To the degree stakeholders have designed or implemented best practices, this is an opportunity to further cement industry standards for patient safety, education, and competency. All interested stakeholders can submit comments electronically via www.regulations.gov, using Docket Number FDA-2018-N-1910. Comments are due July 30, 2020. Should your organization want assistance with the preparation of your comments, Penn Avenue Law & Policy is happy to help.

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