Section 3060(a) of the 21st Century Cures Act (herein referred to as the Cures Act), enacted on December 13, 2016 (Pub. L. 114-255), amended the Federal Food, Drug, and Cosmetic Act (herein referred to as the FD&C Act) to exclude certain medical software functions from the definition of device under section 201(h) of the FD&C Act (21 U.S.C. 321(h)). These software functions are specified in section 520(o)(1) of the FD&C Act and the intended uses of such software functions can be summarized as follows: (1) administrative support of a health care facility; (2) maintaining or encouraging a healthy lifestyle and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition; (3) serving as electronic patient records when not intended to interpret or analyze patient records; (4) transferring, storing, converting formats, or displaying data; or (5) unless interpreting or analyzing a clinical test or other device data, providing certain types of limited clinical decision support to a health care provider.
Section 3060(b) of the Cures Act (herein referred to as section 3060(b)) requires that the Secretary of Health and Human Services (HHS) publish a report every two years that examines information available to the Secretary on any risks and benefits to health associated with the software functions described in section 520(o)(1) of the FD&C Act, and provides summary findings regarding the impact of these non-device software functions on patient safety, including best practices to promote safety, education, and competency. This document is the third report pursuant to section 3060(b) since the enactment of the Cures Act.
In an effort to identify new information published since the Report on Risks and Benefits to Health of Non-Device Software Functions – November 2020 (herein referred to as the 2020 Report), the Food and Drug Administration (FDA) collected information from a variety of sources as defined in section 3060(b). This section 3060(b) report includes information from a variety of sources reported on, or pertaining to, United States (U.S.) populations from July 31, 2020, to July 31, 2022. This section 3060(b) report also includes information from comments submitted to the public docket (FDA-2018-N-1910-0047) from the opening of the docket on July 14, 2022 through the close of the docket August 15, 2022.