FDA: Benefits beat risks with unregulated medical software
- FDA struck a favorable tone in a public report it issued Thursday addressing safety and best use practices for medical software functions that aren't included in its definition of software as a medical device (SaMD).
- The agency outlined five major non-device software functions: administrative support of a healthcare facility; products that encourage or maintain a healthy lifestyle; certain types of electronic patient records; certain types of software that transfers, stores or displays clinical laboratory tests or other device data and results; and certain types of clinical decision support software.
- Though these types of software are not regulated by FDA and officials encourage consumer and clinician diligence, the agency concluded that their benefits to patient health and safety outweigh potential risks.
Clarification of medical software regulation has been a work in progress, particularly since Sec. 3060 of the 21st Century Cures Act amended Sec. 520 of the Food, Drug and Cosmetics Act in 2016 and FDA released its Digital Health Innovation Action Plan in 2017.
The five non-device software categories cover everything from EHRs, to e-prescribing software, to mindfulness apps, all of which are excluded from the International Medical Devices Regulators Forum definition for SaMD, which is "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."
These examples represent health technologies with which providers and patients alike are interacting at massive rates. The global EHRs market could reach $33.4 billion by 2025, as estimated by Grand View Research. And Headspace, a mindfulness app like the ones FDA called out, was valued at $250 million earlier this year.
"While we've been working to streamline the agency's oversight of digital health products that we regulate, we also know that there are many digital products consumers are using for their general wellness or to track their health information that aren't regulated as devices by the FDA," Commissioner Scott Gottlieb said in a press release.
The FDA analysis of the five categories considered impact to patient safety, benefits and risks to health, and best practices to promote safety, education and competency.
In the case of EHRs, FDA cited a 27% drop in reported patient safety events under the adoption of the systems, but also noted one death that may have occurred due to incorrect patient data reporting that impacted care. FDA also reported a death that may have been caused by an e-prescribing malfunction, and a clinical decision support software bug that resulted in incorrect medication dosing for a patient.
But largely, the FDA analysis was more positive than negative. For software categories addressing healthy lifestyle maintenance, or the transfer, storage or display of data, FDA's review found no adverse safety impacts. The agency tipped its hat to software used to identify drug interaction-induced adverse reactions, and to step trackers that have meaningfully increased activity levels.
Since 21st Century Cures was enacted, CDRH has addressed SaMD and other software issues through guidance on clinical evaluation, clinical and patient decision support software and medical device accessories and their classification pathways. CDRH will rerelease this particular risk-benefit medical software report with updated data biennially. The device group's next Cures deliverable is a report to Congress on Breakthrough Devices, due by Jan. 1.
Outside of Cures, FDA's software Pre-Cert program is the action to watch in 2019. The agency teased an announcement Thursday about the program's testing plan, coming within weeks.