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  1. FDA In Brief

FDA In Brief: FDA takes new steps to advance risk-based regulation of digital health tools

December 13, 2018

Media Inquiries

  Stephanie Caccomo

“The FDA is continuing to advance an approach to digital health that promotes innovation and protects patient safety, while recognizing that this is a rapidly evolving field. Today, we’re releasing a report on the benefits and risks of digital health tools that are not regulated by the FDA as medical devices, so we can better understand how these products affect patient care,” said FDA Commissioner Scott Gottlieb, M.D. “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. The health care system is also increasingly relying on digital tools like electronic health records to advance patient care. Today we’re informing health care providers, patients and developers about how these products fit into the digital health landscape and how they may or may not impact patient health. We’re releasing our analysis of the potential benefits and risks of software products that fall in this category, such as e-prescribing software or mindfulness apps. While we believe that the benefits of these products generally outweigh the risks to patients, we still encourage consumers and health care providers who use these technologies to stay informed about the benefits and risks of these and any digital health products they are considering using or recommending for their patients. Moving forward, the FDA will continue to update this report to ensure the agency is striking the right balance in our approach to digital health. Our commitment to advancing patient access to innovative technologies will also include an announcement in the coming weeks about our Precertification Program for digital health technologies that FDA regulates, which will include details such as our testing plan for products in 2019.”

Today, the FDA posted a report on an important provision of the 21st Century Cures Act (Cures Act), Report on Non-Device Software Functions: Impact to Health and Best Practices. The Cures Act amended the Federal Food, Drug, and Cosmetic Act to exclude certain software functions from the definition of a medical device and thereby FDA regulation. Such functions include software intended for use as general wellness software products, certain types of electronic patient records and more.

The FDA examined information on these non-device software functions and the impact of such software functions on patient safety, including best practices to promote safety, education and user competency related to such functions. This report highlights the agency’s findings. In general, the FDA’s analysis found more benefits than risks to patient safety and health from the use of these digital products. The report also details best practices for health care providers, patients and developers related to implementation and training that could promote safety, education and use of the devices.

The report, which will be published biennially, focuses on five types of software functions, as required by Congress, including: administrative support of a health care facility, like e-prescribing software that sends prescription orders directly from the point-of-care to a pharmacy; products that encourage or maintain a healthy lifestyle, like mindfulness apps; 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, like those that identify drug interactions.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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