Digital Health

Digital Health is Driving New Regulatory Models

Digital health technologies are rapidly changing how health care is delivered, and are helping individuals take control of their health. Many digital technologies have intended uses that fall under the scope of FDA’s device jurisdiction, but the agency’s regulatory system historically has not been designed to review, clear, approve, or otherwise respond to these products at the rate at which they develop and change. FDA’s Digital Health Center of Excellence is developing innovative regulatory approaches that are efficient and least burdensome, while continuing to meet the agency’s standards for safe and effective products. 

Which Digital Health Technologies are Regulated by FDA?

Digital health technologies include personalized medicine tools, telehealth and telemedicine, wearables, health information technology (IT), clinical decision support software, and mobile apps. FDA recognizes that digital health can improve the accuracy and efficiency of patient care, but many of these products satisfy the statutory definition for devices under the Federal Food, Drug, and Cosmetic Act (FDCA). 

For example, software intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases and other conditions is generally regulated as a device. However, under the 21st Century Cures Act, enacted in December 2016, software is not a device if it meets four criteria:

(1) Not intended to acquire, process, or analyze a medical image or signal from an IVD or a pattern or signal from a signal acquisition system;

(2) Intended to display, analyze, or print medical information;

(3) Intended to support or provide recommendations to a healthcare professional (HCP) about prevention, diagnosis, or treatment of a condition; AND

(4) Intended to enable an HCP to independently review the basis for a recommendation, without intending for the HCP to primarily rely on the recommendation to make a clinical diagnosis or treatment decision for an individual patient.

If software fails just one criterion, it is subject to FDA regulation.

In January 2026, the agency updated its guidance on clinical decision support software. This document clarifies how the statutory criteria apply to new and emerging software functions, including for wearables. In compliance with the Cures Act, FDA has also issued guidance documents about changes to existing medical software policies under the Cures Act; general wellness products; mobile medical apps; medical device data systems, medical image storage devices, and medical image communication devices; and off-the-shelf-software.

Penn Avenue Law & Policy Can Chart a Regulatory Course for Digital Health Technologies

Penn Avenue Law & Policy can advise you regarding the current regulatory status of your software and digital health technologies. The firm can help determine potential future pathways for your products, based on FDA’s current thinking and your business goals. Christine P. Bump has represented companies of all sizes in the digital technology space and has the experience and ability to steer rapidly changing technologies through evolving regulatory landscapes.