How is Digital Health Regulated in the U.S.?

How is Digital Health Regulated in the U.S.?

March 18, 2022 By

Digital Health covers a broad scope of categories in mobile health, health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Digital health tools range from mobile medical apps and software to artificial intelligence and machine learning. These tools could significantly improve the accuracy and efficiency in diagnosing and treating disease as well as in enhancing the delivery of health care. Today, digital health technologies utilize computing platforms, connectivity, software, and sensors, from applications in general wellness to applications as medical devices. The benefits of digital health technologies are enormous! Providers and other stakeholders use them to reduce inefficiencies, improve access, reduce costs, increase quality, and make more personalized medicine for patients. Patients and consumers can also use them to better manage and track their health and wellness-related activities. It is not only a new way to communicate but also an innovative way to monitor health and well-being.


Many approved medical devices are being updated to add digital features. The FDA’s Center for Devices and Radiological Health (CDRH) has been working on the following topics to provide clarity using practical approaches that balance benefits and risks:

Given the wide application of digital health products, the FDA has published many Guidance Documents to provide clarity on the FDA’s regulation of digital health products:

The CDRH has also established the Digital Health Center of Excellence to advance health care. The regulatory pathways differ depending on the type of digital health products. Should you require additional information on the regulations of your digital health products or need help applying one, contact us today for details.