Importance to FDA

Digital health technologies (DHTs) are systems that use computing platforms, connectivity, software, and/or sensors for healthcare and related uses. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device. They include technologies intended for use as a medical product, with, or as an adjunct to other medical products (devices, drugs, and biologics). They may also be used to develop or study medical products. Some DHTs may meet the definition of a medical device, while others do not. The FDA Digital Health Center of Excellence serves as a resource for internal and external stakeholders to accelerate advancements in digital health. Furthermore, the DHCoE coordinates Agency-wide digital health work, providing regulatory advice and supporting regulatory review of DHTs.

DHTs are helping to move healthcare from the clinic to patients by improving understanding of patient behavior and physiology outside traditional clinical settings and potentially enabling early therapeutic interventions. DHTs, such as sensors and other telehealth technologies, provide important opportunities in clinical trials to gather information directly from patients at home (decentralized clinical trials), and to gather data more frequently or continuously as they go about their lives. DHTs using advanced algorithms may be susceptible to errors or bias, which may lead to malfunction or misinterpretation of health data. Therefore, regulatory science tools and methods, such as simulations to test algorithm performance, need to be developed to protect data integrity, promote health equity, and improve overall reliability of DHTs.

Examples

• FDA is developing non-clinical assessment methods to evaluate electrocardiogram (ECG) analysis algorithms under noisy conditions, representing real-life device use scenarios. ECGs record the electric signal from the heart and can be used to diagnose abnormal heart rhythms such as atrial fibrillation. This study may enable device manufacturers to gain meaningful performance estimates of their ECG analysis algorithms, especially when such algorithms use inputs from DHTs.
• FDA established a Medical Extended Reality Program under which to conduct research on medical extended reality-based medical devices, in addition to activities in the Patient Monitoring and Control Program: Research on Patient Monitoring and Control Devices.
• Scientific evaluation of the sources of variability in smartphone- and smartwatch- based wearable sensors in Human-Device Interaction Program: Research on Human Interaction with Medical Devices | FDA
• FDA is collaborating with CERSIs to study the use of DHTs (actigraphy) in patients with heart failure and in children with depression. Actigraphy monitors cycles of human activity and rest using a wearable watch-like instrument. These studies may support the use of DHTs in the evaluation of new drugs for heart failure and depressive disorders.
• FDA and NCATS/NIH built a mobile application and website called CURE ID allowing healthcare providers globally from all over the world to share and communicate information about the use of existing drugs in clinical practice in new ways (“repurposing”) — including in pregnant patients to treat cancer and infectious diseases such as COVID-19. The CURE Pregnancy Treatment Repository application is gathering data on drugs used during pregnancy to expand our knowledge about their effects in pregnant women.