Digital health encompasses a wide range of novel digital technologies related to health and medicine. These include mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.
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These technologies can empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings, reports FDA.
From simple wearable devices to artificial intelligence-powered robotics, digital technology has been driving a revolution in health care. Digital health tools have a huge potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of health care for the individual. Digital tools are providing doctors and clinicians a more holistic view of the patient’s health and also giving the patient more control over their health.
How Is the FDA Advancing Digital Health?
The FDA’s Center for Devices and Radiological Health (CDRH) has established the Digital Health program, which seeks to better protect and promote public health and provide continued regulatory clarity by:
- Fostering collaborations and enhancing outreach to digital health customers, and
- Developing and implementing regulatory strategies and policies for digital health technologies.
How Are Digital Health Products Used?
Providers and other stakeholders are using digital health technologies in their efforts to:
- Reduce inefficiencies,
- Improve access,
- Reduce costs,
- Increase quality, and,
- Make medicine more personalized for patients.
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Why Is the FDA Focusing on Digital Health?
Many stakeholders are involved in digital health activities. These include patients, health care practitioners, researchers, traditional medical device industry firms, and firms new to the FDA regulatory requirements, such as mobile application developers, the FDA report said.
The following are topics in the digital health field on which the FDA has been working to provide clarity using practical approaches that balance benefits and risks:
- Artificial Intelligence and Machine Learning (AI/ML) in Software as a Medical Device
- Cybersecurity
- Device Software Functions, including Mobile Medical Applications
- Health IT
- Medical Device Data Systems
- Medical Device Interoperability
- Software as a Medical Device (SaMD)
- Telemedicine
- Wireless Medical Devices
