What is Digital Health?

Mobile health (health), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine are all examples of digital health.

Digital technology has been driving a revolution in health care, from mobile medical apps and software that support clinical decisions doctors make every day to artificial intelligence and machine learning. Digital health tools have enormous potential to improve our ability to accurately diagnose and treat disease, as well as to improve individual health care delivery.

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What Are the Benefits of Digital Health Technologies?

Through data access, digital tools are providing providers with a more holistic view of patient health and giving patients more control over their health. Digital health has the potential to improve medical outcomes and increase efficiency.

These technologies have the potential to empower consumers to make more informed decisions about their own health and to provide new options for facilitating prevention, early detection of life-threatening diseases, and chronic condition management outside of traditional health care settings. Digital health technologies are being used by providers and other stakeholders in their efforts to:

• Reduce inefficiencies,
• Improve access,
• Lower costs,
• Improve quality, and
• Make medicine more personalized for patients.

Patients and consumers can use digital health technologies to better manage and track their health and wellness-related activities.

The use of technologies such as smart phones, social networks, and internet applications is not only changing the way we communicate, but it is also providing innovative ways for us to monitor our health and well-being and providing us with greater access to information.

The FDA’s Focus in Digital Health

Many medical devices can now connect to and communicate with other devices or systems. Existing FDA-approved, authorised, or cleared devices are being updated to include digital features. New types of devices with these capabilities are being investigated.

Patients, health care practitioners, researchers, traditional medical device industry firms, and firms new to FDA regulatory requirements, such as mobile application developers, are all involved in digital health activities.

The FDA has been working to provide clarity on the following digital health topics using practical approaches that balance benefits and risks:

• As a Medical Device, Software (SaMD)
• Artificial Intelligence and Machine Learning (AI/ML) in Medical Software
• Software Functions of Cyber security Devices, including Mobile Medical Applications
• Medical IT Health IT Information Technology
• Interoperability of Medical Devices
• Telemedicine
• Medical Devices That Are Wireless