American FDA perspective on digital health

What is Digital Health?

The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.

From mobile medical apps and software that support the clinical decisions doctors make every day to artificial intelligence and machine learning, digital technology has been driving a revolution in health care. Digital health tools have the vast potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of health care for the individual.

Digital health technologies use computing platforms, connectivity, software, and sensors for health care 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, in a medical product, as companion diagnostics, or as an adjunct to other medical products (devices, drugs, and biologics). They may also be used to develop or study medical products.

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What Are the Benefits of Digital Health Technologies?

Digital tools are giving providers a more holistic view of patient health through access to data and giving patients more control over their health. Digital health offers real opportunities to improve medical outcomes and enhance efficiency.

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 health care settings. 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.

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 also providing innovative ways for us to monitor our health and well-being and giving us greater access to information. Together, these advancements are leading to a convergence of people, information, technology, and connectivity to improve health care and health outcomes.

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The FDA’s Focus in Digital Health

Many medical devices now have the ability to connect to and communicate with other devices or systems. Devices that are already FDA approved, authorized, or cleared are being updated to add digital features. New types of devices that already have these capabilities are being explored.

Many stakeholders are involved in digital health activities, including 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's Center for Devices and Radiological Health (CDRH) is excited about these advances and the convergence of medical devices with connectivity and consumer technology. 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:

• Software as a Medical Device (SaMD)
• 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
• Telemedicine
• Wireless Medical Devices

As another important step in promoting the advancement of digital health technology, CDRH has established the Digital Health Center of Excellence which seeks to empower digital health stakeholders to advance health care.

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Who Regulates Mobile Health Apps?

If you are developing a mobile health app that collects, creates, or shares consumer information, use the tool on the Federal Trade Commission's website to find out when the FDA, Federal Trade Commission (FTC), or Office of Civil Rights (OCR) laws apply.

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Source: US Food & Drugs Administration