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.
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.
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 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.
How Is the FDA Advancing Digital Health?
Reimagining the FDA's Approach: Digital Health Innovation Action Plan
The Digital Health Innovation Action Plan (PDF) outlines our efforts to reimagine the FDA's approach to ensuring all Americans have timely access to high-quality, safe, and effective digital health products. As part of this plan, we committed to several key goals:
- Issuing guidance to modernize our policies, including the 2019 "Clinical Decision Support Software" draft guidance and "Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act" final guidance.
- Increasing the number and expertise of digital health staff at the FDA.
- Developing the Digital Health Software Precertification Pilot Program ("Pre-Cert").
The FDA will host a webinar series for industry and others interested in learning more about these software-related guidances:
- November 4: Clinical Decision Support Software draft guidance
- November 14: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act final guidance as well as the four related final guidance documents.
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.
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.
Why Is the FDA Focusing on 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 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:
- Wireless Medical Devices
- Device software functions, including Mobile Medical Applications
- Health IT
- Medical Device Data Systems
- Medical Device Interoperability
- Software as a Medical Device (SaMD)
- General Wellness
Who Regulates Mobile Health Apps?
If you are developing a mobile health app that collects, creates, or shares consumer information, use the tool on Federal Trade Commission's website to find out when the FDA, Federal Trade Commission (FTC), or Office of Civil Rights (OCR) laws apply:
Jobs in the FDA's Digital Health Program
The FDA seeks software engineers, artificial intelligence and machine learning engineers, security researchers, user interface and user experience designers, and product managers to be a part of the Division of Digital Health. If you are interested, email firstname.lastname@example.org with Subject: "Resume."
For more information about the duties, read the digital health job description.
- Report on Non-Device Software Functions: Impact to Health and Best Practices - December 2018
- FDASIA Health IT Report
- Home Health and Consumer Devices