FDA issues Digital Health Innovation Action Plan
On March 26, 2020, the FDA published a paper called “Digital Health Innovation Action Plan” outlining the 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, the FDA committed to several key goals:
- Issuing guidance to modernize their policies.
- Increasing the number and expertise of digital health staff at the FDA.
- Developing the Digital Health Software Precertification Pilot Program (“Pre-Cert”).
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?
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 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
- Device Software Functions, including Mobile Medical Applications
- Health IT
- Medical Device Data Systems
- Medical Device Interoperability
- Software as a Medical Device (SaMD)
- Wireless Medical Devices
Please find the complete FDA article here.
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