September 26, 2018
By: Scott Gottlieb, M.D.
FDA Commissioner Scott Gottlieb, MD
When the Food and Drug Administration recently granted marketing authorization for two medical apps for Apple’s new Watch, it marked a significant step forward for the agency’s overall approach to the development of digital health.
As described in existing guidance, the FDA generally reviews medical apps without reviewing the general purpose computing platform they sit upon, such as a phone. Similarly here, the FDA reviewed the apps intended for a medical purpose, in this case to identify possible atrial fibrillation, as medical devices, and did not review the underlying general purpose hardware, in this case a sensor, on which they sit and draw their functionality. But the difference was that that phone didn’t have a heart monitor sensor built into it to generate an ECG. The new watch did. With the watch, what we said was simple: sensors that are general purpose can also be decoupled from review of a medical app and we wouldn’t regulate or turn the entire platform into a medical device, just to enable a platform to host software with medical functionality. And the policy we advanced was to say that only the apps intended for a medical purpose, in this case to identify possible atrial fibrillation, would be reviewed and cleared as medical devices.
The FDA’s approach to digital health isn’t to regulate the every-day health and lifestyle uses of consumer devices, but rather to focus our resources on reviewing more sophisticated medical apps that sit on top of this general purpose hardware – the functions that have greater ramifications for patient health and where ensuring safety and efficacy of the application is critical. By focusing our review on the functionality of the software, our aim is to encourage greater innovation in digital health, including the use of Artificial Intelligence (AI) and clinical decision support software.
We believe that a modern, flexible, risk-based approach to regulation will reduce time and cost of market entry, assure patient safeguards are in place, and encourage more developers. This includes innovators that are new to healthcare. We want to give more entrepreneurs a chance to translate digital advances into tools that can help benefit patients.
Our review program offers a number of opportunities for companies to reduce review times. For example, we regularly encourage companies to interact with the agency early in their development process, such as through our Q-Submission (QSub) process to help with efficient development of products. Doing so enables the agency to provide feedback early on regarding clinical testing as well other data needed for an efficient review of product. In addition, we are exploring other ways to implement "interactive" review practices where review staff and firms can rapidly communicate and resolve questions or outstanding concerns. For the digital health area, we continue to explore approaches such as "modular" review, which allows us to shorten the timeframe for the review of the formal premarket review submission itself. This sort of regulatory efficiency is one we are looking to apply when appropriate in order to encourage innovation and increase patient access to devices.
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, giving patients more control over their health, and helping redesign physician workflow to better coordinate patient care. Digital health offers real opportunities to improve medical outcomes, enhance efficiency and reduce costs.
The promise of these technologies, and the rapid pace of change in this area, has prompted the FDA to modernize our regulatory approach to better advance safe, effective innovation in this novel area.
In adopting these new policies, we’ve put patient safety at the forefront of our efforts. The promise of this modern technology is its ability to simultaneously promote safety and advance new innovation.
To date, investment in U.S. digital technology industry has lagged other markets due to uncertainty over both the high cost of regulatory burdens and uncertainty of adequate patient safeguards. For the U.S. to have leadership in this industry and to ensure American patients benefit from this science and innovation, the FDA must be as nimble and innovative as the technologies we’re regulating.
This requires us to take modern, flexible, risk-based approaches to regulation in this area. Our goal is to responsibly reduce the time and cost of market entry, to make these opportunities accessible to entrepreneurs who haven’t traditionally entered the highly regulated market for medical products, all while assuring that appropriate patient safeguards are in place. We want to help encourage more developers to translate digital advances into clinically actionable tools to benefit patients.
Last summer, we launched our Digital Health Innovation Action Plan, which outlined our efforts to modernize the FDA’s approach to ensuring all Americans have timely access to high-quality, safe, and effective digital health products. To deliver on this action plan, we committed to launching the digital health software precertification pilot program within the Center for Devices and Radiological Health (CDRH), and issuing new guidance to modernize our policies and outline our efforts to promote innovation in digital health. We’re in the early innings of the digital health revolution. The applications that have been developed to date are the first wave of advances. We see many more disruptive opportunities right around the corner.
The traditional paradigm of medical device regulation does not suit digital health technologies in a way that optimizes and fully leverages their potential impact on healthcare and patients. Digital health technology changes at a rapid pace. The highly iterative nature of these tools requires a flexible regulatory approach to allow product developers, patients, and regulators to keep pace with the software updates that happen frequently in this space. Having a regulatory framework that enables a rapid cycle of product improvement is integral to ensuring innovation and success for digital health technologies. The precertification model is ideally suited to these challenges. Our pilot will explore a regulatory approach that suits the technology and meets our standards for safety and efficacy.
To build on these efforts, we have sought additional resources as part of the FDA’s FY2019 Budget. The President’s budget includes a proposal to create a Center of Excellence for Digital Health (CoE) that would advance this pre-certification model for digital health -- modernizing our regulatory approach to help this industry grow and reach its full potential, while protecting patients. It would also explore building a new capacity to evaluate third-party certifiers of digital technologies under a precertification program, who will play a key role in the efficient development of these products.
This new CoE also will create a cybersecurity unit to complement the advances in software-based devices, and to aid in the review of cyber advances affecting the more traditional hardware and software based medical devices. In addition, the CoE would establish a public-private multi-disciplinary effort to bring together a broad range of requisite expertise to serve as a resource for industry and the FDA to assess cybersecurity vulnerabilities and incidents and help identify effective solutions.
As we advance digital health tools to improve patient care, we’re also modernizing our approach to making sure these products are safe. A significant area of concern remains cybersecurity. The FDA is taking a lead role in medical device cybersecurity to address an unmet gap in the healthcare and public sector. Cybersecurity requires a multi-disciplinary focused team to bring together a range of requisite expertise to fully assess and validate high-risk/high-impact vulnerabilities and incidents, including potential patient safety implications. The FDA will leverage this new, public-private entity to complement the efforts of the agency’s cybersecurity unit and other government efforts.
As we advance digital tools for use by patients, we also need to invest in the digital tools that we use to support our own regulatory activities. A key element of this is the information technology we use. This represents another important area of investment that’s needed to support the modernization of our oversight of digital health and related technologies. The FDA must implement a modern, agile knowledge and work management system with the cloud-based data storage necessary to support our regulatory approach. This system will foster the review of breakthrough device innovations, help identify, prevent and address cybersecurity vulnerabilities and incidents, foster the more timely detection of safety risks, facilitate the use of advanced manufacturing processing, and leverage real world evidence. These platforms are critical to implementing a total product life cycle approach to device oversight and would provide continuous learning for our program and technology developers, supporting advances in device safety, manufacturing and innovation. Part of our investment in digital health includes advancing these regulatory tools.
The FDA plays a critical role in supporting continued innovation in digital health. It’s an area of intense focus for us precisely because the public health opportunities are so meaningful. The President’s budget provides us with resources that will allow the FDA to fully realize this opportunity.
Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration
Follow Commissioner Gottlieb on Twitter @SGottliebFDA