20 Jun 2017   |   US

New head of FDA sets out plan for regulating digital health devices

Greater certainty about what types of digital health technology will be regulated by FDA will foster innovation and help the agency to devote more resources to higher risk priorities, says Scott Gottlieb

The newly-appointed commissioner of the US Food and Drug Administration, (FDA) Scott Gottlieb has set out details of the agency’s new digital health innovation plan, including a post-marketing approach to regulation of mobile health apps and devices.

In a blog on the FDA website, Gottlieb notes that according to one estimate, in 2016 there were 165,000 health-related apps available for Apple or Android smartphones. Forecasts predict that such apps would be downloaded 1.7 billion times by 2017.


From mobile apps and fitness trackers to clinical decision support software, digital technologies have the power to transform health care in important ways, Gottlieb says. These include:


  • Empowering people to make more and better decisions every day about their own health, monitor and manage chronic health conditions, or connect with medical professionals, using  consumer-directed apps and other technologies;


  • Enabling better and more efficient clinical practice and decision making through decision support software and technologies, to assist in making diagnoses and developing treatment options; managing, storing, and sharing health records; and managing schedules and workflow;


  • Helping to address public health crises, such as the opioid epidemic that is devastating many American communities. The FDA ran a prize competition to encourage the development of a mobile app to help connect opioid users experiencing an overdose with nearby carriers of the prescription drug naloxone for emergency treatment.


For these and other digital technologies to take hold and reach their fullest potential, the FDA needs to be forward-leaning in making sure it has implemented the right policies and regulatory tools, and communicated them clearly, to encourage safe and effective innovation. “In this rapidly changing environment, ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures,” Gottlieb writes.

Policies must be clear enough for developers to apply them on their own, without having to seek out, on a case-by-case basis, FDA’s position on every individual technological change or iterative software development.

The 21st Century Cures Act, passed in December 2016, revised FDA’s governing statute to, among other things, make clear that certain digital health technologies, such as clinical administrative support software and mobile apps that are intended only for maintaining or encouraging a healthy lifestyle, generally fall outside the scope of FDA regulation.

Such technologies tend to pose low risk to patients but can provide great value to the healthcare system.

FDA is working to implement the digital health provisions of the 21st Century Cures Act and, in the coming months, will be publishing guidance to further clarify what falls outside the scope of FDA regulation and to explain how the new statutory provisions affect pre-existing FDA policies.

The agency will provide guidance to clarify its position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not.

In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements. Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA’s compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher risk priorities.

In addition, FDA is planning to pilot an entirely new approach to regulating this technology, in the autumn. While the pilot programme is still being developed, the agency is considering whether and how it can create a third party certification programme under which lower risk digital health products could be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review.

Gottlieb says certification could be used to assess, for example, whether a company consistently and reliably engages in high quality software design and testing (validation) and ongoing maintenance of its software products. Employing a unique pre-certification programme for ‘software as a medical device’ could reduce the time and cost of market entry for digital health technologies.

In addition, post-market collection of real-world data might be able to be used to support new and evolving product functions. For example, product developers could leverage real-world data gathered through the National Evaluation System for health Technology (NEST) to expedite market entry and subsequent expansion of indications more efficiently.

NEST will be a federated virtual system for evidence generation composed of strategic alliances among data sources including registries, electronic health records, payer claims, and other sources. The Medical Device Innovation Consortium (MDIC), is serving as an independent coordinating centre that operates NEST.

MDIC will shortly be announcing the establishment of a governing committee for the NEST coordinating centre comprised of stakeholder representatives of the ecosystem, including patients, healthcare professionals, healthcare organisations, payers, industry, and government.

FDA has been establishing strategic alliances among data sources to accelerate NEST’s launch with the initial version of a fully operational system anticipated by the end of 2019.

Applying a company-based approach, rather than the traditional product-based approach, combined with leveraging real-world evidence, would create market incentives for greater investment in and growth of the digital health technology industry. Such processes could enable developers to deploy new or updated software more rapidly and would help FDA to better focus resources.

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