- Food and Drug Administration Commissioner Scott Gottlieb laid out plans Thursday for a "Digital Health Innovation Plan" which will be aimed at streamlining the path to market for digital medical devices and clarifying the agency's position on health tools like mobile apps.
- Center to Gottlieb's plans is a pilot program that would establish a third-party certification system for low-risk digital products. While still under development, the initiative would allow such products to be marketed without FDA pre-market review and simplify the review process for higher-risk products.
- More immediately, the FDA plans to publish guidance in the coming months on what falls outside the scope of FDA regulation as well as explain how the recently codified 21st Century Cures Act will affect existing agency policies.
Gottlieb has moved quickly in his first month as FDA commissioner, surprising many with a request to Endo Pharmaceuticals to pull its opioid Opana ER from the market while also staking out positions on drug pricing and the approval process for generic drugs.
The newly unveiled plan on digital health is in keeping with Gottlieb's known views on the issue.
Writing in a blog post, Gottlieb cites an estimate from The Economist that tallied 165,000 health-related apps for Apple and Android smartphones. Such apps will have been downloaded 1.7 billion times by the end of the year, according to forecasts.
While many of these are likely to gather digital dust in the depths of a phone or tablet, there is obviously a hunger for health and well-being support from the general public, as well as from patients and physicians. Users for these apps include healthy people trying to improve their lifestyles, patients looking for clinical advice, or healthcare professionals seeking to improve their clinical practice and decision-making.
However, current lack of clarity over which apps are covered by FDA regulation can leave developers and investors uncertain about committing to development.
Gottlieb's plan is aimed at correcting this by providing cleared guidance if and when products fall inside the scope of regulations, or are low enough risk not to require regulatory assessment.
"To encourage innovation, FDA should carry out its mission to protect and promote the public health through policies that are 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," Gottlieb wrote.
The 21st Century Cures Act made clear digital health technologies such as clinical administrative support software or mobile lifestyle apps will generally fall outside the scope of FDA regulation. But the FDA under Gottlieb looks to be building on that foundation further.
The pilot third-part certification program would be a cornerstone towards that approach, Gottlieb wrote.
Another approach would include the use of real-world data, collected post-market, to help support both new product development and the evolution of existing products. The FDA is working with data providers to accelerate the launch of the National Evaluation System for Health Technology (NEST), a virtual system that links data sources including registries, electronic health records, payer claims, and other sources. An initial launch of NEST is expected by the end of 2019.
Taken together, these approaches could create market incentives to drive further investment into the digital health technology industry. That this plan comes within Gottlieb's first month since taking office also indicates its importance to Gottlieb, who has been eager to encourage innovation and ease regulatory burdens in areas not likely to compromise patient safety.