US FDA Commissioner Scott Gottlieb announced a coordinated strategy to remove regulatory ambiguity from the burgeoning field of digital health and keep agency device reviewers' hands off new software and mobile apps in as many cases as possible.
Gottlieb outlined his broad-strokes vision in a June 15 blog post, highlighting a plan to implement the software provisions in the 21st Century Cures Act and go beyond them to deregulate where possible, and map out a pilot oversight program that would rely on third-party pre-certification of developers' design and validation procedures.
"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 stated. "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 had championed a lighter regulatory touch for digital health devices before taking on the commissioner post, as part of a health IT advisory body for the Department of Health and Human Services and as a public commentator. (Also see "Consumer-'Empowering' Devices Called Out In Gottlieb's First FDA Speech" - Medtech Insight, 16 May, 2017.)
At least one industry representative said the announcement from Gottlieb was a highly positive development for health software developers. "Holy smokes. It's amazing what an election will do," said Bradley Thompson, counsel for the Clinical Decision Support (CDS) Coalition, an industry group of health-care software developers. "All in all, I feel like I’ve died and gone to heaven."
FDA's device center has already in recent years advanced policies that favor avoiding active FDA oversight of digital-health tools that are lower risk, but software developers have complained that the policies left too many unanswered questions for future oversight of the space. The Cures Act, enacted in December, aimed to address that by defining specific categories of products, including wellness and clinical administrative support software, that will outside of FDA's jurisdiction. (Also see "'Cures' Bill Circumvents FDA On Medical Software Regs" - Medtech Insight, 30 Nov, 2016.)
Gottlieb said June 15 that FDA plans to publish guidance in the coming months to further clarify what falls outside the FDA's regulatory scope and explain how Cures software provisions impact the agency's pre-existing policies.
"FDA will provide guidance to clarify our position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not," said Gottlieb. "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," he added.
Gottlieb also appeared to put his support behind a new paradigm for regulating digital health tools that agency officials have been floating in recent months. It would be based on certifying a company's internal procedures as a means to providing a quicker, and less costly, route to market.
"While the pilot program is still being developed, we are considering whether and how, under current authorities, we can create a third-party certification program 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," the commissioner explained.
"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," he said.
This aligns closely an "FDA pre-check" program that has been discussed by Bakul Patel, who heads digital health policy within the device center. (Also see "Software Fast Track? US FDA Asks Developers To Envision 'Precheck' Program" - Medtech Insight, 9 Mar, 2017.)
Thompson, with the CDS Coalition and also an attorney with Epstein Becker & Green, strongly supports the concept, and says it is one his group has advocated for.
"In advocating for the pre-check idea, we have advanced the notion that software creates certain unique opportunities to collect data on an almost real-time basis from the marketplace, and make continuous improvement through changes to the software," he said. "We’ve argued that that strength of the software development model could be used as a basis for creating the expedited pathway to market. It would seem as though FDA is interested in pursuing that line of thought."
In his blog, Gottlieb also goes on to state digital health products could benefit from the National Evaluation System for health Technology (NEST) program that FDA is helping develop in collaboration with partners such as the Medical Device Innovation Consortium (MDIC). If the project gets off the ground and is successful, it is intended to create a new paradigm for medical devices in general where products can be brought to market with less premarket data requirements as long as sponsors provide more supporting post-market real-world evidence for their products.
"Applying this firm-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," he added. "Such processes could enable developers to deploy new or updated software more rapidly and would help FDA to better focus our resources."
The plan would come along just as FDA is set to benefit from additional user-fee resources to support digital-health reviews and, in particular, launch a new digital health unit within the device center. (Also see "User-Fee Facts: 10 Key Medtech Details From US FDA Agreements" - Medtech Insight, 11 May, 2017.)
An FDA Turnaround?
Thompson says that since 2011, the CDS Coalition has been urging FDA to publish guidance to clarify the scope of its oversight of clinical decision support software and tackle other unresolved digital health issues. While even just a few months ago, the agency seemed unsure what to do in the area, the attorney noted, Gottlieb now appears to be accelerating forward.
"That is music to my ears," Thompson said. "Indeed, it seems that FDA is committed to going beyond just the technology addressed in the 21st Century Cures Act," he said. "Legislation always covers at best a few of the larger categories, and there is truly much more work to be done. Although it is not specifically addressed, we are very hopeful that the plan includes addressing software used in connection with pharmaceuticals."
As the agency develops guidance documents to implement the Cures Act, Thompson says he hopes FDA will look at the consensus guidelines that the coalition has developed on the transparency provisions in the legislation.
"Specifically, the coalition has been spearheading the development of guidelines for designing clinical decision support software to preserve the health-care professional's role in decision-making," said Thompson. "The guidelines address how to empower health-care professionals to be able to adequately review the basis of recommendations software makes."
Wade Ackerman, a partner at Covington & Burling, also lauded Gottlieb's push to reform the agency's regulation of digital health. Ackerman previously served as senior FDA Counsel for the Senate HELP Committee, where he played a lead role in forming the software provisions and other sections of the Cure Act.
"While Congress addressed some aspects of FDA's regulation of health software in the 21st Century Cures Act last year, the digital landscape continues to evolve rapidly," Ackerman said. "FDA's intent to outline a new digital health innovation plan appears to recognize that developers across the life sciences, technology, and health-care sectors are finding new ways to harness the power of data and information technology to create cutting-edge innovations that will empower consumers and improve patient care."
Medical device lobby group AdvaMed, which recently created a new arm called AdvaMed Digital dedicated to representing digital health companies, says they are reviewing the plan and are looking forward to working with the agency on it.
"We are committed to working with FDA on ways to streamline review processes for digital health technologies that will maintain the agency's robust standard for safety and effectiveness while promoting the rapid innovation for which this sector is known," said Zach Rothstein, AdvaMed associate VP for technology and regulatory affairs.