Digital tool use is growing, and rapidly. To keep up with these changes, the Food and Drug Administration released a Digital Health Innovation Action Plan over the summer. It aimed to redesign medical device regulation to effectively address new tools, while also making way for innovation in the field.
The FDA quickly followed up the plan with several initiatives, including the launch of its Digital Health Software Precertification Pilot Program, which looks to fast-track the development and uses of digital health technologies. The FDA chose nine companies to participate in the program in September, including Fitbit, Samsung and Apple, among others.
Now, to close out the year, the agency has released three policy documents that will shape future health IT oversight and innovation.
“We recognize that our regulations play a crucial role in the efficient development of such technologies. Therefore, our approach to regulating these novel, swiftly evolving products must foster, not inhibit, innovation,” FDA Commissioner Scott Gottlieb said in a statement. “Moreover, we must always lean in the direction of enhancing access to more information — not restricting information flow — given the ability of reliable information to positively impact daily life.”
Aside from encouraging innovation, the three new guidances — two drafts and one final — also address key provisions of the 21st Century Cures Act that seek to lay out the FDA’s role in digital health — where it is needed and where it is not.
These three new guidances include:
A Clarifying Look at Clinical Decision Support Software
As the pool of health data grows thanks to technologies such as wearables that collect data on everyday activities, the need to sift through data and use it to create actionable insights is rising. Backed by machine learning, clinical decision support (CDS) software aggregates and digests healthcare data to help inform or support clinician decisions on treatment options, diagnostic tests and more.
“This type of technology has the potential to enable providers and patients to fully leverage digital tools to improve decision-making,” Gottlieb said. “We want to encourage developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating old and new medical maladies.”
The FDA hopes to do this by releasing a new draft guidance that will clarify which types of CDS will not qualify as medical devices, and therefore not fall under FDA regulation.
Essentially, the guidance outlines that CDS or similar patient decision support (PDS) software that allow the clinician to “independently review the basis for the recommendations” will not fall under FDA guidance. Software that analyzes or processes “images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram” and uses these analyses to make treatment recommendations will fall under FDA oversight.
FDA Steps Away from Medical App Regulation
The FDA’s second draft guidance, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act,” addresses the types of digital tech that will no longer be classified as a medical device, such as certain apps.
“We’re making clear that certain digital health technologies — such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle — generally fall outside the scope of the FDA’s regulation. Such technologies tend to pose a low risk to patients, but can provide great value to consumers and the healthcare system,” Gottlieb said.
Changes are likely coming to existing guidance, including topics such as general wellness and mobile medical applications, to create a clear distinction between which digital health tech needs regulation and which does not.
“We’re saying that many of these products no longer qualify as medical devices that would be subject to the FDA’s oversight,” Gottlieb stressed.
Final Guidance on SaMD Shapes Global Health IT
The agency has issued final guidance on its international harmonization efforts, which establish “common principles for regulators to use in evaluating the safety, effectiveness and performance" of Software as a Medical Device (SaMD).
It offers global guidelines for providers to recognize and assess the risk of SaMD.
“The agency’s adoption of these principles provides us with an initial framework when further developing our own specific regulatory approaches and expectations for regulatory oversight, and is another important piece in our overarching policy framework for digital health,” Gottlieb said.
Going forward, the FDA hopes these three new policies will help to shape its digital health oversight in a way that speeds up innovation and access while maintaining safety for patients everywhere.
“Our aim is to provide more clarity on and innovative changes to our risk-based approach to digital health products so that innovators know where they stand relative to the FDA’s regulatory framework,” Gottlieb said.