From draft and final guidance to 510(k) approvals and rejections, the Food and Drug Administration was highly active in digital health last year, with no sign of slowing down. Here’s a summary of last year’s activity, and speculation on what’s ahead…
“Fair balance” is fundamental to compliant pharma marketing, efficacy claims precisely matched with safety information. That principle is central to the Food and Drug Administration’s own mission, that of being “responsible for protecting the public health by ensuring the safety, efficacy, and security” of drugs. In addition to protection, the FDA mandate includes “helping the public get the accurate, science-based information they need to use medical products” to “maintain and improve their health.”
Consistently keeping the public both informed and safe is never easy, especially as digital communications technology makes control steadily more difficult. From space limitations to messaging fragmentation to user generated content, the Internet—and especially social media—have induced a paradigm shift demanding new guidance. In parallel, the increasing sophistication and utilization of electronic tools have put pressure on the FDA to regulate medical devices. Taken together, “digital health” has become a strong focus.
Acknowledging how digital health can reduce inefficiencies and costs, increase access, quality, and personalization, and enable better management and tracking of health-related activities, the FDA is excited about the “convergence of people, information, technology, and connectivity to improve health care and health outcomes.” That powerful mojo demands collaboration and outreach to digital health customers, and fresh regulatory strategies and policies for the ever-evolving tech, manifest in the form of a busy 2016. The highlights:
June Bride: Patient Access to Medical Device Data
The pressure between patient demands for ownership of their personal medical data and healthcare company concerns regarding its release were finally addressed by draft guidance. HIPAA is designed to prevent manufacturers from sharing patient-specific information with health plans and providers without consent—but the guidance clarified the privacy rule doesn’t preclude a company from sharing that personal data with the patient. The draft guidance also actually encouraged its dissemination, music to the ears of advocates.
Although the guidance was “non-binding” and only made recommendations, industry and even patient groups immediately expressed concerns as to intent and action, content and context. Since most patient-specific information is developed for healthcare providers and manufacturers, making it sufficiently “health-literate” for patient audiences is often challenging. To preclude added complexity and confusion, commentators have asked the FDA for additional clarity regarding the preferred frequency and means of communication.
Midsummer Night’s Dream: Evidence, Wellness, and Software
Regulatory ambiguity engenders uncertainty, precipitating hesitancy and often inaction, ultimately hampering innovation. The FDA Center for Devices and Radiological Health has understood the concern, responding with both final and draft guidance last July and August covering a wide range of issues important to digital health. Arguably the most promising is the Use of Real-World Evidence (“RWE”) draft guidance, a welcome approach to research, data, and safety that also made its way into the 21st Century Cures Act.
Since formal clinical trials are expensive, time-consuming, and limited in the range and type of data, the acquisition and analysis from outside sources—including observational, registry, and retrospective studies, case reports, healthcare claims, EHRs, public channels, and others—would greatly expedite and empower the medical device R&D process. The welcome draft guidance describes acceptable circumstances for real-world data (“RWD”) usage, requirements for sources, and provides use cases as examples of viable precedent.
“To Regulate or Not to Regulate, That is the Medical Device Question”
Clearly delineating the boundary between an unregulated health/wellness app and an FDA-approved medical device was the question facing developers until the FDA stamped “final” on their pivotal guidance addressing exactly that: General Wellness: Policy for Low-Risk Devices outlines two different categories for general wellness devices that fall outside of FDA regulation, helping the industry more efficiently develop products they can rest assured knowing will or won’t need the relatively long and complex approval process.
The first category of device/app not requiring approval are those that make no reference to diseases or conditions, and excludes any claims related to weight loss, physical fitness, and “recreational use,” such as stress or sleep management, self-help, or sexual function. The second category do reference diseases or conditions, but only in two specific ways: Either helping to reduce their risk, or help patients live with them. For details and source of the algorithm below, see the Klick Health POV on the differentiation process:
Yet another important document addressed a similar question about when or when not to submit a device for approval, this one sharing criteria for Deciding When to Submit a 510(k) for a Sofware Change to an Existing Device. The challenge is common, since software and firmware updates are frequent, and can change essential features of a device, potentially putting it into a category that requires formal approval. The draft guidance offered developers with an algorithm to help determine potential 510(k) status:
Winter Wonders: Software as a Device, Cybersecurity, and 1-Click
As coding becomes increasingly sophisticated, the boundary between analog and digital worlds dissolves, virtual and augmented reality being striking examples. “Software as a Device” (SaMD) is another such category, increasingly significant for digital health, where diagnostics and even treatment are handled entirely through 0s and 1s. In October the FDA added draft guidance covering SaMDs into the federal registry, the document written by an international third-party regulatory forum—Apple serving as a secret advisor to the project.
Defining SaMD as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device,” the draft guidance applies similar criteria as other guidance, basing inclusion or exclusion criteria on risk category. What’s fascinating is how the line between hardware and software continues to erode, compelling the FDA to regulate software like a physical object, transforming medicine in the process, and thrusting digital health front and center of it all.
Another key guidance that went from draft to final recently was the “Postmarket Management of Cybersecurity in Medical Devices” covering Web-connected devices such as insulin pumps and pacemakers. Responding to industry concerns and a report demanding regulatory action to address the many ongoing privacy and securituy threats, the FDA finalized their recommendations for the continuous monitoring of vulnerabilities, establishing risk mitigation programs, and proactive security troubleshooting.
Capping the year, the FDA published a notice in the Federal Register asking for comments on “Character-Space-Limited Online Prescription Drug Communications,” essentially focused on the feasibility and potential effectiveness of the “1-click rule.” Originally thought to be part of the 21st Century Cures Act, if proven efficacious and safe the ability to redirect consumers from a drug claim made in space limited digital channels such as search ads or social media posts to safety information “1-click” away could be a game changer.
Ups and Downs: Device Approvals, Rejections, and Aspirations
Last year was not only robust for guidance and industry feedback, but 510(k). Overall the depth and breadth of medical device approvals was astonishing, reflecting the increasing sophistication of the technology and user adoption—and FDA eagerness to encourage innovation. From Microsoft Kinect-based therapeutics to connected contact lenses, wearable pain relievers to Wifi-enabled thermometers and male fertility and breast milk apps to diagnostic tools and wireless blood glucose monitoring, the digital health revolution is here.
As we know the FDA can giveth, but also take away: Several promising medical devices didn’t see the light of day in 2016, such as a sensor-equipped pill and a controversial personal health scanner. But amid the misfires come exciting research and rumors from tiny digital health startups to global technology behemoths like Apple—alleged to be developing multiple medical devices, including two cardiac devices and a diagnostic ResearchKit app for Parkinson’s disease. The year ahead should usher in even more excitement.
Year of Digital Health: 2017
Two major developments herald change ahead: The signing of the 21st Century Cures Act, and the election of Donald Trump. The former provides even more clarity on digital decision support tools, real world evidence, and numerous factors impacting digital health. The latter hints at reduced regulation and expedited processes. Meanwhile, the FDA’s own list of Proposed Guidance Development for 2017 holds tremendous promise, and reveals their continued commitment and enthusiasm to digital health innovation.
Consult with a Regulatory Expert
Is your marketing and commercialization partner on top of the constantly shifting and complex regulatory reality? Do they understand the slew of new guidance and 510(k) actions, and know how to apply the learnings and lessons to your own digital health initiatives? Here at Klick Health we look at all the data through a unique lens that offers key insights. We offer curated, fluid, and personally relevant regulatory and technology consultancy to optimize your speed and efficiency, and keep your brands nimble and adaptive. Let’s talk!