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This article will dive into the details of FDA’s movement in mHealth, analyze FDA’s approach, and assess how this movement impacts the use of mHealth in clinical trial settings.
There has been a lot of recent buzz around FDA’s movements with mHealth (or digital health). This year, the FDA released its Digital Health Innovation Action Plan (DHIAP) (which delineates its directives on ensuring high quality, safe and effective mHealth products), announced its alignment with Software as a Medical Device (SaMD) guidance, and publicized its decisions on the Digital Health Software Pre-certification (PreCert) Program. With these announcements, clinical operations personnel can have some form of assurance that there is advancement in the digital health space, however, it is too early for study teams to leverage mHealth devices to generate data that can be used to support primary study outcomes. This article will delve into the details of FDA’s movement in mHealth, analyze FDA’s approach, and assess how this movement impacts the use of mHealth in clinical trial settings.
FDA’s Digital Health Innovation Action Plan
The DHIAP is a response to help with regulating the massive influx of mHealth/digital health products entering
the market, especially with mHealth technologies that make claims to diagnose diseases, such as using mobile device hardware and software to diagnose medical problems, such as using iPhone cameras to diagnose melanomas. Additionally, many in the industry are seeking guidance on mHealth including patients, sponsors/researchers, and digital health companies; the DHIAP promises to offer a draft guidance for public comment in Q4 2017/Q1 2018.
The FDA Pre-Cert Program
The DHIAP provides evidence that the FDA is approaching mHealth regulation from a scalable format, which is aligned with the nature of digital health technology development. Typically, medical device approval requires that manufacturers submit individual 510(K) applications for each medical device. Alternatively, FDA’s Pre-Cert Pilot suggests that the FDA will select and pre-certify specific digital health developers (i.e., companies that are evaluated on objective criteria including advancements in software development/design, and have robust validation and quality approaches towards software development), and once pre-certified, lower risk mHealth products produced by that developer will either not require additional FDA review, or undergo a streamlined premarket review process. Subsequently, the developer can use real world evidence data to then validate the digital health device or app. However, while not stated specifically in the DHIAP, higher risk digital products (according to SaMD guidance) will likely undergo a more stringent review by the FDA. Figure 1 illustrates this process.
Figure 1: FDA Pre-Cert Process for Digital Health Products 
For example, if a pre-certified digital health company, such as Apple, develops a Class I SaMD app, such as an app that informs the patient that they have tachycardia, the FDA would put that app through a streamlined premarket review, and the app would be released relatively quickly for real world evidence data collection. Alternatively, if Apple develops a Class IV medical app that detects and diagnoses melanomas (or where the consequences are high, for example, if the app is generating false positives or false negatives, and could result in patients not going to their dermatologists), the app will likely undergo a more stringent review process by the FDA.
Duke-Margolis Center for Health Policy (DMCHP): Mobilizing MHealth Innovation for Real-World Evidence Generation
The movement on DMCHP mHealth by regulators has spurred thought leaders to collaborate with the FDA to develop papers that help researchers/sponsors to better understand mHealth. The action plan,
defines varying data types that can be collected through digital health tools, identifying opportunities where researchers can tap into mHealth to obtain outcomes data, and emphasizes the importance of fit-for-purpose (i.e., how likely are patients going to use the digital health technology). The action plan also delineates a framework on how to incorporate mHealth studies, and offers recommendations to the industry regarding collaborative efforts to share previous experiences with the research community and digital health companies.
Digital Health in Clinical Trials
There are a lot of digital health initiatives that biopharmaceutical enterprises, CROs, researchers, and digital health companies are implementing to assess the validity of mHealth technologies. In addition, the movement with regulators and thought leaders to help define, and offer guidance shows great promise in the field of mHealth, especially for research use and virtual study visits. Despite advancements in digital health regulation, it is still too early for biopharmaceutical enterprises to feel comfortable with leveraging mHealth to generate data for primary or secondary endpoints; data generated from digital health devices and apps are often used as a supplement outcomes data for secondary study endpoints. Nonetheless, as the field starts to mature, and digital health becomes more widespread and consistent with the FDA, it is likely that the industry will use digital health, rather than traditional data collection methods to support primary study endpoints.