A rising tide lifts all boats: Navigating digital health regulation

By nature, digital health innovation is pushing the envelope, often operating in a gray zone where regulatory requirements may be unclear. However, with a dedicated center of excellence, new guidances, and a policy navigator, the FDA is taking action to provide clarity. As the FDA’s regulation of digital health matures, regulatory choices will become an increasingly crucial element of go-to-market strategy. FDA regulation is a key avenue for demonstrating the validity and efficacy of digital health tools. Regulatory oversight and status determine the types of claims which can be made about a solution, impacting market perception. In order to succeed in the evolving landscape, it is critical that all stakeholders have a clear understanding of regulatory pathways and associated go-to-market implications.

Setting sail

In an effort to bridge the knowledge gap and increase understanding of FDA regulation across the digital health ecosystem, the Digital Medicine Society (DiME) led an initiative that brought together a diverse group of experts from various organizations. We at Rock Health set sail, alongside other digital health gurus and regulatory experts representing Big Tech players; pharmaceutical and medical device manufacturers; digital health startups; ecosystem actors (academic institutions, industry, professional, and trade organizations); and the FDA. Initiative partners aligned around the shared goal of creating action-oriented tools to support digital health innovators in navigating the complex regulatory landscape, understanding the various pathways available, and determining the value and requirements of each option.

The initiative partners were driven by unique perspectives and motivations. FDA regulators joined the initiative to ensure the digital health market and the agency remained aligned and that resulting tools and resources were reflective of the current state of regulations. Experienced innovators and regulatory experts from pharmacos, medtech manufacturers, and digital health startups ensured that the output would be clear and actionable for future developers and their own organizations. Ecosystem actors were motivated to create additional infrastructure to support innovation. Demystifying regulatory pathways would have industry-wide implications—this effort needed all hands on deck.

Clear waters ahead

The DiME Digital Health Regulatory Pathways initiative resulted in the creation of a new tool which serves as a regulatory compass, supporting innovators in understanding whether their digital health solution falls within FDA regulation and, if so, which pathway is appropriate. By enhancing understanding of FDA regulation of digital health across the ecosystem, the initiative’s resources are poised to impact the industry at large.

For builders of digital health solutions—whether enterprises or startups, intrapreneurs or entrepreneurs—understanding regulation can guide strategy (both regulatory and go-to-market) by enabling decisions to be made earlier and with greater confidence. This can lead to a more streamlined path to market. For buyers—whether incumbents, new entrants and middle children, or grown-up startups—understanding regulation can enable regulatory status to serve as criteria for evaluating digital health solutions in the context of selecting vendors, partners, and/or acquisition targets. Whether builders or buyers, a robust understanding of regulations is an important driver of strategic decision making.

Into the regulatory deep…

Ultimately, regulation is a strategic choice in the broader go-to-market approach for digital health solutions. There are considerations and implications to pursuing FDA oversight (or not).

For developers, regulatory status informs the marketing claims which can be made about a solution—especially those related to impact on health (e.g. prevention, diagnosis, and/or treatment of a condition). While regulatory clearance or approval can be time-consuming and costly, failing to navigate the appropriate pathway can result in lost opportunity or even FDA warnings. By following the appropriate regulatory pathway, developers can demonstrate the safety and efficacy of their solutions and differentiate themselves from competitors.

For informed buyers, understanding of where a product falls within the regulatory landscape is crucial. Just because a developer chose not to pursue regulatory oversight (and commensurately makes less claims) does not mean a solution will not impact health. As long as a solution carefully positions itself and limits marketing claims, it can opt to sail under the radar of regulatory scrutiny. On the flip side, regulatory status can serve as the stamp of approval in which buyers can place their trust.

Whether you’re a developer, buyer, or ecosystem actor, understanding digital health regulation is critical and there’s no better place to start (besides the FDA, itself) than DiME’s Digital Health Regulatory Pathways tool and resources. Remember, it is important to weigh the benefits and drawbacks of pursuing regulatory oversight strategically and with a broader go-to-market approach in mind.

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