How to assess the regulatory requirements for your digital health solutions

There is significant ambiguity surrounding the digital health regulatory landscape today. It’s a topic of growing concern as more and more biopharma and medtech companies are developing Digital Therapeutics, Software as a Medical Device (SaMD), connected combination products, companion apps and more.

Challenges with digital health regulation

Global medical device software regulations are nuanced and there are a number of complexities in the specific digital health use cases that companies are looking to deploy. Specifically, assessing whether you need a regulated or unregulated infrastructure for hosting your digital health solutions causes a lot of confusion.

We often hear questions like, “why do I need a regulated Internet of Things (IoT) infrastructure?” or, in the United States, “when can or can’t I leverage a Medical Device Data System (MDDS)?”

After numerous discussions in the field, our team decided to launch a research project to address the burning questions that medtech and biopharma execs are struggling to answer.

As part of our research, our team chatted with industry experts – from biopharma execs to partners at law firms who advise biopharma and medtech companies on how to approach their regulatory strategy when it comes to their underlying infrastructure.

Bradley Merrill Thompson, Epstein Becker & Green, P.C. shared his insights: “If your platform solution does anything beyond transferring, storing, converting the format or displaying medical device data – the definition of a Medical Device Data System (MDDS) – the chances are high that some aspect of a biopharma’s software will be regulated. If you want to manage risk, you need to adopt a more conservative point of view to future-proof your business.”

5 takeaways for your digital health regulatory strategy:

1. Nearly all biopharma and medtech executives are grappling with whether or not to build solutions on top of a regulated or unregulated software infrastructure because there are not clear delineations, definitions or existing guidance documentation to make this decision easy.
2. There is a common misconception that determining whether you need an unregulated IoT platform or a regulated IoT platform is about the product(s) hosted on the platform. This is not the case, however. The need for a regulated platform is predicated on the intended use of the data collected and where the data is processed or analyzed, not about whether you’re hosting data from an FDA regulated Class II or III device.
3. There are a number of limitations of an unregulated or MDDS platform, and most do not offer a sustainable regulatory infrastructure to support more mature digital health solutions.
4. You must contemplate your regulatory strategy for your digital health products now — and in the future.
5. If you have an MDDS platform and you have a regulated intended use of the data on the platform, there is a significant amount of remediation that needs to occur for you to be compliant.

Digital health regulatory white paper

The white paper summarizing our digital health regulatory research goes into detail on each of these 5 takeaways. In it, you’ll learn about the United States and Europe regulatory trends, exactly how an MDDS platform increases your compliance risk, and how to determine if you need a regulated or unregulated infrastructure now and in the future.

Download our new white paper here.