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Digital Health Regulatory Pathways Explained

The digital health market exceeded $142B in 2020 and is projected to grow at over 17% per year through 2027. Digital health has the potential to redefine healthcare and improve lives, but with so many products in the market today, it can be difficult to know which ones are evidence-based and safe for use. Digital health innovators are just as confused as consumers.   

Regulatory strategy can be a differentiator for digital solutions providers in the market. With support for your regulatory strategy decisions, you can pursue the appropriate path for your products and stand out from the competition. 

Regulations don’t have to be daunting. DiMe’s Digital Health Regulatory Pathways project team is developing tools that will make it easier for you to know which pathways exist, if you need them, and how to pursue them so you can go to market faster. You can save time, money, and resources just by figuring out the right regulatory pathway for your products.

Our Partners

We are proud to be working alongside the following industry leaders and regulators to create new regulatory science resources for the field.

Our Project

We want to help you seek regulation when appropriate and open your door to market access opportunities to better serve patients. 

Project Goal

Creating action-oriented tools to support digital health innovators in knowing what it means to be regulated, what pathways exist, and the requirements and value of each option

Project Objectives

Develop an interactive, open-source, public-facing regulatory science tool by defining key questions and explaining differences in pathways.

Create resources to enable commercial success while speeding the passage of high-quality digital health products to market.

Earn the trust of regulators, payers, clinicians, and patients to drive their appropriate use of digital health products.

This initiative is just one part of our implementation work to support the broad acceptance of digital health tools and bring clarity to the U.S. digital health regulatory infrastructure.

Coming Soon: Resources to Demystify Digital Health Regulations

DiMe resources will help you answer…
What regulatory pathway applies to my digital health solution?

How do I know if FDA regulations apply to my product?

Where can I find more information on digital health regulations?

How will regulatory strategy inform my commercial success?

This is just a preview of what’s to come.
These resources will be available in Q1 2023.

Sign up to be the first to know when the resources launch

Our Project in the News

    Advance digital medicine. Redefine healthcare. Join DiMe.

    DiMe’s projects are seeded by our member community, where experts share the greatest barriers to advancing the field of digital medicine. When the most complex and significant roadblocks can be addressed with a cross-ecosystem, pre-competitive approach, that’s where we come in: DiMe convenes multi-stakeholder teams to quickly dive deep into issues and rapidly produce high-quality resources that meaningfully enable progress.
    Join us to be part of the community that drives our project portfolio and learn first about opportunities to participate in upcoming projects.
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