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Navigate global digital health regulatory pathways

Navigating global pathways to scale digital health technologies (DHTs) is complex. These resources are designed to help you with actionable insights to understand and compare regulatory environments across Asia Pacific, Europe, and North America. With country-specific guides, step-by-step flowcharts, and supporting resources, you’ll be equipped to streamline your go-to-market strategies and bring your digital health innovations to patients worldwide faster and more efficiently.

Scale your DHT in key global markets

Assess key global market pathways to bring your DHT through the regulatory process and into patients’ hands. Select a country below to explore further.

Asia Pacific
Europe
North America

Countries at-a-glance

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Don’t see your country? Partner with DiMe to add it to our database, enabling developers to enter your market and reach more patients.

See how others have done it

Explore case studies of companies successfully navigating regulatory landscapes, offering insights into market entry strategies and effective evidence generation.

Big Health: Cross-jurisdictional recognition
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Empatica: Utilizing US data in Europe
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Huma: Clinical evidence transferability
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Luca: Conducting clinical trials in China
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Oviva: Leveraging UK data in Germany
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WELT: Navigating clinical trial comparators
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How will you use these resources in your work? Let us know here, to be featured on our social media and Resource in Action hub.

Do you have a story to share, like these companies? Email regulatory@dimesociety.org to discuss sponsoring the expansion of this collection.

Project partners

DiMe’s global project, International Regulatory Pathways, builds upon the success of the Digital Health US Regulatory Pathways project by combining the expertise of global leaders from across the digital health technology (DHT) industry to foster innovation, drive progress, and harmonize regulatory efforts.

Resources to support your path to market

Library of Digital Health Regulations

Access this continuously updated repository of digital health regulations across key markets. Covering regulatory requirements, HTA processes, and comparative analyses, it serves as a reliable resource for digital health regulations, streamlines your research, and supports policymakers in harmonizing regulatory approaches internationally.
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Navigating emerging global AI regulations: How-to guide for DHT developers

Looking to navigate AI/ML-specific regulatory pathways? This resource covers evidence requirements and market entry strategies for AI-enabled DHTs, helping you understand unique regulatory challenges, optimize evidence generation, and bring your products successfully to market.

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More about this project

Scaling Digital Health Globally: Navigating National Pathways for Patient Access

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Jennifer Bae | IRP Quote

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Katie Chowdhury | IRP Quote

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Alex Cadotte | IRP Quote

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