Digital Medicine Society Launches Resources to Navigate Global Digital Health Regulatory Pathways

Resources will speed the expansion of digital health products worldwide, improving global patient access 

BOSTON, Nov. 19, 2024 /PRNewswire/ -- Today, the Digital Medicine Society (DiMe) unveiled a suite of resources to guide industry in evaluating international regulatory pathways. These resources equip digital health technology developers with essential tools to compare and navigate the evolving, complex regulatory environments of an initial set of key markets across Asia Pacific, Europe, and North America. With these tools in hand, developers will be able to streamline their global go-to-market strategies and bring their solutions to market more quickly and efficiently for the benefit of patients across the globe.

DiMe's resources respond to uncertainty from developers about the requirements for and differences between pathways in Australia, China, England, France, Germany, Japan, South Korea, and the U.S. They include tools like country-specific regulatory guides, step-by-step flowcharts, and AI/ML guidelines that provide DHT developers with clear and actionable pathways to navigate requirements across diverse markets.

"As digital health technologies continue to reshape healthcare, it's vital that innovators incorporate regulatory strategy into their overall business strategy - an approach that will allow them to bring these products to patients globally," said Megan Coder, Vice President of Product and Policy, DiMe. "Using our new resources, developers can navigate regulatory landscapes effectively, boosting their ROI and ensuring that their high-quality, trustworthy digital solutions reach the patients who need them most. We're proud to release this set of resources today and plan to work with partners to expand this initial set to other key markets in the near future."

The launch of these resources marks an expansion of DiMe's regulatory portfolio, helping innovators navigate regulatory requirements to bring new products to market in new geographies and scale globally.

"Navigating international regulatory pathways has been a daunting task for developers looking to scale innovative products to new markets. To date, it's been a lengthy and tedious process to compare markets and incorporate findings into a strategic go-to-market strategy," added Ariel Dora Stern, Alexander von Humboldt Professor & Chair for Digital Health, Economics & Policy, at the Digital Health Cluster of the Hasso Plattner Institute. "DiMe's resources will be a game-changer for both early-stage and experienced developers looking to expand access to their products, getting them into the hands of patients and care teams faster and allowing them to focus on developing high-quality products."

Policymakers and investors can also use the new resources to better evaluate and compare global regulatory markets for digital health products. This results in more transparency and greater access to technology that will improve healthcare worldwide.

DiMe is committed to supporting developers to expand the reach of their products into new markets and improving the lives of those globally. If you would like to partner with us to develop additional country resources, please reach out here.

About the Digital Medicine Society: DiMe is a global non-profit and the professional home for all members of the digital medicine community. Together, we tackle the toughest digital medicine challenges, develop clinical-quality resources on a technology timeline, and deliver these actionable resources to the field via open-source channels and educational programs.

Media Contact: Carla English, [email protected]