What You Should Know:
– 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.
Advancing Global Digital Health: DiMe’s Regulatory Resources for Developers, Policymakers, and Investors
The Digital Medicine Society (DiMe) is a global non-profit organization serving as the professional home for the digital medicine community. Focused on tackling critical challenges, DiMe creates clinical-grade resources on a technology-aligned timeline and disseminates these through open-source platforms and educational initiatives.
DiMe addresses the complexities developers face in navigating regulatory pathways across major markets, including Australia, China, England, France, Germany, Japan, South Korea, and the United States. Its tools include:
– Country-specific regulatory guides outlining unique market requirements.
– Step-by-step flowcharts simplifying navigation through compliance processes.
– AI/ML guidelines offering actionable strategies for the deployment of advanced technologies.
These resources expand DiMe’s regulatory portfolio, empowering innovators to scale globally by navigating complex requirements efficiently. Policymakers and investors can leverage these tools to compare regulatory frameworks, foster transparency, and promote access to transformative digital health technologies worldwide.
By supporting developers in entering new markets and accelerating access to groundbreaking solutions, DiMe reaffirms its commitment to improving healthcare outcomes on a global scale.
“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.”
