By Matthew Brady 
The Digital Medicine Society (DiMe), a global non-profit dedicated to advancing the digital medicine community, has launched a suite of resources to help the digital health industry navigate international regulatory pathways across APAC, Europe, and North America.
The tools include country-specific regulatory guides, step-by-step flowcharts, and AI/ML guidelines, to help developers navigate national pathways for digital health technology market access. This ultimately accelerates the launch of digital health solutions and benefits patients worldwide. Key markets initially covered include Australia, China, England, France, Germany, Japan, South Korea, and the United States.
According to Megan Coder, Vice President of Product and Policy, DiMe, “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. 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.”
Policymakers and investors can also use the new resources to better evaluate and compare global regulatory markets for digital health products, resulting in more transparency and greater access to technology that will improve healthcare worldwide.
Users can access the resources via the International Digital Health Regulatory Pathways microsite. Countries not represented are invited to partner with DiME to be included in the resources.
