21 Nov 2024 | 2 MIN READ

Digital Medicine Society Unveils Resources for Global Digital Health Regulations

The Digital Medicine Society (DiMe) has unveiled a comprehensive suite of resources designed to help digital health technology developers navigate international regulatory pathways. These tools aim to streamline the complex compliance processes across key markets in Asia Pacific, Europe, and North America, enabling developers to accelerate their global go-to-market strategies and bring solutions to patients more efficiently.


DiMe, a global non-profit serving as the professional home for the digital medicine community, focuses on tackling critical challenges by creating clinical-grade resources aligned with technological advancements. These open-source resources and educational initiatives address the regulatory complexities faced by developers in markets such as Australia, China, England, France, Germany, Japan, South Korea, and the United States. Key offerings include country-specific regulatory guides, step-by-step compliance flowcharts, and AI/ML guidelines with actionable strategies for deploying advanced technologies.


These tools not only empower innovators to navigate diverse regulatory requirements effectively but also provide policymakers and investors with insights to foster transparency, compare frameworks, and promote global access to transformative digital health solutions. By supporting market entry and improving access to cutting-edge healthcare technologies, DiMe reinforces its mission to enhance health outcomes worldwide.


Highlighting the importance of regulatory strategy in the success of digital health innovations, Megan Coder, Vice President of Product and Policy at DiMe, stated, “As digital health technologies reshape healthcare, incorporating regulatory strategy into business strategy is essential for global impact. With our new resources, developers can effectively navigate regulatory landscapes, improve ROI, and ensure that trustworthy solutions reach the patients who need them most. We are proud to launch these tools and plan to expand them to additional markets soon.”


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