The Digital Medicine Society (DiMe) is collaborating with Peterson Health Technology Institute (PHTI), ZS Associates and other industry groups to improve the development and implementation of integrated evidence plans (IEPs) for digital health products. The goal is to streamline the path to commercialization by providing information on regulatory requirements, commercial considerations and the needs of key stakeholders. The collaboration aims to speed up the process of development and deployment for innovators. It will create resources aligning with U.S. Digital Health Regulatory Pathways for DHPs and the Evidence DEFINED framework. As healthcare continues to undergo digital transformation, the FDA is also facing challenges in regulating the fast-evolving digital health landscape.
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