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The FDA's Digital Health Center of Excellence (DHCoE), founded in 2020, is a resource for both industry and the public, intending to accelerate innovation in digital health. Recently, they've been involved in several pilots and activities to promote digital health technologies. This blog post will discuss some of their recent work, leadership changes, and the future.

FDA is pioneering the development and enhancement of digital health regulatory paradigms and fostering digital health-focused collaborations. Initially established to meet FDA standards for safe and effective products while providing a regulatory approach tailored for digital health technologies, the DHCoE plans to empower stakeholders by advancing knowledge, awareness, and digital health innovation.

A New Future for the DHCoE

In 2022, the DHCoE will continue to grow and advance its work in the industry. To help support this work and the implementation of the 2022-2025 CDRH Strategic Priorities, Bakul Patel is taking on a new role as the Chief Digital Health Officer of Global Strategy and Innovation of the Center for Devices and Radiological Health, the department DHCoE is based. In this new role, he looks forward to helping drive the FDA's global strategic vision of advancing health with innovative technology. While the FDA is still working on selecting the next Director, the DHCoE will continue its work with patients, developers, healthcare providers, researchers, regulators, and other stakeholders to further the organization’s mission.

Whoever is named as Director of the DHCoE will be responsible for progressing the three core missions:

  1. Connect and build partnerships to accelerate digital health advancements
  2. Share knowledge to increase awareness and understanding, drive synergy, and advance best practices
  3. Innovate regulatory approaches to provide efficient and least burdensome oversight while meeting FDA standards for safe and effective products

In addition to meeting these goals, the DHCoE will also likely continue to focus on raising awareness and understanding of digital health among stakeholders. We can expect to see more updates from the DHCoE as they continue to advance the digital health space.

These developments are something that we are paying keen attention to at MEDIcept. We have decades of experience in the global medical device industry, helping clients navigate complex regulatory pathways, reducing business risk and time-to-market while maximizing the potential for success. Contact us to learn more about how we can help you keep pace with evolving digital health initiatives through your regulatory journey.

 

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About Us

MEDIcept is an international consulting firm offering a full portfolio of services to the medical device and IVD industry. For over 25 years, our unique consulting practice and multidisciplinary team of former FDA, Notified Body, and industry experts have assisted hundreds of companies of all sizes with innovative, compliant, trusted, and cost-effective Regulatory, Quality, Clinical, and Engineering solutions.

For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.