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The Digital Health Center of Excellence (DHCoE) and SBIR

The Federal Drug Administration's (FDA) Center for Digital Radiologic Health (CDRH) welcomed Troy Tazbaz as the CDRH's new Director of the Digital Health Center of Excellence on January 30, 2023.

Troy will support facilitating the phase three initiatives of the DHCoE. These initiatives will focus on growing strategic partnerships, innovative regulatory frameworks for digital health and harmonization with other regulators. These initiatives are critical for small business research and commercialization efforts. It is imperative that the innovation research community has a framework that protects patients rights, address concerns for bias, enhance the health equity of all individuals, and support diversity and encourages agility in the workforce.

What does this mean for Small Business Innovative Research (SBIR)?

To keep it simple, the DHCoE was designed to help align digital health efforts across the FDA. Some may wonder how the FDA regulates medical devices which is contrary to their name (Food & Drug)? The FDA is the oldest comprehensive consumer protection government agency. It's role is to promote and protect health, which covers foods, drugs, biologics, cosmetics, animal and veterinary medicine, and tobacco. It is the home of the CDRH. The CDRH regulates medical devices and radiation emitting products. So for SBIR, digital tools are a common invention developed to solve or aid in solving United States public health management and/or crises.

The DHCoE empowers digital health stakeholders to advance health care by fostering responsible and high-quality digital health innovation. They provide functional services in the following areas for digital health:

  • Digital Health Policy and Technology Support and Training

  • Medical Device Cybersecurity

  • Artificial Intelligence / Machine Learning

  • Regulatory Science Advancement

  • Regulatory Review Support and Coordination

  • Advanced Manufacturing

  • Real World Evidence and Advanced Clinical Studies

  • Regulatory Innovation

  • Strategic Partnerships

Check out their page to learn more about functional services.


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