FDA Announces New Center to Advance Digital Health

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Key Insights

  • The U.S. Food and Drug Administration (FDA) recently launched the Digital Health Center of Excellence under the Center for Devices and Radiological Health (CDRH). 
  • “The Digital Health Center of Excellence will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff,” FDA Commissioner Stephen M. Hahn, MD, said in the news release
  • While digital health adoption had stalled prior to the COVID-19 pandemic, adoption has since accelerated, according to a report from Accenture. 

FDA Announces New Digital Health Center of Excellence

The FDA recently launched the Digital Health Center of Excellence, which is “primarily focused on helping both internal and external stakeholders achieve their goals of getting high-quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight.” 

As FDA Commissioner Stephen M. Hahn, MD, stated: “[The] announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings.” 

The Center will advance digital health technologies in accordance with the FDA’s regulatory and oversight role. Bakul Patel was appointed as the first director. A press release noted that “many aspects of the Digital Health Center of Excellence that are still under development.” Following last year’s specifications, the agency will not provide oversight for digital health technology such as “general health and wellness apps, electronic health record systems, and software systems that provide administrative support to healthcare facilities,” Jessica Kim Cohen reported for Modern Healthcare. However, the Center will monitor technology such as “mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.”

Digital Health Accelerates After Stalling

The announcement comes during a time of increased reliance on digital health tools as a result of the COVID-19 pandemic. According to the Accenture 2020 Digital Health Consumer Survey, “rapid rise of digital health had stalled. Now, COVID-19 may serve to resume the growth.” The report noted that, while “consumers are interested in virtual services, a “cumbersome digital experience” and “concerns over privacy, security and trust remain, along with difficulty integrating new tools and services into day-to-day clinical workflows” continue to present challenges. 

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