FDA Launches the Digital Health Center of Excellence

The Digital Health Center of Excellence (DHCoE) has recently been launched by the US Food and Drug Administration (FDA), strengthening the digital change that the healthcare industry has already embraced.

In the future, within the Center for Devices and Radiological Health (CDRH) of the department, the program will serve as a coordination platform to help with relevant regulatory activities and to provide the FDA as a whole with digital health policy expertise.

As the new center’s first director, the agency named Bakul Patel, who has helped lead the FDA’s regulatory and scientific efforts covering digital health devices since 2010.

The DHCoE is tasked with providing expertise to help accelerate access to digital health tools that are secure and reliable. In this sense, the Digital Health Center of Excellence is building a network of digital health practitioners and is participating in Collaborative Communities to share expertise and experience with FDA workers on digital health issues and goals.

Despite strong overtures in this market, digital health continues to face major challenges, including data consistency, assessment of the reliability of treatment outcomes, and issues of integration between innovative parties.

In digital health exploration, the DHCoE is a much-needed catalyst and aims to overcome these challenges by reducing risk and connecting the innovation dots across the digital health space that encompasses consumer health and wellness wearables, digital health technology, mobile health technology, medical device software (SaMD), and medical product testing technologies.

In addition to providing technical guidance, organizing and encouraging work across the FDA, advancing best practices, and reimagining digital health device oversight, DHCoE’s goal is to enable both internal and external stakeholders to advance health care by facilitating responsible and high-quality digital health innovation.

The Digital Health Center of Excellence has the following objectives:

  • Connect and build alliances to drive developments in digital health
  • Connect and build partnerships to accelerate digital health advancements
  • Share knowledge to increase understanding and awareness, drive synergy, and encourage best practices
  • Innovate regulatory approachesto provide efficient and least burdensome oversight while meeting the FDA standards for safe and effective products

The FDA anticipates the following developments in digital health by achieving the above objectives:-

  • Strategically advance science and evidence for digital health technologies that meetS the needs of stakeholders
  • Efficient access to highly specialized expertise, knowledge, and tools to accelerate access to digital health technology
  • Aligned regulatory approach to harmonize international regulatory expectations and industry standards
  • Increased awareness and understanding of digital health trends
  • Consistent application of digital health technology policy and oversight approaches
  • Reimagined medical device regulatory paradigm tailored for digital health technologies

Since the beginning of the Covid-19 pandemic, the FDA has also taken steps to expand access to digital health resources. For example, the agency temporarily waived certain limitations on the use of software tools for mental health, allowing low-risk digital health products to be sold without a 510(k) premarket warning to the public. But certain quality controls, including software testing and cybersecurity standards, also had to be satisfied.

As part of an effort to modernize digital health policies and regulatory approaches and provide efficient access to highly specialized expertise, information, and resources to accelerate access to secure and effective digital health technologies, the FDA will continue to develop and formalize the organizing framework and operations of the Digital Health Center of Excellence.