Digital Health Center of Excellence

Our goal: Empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.

Our objectives: The Digital Health Center of Excellence aims to:

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

Anticipated outcomes: Through fulfilling these objectives, we anticipate the following advancements across digital health:

• Strategically advance science and evidence for digital health technologies that meets the needs of stakeholders.
• Efficient access to a 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.