Both regulatory science research and partnerships play an integral role in the Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence’s (DHCoE) mission to protect and promote public health by fostering responsible digital health innovation.
Through digital health-focused collaborations, CDRH is fostering regulatory science research that enables FDA’s experts to understand and assess benefits and risks of new digital health technologies; and this research helps ensure the safety or reduce the harm of products used by patients and consumers by providing scientific, non-biased, and objective expertise.
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On October 27, 2022, CDRH’s DHCoE published “Spotlight: Digital Health Regulatory Science Opportunities.” The Spotlight highlights some important research areas identified by stakeholders internal and external to the FDA. In the Spotlight, CDRH’s DHCoE describes these current regulatory science areas of interest in digital health for stakeholders to consider. Advances in digital health occur rapidly and new areas of interest are likely to arise prompting new regulatory science research focus areas throughout the ecosystem.
Patients, researchers, health care providers, medical product manufacturers, technology companies, standards organizations, and many other stakeholders play integral roles in advancing digital health. Strategic alignment among these stakeholders can help focus efforts to optimize research and possible applications of digital health technologies. CDRH’s DHCoE fosters digital-health focused collaborations that advance public health including the following:
FDA’s Centers of Excellence in Regulatory Science and Innovation (CERSIs) are collaborations between the FDA and academic institutions to advance regulatory science through innovative research, training, and scientific exchanges.
Collaborative Communities are continuing forums in which private- and public-sector members work together on medical device challenges. These groups can invite CDRH to participate. CDRH’s DHCoE participates in the following digital health-related collaborative communities:
- Collaborative Community on Ophthalmic Imaging (CCOI)
- National Evaluation System for health Technology Coordinating Center (NESTcc) Collaborative Community
- Pathology Innovation Collaborative Community (PICC)
- Xavier Artificial Intelligence (AI) World Consortium
- MedTech Color Collaborative Community
- Digital Health Measurement Collaborative Community (DATAcc)
CDRH’s Network of Digital Health Experts is a pool of vetted experts available to share knowledge and experience regarding digital health issues with FDA staff on an as-needed basis.
Other collaborations include CDRH’s DHCoE partnership with the Medical Device Innovation Consortium (MDIC)'s Digital Health Initiative.
Through our partnerships and collaborations, CDRH’s DHCoE is fostering regulatory science research projects in several areas important to digital health. This research includes the following topic areas:
Artificial Intelligence/Machine Learning (AI/ML)
- Assessing the Robustness of Clinical Machine Learning Models to Changes in Context of Use
- Data Science Methods for Post-marketing Surveillance of AI Diagnostic Tools and Algorithm-Based Therapeutics
- Benefit-Risk Preferences for the Use of Artificial Intelligence and Machine Learning in Imaging Diagnostics
- AI in Healthcare: Understanding Patient Information Needs and Designing Comprehensible Transparency
- Patient and Provider Informed Labeling of AI/ML-Based Software to Enable Transparency and Trust for Cardiac Monitoring and Diagnostics
- A Quality Assessment Tool for Artificial Intelligence-Centered Diagnostic Test Accuracy Studies: QUADAS-AI
Digital Health Technologies
- Quantifying Physical Function in Cancer Patients Undergoing Chemotherapy Using Clinician-Reported, Patient-Reported, and Wearable Device Data Sources
- Post-Market Evaluation of Smartwatch Cardiovascular Notifications
- Integrating Sensor Generated Data into Data Platforms to Power Clinical Research and Patient Care
- Development of Digital Measures
- Deployment of Digital Measures
Real World Data and Performance
- The Digital Variome: Understanding the Implications of Digital Tools on Health
- Aggregating Multiple Real-World Data Sources Using a Patient-Centered Health-Data-Sharing Platform
Augmented Reality / Virtual Reality
Interested in Collaborating with CDRH’s Digital Health Center of Excellence?
Please visit the DHCoE webpage Ask a Question About Digital Health Regulatory Policies for information on how to collaborate with the DHCoE or to submit questions related to current digital health policies.