In recent years, FDA has increasingly focused on honing its approach to regulating digital health tools and technologies, including those used in the research setting. This presentation focused on the Agency’s risk-based approach to regulation in the digital health space, with a focus on when clinical decision support and artificial intelligence/machine learning software may be considered a medical device subject to FDA regulation.
Topics: 1) The Regulation of Digital Health Tools and Software as a Medical Device, and 2) Update on the Application of the European Union’s General Data Protection Regulation to Research
In the past 18 months there have been several important developments related to the GDPR, including the Schrems II decision, the resulting European Data Protection Board guidance on cross-border data transfers, and the issuance of revised Standard Contractual Clauses. This presentation addressed how each of these items affects researchers.
Topics: 1) The Regulation of Digital Health Tools and Software as a Medical Device, and 2) Update on the Application of the European Union’s General Data Protection Regulation to Research
Presented at: Advancing International Pediatric Clinical Research webinar series: Assent and Consent in the Field: Culture, Context, and Respect
The first conference in the series was a three-hour webinar that focused on applying lessons learned—those sustained and those abandoned– during the COVID-19 pandemic to future work with children in clinical trials.
Each keynote speaker was followed by two moderated panel discussions to:
Deliberate the appropriateness and timing of initiating trials in children, and the different age groups within the broad scope of “children,” using lessons learned from COVID-19 and applying that learning to future pediatric trials.
Address infrastructure, both new and adaptations to existing structures, needed to conduct efficient and ethical pediatric clinical trials on a global scale.
This project is supported by the FDA (R13) Scientific Conference Grant Program.
MRCT Center Faculty Director Barbara Bierer, Executive Director Sarah White, Senior Advisor Luke Gelinas, and Senior Advisor David H. Strauss, authored an article in the Journal of Clinical and Translational Science on “Fair payment and just benefits to enhance diversity in clinical research.”
Released on: July 14, 2021, 11:00 AM.-12 noon. EDT
Discussion Topic: MRCT Center Driving Inclusion in Clinical Research webinar: Simplifying the Complexity of Translation in Clinical Research
Presented at: MRCT Center Leaning In Webinar Series
Moderated by MRCT Center Faculty Director, Barbara Bierer, with guest speakers:
Megan Kasimatis Singleton, JD, MBE, CIP, Associate Dean, Human Research Protections; Director of the Human Research Protections Program, Office of Human Subjects Research, Johns Hopkins University School of Medicine
María José Reyes, MD, Internal Medicine and Infectious Diseases, Medical Director, PanAmerican Clinical Research
Ann E. Taylor, MD, Chief Medical Officer, AstraZeneca
