An overview of the FDA’s recent final guidance on clinical decision support (“CDS”) software, with a focus on its application to clinical research settings.
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.
Released on: November 9, 2021
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.
Released on: November 9, 2021
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
October 2021: Demystifying Schrems II for the Cross-Border Transfer of Clinical Research Data
September 2021: Comments on European Data Protection Board Guidelines 04/2021 on Codes of Conduct as Tools for Transfers
October 2020: How to Fix the GDPR’s Frustration of Global Biomedical Research
April 2020: Comments to the European Commission on the Challenges that GDPR Raises for Research
March 2020: Disruptive and Avoidable: GDPR Challenges to Secondary Research Uses of Data
February 2019: Guidance Regarding Interaction Between GDPR and EU Clinical Trials Regulation Leaves Several Questions Unanswered
January 2019: Letter to the European Data Protection Board on the Board’s November 2018 Draft Guidance on the Territorial Scope of the GDPR
