EMA Audit Report 2023
Executive Summary of the Audit report on Eudravigilance at the European Medicines Agency (EMA).
The General Data Protection Regulation (GDPR) recognises data concerning health as a special category of data and provides a definition for health data for data protection purposes. Though the innovative principles introduced by the GDPR (privacy by design or the prohibition of discriminatory profiling) remain relevant and applicable to health data as well, specific safeguards for personal health data and for a definitive interpretation of the rules that allows an effective and comprehensive protection of such data have now been addressed by the GDPR. Processes that foster innovation and better quality healthcare, such as clinical trials or mobile health, need robust data protection safeguards in order to maintain the trust and confidence of individuals in the rules designed to protect their data.
Executive Summary of the Audit report on Eudravigilance at the European Medicines Agency (EMA).
EDPS Formal comments on the draft Commission Implementing Regulation laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessments
In this edition: What are some of the technologies to watch in 2024? Can social media be used to identify and prevent diseases? News about data protection officers and more. This issue is also part of our podcast series, the Newsletter Digest.
Supervisory Opinion on the use of social media monitoring for epidemic intelligence purposes by the European Centre for Disease Prevention and Control (ECDC)
The 45th edition of the Global Privacy Assembly Annual Meeting took place this year in Bermuda from October 15th through 20th.
All reports and resolutions can be found here.
Following you can find the adopted resolutions during this year's GPA: