On March 5, 2025, the final text of the European Health Data Space (EHDS) was published in the EU Official Journal (see here). In April 2024,we wrote several blog posts on EHDS based on a provisional compromise text. We have now updated those to reflect the final version and included references to the correct
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EFPIA Issues Statement on Application of the AI Act in the Medicinal Product Lifecycle
On April 22, 2024, the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) issued a statement on the application of the AI Act in the medicinal product lifecycle. The EFPIA statement highlights that AI applications are likely to play an increasing role in the development and manufacture of medicines. As drug development is already governed…
EHDS Series – 3: The European Health Data Space from the Health Data User’s Perspective
On March 5, 2025, the final text of the European Health Data Space (EHDS) was published in the EU Official Journal (see here). In early April 2024,we wrote several blog posts on EHDS based on a provisional compromise text. We have now updated those to reflect the final version and included references to the…
California Privacy Protection Agency Takes Next Step on New Automated Decision-Making Regulations and Privacy Risk Assessments
At its March 8, 2024 meeting, the Board of the California Privacy Protection Agency (“CPPA”) moved, by a 3-2 vote, to advance proposed regulations addressing automated decision-making technology (“ADMT”) and risk assessments for the processing of personal information. Notably, the Board’s vote only allows staff to begin paperwork preliminary to a rulemaking; it did not…
U.S. AI, IoT, CAV, and Privacy & Cybersecurity Legislative & Regulatory Update – First Quarter 2023
This quarterly update summarizes key legislative and regulatory developments in the first quarter of 2023 related to Artificial Intelligence (“AI”), the Internet of Things (“IoT”), connected and autonomous vehicles (“CAVs”), and data privacy and cybersecurity.…
European Commission Proposes New Artificial Intelligence Regulation
In April 2021, the European Commission released its proposed Regulation Laying Down Harmonized Rules on Artificial Intelligence (the “Regulation”), which would establish rules on the development, placing on the market, and use of artificial intelligence systems (“AI systems”) across the EU. The proposal, comprising 85 articles and nine annexes, is part of a wider package…
European Commission Conducts Open Consultation on the European Health Data Space Initiative
On December 23, 2020, the European Commission (the “Commission”) published its inception impact assessment (“Inception Impact Assessment”) of policy options for establishing a European Health Data Space (“EHDS”). The Inception Impact Assessment is open for consultation until February 3, 2021, encouraging “citizens and stakeholders” to “provide views on the Commission’s understanding of the current situation,…