Summary

The AI Act: Progressing Faster Than Expected

The European Parliament is scheduled to vote on the legislation March 13, and one of the lawmakers leading the legislation said he expects it to pass easily. Under the current timeline the law would largely take effect in 2026, although some provisions would kick in this year.

The EU Parliament has rescheduled its vote to March 13, a full month sooner than originally planned. According to statements from Members of Parliament, the parliamentary vote is expected to closely mirror the committee's decision. The Act is anticipated to be approved by a significant majority of the members.

Next Steps: Following the Parliament's vote, the Council, consisting of governments from EU member states, will officially approve the Act. According to the present schedule, the law is set to come into full effect by 2026, though certain elements may be implemented as early as this year.

Overview of the Act:

  • The Act aims to categorize AI applications according to their risk level, imposing bans on specific applications such as "emotion recognition" in workplaces, which could lead to the highest penalties: either 7% of worldwide revenue or 35 million euros (approximately $38 million), whichever is greater.
  • The legislation will affect companies operating within the 27-country bloc and developers of AI systems used in the EU, regardless of their location, including those in the USA.
  • Any company that introduces a product to the EU market will need to comply with the AI Act, meaning its products must adhere to the regulations set forth by the Act.

Click here to read more

Seamus Larroque

CDPO / CPIM / ISO 27005 Certified

Home

Discover our latest articles

View All Blog Posts
July 16, 2025
Clinical Trial Sponsor
Clinical Trials

Data Protection Strategies for Phase III Clinical Trials

Phase III clinical trials require strict compliance with privacy and data protection laws across multiple jurisdictions, including GDPR obligations, local authorizations, and ethics committee oversight. The article outlines practical strategies such as the “funnel approach” to harmonize global frameworks, manage cross-border transfers, appoint Data Protection Officers, and ensure proper informed consent documentation. It also emphasizes the need for local representatives, jurisdiction-specific formalities, and standardized templates to maintain compliance and avoid delays in global studies.

June 10, 2025
AI
USA
Biotech & Healthtech

Addressing the Data Protection and Ethical Challenges posed by AI in Health – Part 2

Our latest analysis: U.S. vs EU—AI regulation shaping healthcare’s future.