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
June 11, 2026
Events
Data Governance
Data Privacy Enforcement
Health Data Warehouse

Vendor GDPR in Clinical Trials: What the IQVIA CNIL Ruling Changes for Sponsors and Healthtech Companies

On 26 May 2026 the CNIL fined IQVIA Operations France EUR 5 million for failures in its two authorised health data warehouses, LRX and EMR. The decision exposes weaknesses in CRO data protection practice that have direct consequences for every pharmaceutical sponsor relying on a CRO to process patient, prescription or trial data. This article unpacks the four areas of failure, explains why pseudonymisation no longer offers the cover many sponsors assume, and sets out a practical oversight checklist for sponsor data controllers.

February 9, 2026
AI
Biotech & Healthtech
Regulations & Guidelines
Healthcare

EU AI Act for Healthcare: What Life Sciences Companies Need to Know before August 2026

EU AI Act 2026 healthcare enforcement requires immediate compliance to avoid penalties.

February 2, 2026
Healthtech
US Privacy Law
USA

Navigating US Regulatory Requirements for AI-Powered Medical Devices: A Comprehensive Guide to FDA, HIPAA, and IRB Compliance

US AI medical device compliance requires navigating FDA, HIPAA, IRBs, and consent waivers strategically.

FAQs

Our frequently questions

No items found.