Jun 24, 2026
AI
Clinical Trial Information System
Biotech & Healthtech
Data Governance
Regulations & Guidelines

Weekly Digest: EU AI Act Prohibitions, GDPR Enforcement and Clinical Trial Developments - Week of 22 June 2026

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EU AI Act Prohibitions, GDPR Enforcement and Clinical Trial Developments

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EU AI Act Prohibitions, GDPR Enforcement and Clinical Trial Developments
June 24, 2026
AI
Clinical Trial Information System
Biotech & Healthtech
Data Governance
Regulations & Guidelines

Weekly Digest: EU AI Act Prohibitions, GDPR Enforcement and Clinical Trial Developments - Week of 22 June 2026

AI healthcare rules tighten as EU, US and GDPR developments accelerate.

Diagram illustrating joint controllership roles among sponsors, EMA and Member States within the CTIS data protection framework under EU CTR 536/2014 and GDPR
June 22, 2026
Clinical Trial Information System
Biotech & Healthtech
Clinical Trial Sponsor

CTIS Data Protection: Joint Controllership, GDPR Obligations and Sponsor Responsibilities

Understand CTIS data protection obligations under EU CTR 536/2014 and GDPR. Learn how the Joint Controllership Arrangement allocates roles among sponsors, EMA and Member States.

Diagram contrasting pseudonymisation and anonymisation of clinical trial participant data under GDPR, with CNIL enforcement context
June 19, 2026
Biotech & Healthtech
Healthtech
Data Governance

Pseudonymisation Clinical Trials: CNIL's Enforcement Clarifications and What They Mean for Life Sciences Organisations

CNIL's 2026 enforcement action clarifies the line between pseudonymisation and anonymisation in clinical trials. Learn the GDPR implications and recommended practices.

Abstract graphic showing interconnected data nodes over a European map, representing cross-border health data governance and AI regulation
June 17, 2026
EU Privacy Law
Biotech & Healthtech
Clinical Trials
Data Breach
GDPR

Weekly Privacy & AI Regulation Digest: Shadow AI, EDPB Templates, EHDS and Global Reform - Week of 16 June 2026

Shadow AI risks, EDPB breach and DPIA templates, the European Health Data Space, Canada's PIPEDA replacement and APAC consent divergence, this week's key updates.

A data protection officer reviewing a DPIA clinical trials checklist on a laptop, with EU regulatory documents visible on the desk
June 15, 2026
Biotech & Healthtech
Data Protection Impact Assessment

DPIA Clinical Trials: How the EDPB Harmonised Template Reshapes Sponsor Obligations

The EDPB's 2026 harmonised DPIA template changes how sponsors conduct data protection impact assessments in clinical trials. Learn what it means for your programme.

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.