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A clinical data reviewer examining an automated decision output on a screen, representing human oversight in GDPR clinical trials under the EDPS ADM checklist framework
July 6, 2026
GDPR
Regulation
Clinical Trials
US Privacy Law
EU Privacy Law

Human Intervention in Automated Decision-Making: What the EDPS Checklist Means for Life Sciences

The EDPS checklist on human intervention in automated decision-making carries direct implications for GDPR clinical trials. Learn what effective oversight requires.

A clinical trial investigator reviewing an informed consent form with a data protection checklist highlighting the ethnicity data justification section
July 3, 2026
ICF
GDPR
Clinical Trials
Ethics Committee
Combination Products

Informed Consent Form (ICF) and Ethnicity Data: Justification Requirements Under GDPR and MR-001

Ethics committees require scientific justification for ethnicity data in the ICF. Learn how GDPR Article 9, MR-001 and EU CTR 536/2014 apply to your clinical trial.

Abstract digital illustration showing a medical cross symbol overlaid on a data-flow network map, representing health data privacy and AI regulation themes
July 3, 2026
Healthtech
Regulations & Guidelines
DPIA
AI
Data Transfers

Health Data Under Pressure: US Legislative Shifts, AI Privacy Risks and EU Cloud Sovereignty Disputes | Weekly Digest

This week: a US health data broker bill, Supreme Court FTC ruling threatening EU-US data flows, AI membership inference risks, and French cloud sovereignty tensions.

June 29, 2026
Biotech & Healthtech
Clinical Trials
AI

Data Protection in Clinical Trials: Governing AI-Assisted Data Flows Under GDPR

AI intensifies clinical trial data protection, requiring end-to-end governance and inspection-ready controls.

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.