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Latest Articles & News

Abstract illustration of interconnected nodes representing clinical trial data flows, wearable devices and EU regulatory symbols against a dark blue background
October 14, 2026
Regulations & Guidelines
GDPR
Clinical Trials
LLMS
Software as a Medical Device (SaMD)

Weekly Privacy, AI and Clinical Trials Digest: Smart Glasses, GDPR Deadlock, Healthcare Cyber Threats and EU Biotech Act Upheaval

This week: EDPB targets smart glasses makers, EU Digital Omnibus stalls, CTIS faces 70% rebuild, healthcare cyberattacks surge and Italy enforces the EU AI Act.

Researcher reviewing AI-generated diagnostic imaging data on a screen in a clinical trial setting, with GDPR compliance documents visible on a desk
October 12, 2026
Regulations & Guidelines
GDPR
LLMS
US Privacy Law
Health Data Strategy

Medical trials and AI: navigating the GDPR, EHDS and EU AI Act overlap

Legal uncertainty surrounds AI use in medical trials. Learn how GDPR, the EHDS and the EU AI Act interact and what sponsors must do to stay compliant.

Diagram showing the CHAIN federated network connecting hospitals, health data hubs and cardiovascular disease registries across 20 European countries under the EHDS and EU AI Act framework
October 9, 2026
Healthtech
Regulations & Guidelines
GDPR
Big Data
Health Data Strategy

AI passports and EHDS: what the CHAIN network means for health AI governance

The EU CHAIN network introduces AI Passports and federated health data models. Learn what this means for GDPR compliance, high-risk AI obligations and clinical sites.

Abstract digital illustration of a secure health data network with EU and US regulatory symbols overlaid on a genomic strand background
October 8, 2026
Data Breach & Cybersecurity
Big Data
GDPR
Cybersecurity
Clinical Trials

Healthcare Data Breaches, AI Transparency and Clinical Research Standards: Weekly Digest

This week: Danish CPR breach, IQVIA Garante fine, OpenAI EU watermarking, Epic MyChart flaws, NIH funding decline and cancer trial QoL standards.

A regulatory compliance officer reviewing audit log data on a secure clinical trial management platform, illustrating vendor GDPR obligations in life sciences
October 5, 2026
GDPR
Clinical Trials
Regulations & Guidelines
Cybersecurity

Vendor clinical trials: audit trails, logging gaps and sub-processor obligations

Understand vendor GDPR obligations in clinical trials, including audit-trail requirements, sub-processor controls and breach notification under Articles 28, 33 and 34.

Researcher reviewing health survey data on a tablet in a clinical research setting, representing data governance challenges in clinical studies
October 2, 2026
Data Governance
GDPR
Health Data Strategy
AI
Regulations & Guidelines

Clinical studies and disability data governance: what life sciences sponsors must track

Learn how proposed cuts to US federal health surveys affect clinical studies, real-world evidence and cross-border data benchmarking for life sciences sponsors.