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Latest Articles & News

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.

March 12, 2025
Clinical Trials
Biotech & Healthtech
Data Transfers
Regulations & Guidelines
Clinical Trial Sponsor

Navigating Privacy Requirements for Clinical Trials Across Jurisdictions: Focus on China

China’s data protection regulations play a crucial role in clinical trials, requiring sponsors and researchers to comply with multiple laws, including the PIPL, GCP-2020, and cross-border data transfer rules. Unlike other jurisdictions, China imposes strict consent requirements, risk assessments, and regulatory filings, making compliance a key factor when selecting trial locations and managing participant data.

October 14, 2024
Clinical Trials
Guideline

Analyzing the Similarities and Differences Between ICH-GCP and GDPR in Clinical Trials

ICH-GCP and GDPR are vital for clinical trials, setting standards for participant protection and data integrity, with distinct focuses and enforcement approaches.

September 9, 2024
Biotech & Healthtech
Data Breach
Health Data Strategy

Comprehensive Cyber Insurance for the Life Sciences Industry

Cyber insurance provides coverage to businesses, including those in the life sciences industry, to protect against losses from cyberattacks, such as data breaches, ransomware, and other threats. For life sciences companies, which handle high-value intellectual property and sensitive data, tailored cyber insurance policies offer essential protection against financial, legal, and reputational damage while complementing existing cybersecurity measures.