HRA-Approved Privacy Language for Clinical Trial Consents
The Health Research Authority (HRA) in the UK has released updated, approved language for the privacy sections of informed consent forms (ICFs) and participant information sheets (PIS) used in clinical trials. This new guidance offers sponsors standardized language that complies with GDPR and UK data protection laws, helping sponsors clearly communicate data privacy practices to […]
Why Non-EU Sponsors must sign Controller-Processor SCC’s with vendors in third-countries?
The EDPB in its Guidelines 05/2021 on the Interplay between the application of Article 3 and the provisions on international transfers as per Chapter V of the GDPR, has provided the following example of a direct collection of data and a transfer to a service provider outside the EU. Example 2: Controller in a […]
GDPR Compliance Guide: CRO Obligations Under EUCROF Code
The European Contract Research Organization Federation (EUCROF) reached a significant milestone on September 12, 2024, with the official approval of its Code of Conduct for Service Providers in Clinical Research. This Code offers a comprehensive framework for Contract Research Organizations (CROs), guiding them in aligning their data processing practices with the General Data Protection Regulation […]
UAE Clinical Trials: Progress, Privacy, & Global Standards
The United Arab Emirates (UAE) is positioning itself as a key player in the global healthcare landscape, with significant investments in medical research and innovation. Among the areas receiving growing attention are clinical trials, which are vital for the development of new drugs, treatments, and medical devices. The UAE’s efforts in this domain are not […]
Third-Party Data Sharing in Clinical Trials: Navigating GDPR Compliance
In clinical trials, collaboration with third parties, such as contract research organizations (CROs), vendors, and strategic partners, is essential for advancing research and bringing new therapies to market. However, the sharing of sensitive data with these entities presents challenges, particularly regarding compliance with data protection regulations such as the General Data Protection Regulation (GDPR) and […]
GDPR Enforcement in Health Sector: Trends, Challenges & What’s Next
The health sector in the European Economic Area (EEA) and the UK is one of the most highly regulated sectors in terms of data protection, given the sensitive nature of the personal data it handles. Since the introduction of the General Data Protection Regulation (GDPR) in 2018, data protection authorities (DPAs) have been actively enforcing […]
The Hidden Risks of Genetic Data: A New Era of Discrimination?
The recent ban in Australia on life insurers, using genetic test results to determine coverage or premiums, highlights a growing concern about the misuse of genetic information. As genetic testing becomes more common, it opens up opportunities for discrimination across multiple sectors, not just insurance. While the ban protects individuals from one type of discrimination, […]
GDPR and EU AI Act: Compliance Guide for the Healthcare Sector
Artificial Intelligence (AI) is revolutionizing the healthcare sector, enhancing everything from diagnostics to treatment planning and patient care. As AI becomes more integrated into these critical functions, regulatory frameworks are evolving to address the unique challenges posed by these technologies. The recent implementation of the EU AI Act on August 1, 2024, combined with the […]
Founder’s voice: Noyb vs Microsoft’s Xandr – Impact on Biopharma
In a significant development in the realm of data privacy and protection, Noyb (None of Your Business), the European privacy advocacy group founded by renowned privacy activist Max Schrems, filed a GDPR complaint against Microsoft’s Xandr in Italy on July 1, 2024. The complaint accuses Xandr of failing to respond adequately to data access requests […]
Leveraging AI in Biopharmaceuticals: Ensuring GDPR Compliance
The integration of Artificial Intelligence (AI) into the biopharmaceutical industry is revolutionizing drug development, offering the potential for significant advancements in personalized medicine, clinical trials, and drug discovery. However, as AI systems increasingly process personal data, ensuring compliance with the General Data Protection Regulation (GDPR) becomes crucial. This article explores the transformative applications of AI […]
