News & Analysis as of

Life Sciences Personal Data Clinical Trials

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

TransPerfect Legal

GDPR Compliance: At the Intersection of AI and Life Sciences

TransPerfect Legal on

Late last month, the Association of Corporate Counsel (ACC) hosted a panel on artificial intelligence and how it is rapidly transforming the life sciences sector, allowing companies to leverage large datasets to accelerate...more

Nelson Mullins Riley & Scarborough LLP

EMA Finalizes Guidance on Safeguarding PPD and CCI in Clinical Trial Filings in the European Economic Area (EEA)

The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more

Nelson Mullins Riley & Scarborough LLP

Clinical Research and Patient Data Protection are at a Complicated Intersection

The privacy landscape in the United States and much of the world is quickly evolving around the framework of the General Data Protection Regulation (GDPR) within the European Economic Alliance (EEA). Clinical trials involve...more

Butler Snow LLP

International Privacy Laws and Clinical Trials

Butler Snow LLP on

Recent developments in international privacy laws have complicated the conduct of clinical trials outside of the United States. Since the privacy law of the European Union – the General Data Protection Regulation or “GDPR” –...more

Hogan Lovells

The importance of conscientious health data collection in European clinical trials

Hogan Lovells on

Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more

Dechert LLP

GDPR and the EU Clinical Trials Regulation

Dechert LLP on

On 23 January 2019, the European Data Protection Board (“EDPB”) issued an opinion on the interplay between the EU General Data Protection Regulation (“GDPR”) and the EU Clinical Trials Regulation (“CTR”). The CTR is not yet...more

Hogan Lovells

EDPB Advises on Lawful Grounds for Processing Personal Data in Clinical Trials

Hogan Lovells on

With the coming into effect of the General Data Protection Regulation (GDPR), those conducting clinical trials in the EU face a complex set of rules ranging from lawful grounds for processing and transparency to restrictions...more

WilmerHale

Data Protection Rules Could Seriously Impede Clinical Trials in Europe

WilmerHale on

The European Data protection Board (“EDPB”), which is composed of representatives of the national data protection authorities and the European Data Protection Supervisor, recently adopted an Advisory Opinion (“Opinion”) on...more

Hogan Lovells

A look at how AI and blockchain could solve data management and integrity issues in a life sciences environment and the challenges...

Hogan Lovells on

Blockchain and artificial intelligence (AI) are opening new doors towards improving data efficiency in the life sciences industry. But these technologies may also impose unique limitations and curtail the traditional role of...more

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