News & Analysis as of September 18, 2024

Personal Data

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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -

GDPR Compliance: At the Intersection of AI and Life Sciences

TransPerfect Legal on 5/2/2024

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

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

Nelson Mullins Riley & Scarborough LLP on 7/20/2023

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

ICO consults on new guidance for conducting scientific research under the UK GDPR

Hogan Lovells on 3/2/2022

Research and development, innovation, product and service improvement, AI design and deployment...these are key commercial drivers for the successful modern business. They also underpin technological, medicinal, and other...more

Heads up! New Spanish Code of Conduct on personal data in clinical trials and pharmacovigilance

Hogan Lovells on 3/1/2022

The Spanish Data Protection Authority published on Friday on its website the new "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well as pharmacovigilance"...more

International Privacy Laws and Clinical Trials

Butler Snow LLP on 9/20/2021

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

CNIL Issues Provisional Recommendations for Remote Quality Control of Clinical Trials During the Health Crisis

McDermott Will & Emery on 5/5/2021

Given the challenges of conducting clinical trials during the COVID-19 pandemic, many countries — including France — have allowed for some use of remote quality controls. In response to guidelines issued recently by European...more

The importance of conscientious health data collection in European clinical trials

Hogan Lovells on 1/17/2020

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

Medical Research Council Advises on How to Anonymise Information for Research Purposes

Hogan Lovells on 10/16/2019

Anonymisation has always been (and still is) a real challenge for those carrying out clinical research. To shed some light on this matter, the Medical Research Council (MCR) – which is part of UK Research and Innovation – has...more

GDPR – The Year in Review

Hogan Lovells on 5/30/2019

Following the one-year anniversary of the coming into effect of the GDPR, Hogan Lovells’ Privacy and Cybersecurity practice has prepared a compilation of key GDPR-related developments of the past 12 months. The compilation...more

EDPB’s Position on Clinical Trials Creates Friction with Other EU Legislation

Hogan Lovells on 4/25/2019

Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of...more

EDPB Clarifies Use of Consent and Other Legal Grounds for Clinical Trials, but Challenges Remain

Latham & Watkins LLP on 3/22/2019

European regulators are expected to align their processes and guidance to accommodate the EDPB’s recommended approach to processing special categories of personal data. In January, the European Data Protection Board (EDPB)...more

GDPR and the EU Clinical Trials Regulation

Dechert LLP on 2/23/2019

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

EDPB Issues Opinion on the Interplay between the Clinical Trials Regulation and the GDPR

Foley Hoag LLP - Security, Privacy and the... on 2/21/2019

On January 23, 2019, the European Data Protection Board (“EDPB”) issued an interesting opinion about personal data processed in relation to clinical trials. The main role of the EDPB – which succeeded the Article 29...more

The Legal Basis for Processing Personal Data in the Context of Clinical Trials in the EU: The European Data Protection Board...

WilmerHale on 2/20/2019

On January 23, 2019, the European Data Protection Board (“EDPB”), which is composed of representatives of the national data protection authorities and the European Data Protection Supervisor, adopted an Advisory Opinion...more

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

Hogan Lovells on 2/14/2019

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

Data Protection Rules Could Seriously Impede Clinical Trials in Europe

WilmerHale on 2/12/2019

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

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