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Personal Data Data Protection Clinical Trials

Latham & Watkins LLP

Preparing for the European Health Data Space - Opportunities and Challenges for Europe’s Digital Future

Latham & Watkins LLP on

The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more

Goodwin

Life Sciences Companies Must Navigate the DOJ Data Rule

Goodwin on

Life sciences companies have long been outside the scope of US national security regulations and benefited from significant exemptions under US privacy laws. ...more

Hogan Lovells

DOJ restricts data transfers to protect national security; research exemptions expanded in final rule

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The U.S. Department of Justice (DOJ) has finalized its rule on “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” which restricts data brokerage...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

Hogan Lovells

Pharmacovigilance in Spain: Takeaways from the new code of conduct (Part 2)

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Some weeks ago, we described the highlights of 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" (CoC) and the impact on data...more

Hogan Lovells

Clinical trials in Spain: Takeaways from the new code of conduct (Part 1)

Hogan Lovells on

Last week we raised our hands to inform you about the Spanish Data Protection Authority’s approval of the "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well...more

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

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

Hogan Lovells on

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

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

McDermott Will & Schulte

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

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

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

GDPR – The Year in Review

Hogan Lovells on

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

Hogan Lovells

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

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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

Foley Hoag LLP - Security, Privacy and the...

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

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

WilmerHale

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

WilmerHale on

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

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

California Consumer Privacy Act: The Challenge Ahead — Introduction to Hogan Lovells’ Blog Series

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Groundbreaking. Watershed. Unprecedented. - We have heard the California Consumer Privacy Act of 2018 (CCPA) called all these things and more since its enactment on June 28, ?2018. Our experience to date has confirmed the...more

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