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General Data Protection Regulation (GDPR) › Personal Data › Pharmaceutical Industry

Follow this channel for updates and analysis on all aspects of the European Union's General Data Protection Regulation, a reform of EU's data protection rules that impacts... more +
Follow this channel for updates and analysis on all aspects of the European Union's General Data Protection Regulation, a reform of EU's data protection rules that impacts individuals throughout the Union and all businesses operating therein. less -
White & Case LLP

AI implementation & data protection regulation: German authorities publish guidelines for implementing AI in compliance with the...

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The German federal and state data protection authorities published guidelines for the implementation and use of AI in compliance with the European Union's regulation of personal data ("Guidelines")....more

TransPerfect Legal

GDPR Compliance: At the Intersection of AI and Life Sciences

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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

Clinical Research and Patient Data Protection are at a Complicated Intersection

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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

Hogan Lovells

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

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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

Hogan Lovells

UK ABPI transfer of value disclosures: transitioning from consent to legitimate interests

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UK pharmaceutical companies have historically relied upon consent as the lawful basis for the disclosure of healthcare professionals’ personal data relating to transfers of value. However, the low consent rates and the...more

Hogan Lovells

The importance of conscientious health data collection in European clinical trials

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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

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

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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

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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...

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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

Hogan Lovells

Belgian sunshine rules – Submissions required by 31 May 2018 at the latest

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On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act”) was adopted by the Belgian Ministry for Public Health....more

Hogan Lovells

Best practices for managing cybersecurity risks related to IoT-connected medical devices

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Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more

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