What does GDPR mean for patient data from global clinical trials?

25 July 2018

The General Data Protection Regulation (GDPR) came into force on May 25, 2018. In an Expert View piece, Christian Hebenstreit — general manager and senior vice president at Medidata Solutions — explores the ramifications that this far-reaching change to data regulation could have on the life sciences industry.

Article 1 of the GDPR talks of the fundamental rights and freedoms of natural persons and their right to the protection of personal data; how the free movement of personal data within the European Union shall be neither restricted nor prohibited for reasons connected with the protection of natural persons with regard to the processing of personal data.

It is clear that GDPR is a positive move for Europe - it is the most significant change in European data privacy regulation in 20 years—but in many ways is not so different from the prior Data Protection Directive.

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