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The European Union General Data Protection Regulation
(GDPR)

What is GDPR?

The European Union (EU) General Data Protection Regulation (GDPR) is the most important change in data privacy regulation in 20 years. The regulations can be enforced from 25 May 2018, at which time any organization which does not comply may face heavy fines. The GDPR (Regulation (EU) 2016/679) replaces the Data Protection Directive 95/46/EC, designed to harmonize data privacy laws across Europe, to protect and empower all EU citizens data privacy and to reshape the way organizations across the region approach data privacy.

The aim of the GDPR is to standardize and strengthen the protection of personal data across the EU and for other country’s data being “processed” within the EU. As such, this is an issue for all to take note, not just those based in Europe. Under the new regulations, all company processing of the personal data of subjects residing in the Union must comply, regardless of the company’s other global locations.

How will it impact the clinical trials industry?

The increasing use of the internet, electronic records, and the advancement of clinical trial technologies enabling the collection and use of data, has no doubt played a part in the need for new regulations. Big data is becoming increasingly important in clinical research, which also poses new challenges for data security and privacy.

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