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Term of the Day

Natural History Study

A natural history study is a preplanned intended to track the course of the disease. Its purpose is to identify demographic, genetic, environmental, and other variables (e.g., treatment modalities, concomitant medications) that correlate with the disease’s development and outcomes. Natural history studies are likely to include patients receiving the current standard of care and/or emergent care, which may alter some manifestations of the disease.

G

GDPR General Data Protection Regulation

The EU general data protection regulation (GDPR) is a privacy and security regulation applicable in the European Union and in the European Economic Area. 

This regulation updated and modernized the principles of the 1995 data protection directive. It was adopted in 2016 and entered into application on the 25th of May 2018.

The GDPR defines:

  • individuals’ fundamental rights in the digital age
  • the obligations of those processing data
  • methods for ensuring compliance
  • sanctions for those in breach of the rules

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