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.

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Legal basis for processing

The General Data Protection Regulation requires data controllers to demonstrate one of these six legal bases for processing: consent, necessity, contract requirement, legal obligation, protection of data subject, public interest, or legitimate interest of the controller. The controller is required to provide a privacy notice, specify in the privacy notice the legal basis for the processing personal data in each instance of processing, and when relying on the legitimate interest ground must describe the legitimate interests pursued.