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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.

A

Appropriate safeguards

The General Data Protection Regulation refers to appropriate safeguards in a number of contexts, including the transfer of personal data to third countries outside the European Union, the processing of special categories of data, and the processing of personal data in a law enforcement context.

This generally refers to the application of the general data protection principles, in particular purpose limitation, data minimisation, limited storage periods, data quality, data protection by design and by default, legal basis for processing, processing of special categories of personal data, measures to ensure data security, and the requirements in respect of onward transfers to bodies not bound by the binding corporate rules. This may also refer to the use of encryption or pseudonymization, standard data protection clauses adopted by the Commission, contractual clauses authorized by a supervisory authority, or certification schemes or codes of conduct authorized by the Commission or a supervisory authority.

Those safeguards should ensure compliance with data protection requirements and the rights of the data subjects appropriate to processing within the European Union.

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