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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

Automated individual decision

An automated individual decision is a decision which significantly affects a person and which is based solely on automated processing of personal data in order to evaluate this person. Such an evaluation may relate to different personal aspects, such as performance at work, creditworthiness, reliability, conduct, etc.

Article 22 of Regulation (EU) 2016/679 and Article 24 of Regulation (EU) 2018/1725 lay down the right for individuals to object to decisions about them and solely based on automated means, unless certain conditions are fulfilled or appropriate safeguards are put in place.

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