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.
An adequacy decision is a decision adopted by the European Commission on the basis of Article 45 of the GDPR, which establishes that a third country (i.e. a country not bound by the GDPR) or international organisation ensures an adequate level of protection of personal data. Such a decision takes into account the country's domestic law, its supervisory authorities, and international commitments it has entered into.
The effect of such a decision is that personal data can flow from the EU Member States and the European Economic Area member countries to that third country, without any further requirements. The European Commission publishes a list of its adequacy decisions on its website.