Glossary

Discover full dictionary

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510 K
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Accountability
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Accuracy
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Ad-Hoc Services
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Adequacy decision
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Adverse event
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Analysis data model (ADaM)
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Anonymization
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Appropriate safeguards
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Article 29 Working Party
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Artificial Intelligence
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Automated individual decision
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Auxiliary medicinal product
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Best-in-class drugs
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Binding corporate rules (BCR)
B
Biometric data
B
Biotechnology
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Central Laboatory
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Central imaging
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Chemistry, Manufacturing, and Controls (CMC)
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Term of the Day

Informed consent

Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.

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Adequacy decision

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.

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