Glossary

Discover full dictionary

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510 K
A
Accountability
A
Accuracy
A
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
A
Artificial Intelligence
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Automated individual decision
A
Auxiliary medicinal product
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Best-in-class drugs
B
Binding corporate rules (BCR)
B
Biometric data
B
Biotechnology
C
Central Laboatory
C
Central imaging
C
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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Special categories of personal data

Special categories of personal data include data that reveals "racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade-union membership, genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural's sex life or sexual orientation" (Article 10 of Regulation (EU) 2018/1725; Article 9 of the GDPR). This data is also referred to as sensitive data.

The processing of such information is in principle prohibited, except in specific circumstances. It is possible to process sensitive data for instance if the processing is necessary for the purpose of medical diagnosis, or with specific safeguards in the field of employment law, or with explicit consent of the data subject.

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