Glossary

Discover full dictionary

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510 K
A
Accountability
A
Accuracy
A
Ad-Hoc Services
A
Adequacy decision
A
Adverse event
A
Analysis data model (ADaM)
A
Anonymization
A
Appropriate safeguards
A
Article 29 Working Party
A
Artificial Intelligence
A
Automated individual decision
A
Auxiliary medicinal product
B
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.

S

Standard contractual clauses (SCC)

Standard contractual clauses (SCC) are legal tools to provide adequate safeguards for data transfers from the EU or the European Economic Area to third countries.

The European Commission has adopted three Decisions declaring Standard Contractual Clauses to be adequate, and therefore, companies can incorporate the clauses into a transfer contract, but the clauses can't be modified. Four modules were created to accommodate each transfer situation: controller to controller, controller to processor, processor to processor and processor to controller. 

In principle no authorisation is required from data protection authorities to be allowed to use these clauses. A formal notification to the authority might nevertheless be necessary.

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