Glossary

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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.

R

Right to object

According to Regulation (EU) 2018/1725 "The data subject shall have the right to object, on grounds relating to his or her particular situation, at any time to processing of personal data concerning him or her which is based on point (a) of Article 5(1), including profiling based on that provision. The controller shall no longer process the personal data unless the controller demonstrates compelling legitimate grounds for the processing which override the interests, rights and freedoms of the data subject or for the establishment, exercise or defence of legal claims."

This right has to be brought to the attention of the data subject at the time of the first communication at the latest and shall be presented in a clear way separately from any other information (see Article 23 sub (2) of Regulation (EU) 2018/1725)

The data subject may use automated means by technical specifications in order to exercise their right to object in the context of the use of information society services, without prejudice to Articles 36 and 37 (see Article 23 sub (3) of Regulation (EU) 2018/1725 ).

According to Article 23 sub (4) of Regulation (EU) 2018/1725 "Where personal data are processed for scientific or historical research purposes or statistical purposes, the data subject, on grounds relating to his or her particular situation, shall have the right to object to processing of personal data concerning him or her, unless the processing is necessary for the performance of a task carried out for reasons of public interest."

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