Consent of the data subject

Consent management of the data subject means any freely given, specific, informed and unambiguous indication of the data subject’s wishes by which he or she by a statement or by a clear affirmative action, signifies agreement to the processing of personal data relating to him or her (GDPR, Article4 (11)).

For consent to be valid, it must be informed, freely given, and unambiguous indication of the data subject’s wishes. Data subjects can give their consent for predefined, specific and lawful purposes. If the purpose of processing personal data changes, you need to ask for a new consent before starting processing. Therefore, you need to specify the purpose for which data is being collected. As a rule, you are always required to ask for consent when you start processing personal data for a new purpose.

Specific consent can be used as a legal basis when you are processing special categories of personal data (such as health information or ethnic origin). Specific consent is needed when transferring data to third countries or international organisations or when processing includes automated individual decision-making or profling. This applies in health care in such occasions, for example when using new analytical or AI technologies for predictive analytics and in profiling purposes.

Read more: General data protection Regulation: Articles 4(11), 6(1a), 7 and 9 (2.a), recitals (32-33 and 42-43). Guidelines on consent under regulation 2016/679.

Dynamic consent is a new approach to consent that engages individuals in decisions about how their personal information should be used. It is a personalised, digital communication interface that enables two-way communication between participants and researchers, and puts participants at the centre of decision making. It is a practical example of how software can be developed to give research participants control over how their data is used.

With the dynamic consent, for instance, research participants are able to upload additional health data, or researchers may inform participants about new research opportunities or findings. Such ongoing interface may increase the participants' understanding of research and positively impact retention rates.