Specific measures for data-intensive health research without consent: a systematic review of soft law instruments and academic literature.

ABSTRACT: It is a common misunderstanding of current European data protection law that when consent is not being used as lawful basis, the processing of personal data is prohibited. Article 9(2)(j) of the European General Data Protection Regulation (GDPR) permits Member States to establish a legal basis in national law that allows for the processing of personal data for scientific research purposes without consent. However, the European legislator has formulated this "research exemption" as an opening clause, rendering the GDPR not specific as to what measures exactly are required to comply with the research exemption. This may have significant implications for both the protection of personal data and the advancement of data-intensive health research. We performed a systematic review of relevant sof

SUBMITTER: Smit JR 

PROVIDER: S-EPMC10772063 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature