The rules on the processing of personal data for health research purposes have been revised with the implementation of the new Data Protection Act 2018 (Section 36(2)) (Health Research) (Amendment) Regulations 2021 (the “2021 Regulations“). The amendments introduced in the 2021 Regulations include:
- new best practice requirements for explicit consent as a suitable and specific measure to protect the rights and freedoms of individuals;
- new rules on pre-screening individuals for inclusion in health research;
- exempting retrospective chart review studies from the explicit consent requirement;
- deferring the requirement for consent where an individual is incapable of giving consent due to mental or physical incapacity;
- providing an exemption for the requirement of explicit consent as a suitable and specific measure where an individual provided valid consent under the Data Protection Directive which has not been withdrawn; and
- improvements to the appeals process.