On April 21, 2020, the European Data Protection Board (“EDPB”) adopted Guidelines on the processing of health data for scientific purposes in the context of the COVID-19 pandemic. The aim of the Guidelines is to provide clarity on the most urgent matters relating to health data, such as legal basis for processing, the implementation of adequate safeguards and the exercise of data subject rights.
The Guidelines note that the General Data Protection Regulation (“GDPR”) provides a specific derogation to the prohibition on processing of sensitive data under Article 9, for scientific purposes. With respect to the legal basis for processing, the Guidelines state that consent may be relied on under both Article 6 and the derogation to the prohibition on processing under Article 9 in the context of COVID-19, as long as the requirements for explicit consent are met, and as long as there is no power imbalance that could pressure or disadvantage a reluctant data subject. Researchers should keep in mind that study participants must be able to withdraw their consent at any time. National legislation may also provide an appropriate legal basis for the processing of health data and a derogation to the Article 9 prohibition. Furthermore, national laws may restrict data subject rights, though these restrictions should apply only as is strictly necessary.
In the context of transfers to countries outside the European Economic Area that have not been deemed adequate by the European Commission, the Guidelines note that the “public interest” derogation to the general prohibition on such transfers may be relied on, as well as explicit consent. The Guidelines add, however, that these derogations should only be relied on as a temporary measure and not for repetitive transfers.
The Guidelines highlight the importance of complying with the GDPR’s data protection principles, particularly with respect to transparency. Ideally, notice of processing as part of a research project should be provided to the relevant data subject before the project commences, if data has not been collected directly from the individual, in order to allow the individual to exercise their rights under the GDPR. There may be instances where, considering the number of data subjects, the age of the data and the safeguards in place, it would be impossible or require disproportionate effort to provide notice, in which case researchers may be able to rely on the exemptions set out under Article 14 of the GDPR.
The Guidelines also highlight that processing for scientific purposes is generally not considered incompatible with the purposes for which data is originally collected, assuming that the principles of data minimization, integrity, confidentiality and data protection by design and by default are complied with.