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Rows of empty seats from a parliament hemicycle with headphones on desks and electronic voting equipment fitted
Rows of empty seats from a parliament hemicycle with headphones on desks and electronic voting equipment fitted © Bet_Noire

Data-related Legislation

Data-related legislation such as the General Data Protection Regulation (GDPR), the Directive on the Re-use of Public Sector Information (PSI Directive), and the Regulation on the Free Flow of Non-personal Data needs to reflect the practices and needs of researchers and provide legal certainty for their activities.

Why does data-related legislation matter?

Researchers need legal certainty on how they can produce and use data. As research is often done in collaborative and cross-border projects, legal certainty has to be provided by harmonised legislation on an EU level that takes into account the needs and practices of research.

Why does the General Data Protection Regulation (GDPR) matter for research?

GDPR applies to any type of scientific research that uses personal data, such as studies in (bio)medicine, the social sciences, and the arts and humanities. It affects EU researchers who need to be able to collect, process, and re-process personal data and collaborate internationally. During the four year legislative process, that ended in 2016, Science Europe successfully advocated an exemption from several of the general requirements for scientific research in order to facilitate data collection and processing. The provisions became directly applicable in all member state in May 2018, two years after the Regulation entered into force.

Why does the Free Flow of non-personal data Regulation matter for research?

The Regulation on the Free Flow of Non-personal Data, applicable as of May 2019, sets the rules for the collection, processing, and storage of any data that is not considered personal data. New digital technologies and developments, such as cloud computing, big data, artificial intelligence, and the ‘Internet of Things’ rely on the use of large amounts of data to maximise efficiency, enable economies of scale, and develop new services. The Regulation deals with aspects such as data localisation restrictions, lack of trust in the digital market, and data portability. Together with GDPR this Regulation aims to provide certainty on how to deal with data in a legally correct way. Science Europe analysed the 2017 proposal for the regulation and monitored the legislative process up to the adoption of the new Regulation in autumn 2018.

How are GDPR and the Free Flow on Non-personal Data Regulation connected?

The 2018 Regulation on a Framework for the Free Flow of Non-personal Data complements the 2016 General Data Protection Regulation (GDPR). Together the two set the rules for the handling of data in the EU and are part of the European Commission’s ambition to create a ‘European Data Economy’ which should promote the best possible use of digital data.

A European Commission Communication from May 2019 explains the interaction of both regulations in the case of mixed datasets (datasets that consist of personal and non-personal data). In case of a mixed dataset, GDPR applies to the personal data in the dataset and the Regulation on Free Flow of Non-personal Data applies to non-personal data. In cases where personal and non-personal data are linked and cannot be treated separately, GDPR applies to the entire dataset, notwithstanding the portion of personal data in the dataset.

Why does the Directive on the Re-Use of Public Sector Information (PSI) matter for research?

The PSI Directive aims to make as much data as possible held by public-sector organisations available for re-use. The goal is to increase transparency and promote data-driven innovation and fair competition. With its latest revision, which was adopted by the European Institutions in spring 2019, the scope of the Directive was broadened to include research data. Member States will now have to implement policies that foster the sharing of publicly funded research data. Throughout the legislative process, which started in 2017, Science Europe successfully advocated the FAIR data principles, i.e. the requirement of research data being Findable, Accessible, Interoperable, and Re-usable in the final text of the Directive.

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