The Biobanking and BioMolecular resources Research Infrastructure – European Research Infrastructure Consortium (BBMRI-ERIC) is hosting a seminar to assess the impact of the EU General Data Protection Regulation (GDPR) on EU Ninth Framework Programme (FP9) health research and examine how the Code of Conduct for Health Research being developed by BBMRI-ERIC and collaborators will address future health challenges.
Preparations for FP9 (2021-2027) has begun and the European Commission is expected to publish its initial proposal in the first half of 2018. Discussions on the programme’s structure, content, and budget are under way covering sustainability, socio-economic impact, and the use and management of data created by pan-European research infrastructures, including the contribution of these infrastructures to health sciences and research. The GDPR will apply across the EU from 25 May 2018. Articles 40 and 41 of the GDPR are the primary sources of authority for establishing approved codes of conduct to serve as compliance tools for data controllers and processors. Following a series of exploratory meetings in 2017, BBMRI-ERIC has launched a forum to develop a GDPR Code of Conduct for Health Research as the means to comply and to contribute to the proper implementation of GDPR. Through the forum, BBMRI-ERIC is engaging with approximately 80 key stakeholders and a drafting group from across the EU, to outline the GDPR Code of Conduct for Health Research. This code will be vital for enabling and advancing collaborative health research following the application of the GDPR.
The seminar on 6 November 2017 will focus on how the new data protection environment will determine and affect the use of (sensitive) personal data for health sciences in future research collaborations. The seminar will also help participants to understand the policy context for FP9 and how this will be impacted by the GDPR and other regulations, including those covering medical devices and clinical trials. The seminar will also include discussions on how the programme might address biological and medical science research, including the use of sensitive personal data, for the programme to deliver benefits for the EU’s citizens and economy.