EPIUnit-Instituto de Saúde Pública da Universidade do Porto (ISPUP), 4050-600 Porto, Portugal.
Laboratory for Integrative and Translational Research in Population Health (ITR), Porto, Portugal.
Med Law Rev. 2023 May 25;31(2):247-271. doi: 10.1093/medlaw/fwac040.
Linking records could serve as a useful tool for scientific research and as a facilitator for local policymaking. This article examines the challenges and opportunities for researchers to lawfully link routinely collected health and education data with cohort data of children when using it as a tool for scientific research in Portugal. Such linking can be lawfully conducted in Portugal if three requirements are met. First, data processing pursues a legitimate purpose, such as scientific research. Secondly, data linking complies with the legal obligations of research entities and researchers, acting as data controllers or processors, and it respects the rights of children as data subjects. Finally, data linking is based on the explicit written consent of those with parental responsibility for the child. So far, the implementation of the General Data Protection Regulation in Portugal has not facilitated record linkage. It is argued that further harmonised implementation of that Regulation across European Union and European Economic Area Member States, establishing a minimum shared denominator for record linkage in scientific research for the common good, including without explicit consent, is needed.
关联记录可以作为科学研究的有用工具，并为当地政策制定提供便利。本文探讨了研究人员在葡萄牙将常规收集的健康和教育数据与儿童队列数据关联起来作为科学研究工具时，合法关联这些数据所面临的挑战和机遇。如果满足三个要求，葡萄牙可以合法地进行这种关联。首先，数据处理追求合法目的，如科学研究。其次，数据链接符合研究实体和研究人员作为数据控制者或处理者的法律义务，并尊重作为数据主体的儿童的权利。最后，数据链接基于对孩子负有父母责任的人的明确书面同意。到目前为止，葡萄牙对《通用数据保护条例》的实施并没有促进记录链接。有人认为，有必要在整个欧盟和欧洲经济区成员国进一步协调实施该条例，为共同利益在科学研究中建立一个最小的共同记录链接基准，包括无需明确同意。
