The article investigates the issue of knowing whether or not the proposal for a general data protection regulation could improve the patient’s safety. This has been analyzed through the four main contributions that should be expected at least from data protection to the patient’s safety. In our view, data protection should help supporting efficient information systems in healthcare, increasing data quality, strengthening the patient’s rights and drawing the legal framework for performing quality control procedures. Compared to the current legal framework, it is not sure that the proposal might improve any of these contributions to the patient’s safety.
Data protection rules applies to biobanks’ activities to the extent that they fall under the scope of the General Data Protection Regulation, which is already susceptible to raising some difficult issues to solve. If subjected to it, biobanks’ activities will have to comply with the applicable substantive rules governing data processing, data subject’s rights, obligations of data controller and processor, without omitting the specific authorities and mechanisms ensuring data protection effectiveness.
This article aims at opening discussions and promoting future research about key elements that should be taken into account when considering new ways to organise access to personal data for scientific research in the perspective of developing innovative medicines. It provides an overview of these key elements: the different ways of accessing data, the theory of the essential facilities, the Regulation on the Free Flow of Non-personal Data, the Directive on Open Data and the re-use of public sector information, and the General Data Protection Regulation (GDPR) rules on accessing personal data for scientific research. In the perspective of fostering research, promoting innovative medicines, and having all the raw data centralised in big databases localised in Europe, we suggest to further investigate the possibility to find acceptable and balanced solutions with complete respect of fundamental rights, as well as for private life and data protection.