Fondazione Benzi provided with its contribution to the EMA Discussion Paper “The General Data Protection Regulation: Secondary Use of Data for Medicines and Public Health Purposes”.
It is widely acknowledged the huge potential of health data, including electronic health records (EHRs), laboratory data, patient-reported outcomes, as well as data from registries and clinical trials and studies, to provide with evidence supporting public health, medicines development and decision-making process across Europe. Nevertheless, despite the significantly increased scale of health data processed and available to be reused, the huge spread of the FAIR (Findable, Accessible, Interoperable and Reusable) data principles concept and application and the rapid technological development that could lead to fast scientific advances, challenges for the protection of personal data exist and need to be faced. Since the new European General Data Protection Regulation (GDPR) came into force in May 2018, additional obligations on the protection of natural persons with regard to the processing of personal data have been added to the existing ones.
Fondazione Benzi is actively engaged in activities focused on health data and data protection considering that the secondary use of data is widely increasing especially for research purposes and for regulatory decision-making processes and that the FAIR data principles support the idea that data are a resource to be used to formulate and test scientific hypotheses.
Fondazione Benzi’s team went through the European Medicines Agency (EMA) discussion paper and provided with considerations and suggestions on relevant issues that EMA should better address. It was underlined that by increasing the linkage between different types of health data, and their reuse, a lot of benefits could be produced including an increase of disease knowledge, an earlier diagnosis, a better choice of the treatment, particularly for vulnerable populations, like patients affected by rare diseases and children. However, a responsible access to health data by reconciling benefits of data sharing with privacy rights and ethical and regulatory requirements should be considered.
Data should be "as open as possible and as closed as necessary", "open" in order to foster the reusability and to accelerate research, but at the same time they should be "closed" to safeguard the privacy of the subjects!
Stay tuned for further updates on this topic!