From Subjective To Objective Informed Consent In Healthcare: Biobanks In Focus

Healthcare data has long been handled as per the national\local legislative and organizational prerequisites of the healthcare providers across the EU. This inculcates that the healthcare providers goals/objectives substantially dictated the data handling paths of the patients. Where the former could be starkly different from that of the patients/data subjects. Recently, healthcare stakeholders, for patients optimal value care, embedded the idea of Informed Consent (IC) at the onset of data collection. To transform the former, subjective way of data handling by healthcare providers into an objective pan European data handling procedure, the EU introduced General Data Protection Regulation, GDPR. Post GDPR, the EU legitimized patients IC as an integral part at the onset of patients information value care. Now IC, entails patients explicit, well informed , specific, free choice for his/her healthcare data collection and processing, demonstrated in an easily accessible and understandable manner with patients having the right of erasure at any point of data processing (GDPR, article 7). This poses limitations, specifically against scientific research, when applied in biobanks and bio-repositories. Limitations range from Biobanks data collection to data anonymization or/and pseudonymization to the data storage and sharing. In each phase of data handling, the issues and their respective solutions are discussed. Solution lies in defining the public/vital and legitimate interests and in incorporating the broad-open ended informed consent. This is vital for better health outcomes of the patients and the society at large. Regulatory and legislative authorities at the EU and national level must unite to resolve these issues.