JMIR Publications

ABSTRACT

The extensive utilization of personal health data is one of the key success factors of modern medical research. Obtaining consent to the use of such data during clinical care, however, bears the risk of low and unequal approval rates and of consequent methodological problems with the scientific use of the data. In view of these shortcomings, and of the proven willingness of people to contribute to medical research by releasing personal health data, the paradigm of informed consent needs to be reconsidered. The European General Data Protection Regulation gives the EU member states considerable leeway with regard to permitting the research use of health data without consent. Following this approach would however require alternative offers of information that compensate for the lack of direct communication with experts during medical care. We therefore introduce the concept of ‘health data literacy’, defined as the capacity to find, understand and evaluate information about the risks and benefits of the research use of personal health data, and to act accordingly. In concrete terms, health data literacy includes basic knowledge about the goals and methods of data-rich medical research, and about the possibilities and limits of data protection. The responsibility to develop and implement the corresponding means of information should primarily rest with the institutions and people involved in data-rich medical research, and with all those interested in its success.