In order to provide responsible access to health data by reconciling benefits of data sharing with privacy rights and ethical and regulatory requirements, Findable, Accessible, Interoperable and Reusable (FAIR) metadata should be developed. According to the H2020 Program Guidelines on FAIR Data, 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. Additional provisions on the protection of natural persons with regard to the processing of personal data have been endorsed by the European General Data Protection Regulation (GDPR), Reg (EU) 2016/679, that came into force in May 2018. This work aims to solve accessibility problems related to the protection of personal data in the digital era and to achieve a responsible access to and responsible use of health data. We strongly suggest associating each data set with FAIR metadata describing both the type of data collected and the accessibility conditions by considering data protection obligations and ethical and regulatory requirements. Finally, an existing FAIR infrastructure component has been used as an example to explain how FAIR metadata could facilitate data sharing while ensuring protection of individuals.