Recital 11

This Regulation does not affect Member States’ competences concerning the initial registration of personal electronic health data, such as making the registration of genetic data subject to the natural person’s consent or other safeguards. Member States may require that data be made available in an electronic format prior to the application of this Regulation. This should not affect the obligation to make personal electronic health data, registered after the date of application of this Regulation, available in an electronic format.