Legal regulation of health information in some countries of the European Union

Abstract

The development of information technologies has led to a wide variety of types of information and related processes and, thus, to a richer and more complex legal regulation of these processes. This applies in particular in the context of health information. A key point of interest lies in the scope and methodologies of legal regulation concerning various categories of health information, as well as whether specific principles and regulatory norms are established and adhered to in this area.

An examination of the legislative landscape in Bulgaria and several other EU Member States reveals a differentiated approach to the legal regulation of distinct forms of health information.

For instance, matters related to personal health information and information related to medicinal products are governed by legislation of the highest legal authority, occupying the top tier in the hierarchy of legal instruments, both at the European and local levels. It is recognized that these issues significantly impact a substantial portion of the population, necessitating rules that are directly applicable throughout the European Union. As for concerns related to the operation of national healthcare systems, including aspects like medical records, medico-statistical data, and public health, these remain under the jurisdiction of individual Member States. In some areas, such as the ethical aspects of medical treatment and scientific health information, regulation has even reached the level of self-regulation.

The continuous development of information processes and the increasing diversity of information make it necessary to constantly review and improve the legal framework, taking into account the importance of the matter regulated and the range of subjects that will be affected, both in the present and the foreseeable future.