Interoperability as Factor of Law Development in the Digital Economy (eHealth Case)

Abstract

The development of eHealth in the digital economy requires a comprehensive information exchange between all stakeholders. This interaction is ensured through the interoperability of information systems, data, technical solutions, processes and management methods. In an interoperable information environment, a synergistic effect of interaction is achieved, in which each participant benefits from the use of data and increases the efficiency of their activities. Interoperability is necessary to create a single barrier-free information environment based on the principles of openness, transparency, reusability, technological neutrality, user-centricity, information security and privacy. The article reveals the principles of interoperability applicable to the field of e-Health with reference to the experience of the European Union where the concept of interoperability has been most developed. Each of the principles is examined through the prism of legal issues that need to be taken into account during their implementation. Particular attention is paid to standardization, information security requirements (including the security of medical devices and applications), conflict resolution between the principle of long-term storage of data for reuse and legislation on personal data. The article points out the positive steps towards the regulatory and legal support of the interaction of health information systems in the Russian Federation. Thus, the Russian legislation provides the framework for development of the Unified state health information system (EGISZ). However, it stresses the fact that interoperability should not be isolated (intra-industry). Interoperability in a broad sense means openness of interaction with other information systems (intersectoral interaction), the architecture of which should also be built on similar universal standards. This purpose reasons the need to develop a unified strategy for interoperability in the Russian Federation. Such a strategy requires an integrated approach at the national level and participation of all stakeholders in its development and implementation.