From a Legal and Regulatory (L&R) perspective, it is important to note that the epSOS Services will be offered on a pilot basis. They will be provided in compliance with the EU regulatory framework, and as such will not require changes to national legislation governing the provision of health services. As a pilot, the primary objective of the initiative is to gather information and evidence in order to facilitate subsequent full deployment.

The mission of the L&R work area is to ensure that L&R challenges, which are critical to the realisation of the epSOS pilots in real life situations, are appropriately recognised and addressed. This work shall support and guide the Participating Nations (PN) in transferring this knowledge to a national level, and shall support a close collaboration with the Data Protection Authorities of all PNs. At project level, epSOS will collect, process and convert experience from the pilots into practical guidelines on addressing any outstanding issues in the L&R Domain to facilitate progression from pilots to large-scale deployment of these services.

A major challenge is the pursuance of synergies with ongoing policy and implementation initiatives in order to ensure convergence of concepts and development. The Data Protection Directive and its supporting guidance documents are an important input in the work of the L&R Project Domain. Conversely, the work and the knowledge acquired in epSOS shall contribute to the current revision of this Directive.

The legal analysis

A detailed analysis of the L&R issues involved in the epSOS services made it possible to organise them into four main groups relevant to epSOS: data protection and confidentiality; legal issues related to health systems; liability - professional issues and the social context; work protocols, traceability and audit. epSOS has elaborated a set of approximately 100 requirements to be integrated in the design and/or the necessary safeguards.