Project Structure & Results  Work Package 2.1 
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Work Package Output

1. A document delineating the Legal and Regulatory constraints on epSOS design.
2. The default contract terms for Member States engaging in epSOS field trials.
3. A document providing recommendations regarding key data protection aspects.

Deliverables

D2.1.1: Legal and Regulatory Constraints
D2.1.2: Standard Contract Terms for MS Document for Engagement of Pilot Sites

 

Work Package 2.1: Legal and Regulatory Issues

Work Package Description

The goals of WP 2.1 are to analyze and compare Legal and Regulatory (L&R) issues in Participating Member States, to assist Member States in establishing conditions for executing pilot operations in Pilot Member States, and to draw up recommendations for long-term interventions in the field.

It will therefore:

  • create an L&R cross section (layer) of the Use Cases
  • further analyze and understand the current status of national legislations impacting on the implementation of the Use Cases
  • propose a proportionate, minimum set of legal requirements for implementing the Use Cases, focusing on
    • rights of data subjects and supervision on data protection
    • trusted processes, procedures, responsibilities, reporting and auditing of access to, actions on, and use and retention of personal data
    • any additional legal interventions regarding liability and/or provisions at the health systems level that are required to permit execution of the Use Cases
  • propose an epSOS Framework Agreement as the common base for establishing national contractual agreements in order to engage national pilot partners in the participating Member States to effectively operate the epSOS services on a pilot basis
  • supervise, monitor, and process the results of the pilot implementation in order to issue a recommendation for long term L&R operational services, including provisions for national and EU level supervisory authorities and tasks.