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Offer an overview of the eHDSI Reference Documents.

These are the latest source documents added to the eHDSI list of Reference Documents. Once new documents are added, the table will be updated as follows: the ''NEW'' label will be added to the latest documents and removed from the current ones.

Table of Contents





eHDSI Reference Documents


The below table lists the reference documents (used as sources for the eHDSI Requirements Catalogue), identified until this moment and which could impact the eHDSI services.


Generic Documents

Document responsible authority

How the EU works – Your guide to the EU institutions

European Commission, Directorate-General for Communication

Legal acts (Directives, Regulations, Implementing acts)


Health sector specific


Directive 2011/24/UE, on the application of patients’ rights in cross-border healthcare

European Parliament, Council

NEW: Commission Implementing Decision 2011/890/EU on providing the rules for the establishment, the management and the functioning of the network of national responsible authorities on eHealth

European Commission

Implementing Directive 2012/52/EU laying down measures to facilitate the recognition of medical prescriptions issued in another MS

European Commission

REGULATION (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

European Parliament, Council
Agreement between National Authorities responsible for National Contact Points for eHealth on the Criteria required for the participation in Cross-Border eHealth Information Services (draft v2 20/10/2016)eHealth Network, JAseHN Task 6.2
The legal framework and guidance on data protection under the Cross-border eHealth Information Services (CBeHIS) T6.2 JAseHN (draft v2 20/10/2016)eHealth Network, JAseHN Task 6.2
Commission recommendation 2008/594/EC on cross-border interoperability of electronic health record systemsEuropean Commission

The EU legal framework on e-health_E94886_ch13.pdf

Cross-sector

eHealth Network

CEF Telecom guidelines Regulation (EU) N° 283/2014 of 11 March 2014 on guidelines for trans-European telecommunications networks and repealing Decision N° 1336/97/EC

European Parliament, Council

REGULATION (EU) No 1316/2013 establishing the Connecting Europe Facility (CEF)

European Parliament, Council

REGULATION 2016/679, 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (Data protection) - General Data Protection Regulation (GDPR)

European Parliament, Council

NEW: Regulation (EU) 2018/1725 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data

European Parliament, Council

Regulation (EU) No 910/2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (eIDAS)

European Parliament, Council

EIDAS implementing acts

European Parliament, Council

CEF work programme 2015

European Commission

CEF work programme 2016

European Commission
CEF work programme 2017European Commission

Directive 2005/36/EC on the recognition of professional qualifications

European Parliament, Council

Guidelines, frameworks, standards and CEF Building Blocks


Health sector specific


eHN - Governance model for the eHealth Digital Service Infrastructure during the CEF funding

eHealth Network

Guidelines on the electronic exchange of health data under Cross-Border Directive 2011/24/EU, release 2, adopted by the eHN meeting on 21/11/2016:

eHealth Network

Guidelines of an Organisational Framework for eHealth NCP

eHealth Network

European Interoperability Framework

European Commission

Refined European Interoperability Framework, by eHealth Network

European Commission

eHealth interoperability framework study (11/2013)

European Commission
Article 29 Data Protection Working Party WP 189 - Working Document 01/2012 on epSOS

Agreement between National Authorities or National Organisations responsible for National Contact Points for eHealth on the Criteria required for the participation in Cross-Border eHealth Information Services

Draft

Cross sector


CEF Governance model

European Commission

Other references


used as source for the Requirements and recommendations


CEF call eHealth


Non-paper Workplan and budget


D3.1.2 Final definition of functional service - ePrescription

epSOS

D3.2.2 Final definition of functional service - Patient Summary

epSOS

Business requirements of the Central Terminology server


eHealth Member States Experts Group Semantic Task Force Semantic Requirements (draft v0.5)eHDSI
D3.5.2: Semantic Service Specifications, Appendix F: Terminology Access ServicesepSOS

D3.A – PS eP eD CM CDA - Implementation Guide_v1.1 (2015) (supersedes Appendix B1/B2)

EXPAND (D3.A), epSOS (Appendix B1/B2)

D3.9.1 – Appendix B.3 10 ePSOS Central Reference Terminology Server

epSOS

D3.10.1 Appendix A5 – Clinical and semantic issues

epSOS
Framework Agreement on National Contact Points in the context of the Smart Open Services for European Patients Project (epSOS) (version 2)epSOS

D.3.7.2 epSOS Final security services specification definition - epSOS Security Policies

epSOS

Security controls (Req/Rec) - epSOS baseline security catalog: Requirements and Recommendations

epSOS

D3.6.2 Identity management specification definition

epSOS

D3.4.1 - Common Components Specification

epSOS
Test framework

Audit framework– organisational, semantic, technical


Support framework
The use of CEF eID in the CEF eHealth DSI (draft report v2)Study conducted by DIGIT for SANTE A4
SML/SMP/eDelivery PKI Impact Assessment for the CEF eHealth DSIStudy conducted by DIGIT for SANTE A4

NOT used as source for the Requirements and recommendations [1]


IHE profiles: XCPD, XCA, XDR, XCF

IHE

HL7 Clinical Document Architecture release 2

HL7 International

CTS2


ISO27001


ePrescription workflow

IHE

ATNA


D3.8.2 Final National Pilot Set Up and Deployment Guide

epSOS

D3.9.2 Testing methodology, test plan and tools

epSOS

D2.2.7 Recommendations

epSOS


[1] Not to be considered as source for the business needs (implementation guidelines, technical documents…).