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UNIversal solutions in TElemedicine Deployment for European HEALTH care (Grant Agreement No 325215)

Document D5.5 Industry Report on Telemedicine Legal and Regulatory Framework Version 1.0 Work Package:

WP1

Version & Date:

v1.0 / 16th January 2015

Deliverable type:

Report

Distribution Status:

Public

Author:

Cathy Bahr in partnership with Nicole Denjoy

Reviewed by:

U4H IAT members, John Oates

Approved by:

Marco d’Angelantonio

Filename:

D5.5 v1.0 U4H Industry Report on Telemedicine Legal and Regulatory Framework

Abstract This report: analyses the legal and regulatory environments relevant for telemedicine implementations in which the pilot regions operate, as well as in other select Member States; identifies legal and regulatory barriers to telemedicine and to interoperable, multi-vendor integrated device connected systems; recommends appropriate action to address these barriers; and provides feedback towards an improved legal and regulatory environment.

The information in this document is provided as is and no guarantee or warranty is given that the information is fit for any particular purpose. The user thereof uses the information at its sole risk and liability.

D5.5 Industry Report on Telemedicine Legal and Regulatory Framework

Executive Summary The use of telemedicine as a tool to help support better-integrated care is on the rise. One of the ways to support this in Europe is to capitalise on the potential of technological advances in ICT, and accelerate the adoption by (1) establishing an appropriate legal and regulatory framework for telemedicine consistently applied by Member States and by (2) ensuring telemedicine is integrated into, and interoperable with, existing care delivery structures. Telemedicine applications (generally referred to as 'teleologies') are defined as the delivery of healthcare services through the use of Information and Communication Technologies (ICT) in a situation where the actors are not at the same location. The actors can either be two healthcare professionals, or a healthcare professional and a patient 1.

Teleology examples

Telemedicine is at the crossroad of ICT, health policy and

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D5.5 Industry Report on Telemedicine Legal and Regulatory Framework

Document

Link

Proposal for a Directive of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare

http://ec.europa.eu/healtheu/doc/com2008414_en.pdf

Recommendation of the Commission on eHealth Interoperability

https://ec.europa.eu/digitalagenda/en/news/ehealth-interoperabilityframework-study-0

Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the Protection of Individuals With Regard To the Processing of Personal Data by the Community Institutions and Bodies and On The Free Movement of Such Data

http://eur-lex.europa.eu/legalcontent/EN/ALL/?uri=CELEX:32001R0045

Report on Priority Topic Cluster One and Recommendations: Patients’ summaries

http://www.ehealth-era.org/documents/eHERA_D2.3_Patient_Summaries_final_15-022007_revised.pdf

SMART 2007/0059, Study on the Legal Framework for Interoperable eHealth in Europe

http://www.ehealthnews.eu/images/stories/pdf/ ehealth-legal-fmwk-final-report.pdf

The Telemedicine Challenge in Europe, Editor Connect, July 2010

http://www.epractice.eu/files/The%20European %20Files%20%20The%20Telemedicine%20challenge%20in %20Europe.pdf

Public

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