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ITU-D Discussion Paper on Regulatory Challenges of Mobile Health (mHealth) in Europe, June 2014


Within the Regional Initiative for Europe on ICT Applications, including eHealth, adopted by the ITU Resolution 17 (WTDC-10, Hyderabad), ‚ÄčITU-D has prepared  a paper entitled "Filling the Gap: Legal and Regulatory Challenges of Mobile Health (mHealth) in Europe" for discussion by Member States of the Europe region.

ITU-D Discussion Paper "Filling the Gap: Legal and Regulatory Challenges of Mobile Health (mHealth) in Europe"

The paper is intended to provide an analysis of the primary legal challenges faced by European countries with the development of medical information services, and patient health care or follow-up services, accessible over mobile terminals i.e., "mHealth". Part 1 of the paper discusses contextual elements useful for the topic at hand. The paper then articulates a summary of current legal issues facing mHealth around the three notions of medical devices (Part 2), medical information (Part 3) and medical practice (Part 4). Finally, in Part 5, the paper offers some recommendations concerning opportunities and purpose of further in-depth measures for harmonization of national laws.


Please note that this is a work in progress. We would welcome comments/feedback in order to improve and finalize the paper.

We kindly invite the Administratons of the European Member States to please send your comments to: by September 1, 2014.

For all other questions or comments related to this activity you may contact ITU Europe Region unit at