Regulations Initiatives in France for the Interoperability of Communicating Medical Devices

Abstract

Telemedicine has introduced new challenges in health delivery with the introduction of advanced information communication technologies in home care medicine. To meet the high standard of quality in health service delivery, the data flow of medical data must be maintained, which implies harmonization and standardization frameworks within the field of the communicating medical devices. Those medical devices must be certified to prove their effectiveness and compliance with the requirements on health and safety of patients, before to be brought into service or used. But there is no requirement concerning the interoperability of these communicating medical devices. A group of French experts have anticipated the need in developing projects to define communication medical device in the home and by taking part in standardization projects on the interoperability of data and systems in health. They first identified the standardization rules at European and national level and confirmed that most guides and directives are well available. They based their study on three specialties, commonly using medical devices and telemedicine and covering various use cases. Then, they defined a methodology following the IHE International and Continua Alliance approach in order to define the integration profile. Eventually, they defined a generic workflow and an inventory of the integration profiles, norms and standards that can support this generic workflow.