Regulations Initiatives in France for the Interoperability of Communicating Medical Devices

Regulations Initiatives in France for the Interoperability of Communicating Medical Devices

Norbert Noury (Lab. INL INSA Lyon, University of Lyon, France), Karima Bourquard (In-System, Paris, France), Didier Bergognon (CosiLog, Paris, France) and Jean-Bernard Schroeder (Syndicat National De I’Industrie des Technologies Medicales (SNITEM), Paris, France)
Copyright: © 2013 |Pages: 15
DOI: 10.4018/jehmc.2013040104
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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.
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Introduction

Telemedecine has long entered the private environment for monitoring the health at home (Noury, 1992) but is now fast developing with the deployment of “Mobile Healthcare Systems” (Rodrigues, 2009). The home medical monitoring is recommended by most actors, i.e. hospitals, patients, health and territories actors. However in most countries, the deployment is facing legal (Juzoji, 2012) and cultural (Nakayasu, 2012) reluctances. The use of eHealth systems also raises privacy challenges (Raychaudhuri, 2010).

In France, the legislation has now accepted this “form of remote medical practice using information and communication technologies” (art. L6316-1). At national levels, the diagnosis into the relevance of developing telemedicine has now been clearly set out through the many reports that have been produced since 2008 (Simon, 2008).

A patient's physiological parameters can now easily be followed up with affordant biomedical devices (sensors, actuators, machines) which have gained in connectivity. Given the fact that the health status is multiparametric and a patient is likely to be cared for multiple pathologies, there is a risk of explosion in the number of parameters followed up at home. As a consequence, there is a risk of incontrollable deployment of heterogeneous and incompatible technical solutions for the mobile Healthcare systems. Actually, the Mobile Healthcare Systems have not yet been standardized and were mostly developed as embedded systems lacking interoperability. Eventually, we are going to face such problems as excessive load in the network, caused by the uncontrolled spread of the system and un-guaranteed interoperability among the heterogeneous systems. In Kim (2007) it is suggested the possibility to solve this problem by developing interoperating technology between the OSGi and the JADE. The project uMiddle (Nakazawa, 2006) is a bridging framework for universal interoperability that enables seamless device interaction over diverse platforms. This work introduces four design patterns for interoperability frameworks and implements a prototype at a chosen design point: Mediate, Aggregate, Fine-grain, and Infrastructure. The European project Saphire proposes to handle the interoperability problem with efficient middleware (Nee, 2008). But the proliferation of middleware platforms that cater to specific devices has created isolated islands of devices with no uniform protocol for interoperability across these islands. The CodeBlue (Lorincz, 2004) comprises a suite of protocols and services that let many types of devices (wireless sensors, location beacons, handheld computers, laptops, and so forth) coordinate their activities. In a case study of a pervasive technology for diabetes monitoring, the DiaMonD solution, researchers identified that a key barrier for preventing the full realization of wireless solutions lies in the inability of information and necessary data to pass seamlessly from one platform to another (Wickramasinghe, 2012). Connectivity relies on interoperability and standards that become available and will speed up the connectivity of biomedical sensor networks. Furthermore, Telemedicine can only develop with the help of “concerted public/private action concerning the interoperability of solutions within an international framework, the development of good practices for implementing telehealth and the setting up of a public/private committee with the ability to decide on investments.” (FIEEC, 2008). Another point of concern is the Patent issues acting as a hindrance factor against spreading and promoting telemedicine (Tomioka, 2009).

From the standardisation viewpoint, French experts have anticipated these concerns by getting under way and developing projects to define medical device communication in the home and by taking part in standardisation projects on the interoperability of data and systems for health. In this paper, the authors try to develop a comprehensive approach to the several challenges faced with the deployment of telemedicine homecare applications in France. They start with the legal aspects of telemedicine in France and Europe. Then they address the concept and regulations related to interoperability at the French, European and International levels. Then they propose a generic methodology, elaborated on three medical specialities, proposing generic integration profiles, a workflow and its generic model.

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