Quinn Paul, Habbig Ann-Katrin, Mantovani Eugenio, De Hert Paul
Law, Science, Technology & Society, Vrije Universiteit Brussel, Brussels, Belgium.
Eur J Health Law. 2013 Apr;20(2):185-204. doi: 10.1163/15718093-12341267.
This article examines the receptivity of the current EU legal regime towards innovative mHealth technologies and their deployment on a pan-European basis. At present, a coherent legal strategy towards the development of mHealth technologies does not exist. The deployment of such technologies is influenced in an uncoordinated way by various disparate European legislative initiatives. This article focuses on problems that may be encountered by mHealth platforms through application of the Medical Device and Data Protection Frameworks. Theses frameworks are analysed in this article through the lens of a pan-European deployment of mHealth technologies. The aim throughout is to look for potential problems for the deployment of such technologies posed by these frameworks and, where possible, to suggest improvements.
本文探讨了当前欧盟法律制度对创新移动健康技术及其在泛欧洲范围内部署的接受程度。目前，针对移动健康技术的发展不存在连贯的法律战略。此类技术的部署受到欧洲各种不同立法举措的不协调影响。本文重点关注移动健康平台在应用医疗器械和数据保护框架时可能遇到的问题。本文通过移动健康技术泛欧洲部署的视角对这些框架进行分析。总体目标是寻找这些框架给此类技术部署带来的潜在问题，并在可能的情况下提出改进建议。
