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健康信息通信技术:迈向法律框架的协调统一?

Health telematics: towards harmonisation of the legal framework?

作者信息

Skouma Georgia, Van Eecke Patrick

机构信息

Bogaert & Vandemeulebroeke (Landwell), Brussels, Belgium.

出版信息

Stud Health Technol Inform. 2003;96:135-42.

Abstract

The use of telematics in medicine inaugurates a new era in the provision of healthcare services at a global level. The potential of improved quality of care, easy accessibility to innovative treatment and more efficient utilisation of resources are some of the challenges of health telematics applications. A sound legal basis is needed to boost the expansion of ICT systems in healthcare, which is also expected to enhance the confidence of patients and healthcare professionals in the use thereof. Because of the global nature of the Internet, the legal solutions that will be adopted cannot be fragmented on a per country basis. Solid legislation at the EU level that will frame the provision of Information Society services in general is now under construction. Some core EU directives have already been transposed into the national legal systems, while some others are under the way of implementation. It is highly likely that even after their implementation these acts will not secure an ideal harmonisation in the provision of services as far as healthcare is concerned. A flexible regulatory approach is therefore needed to complete the regulatory gaps that the everyday practice has been ascertaining. A remedy to this direction can be the preparation and adoption on an EU scale of self-regulatory instruments, insofar as they can be broadly recognised and enforced by the judge.

摘要

远程信息处理技术在医学领域的应用开启了全球医疗服务的新纪元。提高医疗质量、便捷获取创新治疗方法以及更高效利用资源等潜力,是健康远程信息处理应用面临的一些挑战。需要一个健全的法律基础来推动信息通信技术系统在医疗领域的扩展,这也有望增强患者和医疗专业人员对其使用的信心。由于互联网的全球性,所采用的法律解决方案不能按国家逐个分割。目前正在构建欧盟层面的坚实立法,以总体规范信息社会服务的提供。一些核心欧盟指令已被纳入国家法律体系,而其他一些指令正在实施过程中。就医疗保健而言,即使这些法案实施后,也很可能无法确保服务提供方面的理想协调一致。因此,需要一种灵活的监管方法来填补日常实践中已确定的监管空白。朝着这个方向的一种补救办法可以是在欧盟范围内制定并采用自律性文书,只要它们能得到法官的广泛认可和执行。

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