Callens Stefaan, Galot Adrien, Lamas Eugenia
KU Leuven.
Stud Health Technol Inform. 2013;187:55-63.
Personal health monitoring (PHM) can be defined as comprising all technical systems, processing, collecting, and storing of data linked to a person. PHM involves several legal issues that are described in this paper. This article analyses firstly the short term actions that are needed at the European level to allow personal health monitoring in respect of the interests and rights of patients such as the need to have more harmonised medical liability rules at the EU level. Introducing PHM implies also legal action at the EU level on the long run. These long-term actions are related to e.g. the way in which hospitals are organised in their relation with healthcare professionals and with other hospitals or healthcare actors. The paper analyses finally also how health monitoring projects may change the traditional (non-)relationship between patients and pharmaceutical/medical device industry. Today, the producers and distributors of medicinal products have no specific contact with patients. This situation may change when applying telemonitoring projects and may require new legal rules.
个人健康监测（PHM）可定义为涵盖所有与个人相关的数据链接的技术系统、数据处理、收集和存储。PHM涉及本文所述的若干法律问题。本文首先分析了在欧洲层面为保障患者权益和权利而进行个人健康监测所需的短期行动，例如在欧盟层面需要有更统一的医疗责任规则。从长远来看，引入PHM在欧盟层面也意味着采取法律行动。这些长期行动例如与医院在与医疗保健专业人员以及其他医院或医疗保健行为者的关系中的组织方式有关。本文最后还分析了健康监测项目可能如何改变患者与制药/医疗器械行业之间的传统（非）关系。如今，药品的生产商和经销商与患者没有特定接触。在应用远程监测项目时这种情况可能会改变，并且可能需要新的法律规则。
