Legal aspects of personal health monitoring.

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.