談歐盟規範下智慧健康法治政策發展

An essay on the development of eHealth regulation and policy under the EU legal system

將ICT技術應用在醫療健康產業，一般稱之為智慧健康（eHealth），現已成為新興醫療服務項目，影響所及者將包含病人、醫療服務照護者、一般民眾等等。以歐盟為例，智慧健康政策主要為「數位單一市場政策（Digital Single Market）」以及「智慧型動健康計畫2012～2020」。其中數位單一市場政策將知會健康推行納為重要示範產業，以改善醫療ICT設備間之互通性以及標準化建置為目標。在智慧行動健康計畫2012－2020部分則使以提升病人照護發展為主軸。在歐盟的發展政策中，檢討相關法規配套與調和機制以及各項資料應用發展等已稱為重點項目。本文將以資料保護以及巨量資料為探討核心，就歐盟一般資料保護規則相關條文分析為主軸，並對應我國規範之部分以做為建議參考。

eHealth is generally defined as use information and communication technology for health. The stakeholders in eHealth may include patients, physicians, healthcare providers, and citizens. In the EU, it is constantly developing eHealth policies, which encompasses two main strategies: 1)The Digital Single Market strategy；2)eHealth Action Plan 2012-2020. The first strategy targets ICT standards and interoperability and encourages the free movement of digital services and goods within the EU. The second eHealth Action Plan 2012-2020 focuses on the supporting of research, development and innovation and achievig wider eHealth services as well. However, it has become more important to develop and review the regulatory framework in the word eHealth. This study is to analyze barriers in eHealth.