英國生醫健康資料之整合應用與資料治理規範

The Integration, Application and Data Governance of Biomedical and Healthcare Data in NHS England

生醫健康資料之整合與應用在醫學和公衛研究上具有一定程度之公益性，如何在健康資料之二次利用與個人資訊隱私權保障之間尋求衡平，為我國健保資料庫訴訟案111年憲判字第13號判決之立論核心。英國為使健康資料能有效整合以提供直接照護目的外之二次利用，於2012年通過《健康與社會照護法》，經由該專法授權，於英國國民健保署（National Health Service, NHS）成立健康與社會照護資訊中心（HSCIC）。該中心為英國健保數位部門（NHS Digital）之前身，負責NHS之資料整合與數位轉型。本文旨在評析英國近年來生醫健康資料之應用及治理規範，說明英國健康資料整合之專法模式、資料治理與監管、資料二次利用、退出之例外和外部性，以及近年來NHS為取得公眾信任所進行之公眾溝通，盼能為我國此刻正面臨生醫健康資料二次利用相關法制整備之擘劃，提供相應之外國法例以為參照。

The integration and application of biomedical and healthcare data has a certain degree of public interest in medical and public health research. How to seek a balance between the secondary use of healthcare data and the protection of personal data and privacy is the core argument of the Constitutional Court Decision on the lawsuit regarding the secondary use of data in the National Health Insurance Database in Taiwan. In order to enable the effective integration of healthcare data to provide secondary use for purposes other than direct care, the Health and Social Care Act (HSCA) was passed in England in 2012, which provides a legal basis to establish the Health and Social Care Information Centre (HSCIC) in the NHS England. The HSCIC is the predecessor of NHS Digital, responsible for data integration and digital transformation of the NHS. The purpose of this paper is to analyze the integration, application, and data governance of biomedical and healthcare data in NHS England. The paper analyses NHS England’s legal basis of healthcare data integration, secondary use of data, data governance, and opt-out policies and exemptions, and possible externalities. It is with the hope that the experiences in the NHS England and its public engagement efforts to increase public trust can act as a reference for the like-minded discussions and the current endeavours to establish laws on the secondary use of national health insurance data in Taiwan.