Di Iorio C T, Carinci F, Oderkirk J
J Med Ethics. 2014 Jul;40(7):488-92. doi: 10.1136/medethics-2013-101603.
The European Union (EU) Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by the Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services,but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government,corporate or market research, falls under the same rule.The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical,administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe.
欧盟数据保护条例将对欧洲的公共卫生、卫生服务研究及统计产生深远影响。欧盟委员会的提案在平衡隐私权与健康及医疗保健权方面是一项突破。然而，欧洲议会提出了大量修正案。本文回顾了欧洲议会公民自由、司法和内政委员会提出的修正案及其对健康研究与统计的影响。这些修正案消除了提案带来的大部分创新。值得注意的是，对于诸如医疗服务管理等公共利益，应允许对处理敏感数据的一般禁令有所减损，但健康研究、监测、监督及治理则不适用。仅在获得数据主体同意的情况下，或处理服务于极高的公共利益、无法以其他方式进行且得到法律授权时，才允许出于历史、统计或科学目的处理个人健康数据。研究，无论是学术研究、政府研究、企业研究还是市场研究，都遵循同一规则。拟议的修正案将使涉及对来自临床、行政、保险和调查来源的大量数据进行关联和分析的研究与统计变得困难甚至无法进行，而这些数据有助于改善健康结果、提升卫生系统绩效及治理水平；并且可能使欧洲一些国家为实现尊重隐私的数据用于研究和统计目的所做的努力变得不合法。如果修正案按目前的写法通过，在欧洲，隐私权很可能会凌驾于健康及医疗保健权之上。
