Taylor Mark J
School of Law, The University of Sheffield, Sheffield, UK
Med Law Rev. 2015 Summer;23(3):348-74. doi: 10.1093/medlaw/fwv018. Epub 2015 May 20.
The disclosure of confidential patient data without an individual's explicit consent should be for purposes that persons have reason to both expect and accept. We do not currently have the required level of clarity or consistency in understanding regarding the disclosure of confidential patient information for public health purposes to support effective public dialogue. The Health Service (Control of Patient Information) Regulations 2002 establish a legal basis in England and Wales for data to be disclosed for public health purposes without patient consent. Under the Regulations, there is more than one potential route towards lawful processing: Data may be processed for public health purposes under both Regulations 3 and 5. The alternatives have different safeguards and conditions attached, and their respective applicability to processing for purposes of public health improvement is currently unclear and subject to review. Beyond the need for clarity regarding the safeguards applicable to processing for particular public health purposes, there are reasons to prefer recognition that Regulation 5 is the most appropriate legal basis for disclosure when the purpose is public health improvement rather than public health protection. Where health improvement, rather than protection, is the aim, there is no justification for discarding the additional safeguards associated with processing under Regulation 5.
未经个人明确同意而披露患者机密数据，应出于人们有理由预期并接受的目的。目前，对于为公共卫生目的披露患者机密信息，我们在理解上缺乏必要的清晰度和一致性，无法支持有效的公众对话。《2002年医疗服务（患者信息控制）条例》在英格兰和威尔士确立了在未经患者同意的情况下为公共卫生目的披露数据的法律依据。根据该条例，合法处理数据有不止一条潜在途径：数据可根据条例3和条例5为公共卫生目的进行处理。这两种选择有不同的保障措施和附加条件，目前尚不清楚它们各自对改善公共卫生目的处理的适用性，且有待审查。除了需要明确适用于特定公共卫生目的处理的保障措施外，有理由倾向于承认，当目的是改善公共卫生而非保护公共卫生时，条例5是披露的最适当法律依据。当目标是改善健康而非保护健康时，没有理由抛弃与条例5下处理相关的额外保障措施。
