关于斯里兰卡电子医疗记录的隐私、保密和安全问题的谈判:比较法律分析

Harshani Menaka Ratnayake
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引用次数: 2

摘要

斯里兰卡将在未来十年以越来越快的速度采用电子医疗记录(EMR)。然而,电子病历的处理在其隐私和机密性、记录质量和侵权责任方面构成了相当大的法律挑战。虽然斯里兰卡立法承认电子记录在大多数情况下具有法律效力,但在涉及敏感的个人健康数据时,它没有提供足够的法律支持。本文采用法律研究的比较方法。作者认为这是回答研究问题的适当方法,因为它主要用于“通过获取外国法律制度的知识来促进相互了解”的目的。本文承认,斯里兰卡现有的立法没有规定敏感的个人数据,如电子病历。然而,斯里兰卡的立法已经确立了电子记录的法律效力。本文讨论了美国的各种立法,包括1996年的《健康保险流通与责任法案》(HIPAA), 2005年的《患者安全和质量改进法案》(PSQIA)和2009年的《经济和临床健康卫生信息技术法案》(HITECH)作为参考立法。它还讨论了1998年英国的《数据保护法》和欧盟指令,作为为斯里兰卡建立一个解决电子病历需求的法律框架的参考立法。在法律分析之后,本文提出了从所讨论的立法中调整合适立法的前进方向。其中一些调整包括确定可以建立有效法律记录的标准,创建数据控制者角色,制定可以共享个人健康数据的明确框架,确定在使用电子病历进行研究时应满足的标准,鼓励调整电子病历和所述标准的措施,以及修订《计算机犯罪法》的必要性,以包括处理涉及电子病历的犯罪的具体条款。本文的结论是,在实施此类立法之前,需要从所有相关利益相关者那里获得更广泛的共识,并且不应阻碍IT行业,这可以促进国家医疗保健系统的效率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Negotiating privacy, confidentiality and security issues pertaining to electronic medical records in Sri Lanka: A comparative legal analysis
Introduction Sri Lanka is set to adapt electronic medical records (EMR) at an ever increasing rate in the coming decade. However, handling of EMRs pose considerable legal challenge in relation to its privacy and confidentiality, quality of records and tort based liability. While the Sri Lankan legislation recognise electronic records as legally valid in most instances, it does not provide sufficient legal backing when it comes to sensitive personal health data. Methodology This paper adapts a comparative method of legal research. The author believes this to be an appropriate methodology for answering the research questions as it is primarily used for the purpose of “promotion of mutual understanding by acquiring knowledge of foreign legal systems”. Findings The paper recognizes that the existing Sri Lankan legislation does not provide for sensitive personal data such as EMR. However, the Sri Lankan legislation has already established the legal validity of electronic records. The paper discusses various legislations from the US including the Health Insurance Portability and Accountability Act (HIPAA) of 1996, The Patient Safety and Quality Improvement Act (PSQIA) of 2005 and Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 as reference legislation. It also discusses the Data Protection Act of 1998 in the UK and the EU Directives as reference legislation for establishing a legal framework for Sri Lanka that would address the needs of EMRs. Recommendations Following the legal analysis, the paper proposes a way forward in adapting suitable legislations from the ones discussed. Some of these adaptations include defining the criteria in which a valid legal record can be established, the creation of the role data controller, laying down a clear framework in which personal health data can be shared, defining the criteria that should be met when using EMR for research, measures to encourage the adaption of EMRs and the standards set forth and the necessity to amend the Computer Crimes Act to include specific provisions to deal with crimes involving EMRs. Conclusion The paper concludes by stating the need to obtain wider consensus from all relevant stakeholders before such legislation is implemented and that the same should not hinder the IT industry which can promote the efficiency of the country’s health care system.
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