Harvard TH Chan School of Public Health, FXB Center for Health and Human Rights, Boston, Massachusetts, USA.
Takshashila Institution, Bengaluru, India.
BMJ Glob Health. 2021 Jul;6(Suppl 5). doi: 10.1136/bmjgh-2021-005057.
In August 2020, India announced its vision for the National Digital Health Mission (NDHM), a federated national digital health exchange where digitised data generated by healthcare providers will be exported via application programme interfaces to the patient's electronic personal health record. The NDHM architecture is initially expected to be a claims platform for the national health insurance programme 'Ayushman Bharat' that serves 500 million people. Such large-scale digitisation and mobility of health data will have significant ramifications on care delivery, population health planning, as well as on the rights and privacy of individuals. Traditional mechanisms that seek to protect individual autonomy through patient consent will be inadequate in a digitised ecosystem where processed data can travel near instantaneously across various nodes in the system and be combined, aggregated, or even re-identified.In this paper we explore the limitations of 'informed' consent that is sought either when data are collected or when they are ported across the system. We examine the merits and limitations of proposed alternatives like the fiduciary framework that imposes accountability on those that use the data; privacy by design principles that rely on technological safeguards against abuse; or regulations. Our recommendations combine complementary approaches in light of the evolving jurisprudence in India and provide a generalisable framework for health data exchange that balances individual rights with advances in data science.
2020 年 8 月，印度宣布了国家数字健康使命（NDHM）的愿景，这是一个联邦化的国家数字健康交换平台，医疗服务提供者生成的数字化数据将通过应用程序接口导出到患者的电子个人健康记录。NDHM 架构最初预计将是国家医疗保险计划“阿育王 Bharat”的一个索赔平台，该计划为 5 亿人提供服务。如此大规模的数字化和医疗数据的流动性将对医疗服务的提供、人口健康规划以及个人的权利和隐私产生重大影响。在一个数字化生态系统中，传统的通过患者同意来保护个人自主权的机制将是不够的，在这个系统中，经过处理的数据可以在系统的各个节点之间近乎即时地传输、组合、聚合，甚至重新识别。在本文中，我们探讨了在数据被收集或在系统中传输时寻求“知情”同意的局限性。我们研究了提议的替代方案的优点和局限性，如信托框架，该框架对使用数据的人施加责任；隐私设计原则，依赖于防止滥用的技术保障；或法规。我们的建议结合了印度不断发展的判例法中的互补方法，并为平衡个人权利和数据科学进步的数据交换提供了一个可推广的框架。
