Clinical decision support systems (CDSSs) are digital healthcare information systems that apply algorithms to patient data to generate tailored recommendations. They are designed to support, but neither dictate nor execute, clinical decisions. CDSSs can introduce new risks, both by design features that heighten clinician burden and by outright errors that generate faulty recommendations for care. In the latter instance, if such unintercepted recommendations were to result in harm to the patient, novel legal questions emerge. Does legal responsibility for this harm lie with the clinician, the software developer or both? What is the clearest path to a remedy? Further, how does the Australian regulatory framework provide for oversight and redress? This article analyses the potential forms of legal redress in negligence, contract and under statutory consumer law, for the patient and the clinician. It also examines the Australian regulatory framework, specifically in relation to the Australian Competition and Consumer Commission and the Therapeutic Goods Administration, and reflects on the framework’s adequacy to protect patients and clinicians. It finds that the regulatory approach and the contour of legal risk still centre upon the clinician’s duty to exercise decisional autonomy and to intercept flawed recommendations generated by algorithmic errors within CDSSs.

中文翻译：

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责任在哪里？当患者受到伤害时，分析对有缺陷的临床决策支持系统的法律和监管反应

临床决策支持系统 (CDSS) 是数字医疗保健信息系统，可将算法应用于患者数据以生成量身定制的建议。它们旨在支持但既不支配也不执行临床决策。CDSS 可以引入新的风险，既可以通过增加临床医生负担的设计特征，也可以通过产生错误的护理建议的彻底错误。在后一种情况下，如果这种未被拦截的建议会对患者造成伤害，就会出现新的法律问题。这种伤害的法律责任由临床医生、软件开发商或两者共同承担吗？最明确的补救途径是什么？此外，澳大利亚监管框架如何规定监督和补救措施？本文分析了过失法律补救的潜在形式，合同和法定消费者法，为患者和临床医生。它还审查了澳大利亚的监管框架，特别是与澳大利亚竞争和消费者委员会以及治疗用品管理局有关的框架，并反映了该框架是否足以保护患者和临床医生。它发现监管方法和法律风险的轮廓仍然集中在临床医生行使决策自主权和拦截 CDSS 中算法错误产生的有缺陷建议的责任上。