Artificial intelligence (AI) enables a medical device to optimize its performance through machine learning (ML), including the ability to learn from past experiences. In healthcare, ML is currently applied within controlled settings in devices to diagnose conditions like diabetic retinopathy without clinician input, for instance. In order to allow AI-based medical devices (AIMDs) to adapt actively to its data environment through ML, the current risk-based regulatory approaches are inadequate in facilitating this technological progression. Recent and innovative regulatory changes introduced to regulate AIMDs as a software, or ‘software as a medical device’ (SaMD), and the adoption of a total device/product-specific lifecycle approach (rather than one that is point-in-time) reflect a shift away from the strictly risk-based approach to one that is more collaborative and participatory in nature, and anticipatory in character. These features are better explained by a rights-based approach and consistent with the human right to science (HRS). With reference to the recent explication of the normative content of HRS by the Committee on Economic, Social and Cultural Rights of the United Nations, this paper explains why a rights-based approach that is centred on HRS could be a more effective response to the regulatory challenges posed by AIMDs. The paper also considers how such a rights-based approach could be implemented in the form of a regulatory network that draws on a ‘common fund of knowledges’ to formulate anticipatory responses to adaptive AIMDs. In essence, the HRS provides both the mandate and the obligation for states to ensure that regulatory governance of high connectivity AIMDs become increasingly collaborative and participatory in approach and pluralistic in substance.

中文翻译：

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在医疗保健人工智能的监管治理中落实科学人权

人工智能 (AI) 使医疗设备能够通过机器学习 (ML) 优化其性能，包括从过去的经验中学习的能力。例如，在医疗保健领域，机器学习目前应用于设备的受控设置中，以诊断糖尿病视网膜病变等疾病，而无需临床医生输入。为了让基于人工智能的医疗设备（AIMD）通过机器学习主动适应其数据环境，当前基于风险的监管方法不足以促进这一技术进步。最近引入的创新监管变革旨在将 AIMD 作为一种软件或“软件作为医疗设备”(SaMD) 进行监管，并采用整体设备/产品特定生命周期方法（而不是时间点方法）反映出从严格基于风险的方法向更具协作性、参与性和预见性的方法的转变。这些特征可以通过基于权利的方法得到更好的解释，并且符合科学人权（HRS）。本文结合联合国经济、社会和文化权利委员会最近对HRS规范内容的阐述，解释了为什么以HRS为核心的基于权利的方法可以更有效地应对监管问题。 AIMD 带来的挑战。本文还考虑了如何以监管网络的形式实施这种基于权利的方法，该网络利用“共同知识基金”来制定对自适应 AIMD 的预期反应。从本质上讲，HRS 为各国提供了授权和义务，以确保高连通性 AIMD 的监管治理在方法上变得越来越协作和参与，并且在实质上更加多元化。