PDF(Pubmed)
Abstract：
Population biobanks are an increasingly important infrastructure to support research and will be a much-needed resource in the delivery of personalised medicine. Artificial intelligence (AI) systems can process and cross-link very large amounts of data quickly and be used not only for improving research power but also for helping with complex diagnosis and prediction of diseases based on health profiles. AI, therefore, potentially has a critical role to play in personalised medicine, and biobanks can provide a lot of the necessary baseline data related to healthy populations that will enable the development of AI tools. To develop these tools, access to personal data, and in particular, sensitive data, is required. Such data could be accessed from biobanks. Biobanks are a valuable resource for research but accessing and using the data contained within such biobanks raise a host of legal, ethical, and social issues (ELSI). This includes the appropriate consent to manage the collection, storage, use, and sharing of samples and data, and appropriate governance models that provide oversight of secondary use of samples and data. Biobanks have developed new consent models and governance tools to enable access that address some of these ELSI-related issues. In this paper, we consider whether such governance frameworks can enable access to biobank data to develop AI. As Italy has one of the most restrictive regulatory frameworks on the use of genetic data in Europe, we examine the regulatory framework in Italy. We also look at the proposed changes under the European Health Data Space (EHDS). We conclude by arguing that currently, regulatory frameworks are misaligned and unless addressed, accessing data within Italian biobanks to train AI will be severely limited.
摘要：
人口生物银行是支持研究的日益重要的基础设施，将成为提供个性化医疗的急需资源。人工智能（AI）系统可以快速处理和交叉链接大量数据，不仅可用于提高研究能力，还可用于根据健康状况帮助复杂的疾病诊断和预测。AI,因此,可能在个性化医疗中发挥关键作用，生物银行可以提供许多与健康人群相关的必要基线数据，这将有助于开发人工智能工具。为了开发这些工具，访问个人数据，特别是,敏感数据,是必需的。这样的数据可以从生物银行访问。生物银行是研究的宝贵资源，但是访问和使用此类生物银行中包含的数据会带来许多法律问题，伦理,社会问题（ELSI）。这包括对管理收藏品的适当同意，storage,使用,分享样本和数据，以及适当的治理模型，对样本和数据的二次使用进行监督。生物银行已经开发了新的同意模型和治理工具，以实现解决这些ELSI相关问题的访问。在本文中,我们考虑这样的治理框架是否可以访问生物库数据以开发人工智能。由于意大利拥有欧洲使用遗传数据最严格的监管框架之一，我们研究了意大利的监管框架。我们还将在欧洲健康数据空间（EHDS）下查看拟议的更改。我们最后认为，目前，监管框架不一致，除非得到解决，在意大利生物银行中访问数据以训练AI将受到严重限制。
