论我国可信健康数据空间建构的法治保障

On the Guarantee of Law in the Construction of Trusted Health Data Space in China

  • 摘要: 可信数据空间是基于共识规则连接多元主体、实现数据资源互操作共享的基础设施载体,构筑了数据要素价值共创的应用生态,也是全国一体化数据市场建设的关键支撑。在健康数据领域,其应用能有效整合碎片化信息以降低重复医疗检测成本及资源浪费,支撑个性化精准医疗服务发展,赋能科研创新、公共卫生决策及国家战略布局。然而,当前我国可信健康数据空间建设正面临多重制度壁垒,包括权益界定模糊导致授权受阻、客体分类缺失抑制利用效能、规范体系冲突加剧合规风险、监管机制缺位引致执行乏力等。其产生的诱因之一在于健康数据规制理论存在结构性困境——理论迭代滞后、治理形式主义、与新技术对话脱节。为此,应以数据空间正义理论与产权利益平衡理论为双核指导,通过推进“三权分置”改革明晰权益边界、构建动态分级标准优化数据分类、加速专项立法整合规范框架以及建立守门人制度落实责任闭环,最终为健康中国与数字中国战略实现,构筑兼具规则硬约束与治理弹性适应力的制度基座。

     

    Abstract: Trusted data space is an infrastructure carrier that connects multiple subjects based on consensus rules and realizes the interoperability and sharing of data resources, which builds an application ecology for the co-creation of data element value and is also a key support for the construction of a national integrated data market. In the field of health data, its application can effectively integrate fragmented information to reduce the cost of repeated medical testing and waste of resources, support the development of personalized precision medicine services, and empower scientific research innovation, public health decision-making, and national strategic layout. However, the current construction of trusted health data space in China is facing multiple institutional barriers, including ambiguous definition of rights and interests leading to obstruction of authorization, lack of object classification inhibiting utilization efficiency, conflicts in normative systems exacerbating compliance risks, and lack of regulatory mechanisms leading to weak implementation. One of the reasons for this is that there are structural dilemmas in health data regulation theory—lagging theoretical iteration, governance formalism, and disconnection from new technology. To this end, it is necessary to take the theory of data space justice and balance of property rights and interests as the dual-core guidance, clarify the boundaries of rights and interests by promoting the reform of separation of powers, build dynamic grading standards to optimize data classification, accelerate the integration of special legislation and normative frameworks, and establish a closed loop of responsibility for the implementation of the gatekeeper system.

     

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