| 关 健.法律框架下构建医学科学数据共享机制和保障体系[J].中国科技资源导刊,2020,(2):62~68 |
| 法律框架下构建医学科学数据共享机制和保障体系 |
| Establish the Mechanism and Its Support System of Scientific Data Sharing in Healthcare under the Legal Framework |
| 投稿时间：2020-02-13 |
| DOI： |
| 中文关键词: 共享机制；医学科学数据；隐私保护；数据安全；权益；运行保障；民法原则 |
| 英文关键词: sharing mechanism, scientific data in healthcare, privacy protection, data safety, rights and
interests, operation support, principles of civil law |
| 基金项目: |
| 作者 | 单位 | | 关 健 | （中国医学科学院北京协和医院，北京 100730） |
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| 摘要点击次数: 1375 |
| 全文下载次数: 2933 |
| 中文摘要: |
| 医学科学数据成为科技资源，其共享成为全球趋势。数据共享的可持续发展需要合理可行的共享机制和有
效的支撑体系。本文分析在我国现有法律框架下构建医学科学数据共享机制的几个重要问题。首先分析了构建医学科
学数据共享机制整体框架需要考虑的因素。进而以民法原则为基础、结合国际共识和伦理基本原则确定了医学科学数
据共享应该遵循的重要原则；提出共享机制的核心内容，即根据法律法规确定利益相关人的权利义务。最后提出共享
机制有效运行的法律、伦理、管理和技术综合保障体系和相关建议。 |
| 英文摘要: |
| Scientific data in healthcare has become a kind of valuable innovative resource, and its sharing has
become a global trend. The sustainable development of data sharing needs a reasonably practicable sharing
mechanism. Here in this article some important issues is discussed and analyzed for establishment of the sharing
mechanism under the Chese current legal framework. Some frame contexts for establishment of scientific
data sharing mechanism is briefly analyzed. The primary principles to be followed in scientific data sharing is
also analyzed from the perspective of law. The central contents of the sharing mechanism and the mechanism
operation-guarantee system is put forward. Besides, some preliminary suggestions important for the improvement
of law and ethical management are provided. The author believed that the sharing mechanism of scientific data in
healthcare should be established mainly based on the principles of civil law; The primary principles guiding data
sharing should be combined with international consensus and basic ethical principles. Moreover, the focus content
of the mechanism should be confirmed in accordance with laws and regulations, especially to clarify the rights
and obligations of stakeholders. Finally, a comprehensive system composed of law, ethics, management norms and
technical support is needed for ensuring the effective operation of sharing mechanism. |
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