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基层医疗中个人数据的研究与保护

[Research and protection of personal data in Primary Care].

作者信息

Garrido Elustondo Sofía, Cabello Ballesteros Luisa, Galende Domínguez Inés, Riesgo Fuertes Rosario, Rodríguez Barrientos Ricardo, Polentinos Castro Elena

机构信息

Técnico de Salud, Unidad Docente Multiprofesional de Atención Familiar y Comunitaria Sureste de la Gerencia de Atención Primaria de Madrid, Madrid, España.

出版信息

Aten Primaria. 2012 Mar;44(3):172-7. doi: 10.1016/j.aprim.2011.02.009. Epub 2011 Jul 29.

DOI:10.1016/j.aprim.2011.02.009
PMID:21802790
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7025257/
Abstract

Research is one of the fundamental functions that have to be carried out in Primary Care. The clinical information stored in different records arising from medical care is a basic tool for this activity. The use of personal data for the purposes of research is legitimate according to our laws; however, this information must be treated confidentially at all times. Two alternatives are available for this. One is to obtain the informed consent of the patient, and the other is to dissociate the handling of the information. But in some situations, the compliance to legal demands when obtaining data for research is not easy, there being a series of obstacles which in many cases makes it impossible to carry out research. In this article, we will give guidance on how to access the information contained in records while respecting the rights of the patient and the current legislation.

摘要

研究是基层医疗必须开展的基本职能之一。医疗过程中存储在不同记录里的临床信息是这项活动的基本工具。根据我国法律,为研究目的使用个人数据是合法的;然而,这些信息必须始终得到保密处理。对此有两种选择。一种是获得患者的知情同意,另一种是使信息处理脱钩。但在某些情况下,为研究获取数据时遵守法律要求并非易事,存在一系列障碍,在许多情况下使得无法开展研究。在本文中,我们将就如何在尊重患者权利和现行法律的同时获取记录中包含的信息提供指导。

相似文献

1
[Research and protection of personal data in Primary Care].基层医疗中个人数据的研究与保护
Aten Primaria. 2012 Mar;44(3):172-7. doi: 10.1016/j.aprim.2011.02.009. Epub 2011 Jul 29.
2
The use of personal data from medical records and biological materials: ethical perspectives and the basis for legal restrictions in health research.医疗记录和生物材料中个人数据的使用:伦理视角及健康研究中法律限制的依据
Soc Sci Med. 2004 Nov;59(9):1975-84. doi: 10.1016/j.socscimed.2004.02.032.
3
Alternatives of informed consent for storage and use of human biological material for research purposes: Brazilian regulation.用于研究目的的人类生物材料存储和使用的知情同意替代方案:巴西法规
Dev World Bioeth. 2014 Dec;14(3):127-31. doi: 10.1111/dewb.12012. Epub 2012 Dec 21.
4
Research using electronic health records: Balancing confidentiality and public good.利用电子健康记录进行的研究:平衡保密性与公共利益。
J Prim Health Care. 2018 Dec;10(4):288-291. doi: 10.1071/HC18040.
5
[Ethics guidelines for the creation and use of registries for biomedical research purposes].[生物医学研究目的注册库创建与使用的伦理准则]
Rev Esp Salud Publica. 2008 Jan-Feb;82(1):21-42. doi: 10.1590/s1135-57272008000100003.
6
[Accessing medical records for research purposes].[出于研究目的获取医疗记录]
Rev Derecho Genoma Hum. 2013 Jul-Dec(39):137-72.
7
Government views on confidentiality: confidentiality, use and disclosure of personal health information.政府对保密的看法:个人健康信息的保密、使用和披露。
Bull Med Ethics. 1994 Aug;No. 100:18-24.
8
New European guidelines for the use of stored human biological materials in biomedical research.欧洲关于在生物医学研究中使用储存的人类生物材料的新指南。
J Med Ethics. 2004 Feb;30(1):99-103. doi: 10.1136/jme.2003.003467.
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Requiring consent vs. waiving consent for medical records research: a Minnesota law vs. the U.S. (HIPAA) privacy rule.医疗记录研究中的同意要求与同意豁免:明尼苏达州法律与美国(《健康保险流通与责任法案》)隐私规则的对比
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[Use of Electronic Medical Records for Research: New Ethical Challenges and Possible Solutions].[电子病历用于研究:新的伦理挑战与可能的解决方案]
Acta Med Port. 2019 May 31;32(5):332-334. doi: 10.20344/amp.11280.

本文引用的文献

1
Written informed consent and selection bias in observational studies using medical records: systematic review.使用医疗记录的观察性研究中的书面知情同意和选择偏倚:系统评价
BMJ. 2009 Mar 12;338:b866. doi: 10.1136/bmj.b866.
2
Research on medical records without informed consent.未经知情同意的医疗记录研究。
J Law Med Ethics. 2008 Fall;36(3):560-6. doi: 10.1111/j.1748-720X.2008.304.x.
3
Whose interest? British newspaper reporting of use of medical records for research.谁的利益?英国报纸对医学记录用于研究的报道。
J Health Serv Res Policy. 2008 Jul;13(3):140-5. doi: 10.1258/jhsrp.2008.007126.
4
[Ethics guidelines for the creation and use of registries for biomedical research purposes].[生物医学研究目的注册库创建与使用的伦理准则]
Rev Esp Salud Publica. 2008 Jan-Feb;82(1):21-42. doi: 10.1590/s1135-57272008000100003.
5
Low risk research using routinely collected identifiable health information without informed consent: encounters with the Patient Information Advisory Group.在未获得知情同意的情况下使用常规收集的可识别健康信息进行的低风险研究:与患者信息咨询小组的接触
J Med Ethics. 2008 Jan;34(1):37-40. doi: 10.1136/jme.2006.019661.
6
Patient records. Privacy rule creates bottleneck for U.S. biomedical researchers.患者记录。隐私规定给美国生物医学研究人员造成了瓶颈。
Science. 2004 Jul 9;305(5681):168-9. doi: 10.1126/science.305.5681.168.
7
Registry research and medical privacy.注册研究与医疗隐私。
N Engl J Med. 2004 Apr 1;350(14):1452-3. doi: 10.1056/NEJMe048027.
8
[Research in primary care?].[基层医疗保健研究?]
Aten Primaria. 2003 Mar 31;31(5):281-4. doi: 10.1016/s0212-6567(03)79179-3.
9
Data protection legislation: interpretation and barriers to research.数据保护立法:研究的解释与障碍
BMJ. 2000 Oct 7;321(7265):890-2. doi: 10.1136/bmj.321.7265.890.
10
[Investigation and primary care].[调查与初级保健]
Aten Primaria. 1999 May;23 Suppl 1:66-70.