Ihle P
Universität zu Köln, Köln, BRD.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2008 Oct;51(10):1127-34. doi: 10.1007/s00103-008-0647-x.
Personally identifiable routine data generated by the SHI (statutory health insurance) offer inexpensive and large amounts of data gathered over long periods of observation for use in numerous fields of application including health services research and epidemiology of health care. As a source of medical health information, these data are subject to particular EU data protection directives according to which they can only be used under certain conditions and following careful consideration of the various interests involved. These interests include the protection of personal privacy, on the one hand, and the freedom of research, on the other. As personally identifiable data, these data are fully subject to general and specific data privacy regulations, such as the consideration of intended use; the specification of forms of data processing, duration of use, and group of users; and the development of a data protection concept. If primary data are additionally collected, the patient is to be fully informed about the intended contents of analysis and the use of his/her data in order that informed consent can be provided. Methodological standards such as the verification of completeness and plausibility are also to be met when compiling an insuree database.
法定医疗保险（SHI）生成的个人可识别常规数据提供了长期观察收集的大量低成本数据，可用于包括卫生服务研究和医疗保健流行病学在内的众多应用领域。作为医疗健康信息的来源，这些数据受欧盟特定数据保护指令的约束，根据这些指令，只有在特定条件下并仔细考虑所涉及的各种利益后才能使用。这些利益一方面包括个人隐私保护，另一方面包括研究自由。作为个人可识别数据，这些数据完全受一般和特定数据隐私法规的约束，例如考虑预期用途；规定数据处理形式、使用期限和用户群体；以及制定数据保护概念。如果额外收集原始数据，则应向患者充分告知分析的预期内容以及其数据的使用情况，以便能够提供知情同意。在编制被保险人数据库时，还应满足诸如完整性和合理性验证等方法标准。
