[Data protection and methodological aspects in compiling a routine database from statutory health insurance data for research purposes].

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.