Datenschutz und Datenzugang (I): Bundesdatenschutzgesetz und Sozialgesetzbuch unter dem Aspekt der Durchführung arbeitsmedizinisch-epidemiologischer Studien in der Bundesrepublik Deutschland.

The regulations applicable to research in occupational epidemiology are the federal data protection (confidentiality) law (BDSG), the social welfare code (SGB), medical professional secrecy regulations and the federal statistics law (BStatG). The SGB, medical professional secrecy, and BStatG codes take precedence over BDSG rulings. This paper discusses BDSG and SGB. Medical professional secrecy and BStatG will be the topic of another publication (Datenschutz and Datenzugang II). The BDSG permits processing and utilization of personal data only if 1. this is permitted by BDSG or a law with higher priority, or 2. if the individual concerned has given her or his informed consent. According to the BDSG private research institutes can have access to personal data collected within non-public institutions only via section 28 (2) without consent of the individual. The "research paragraph" section 40 governs the processing and utilisation of personal data by research institutions. As a rule, the SGB permits access to epidemiological data sources only with the informed consent of the individuals concerned. The exception is section 75 SGBX. This paragraph permits disclosure of personal data without the individual's consent by the relevant public institution only if public interest considerably outweighs the private concerns. To our knowledge, however, this clause has had no practical significance. The concept of "informed consent" is discussed in detail, including the requirements for a legal form for informed consent. The legal codes of the BDSG, professional secrecy, and BStatG permit the transfer of personal data if the individuals concerned remain anonymous. This paper deals in detail with the concept of "anonymity".(ABSTRACT TRUNCATED AT 250 WORDS