This paper reviews the use of information in medical databases, such as those relevant to epidemiological research in general, and pharmaco-epidemiological studies in particular. Issues covered include confidentiality and privacy, as well as regulatory guidelines.
BerglundCA.Australian standards for privacy of health records in research: implications of the Commonwealth Privacy Act. Med J Australia.1990;152:664–669.
2.
CapronAM.Protection of research subjects: do special rules apply in epidemiology?J Clin Epidemiology.1991;44(suppl 1):81S–85S.
3.
FlussSSSimonFGutteridgeF.Development of international ethical guidelines for epidemiological research and practice. In: BankowskiZBryantJHLastJM (Eds). Ethics and epidemiology: International guidelines. Proceedings of the XXVth CIOMS Conference. Geneva, Switzerland; 1990.
4.
Department of Health and Human Services Food and Drug Administration.Protecting the identity of reporters of adverse events and patients; Preemption of disclosure rules. Proposed rule. Federal Register January 27, 1994;59(18).
5.
VaughanJPMorrowRH (Eds), Manual of epidemiology for district health management.Geneva: World Health Organization, 1989;169–174.
6.
In: International Digest of Health Legislation.1990;41(1):148–152.
7.
Commission of the European Communities.Amended proposal for a Council Directive on the protection of individuals with respect to the processing of personal data and on the free movement of such data. COM(92) 422 final-SYN 287. Brussels; October 15, 1992.
8.
CIOMS International Guidelines for ethical review of epidemiological studies. Geneva; 1991.
9.
Pharmaceutical Manufacturers Association.PMA issues statement on patient confidentiality in Rx databases. PMA Newsletter. November 16, 1992.
10.
BrahamsD.Secrecy and product liability litigation. Lancet.1990;336:737.
11.
KnoxEG.The confidentiality of medical records: the principles and practice of protection in a research-dependent environment. Report of working party of Advisory Panel for Social Medicine and Epidemiology in European Economic Community. Luxembourg, Commission of the European Communities; 1984.
KnoxEG.Confidential medical records and medical research. Brit Med J.1992;304:727.
14.
LyngeE.European directive on confidential data: a threat to epidemiology. Br Med J.1994;308:490.
15.
VandenbrouckeJP.Medische ethiek en gezondheidsrecht; hinderpalen vor de verdere toename van kennis in de geneeskunde?Ned Tijdschr Geneeskd.1990;134:5–6 (in Dutch).
16.
KwederS.Confidentiality of databases: a regulatory view. Presentation at the DIA International Seminar on Adverse Reactions, New Orleans, October 24–27, 1993.
