American Journal of Epidemiology · 2000 · 78 citations · 9 references
LawHealth InformaticsHealth LawClinical Research RegulationElectronic Health RecordsHealth Information SecurityData ArchivingData ConfidentialityData ProtectionData Sharing PoliciesParticipant ConfidentialityPrivacy LawConfidentialityConfidentiality Of Medical RecordsHealth Data ProtectionInstitutional Disclosure PoliciesLegal Protection FrameworksMedical ConfidentialityPatient Data ConfidentialityState Statutory Regulation
Fast computers and the Internet have enabled large collaborative research by allowing data transfer from multiple sites to a single repository, but standards for data security are needed to protect participant confidentiality. This paper outlines the careful planning required to secure legal protection and data security, including understanding applicable state and federal safeguards, establishing rules or guidelines for data handling, and ensuring secure storage of paper and electronic records. The authors performed a medicolegal analysis of federal laws, state statutes, and institutional policies across eight states and three health care settings in a breast‑cancer surveillance consortium that electronically contributed data to a centralized repository during 1996–1998 through Dartmouth Medical School. They found that multiple state and federal laws protect research participant confidentiality, with the Federal Certificate of Confidentiality providing the strongest protection by superseding state law, being court‑tested, and extending safeguards against forced disclosure to both health care providers and patients. Published in Am J Epidemiol 2000;152:371–8.
The convenience of fast computers and the Internet have encouraged large collaborative research efforts by allowing transfers of data from multiple sites to a single data repository; however, standards for managing data security are needed to protect the confidentiality of participants. Through Dartmouth Medical School, in 1996–1998, the authors conducted a medicolegal analysis of federal laws, state statutes, and institutional policies in eight states and three different types of health care settings, which are part of a breast cancer surveillance consortium contributing data electronically to a centralized data repository. They learned that a variety of state and federal laws are available to protect confidentiality of professional and lay research participants. The strongest protection available is the Federal Certificate of Confidentiality, which supersedes state statutory protection, has been tested in court, and extends protection from forced disclosure (in litigation) to health care providers as well as patients. This paper describes the careful planning necessary to ensure adequate legal protection and data security, which must include a comprehensive understanding of state and federal protections applicable to medical research. Researchers must also develop rules or guidelines to ensure appropriate collection, use, and sharing of data. Finally, systems for the storage of both paper and electronic records must be as secure as possible. Am J Epidemiol 2000;152:371–8.
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