Multicenter patient records research: security policies and tools.
Medical Records Systems, Computerized
Multicenter Studies as Topic
The expanding health information infrastructure offers the promise of new medical knowledge drawn from patient records. Such promise will never be fulfilled, however, unless researchers first address policy issues regarding the rights and interests of both the patients and the institutions who hold their records. In this article, the authors analyze the interests of patients and institutions in light of public policy and institutional needs. They conclude that the multicenter study, with Institutional Review Board approval of each study at each site, protects the interests of both. "Anonymity" is no panacea, since patient records are so rich in information that they can never be truly anonymous. Researchers must earn and respect the trust of the public, as responsible stewards of facts about patients' lives. The authors find that computer security tools are needed to administer multicenter patient records studies and describe simple approaches that can be implemented using commercial database products.