Medical records and privacy: empirical effects of legislation.

OBJECTIVE: To determine the effects of state legislation requiring patient informed consent prior to medical record abstraction by external researchers for a specific study. DATA SOURCES/STUDY SETTING: Informed consent responses obtained from November 1997 through April 1998 from members of a Minnesota-based IPA model health plan. STUDY DESIGN: Descriptive case study of consent to gain access to medical records for a pharmaco-epidemiologic study of seizures associated with use of a pain medication that was conducted as part of the FDA's post-marketing safety surveillance program to evaluate adverse events associated with approved drugs. DATA COLLECTION: The informed consent process approved by an institutional review board consisted of three phases: (1) a letter from the health plan's medical director requesting participation, (2) a second mailing to nonrespondents, and (3) a follow-up telephone call to nonrespondents. PRINCIPAL FINDINGS: Of 140 Minnesota health plan members asked to participate in the medical records study, 52 percent (73) responded and 19 percent (26) returned a signed consent form authorizing access to their records for the study. For 132 study subjects enrolled in five other health plans in states where study-specific consent was not required, health care providers granted access to patient medical records for 93 percent (123) of the members. CONCLUSION: Legislation requiring patient informed consent to gain access to medical records for a specific research study was associated with low participation and increased time to complete that observational study. Efforts to protect patient privacy may come into conflict with the ability to produce timely and valid research to safeguard and improve public health.

Evidence for self-selection among health maintenance organization enrollees.

Inpatient utilization and health care costs of employees and their families were studied for 11 employee groups covered by Blue Cross and Blue Shield in the Minneapolis-St Paul area during the year before optional health maintenance organization (HMO) enrollment. Before enrolling in HMOs, those joining averaged 53% fewer inpatient days (470 days/1,000 v 994 days/1,000) than those retaining fee-for-service (FFS) coverage. Both hospital and professional expenditures were lower among HMO enrollees. Age-specific analysis showed higher inpatient use of continuing FFS subscribers in every category. Self-selection may be an important determinant of differences in use and costs when comparing HMOs with FFS coverage.