Johns Hopkins Medicine Seeks HIPAA Medical Privacy Rule Waiver
Johns Hopkins Medicine has requested HHS approval for a proposal to ask patients to waive certain rights under the Health Insurance Portability and Accountability Act medical privacy rule to allow researchers to search their medical records to find clinical trial volunteers, the Baltimore Sun reports. Under the proposal, Johns Hopkins would ask new patients to sign a form that would provide researchers with "blanket approval" to examine their medical records; researchers could not examine the medical records of patients who do not sign the form. According to Johns Hopkins, the proposal is a "straightforward attempt to balance patients' rights" under the new medical privacy rule with "researchers' need to find volunteers for human tests of drugs and devices," the Sun reports (Bell, Baltimore Sun, 7/6). The HIPAA medical privacy rule, which took effect in April, allows providers to share patient medical records for the purposes of treatment and other "health care operations." Under the regulation, providers must obtain consent from patients before they can disclose medical records in "nonroutine" cases. However, providers do not have to obtain written consent before they disclose medical records. Providers only have to inform patients of their new rights and make a "good faith effort" to obtain written acknowledgment from patients that they have received the information (California Healthline, 4/14).
Joanne Pollack, vice president and general counsel for Johns Hopkins, said that the proposal would help clarify the "confusing maze of rules applicable to recruitment for clinical trials." She added that the proposal would "prevent situations in which patients are unnerved by researchers who want to recruit them for a trial based on medical conditions they thought were private," the Sun reports. However, opponents said that the proposal would "add to the confusing load of paperwork patients must review before they're treated, leading them to sign without realizing what the form permits," the Sun reports. In addition, opponents said that the proposal would violate the "spirit" of the HIPAA medical privacy rule. Katharina Kopp, program manager for the Health Privacy Project, said, "We don't want to stop research, ... but the authorization is way too broad" (Baltimore Sun, 7/6).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.