Privacy rule takes its toll on research

CHICAGO (AP) — A federal patient privacy rule has had a chilling effect on medical research, making it tougher to recruit patients and use their health records, the first national survey on the topic suggests.

Two-thirds of the more than 1,500 epidemiologists surveyed said the Health Insurance Portability and Accountability Act, also called HIPAA, has made their research more difficult.

Important research has been stymied by the privacy rule, said Dr. Roberta Ness of the University of Pittsburgh, who led the survey. One in nine researchers said they had abandoned a research idea because they thought it wouldn’t be approved because of the HIPAA privacy rule.

A Pittsburgh colleague of Ness’ said enrollment in a study on preeclampsia, a complication of pregnancy, dropped from eight women a week to one per week because of HIPAA. Researcher Nina Markovic said they weren’t allowed to look at patient information and recruit women only for the preeclampsia study. Instead, clinic staff had to ask patients to join a registry that gave all researchers access to their medical charts.

Eventually, the researchers reached a compromise with the hospital and got the recruitment rate up to four women per week.

“We never did reach our final estimated recruitment numbers,” Markovic said.

The rule also put on hold a 25-year study of stroke and heart disease that used the medical records of more than 40,000 Minnesotans, said Dr. Russell Luepker of the University of Minnesota.

“We’ve been waiting to see if HIPAA becomes more clear and defined and reassures the hospitals that they’re not going to jail if they work with us,” Luepker said.

The survey results appear in today’s Journal of the American Medical Association. The Web-based survey had weaknesses, Ness acknowledged. Respondents were recruited by e-mail sent to more than 10,000 members of 13 epidemiology societies, so individuals could have answered the survey more than once. Scientists with strong feelings may have been more likely to participate, which would have skewed the results.

A privacy advocate said the protections offered by HIPAA are needed and desired by patients.

“The public DOES overwhelmingly support research but not without consent,” said Dr. Deborah Peel of the Patient Privacy Rights Foundation, a watchdog group, in an e-mail.