CHICAGO — 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 (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 appeared in last Wednesday’s Journal of the American Medical Association (JAMA).
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.
Most Americans want to know how their personal medical records are used in research and want to be asked for their consent before those records are used, Peel said.
Medical research was never the target of HIPAA. It was intended to make it easier for people to keep their health insurance coverage when they change jobs. HIPAA, which went into effect in 2003, set standards for protecting patient privacy during the electronic transfer of information.
The rule makes exceptions for certain research. Public health agencies can monitor disease outbreaks, for example, and scientists can seek waivers to analyze health records without authorization from each patient. Researchers also can use data that has been stripped of information that would identify patients.
The rule has resulted in longer consent forms that patients are less likely to read before taking part in research, said Dr. Norman Fost of the University of Wisconsin School of Medicine. Fost, who was not involved in the survey, wrote an accompanying editorial in JAMA.
“Patients are worse off. They are drowning in more material and don’t know where to start,” Fost said in an interview.
Institutional review boards, which oversee research, spend valuable time complying with HIPAA requirements that could be better spent on protecting the rights of research subjects, Fost said.
“It’s like requiring pilots to make sure tray tables are in their full upright and locked position when they should be flying the plane,” he said.
The survey was commissioned by the Institute of Medicine, which has a committee studying the issue.