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Rules on Patients' Medical Data Hampering Research

In survey, most scientists said current laws are too cumbersome

TUESDAY, Nov. 13 (HealthDay News) -- Regulators may be going too far in their efforts to protect human research subjects, a new survey of research scientists suggests.

Two-thirds of doctors recently surveyed said that the Health Insurance Portability and Accountability Act (HIPAA), which oversees the release of patients' medical information, has hindered research. Only one-quarter felt the new rules had actually enhanced patients' confidentiality and privacy.

"According to the scientists surveyed, HIPAA is slowing and adding cost to clinical and population research. This has the potential to delay important research findings," said Dr. Roberta B. Ness, the study's lead author and chair of the department of epidemiology at the University of Pittsburgh Graduate School of Public Health.

"The pendulum has been swinging for decades and is continuing at light speed. There is no sign of it swinging back," added Dr. Norman Fost, author of an accompanying editorial and chair of the Institution Review Board at the University of Wisconsin School of Medicine and Public Health in Madison.

The study is published in the Nov. 14 issue of the Journal of the American Medical Association.

The original intent of the 1996 HIPAA Privacy Rule was to allow consumers to carry their insurance from job to job. But the final version tilts more toward protecting the privacy of medical records and information.

"Currently, an Institute of Medicine/National Academies panel is considering what suggested actions should be taken," Ness noted. "These may include suggesting changes in the rule or better guidance and implementation. That report should be out next summer or fall."

According to background information in this paper, HIPAA was supposed to find a balance between protecting individuals' privacy and allowing the use and disclosure of the information for social goals.

The rule allows health-care provider organizations to disclose individual information for research purposes, but only if the researcher gets written consent from each patient or obtains a waiver of the requirement.

There has been some evidence that HIPAA has slowed or even halted research, but there have been no large, generalized studies until now.

This study, commissioned by the Institute of Medicine, is based on surveys filled out by more than 1,500 epidemiologists conducting research on U.S. human subjects.

More than two-thirds (about 68 percent) of respondents said that the HIPAA Privacy Rule has made research more difficult at a level of 4 to 5 on a 5-point scale (5 indicating a great deal of added cost and time to complete a study).

Almost 40 percent said HIPAA had increased research costs in the high range, and half said that a high degree of additional time was now needed to complete research projects.

Almost half felt that the rule had greatly affected research related to public health surveillance.

Only 10.5 percent of respondents indicated that the rule had strengthened public trust, and only about 26 percent felt the rule enhanced participant confidentiality and privacy to a great degree.

Respondents also felt that the privacy rule had a negative influence on human subjects' protection more often than it had a positive influence.

"The one positive was that 25 percent felt that HIPAA had increased privacy," Ness said.

An accompanying editorial described a system mired in minutiae, including requirements for meticulous documentation.

The solution?

"The research community needs to push back. It needs to stop just caving in," said Fost, who is also professor of pediatrics and founder/director of the bioethics program at Wisconsin and who has received national recognition for his efforts to protect human research subjects. "It may be that there needs to be litigation," he said.

And, added Fost, "the basic structure [for research] that is already in place is very good. There's no question that the profession was not doing a good job on their own, and they needed to be forced to set up IRBs [institutional review boards] and make them work. But in 1983, a presidential commission concluded that the system was working very well."

More information

To learn more about HIPAA, visit the U.S. Department of Health and Human Services.

SOURCES: Roberta B. Ness, M.D., professor and chair, department of epidemiology, Graduate School of Public Health, University of Pittsburgh; Norman Fost, M.D., chair, Institutional Review Board, professor, pediatrics and founder/director, bioethics program, University of Wisconsin School of Medicine and Public Health, Madison; Nov. 14, 2007, Journal of the American Medical Association

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