Pitt Survey: Privacy Rules Slow Medical Research, Add Cost

Ness’ report in JAMA says many health care studies delayed or abandoned

Federal rules intended to protect patient privacy also slow research necessary to find treatments and cures, a Pitt survey has found.

Implementation of the U.S. Health Insurance Portability and Accountability Act (HIPAA) has severely eroded the process of scientific research, delaying some clinical studies and curtailing others before they even begin, said Roberta B. Ness, professor and chair of the Department of Epidemiology in Pitt’s School of Medicine.

Her findings, reported last month in the Journal of the American Medical Association, are part of the first national survey of epidemiologists commissioned by the Institute of Medicine, part of the National Academies of Science.

“HIPAA is adversely affecting our ability to conduct biomedical research,” said Ness, who also serves as an associate investigator at the Magee-Womens Research Institute (MWRI) and as an advisor to the Institute of Medicine committee studying the issue. “The privacy rule has made research more costly and time consuming. As a result, some possibly important studies are just not being done.”

Epidemiologists analyze the development and control of a wide array of illnesses and their impact on public health.

Ness’ report, titled “Influence of the HIPAA Privacy Rule on Health Research,” appeared in the Nov. 14 issue of JAMA.

She surveyed 1,527 epidemiology practitioners employed in academia, government, industry, and other groups. Two-thirds of the respondents said that HIPAA had made research “a great deal” more difficult to accomplish.

In addition, a significant proportion of respondents reported more negative consequences for protecting human subjects than positive effects.

All respondents were part of the Joint Policy Committee of the Societies of Epidemiology, which cosponsored the study.

“We asked questions about both positive and negative potential impacts from the HIPAA privacy rule, including the impact on subject privacy, confidentiality and public trust, as well as on research procedures,” Ness said. “Almost 40 percent of respondents indicated that the privacy rule had increased research costs by a large degree, and nearly half said that significant additional time was required under the rule to complete projects.”

Established in 2003, HIPAA was designed to enhance patient privacy by restricting access to medical records while preserving the legitimate use of such information for important social goals.

Ness said that academic institutional review boards (IRBs) and other institutional bodies that govern research on human subjects vary widely in their interpretation of the rule. That, she said, has resulted in a mishmash of conflicting procedures across the country, adding that some IRBs continue “business as usual,” while others have essentially shut down many research projects.

“According to our survey, there is a perception that HIPAA may even be having a negative effect on public health surveillance practices, and a lot of it is because of this variability in interpretation,” said Ness, president-elect of the American College of Epidemiology. “Some public health departments are defining a much broader portfolio of activities as research, and, therefore, are subject to HIPAA, more than other health departments. At this point, we’re not absolutely sure what that means in terms of public health – whether this poses any threat to combating epidemics or other dangers.”

While documenting negative HIPAA effects on a nationwide basis has been difficult, single-institution experience indicates widespread problems.

Recruitment for one study being conducted here at Pitt, for example, declined from more than a dozen people a week prior to HIPAA to an average of five at most after the rule took effect.

At the University of Michigan, patient consent for a study declined from more than 96 percent to 34 percent. In another study at Michigan, the implementation of HIPAA resulted in a nearly 73 percent decline in patient recruitment and a threefold increase in the time spent recruiting.
At the same time, only a quarter of epidemiologists said they thought HIPAA had achieved its goal of improving the confidentiality of patient information.

“Public opinion polls show that more than 90 percent of the public thinks it’s a priority for us to proceed expeditiously in uncovering new causes of and treatments for disease,” Ness said. “Without any question, this survey suggests that the HIPAA legislation is impeding the progress of such research. And for those institutions that may have a breakthrough in the offing, it’s going to add months to years to discovery.”