November 13, 2007 / 9:19 PM / in 11 years

Too much privacy? U.S. law makes research harder

CHICAGO (Reuters) - U.S. privacy laws designed to protect patients’ health information have had the unintended effect of impeding scientific research, stalling clinical studies and halting others altogether, U.S. researchers said on Tuesday.

A medical history form of a cancer patient is seen at Georgetown University Hospital in Washington May 23, 2007. U.S. privacy laws designed to protect patients' health information have had the unintended effect of impeding scientific research, stalling clinical studies and halting others altogether, U.S. researchers said on Tuesday. REUTERS/ Jim Bourg

Nearly 70 percent of clinical scientists in a national survey said U.S. Health Insurance Portability and Accountability Act or HIPAA, enacted in 2003, has made research more difficult, according to the study published in the Journal of the American Medical Association.

Almost 40 percent of those surveyed said HIPAA has added to the cost of research and half said it has slowed the pace of research.

“HIPAA is adversely affecting our ability to conduct biomedical research,” Dr. Roberta Ness of the University of Pittsburgh said in a statement.

The health privacy law was intended to balance the protection of information that could be traced back to individuals while still making it available for social good, such as medical research.

What it has become, Ness and colleagues said, is a stumbling block to scientific research, forcing researchers to spend too much time with paperwork that does little to protect patients.

To assess the impact HIPAA on scientific research, Ness and colleagues surveyed epidemiologists who use large pools of data to study disease in humans. More than 1,500 participated.

The researchers asked both positive and negative questions about the impact of HIPAA and asked the respondents to rank them on a scale of 1 to 5 in terms of impact.


What they found was about two-thirds believed HIPAA has made research a great deal more difficult to accomplish, while only 25 percent felt it was actually improving privacy.

“On the whole, respondents felt that HIPAA is having more of a negative than a positive impact on human subjects protection,” Ness said in an e-mail.

“The consent forms have become so long with the addition of HIPAA that subjects may not be understanding what they are agreeing to,” she said.

“It is deterring people from doing research on databases that involves very little risk and very little privacy intrusion,” said Norman Fost of the University of Wisconsin School of Medicine and Public Health.

“It is scaring people out of the field,” Fost, who wrote an editorial the problems of over-regulating of medical research, said in a telephone interview.

It also may be skewing study results because many databases exclude information that did not meet HIPAA requirements, he said.

And HIPAA may even be having an impact on public health, Ness said, adding that some institutions are interpreting the law so strictly that it is impeding the collection of public health information.

“At this point, we are not absolutely sure what that means in terms of public health — whether this poses any threat to combating epidemics or other dangers,” Ness said in a statement.

Relief may come this summer when an Institute of Medicine panel offers recommendations on how to reduce the burden of HIPAA compliance on public health research, said Ness, who is an adviser to the committee.

Editing by David Wiessler

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