Privacy Law Thwarts Medical Research

Getting permission to create registries a problem, experts say

WEDNESDAY, March 31, 2004 (HealthDayNews) -- In today's climate of fear over having medical records disclosed, researchers complain that doing important public health research has become impossible.

In 1996, the U.S. government passed the Health Insurance Portability and Accountability Act (HIPAA), which insures the privacy of your health records. As part of that law, researchers are required to get your permission before any of your medical information can be used in research.

What upsets many researchers is that this law prevents establishing registries of various diseases. A registry is a database of every case of a disease and includes the condition, the treatment and the outcome -- but not the patient's name or contact information.

When creating a registry, "unless you can get universal participation, you are going to get skewed results," says Dr. Jeffrey M. Drazen, editor-in-chief of the New England Journal of Medicine. "If there is not this level of participation, you will learn something different from the truth."

Drazen and deputy journal editor Dr. Julie R. Ingelfinger express their opinions on the topic in an editorial in the April 1 issue of the journal.

Drazen says these registries can be created under the law, but institutional review boards at universities and hospitals, which must approve this research, are reluctant to waive informed consent out of fear of running afoul of the privacy law.

Drazen would like to see registries for all diseases, including diabetes, cancer, heart disease, stroke and asthma.

Drazen says that "disease registries are the yardstick by which we measure our actual medical progress."

The importance of these registries is that they track diseases over time in the whole country and let researchers compare the outcomes and effects of new treatments. "Registries can be of big value in understanding how care is delivered," he says.

"There needs to be an initiative at the government level to suggest that informed consent should be waived for this kind of research," Drazen says. "The government could do a lot to move this type of research forward."

The government needs to make clear what is and is not allowed, Drazen says. This would both protect a patient's privacy and make it possible to do this important research, he adds.

Drazen says that if you are in a research database used for medical knowledge, you are at almost no risk of having your information disclosed. "No one is going to find out who you are, call you up and try to sell you something or tell you you're no longer insurable," he says.

In the same issue of the journal, Canadian researchers prove the point in their analysis of a failed attempt to create a national registry of stroke patients. That country has similar privacy laws.

When researchers tried to set up a national stroke registry, they found that they were able to get consent from only about 50 percent of all the eligible patients, says lead author Dr. Jack Tu, a senior scientist at the Institute for Clinical Evaluative Sciences and an associate professor of medicine at the University of Toronto.

Because of the need for consent, they could not get permission from patients who died, patients with minor strokes who left the hospital, patients who didn't speak English or French, and patients with brain damage, Tu says.

"What we ended up with was a biased sample," he adds. "If we want to have comprehensive data, we need to have access to patient records to gather anonymous information to improve patient care."

It is not practical to have to obtain consent from all patients, many of whom are unable to give it, Tu says.

Both Tu and Drazen note that exceptions are already made for creating registries of emerging diseases such as SARS and West Nile virus. In addition, most states already require doctors to report cases of infectious disease, such as sexually transmitted diseases.

"We need to strike a balance between patient privacy and medical research," Tu says. "We need to realize that there are a lot of important studies that need to be conducted using confidential patient information, and we need the support of patients and the public to allow those kinds of studies to continue."

More information

The Department of Health and Human Services can tell you about medical privacy, and the American Medical Association has a page on informed consent.

Related Stories

No stories found.
logo
www.healthday.com