Study: National medical privacy law makes health research harder, more expensive

NEW ORLEANS -- As the one-year anniversary of the nation's medical privacy law approaches, a new study shows the negative impact that its implementation may be having on certain kinds of health research.

At the Annual Scientific Session of the American College of Cardiology here, researchers from the University of Michigan Cardiovascular Center recently showed how HIPAA, the national medical privacy act, severely affected their ability to study heart attack patients after they left the hospital.

This kind of long-term "outcome" study is crucial for evaluating medical care, such as the number of patients who die or have complications after surgery or hospitalization.

But HIPAA requires written authorization from a patient before he or she can be contacted to gather personal health information for a research study. The U-M researchers had previously used a verbal privacy authorization, obtained when they called patients at home months after they left the hospital.

But when they switched from the verbal consent to a HIPAA-compliant written authorization that had to be mailed to patients and mailed back, they found a sizable drop in the percentage of patients who gave consent to be called.

The percentage participation plummeted from 96.1 percent to 38.5 percent. As a result, the consented population was not representative of the entire population of patients the researchers wanted to study. That could bias study results.

"On top of this impact on the quality of data, the costs involved in asking for this written authorization were substantially larger than those for the verbal system," says Eva Kline-Rogers, M.S., N.P., who helped lead the study. "To get consent from one patient, we calculated we'd spend $14.50 per patient in the first year of the study for computer, training, staff, administrative and mailing costs, and $7.50 each year afterward."

To avoid the mailed authorization approach, by asking patients

Contact: Kara Gavin
University of Michigan Health System

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