NCPA - National Center for Policy Analysis


August 13, 2004

The Privacy Rule of the 1996 Health Insurance Portability and Accountability Act (HIPAA) may benefit patients in restricting the use of their health records, but it is creating problems for medical researchers, according to Science magazine.

The rule creates cumbersome obstacles for researchers obtaining permission to use patient data for research:

  • Researchers must obtain an individual's written permission to use patient data in a study, but studies already have consent forms that require a patient's approval.
  • Phone calls to health care institutions to allow for scanning of medical data must now be replaced by written requests.
  • Repositories and research databases of patient tissue samples previously required one blanket consent for each patient for studying the tissue and keeping data private, but now a patient must give their consent each time the data is used.
  • Sharing of pedigree and genetic information is limited as well; William Isaacs of Hopkins studies prostate cancer genetic data at 14 different institutions, but is prohibited from pooling the data to look for cancer susceptibility genes.

Researchers are frustrated at having to get patient consent for each new study, especially since patients move and die, making obtaining every single contact difficult, if not impossible.

Moreover, observers claim there is no evidence that the Privacy Rule is keeping patient data any safer. Researchers are more concerned over social cost of research not being done due to HIPAA rules.

However, a few researchers claim that the privacy rule benefits the medical industry by forcing more stringent procedures on researchers. The Health and Human Services Department is currently attempting to clear up the ambiguities in the rule.

Source: Jocelyn Kaiser, "Privacy Rule Creates Bottleneck for U.S. Biomedical Researchers," Science 305, no. 5681, July 9, 2004.

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