Regulation of medical research is hampering improvement in US health care, critics say

BMJ 2009; 339 doi: (Published 20 August 2009) Cite this as: BMJ 2009;339:b3370
  1. Bob Roehr
  1. 1Washington, DC

    Regulations and practices in the United States designed to protect patients and their privacy are impeding medical research and in some instances making it prohibitively expensive, a leading medical society says.

    The rules are hindering improvements in care, says the Infectious Disease Society of America in an article in Clinical Infectious Diseases (2009;49:328-35, doi:10.1086/605454). The society is seeking to clarify and simplify the regulations while maintaining protection of patients.

    A big obstacle, the society’s article says, is the Health Insurance Portability and Accountability Act, enacted in 1996 to protect patients in care, with a rolling series of implementation dates. But research carried out with informed consent is a very different situation from standard health care, said William Burman, director of the infectious disease clinic at Denver Public Health and head …

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