The Association of Clinical Research Organizations, which represents the global CRO industry, today released the following statement regarding a proposed privacy rule from the Department of Health and Human Services (HHS):
“By allowing the continued availability of anonymized 'limited data sets' without requiring cumbersome and impractical individual authorizations, HHS has recognized the integral role such data plays in areas like drug safety monitoring, comparative effectiveness research, public health surveillance, health care operations and elsewhere.”
"The Association of Clinical Research Organization is pleased that the proposed privacy rule from Department of Health and Human Services strikes an appropriate balance between the critical needs of researchers for access to health information and the desire to protect the privacy of individual's health records.
"By allowing the continued availability of anonymized 'limited data sets' without requiring cumbersome and impractical individual authorizations, HHS has recognized the integral role such data plays in areas like drug safety monitoring, comparative effectiveness research, public health surveillance, health care operations and elsewhere.
"The proposed rule will also facilitate clinical research through the allowance of 'compound authorization' whereby a researcher will be able to obtain a single consent for a research project that includes both a clinical trial and tissue banking of specimens, rather than obtaining separate consent for each activity.
"ACRO urges HHS to consider additional changes to the HIPAA rules that would streamline the research process, such as allowing researchers to seek individual authorization for 'future and unspecified' studies, which is currently prohibited."
This proposed rule implements provisions of The Health Information Technology for Economic and Clinical Health Act (HITECH) passed in February 2009, which greatly expanded the privacy provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
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