ACRO Pleased that Proposed HHS Privacy Rule Addresses Concerns of Health Researchers
FOR IMMEDIATE RELEASE
Media Contact: John Lewis
ACRO Pleased that Proposed HHS Privacy Rule
Addresses Concerns of Health Researchers
Washington, DC, July 13, 2010 –– 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):
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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The Association of Clinical Research Organizations (ACRO) represents companies whose focus is clinical research. The association provides an active voice for the global CRO industry, which provides specialized services that are integral to the development of drugs, biologics and medical devices. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ approximately 70,000 professionals worldwide and annually conduct more than 9,000 clinical trials involving nearly two million participants in 115 countries. For more information, please visit www.www.acrohealth.org.