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HIPAA in Research-Institute of Medicine (IOM) project underway, others

From IOM's website-chock full of important projects (1): IOM's Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule- is investigating the effects on health research of the Privacy Rule regulations implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA) section on Administrative Simplification. As data and evidence allow, the needs and benefits of patient privacy will be balanced against the needs, risks, and benefits of identifiable health information for various kinds of health research. The committee will formulate recommendations for alterations or retention of the status quo accordingly and prepare a report.
Several helpful powerpoint presentations from the Feb. meeting are archived on the website.
More specifically, this Committee plans to consider/review:
-the range of study types (clinical trials, epidemiologic designs, research using tissue repositories and databases, public health research, and health services research);
-research carried out by a full range of sponsors (government, public/private academic, for-profit sectors, including the pharmaceutical, biotechnology,medical device industries);
-provisions of the Privacy Rule relevant to health research, including those dealing with authorizations and accounting for disclosures of personal health information, de-identification of data, reviews preparatory to research, and others;
-issues of interpretation/implementation of the Privacy Rule and overlapping provisions of the Common Rule/FDA regulations (in existence much longer);
-potential impact of the Rule on: public health research, recruitment of research subjects for studies, conduct of research internationally, research using data and biomaterials in databases and tissue repositories; and
-needs for privacy of identifiable personal health information and the value of such privacy to patients and the public.
Another project underway: IOM's Forum on the Science of Health Care Quality Improvement and Implementation; their goals are to (i)advance the understanding of the value and appropriate role of research philosophies, cultures, and methods and (ii) develop greater awareness and support for appropriate approaches and methods by key stakeholder groups.
Also, an IOM ad hoc committee will undertake a comprehensive review/analysis of the health consequences of lacking health insurance coverage including, for example, the effect on morbidity/mortality for the uninsured population overall and for certain vulnerable groups such as persons with chronic disease and older adults in the years preceding Medicare eligibility (12-month study).
(1) http://www.iom.edu/ Established in 1970 under the charter of the National Academy of Sciences, IOM provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. IOM's mission embraces the health of people everywhere.

IOM's work is organized into seventeen topic areas: mental health, child health, food & nutrition, aging, women's health, education, public policy, healthcare & quality, diseases, global health, workplace, military & veterans, health sciences, environment, treatment, public health & prevention, and minority health.

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This page contains a single entry from the blog posted on May 10, 2008 7:56 AM.

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