IOM committee: the HIPAA Privacy Rule's effects on health research

A new Institute of Medicine committee has been formed to assess the impact of the HIPAA Privacy Rule -- the committee's charge is titled "Health Research and the Privacy of Health Information - The HIPAA Privacy Rule." It began June 1, 2007, first formal meeting in mid-June, and is expected to run for 16 months.

From the project description:

"An IOM committee will investigate 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 and prepare a report. In conducting the study, the committee will:

• consider the range of study types, such as clinical trials, epidemiologic designs, research using tissue repositories and databases, public health research, and health services research, to the extent that available data and evidence allow
• consider research carried out by the full range of sponsors: government, public and private academic, and for-profit sectors, including the pharmaceutical, biotechnology and medical device industries
• review 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, and on reviewing them, may identify provisions that merit priority attention and analysis
• take into consideration issues of interpretation and implementation of the Privacy Rule, as well as of harmonization with overlapping provisions of the Common Rule and FDA regulations, which have been in existence much longer
• examine the potential impact of the Rule on public health research, on the recruitment of research subjects for studies, on carrying out research internationally, and on research using data and biomaterials in databases and tissue repositories
• consider the needs for privacy of identifiable personal health information and the value of such privacy to patients and the public

Additional information:
- the committee membership roster and additional information is available here
- background and educational materials on the HIPAA privacy regulations and what they mean for health care researchers
- an Annals of Internal Medicine piece from last year noting some of the main concerns of clinical researchers related to the rule (PDF file)
- a quick PubMed search focusing on discussions of the rule's impact on research (informed consent, participation/recruitment, research collaboration networks, etc.)