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:

1. 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 
2. 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
3. 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
4. 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
5. 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
6. consider the needs for privacy of identifiable personal health information and the value of such privacy to patients and the public

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.