Health Research and the Privacy of Health Information - The HIPAA Privacy Rule

Type: Consensus Study
Topics: Biomedical and Health Research, Health Services, Coverage, and Access, Public Health
Board: Board on Health Sciences Policy

Activity Description

An IOM committee investigated 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 prepared a report.  In conducting the study, the committee:

  1. considered 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 allowed 
  2. considered 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. reviewed 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, identified provisions that merit priority attention and analysis
  4. took 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. examined 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. considered the needs for privacy of identifiable personal health information and the value of such privacy to patients and the public

As data and evidence allowed, the needs and benefits of patient privacy was  balanced against the needs, risks, and benefits of identifiable health information for various kinds of health research.

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