Response of the Department of Health and Human Services to NBAC's Report 'Research Involving Human Biological Materials: Ethical Issues and Policy Guidance'. Recommendations Regarding the Use of Medical Records in Research on Human Biological Materials


Recommendation 23. Because many of the same issues arise in the context of research on both medical records and human biological materials, when drafting medical records privacy laws, state and federal legislation should seek to harmonize rules governing both types of research. Such legislation, while seeking to protect patient confidentiality and autonomy, should also ensure that appropriate access for legitimate research purposes is maintained.


The Working Group agrees with Recommendation 23. While there is significant similarity and overlap between research involving human biological materials and research involving medical records, there are also important differences between these two types of research. Analysis is necessary to determine how best to harmonize laws and regulations governing both types of research in order to ensure adequate and equal protection in a fair and practical manner. Although this recommendation is addressed to Congress and to state legislatures, DHHS is actively involved in efforts to improve health records privacy and can serve as a resource to those at the state level who will be drafting such health privacy laws and regulations.

Proposed Action

No DHHS action is required.

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