NRPM: Standards for Privacy of Individually Identifiable Health Information. a. Importance of research and the need for protected health information.


Much important and sometimes lifesaving knowledge has come from studies that used individually identifiable health information, including biomedical and behavioral research, epidemiological studies, health services research, and statistical activities. This type of research has lead to dramatic improvements in the nation’s health. For example, the results of such research include the association of a reduction in the risk of heart disease with dietary and exercise habits, the association between the use of diethylstilbestrol (DES) by pregnant women and vaginal cancer in their daughters, and the value of beta-blocker therapy in reducing re-hospitalizations and in improving survival among elderly survivors of acute myocardial infarction.

Likewise, research on behavioral, social, and economic factors that affect health, and the effect of health on other aspects of life may require individually identifiable health information. Studies of this kind can yield important information about treatment outcomes and patterns of care, disease surveillance and trends, health care costs, risk factors for disease, functional ability, and service utilization – which may ultimately lead to improvements in the quality of patient care, the identification and eradication of public health threats, and the development of new devices and pharmaceutical products. For example, such research uncovered the fact that disease screening and treatment patterns vary with the race of the person, which in turn has lead to focused outreach programs to improve health. Such research showed that the results of certain highly invasive surgical treatments are better when the care is provided in hospitals that performed a high volume of these procedures.

It is not always possible for researchers to obtain the consent of every subject that a researcher may wish to include within a study. Thousands of records may be involved. Tracking down the subjects may entail costs that make the research impracticable. The requirement to obtain consent also may lead to biased study results, because those who refuse consent may be more or less likely than average to have a particular health problem or condition. This may be a particular concern where the research topic involves sensitive or potentially embarrassing information. At the same time, the privilege of using individually identifiable health information for research purposes without individual authorization requires that the information be used and disclosed under strict conditions that safeguard individuals’ confidentiality.