In some cases, achieving our strategic goals and objectives may be impeded by factors that are beyond the control of the Department of Health and Human Services (HHS). For example, national or local economic conditions can influence whether we are successful in helping families on welfare become economically independent. In some cases, there may b
Many programs within the Department have goals, objectives, and target populations that appear similar. Likewise, many Department programs appear to duplicate or overlap programs in other Federal agencies. Many state, local, and private sector programs also have goals, objectives, and target populations in common with Department programs. Because
External ethical oversight provides additional protection for research subjects. Prime examples in the U.S. are the Institutional Review Boards (IRBs) that supervise human-subjects research conducted under Federal jurisdiction, which is very broad. IRBs are carefully constituted boards that conduct independent oversight of research. 73
A universally endorsed ethical precept is that it is permissible to collect and use personally identifiable data, if the data-subject agrees to the conditions of data protection and use. The ideal is prior, informed, freely granted, specific consent . Researchers strive for this to varying degrees, and achieve it to varying degrees. 68,
Much very useful health research is performed on completely anonymized data. If for a particular research project there are no compelling reasons for retaining at least potential identifiability, anonymized data should be used. Though this injunction might sound unnecessary, it is stated here because often, data with identifiers are used just beca
From a privacy-protection perspective, there is a very wide distinction between personally identifiable data and truly anonymized data . But in practice the demarcation between these extremes is not sharp. Attending assiduously to where particular data lie on the spectrum between them, and especially to data that are somewhere in the middle, i
Research on healthcare markets has to be noted here because often such market research now is being performed by, or for, units of organizations that have access to personal data collected for clinical research or disease management.
Among the most important resources for research are databases and registries of health experience. Some are highly specialized but not very large; some are broad and enormous. Some are maintained only for research; some are primarily maintained for administrative or other purposes but are available for research. They may be organized by illness (l
This study takes it as given that because members of society benefit greatly from health research, research— if it is for justifiable purposes, and is conducted with proper protection of subjects —must continue to be allowed controlled access to individuals' health data.
Wrongful disclosure of confidential health data may occur either through carelessness— through gossip in a clinic, for instance, or lazy discarding of clinical records—or through deliberate transgression, either by someone associated with the data-holder or by an outsider.
The ethos surrounding research on humans was recast and codified after World War II, as the world coped with the revelation of the medical atrocities perpetrated by the Nazis. The resulting "Nuremberg Code"—the opening sentence of which was, "The voluntary consent of the human subject is absolutely essential"—established principles having to d
An inevitable logical starting-point is the hallowed medical privacy tradition dating back at least as far as Hippocrates—but one doesn't have to be cynical to surmise that even Dr. H's own receptionist may have gossiped about patients' foibles and maladies.... The precept of nondisclosure is an ideal. But it has been, and should still be, centr
Privacy is a deeply felt but elusive concept. Everyone is sensitive to having his privacy violated. The concepts of "personal matters" and "intimate knowledge" are familiar, as is the notion that individuals live in a "private sphere" over which they are to be granted autonomy. The right to private life was proclaimed in the Universal Declaration
The public are rightly concerned about the erosion of privacy of information about health, for at least the following reasons taken together.
At issue right now—as health care is rapidly becoming industrialized, collectivized, and computerized—is to what extent society will preserve the cherished tradition of patient–healthcare provider confidentiality with its many implications, and the related relationships of trust with those who perform health research. Also at issue is whet
A new "Health Insurance Portability and Accountability Act," which became law in August 1996, established several provisions relating to confidentiality of medical records as they are handled in health insurance, billing and payment data, and the like. How these are worked out will have implications for how data are accessed and processed in healt
The Report identifies many problem areas. The following are four large groups of issues that, while not entirely new, are growing rapidly in scale and complexity, and must urgently be attended to: Secondary uses of data, and data linking Research on private-sector health data Cybersecurity Genetic privacy. Issue cluster: Secondary res
The following principles are recommended for organizations that conduct, sponsor, or regulate health research involving personally identifiable data. They can be transposed into professional guidelines, standard operating principles, regulations, or laws. Criteria and procedures should be established that are specific to the context.
From a privacy-protection perspective, there is a very wide distinction between personally identifiable data and truly anonymized data . But in practice the demarcation between these extremes is not sharp. Attending assiduously to where particular data lie on the spectrum between them, and especially to data that are somewhere in the middle,