On October 24, 1995, after five years of deliberation, the European Parliament and the Council of the European Union (E.U.) adopted a "Directive on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data" (hereafter, Directive). 80
In contrast to the U.S., most European countries have for some years had in effect broad data- protection laws, based on human rights principles. All focus on personally identifiable data. Most deal with legitimacy of need-to-know; with notification of data-subjects, and consent; with data-subject rights, such as the right to examine data about on
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,
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
One of the most reassuring things a research organization can say with respect to the privacy of the people whose health data it is studying, is: "We don't know the personal identity of our data- subjects; and we really don't want to know." 60 This should not necessarily mean that no-one can trace back to the data-subject if scientific reason
A prime example of innovation is the elaborate work of developing and improving the use of pharmaceuticals, medical devices, diagnostic instruments and tests, vaccines, and other "tools" of health care. 53 After much preliminary screening, an experimental entity or procedure is subjected to a long series of clinical trials , perhaps on tens of
Whether or not they are to be considered "research," a classic category of investigations have to do with coping with disease outbreaks and epidemics, and with other emerging or emergency threats.
All over the world, health and disease are monitored. Starting with prenatal observations and birth data, throughout life health-related measurements and observations accumulate. Analyses are made to portray the "natural history" of diseases and disabilities—how they start, progress in a person or spread to others, and run their courses. Also an
Contemporary health research is generating a multitude of benefits for humankind, and the future benefits look at least as promising. The following sketches can hardly do justice to the myriad complex activities. But they indicate some of the research purposes and approaches, the character of the data, and the privacy-protection problems involved.
Health data are zipped around the world all day every day, by government research agencies, pharmaceutical firms, academic researchers, and many others. Data on Americans are transferred, American institutions do much data-transferring, and data are transferred for important American purposes.
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
Obviously some kinds of data are felt by data-subjects or the public in general to be especially sensitive. A commonly cited example is that HIV–AIDS data are much more sensitive than, say, data about wrist fracture. Whether sensitivity is somehow justified will always be debatable within the context. But for purposes of ethical practices, polic
So many kinds of health data are collected that it would be distracting and soporific to do more here than take note of the major categories. But it is essential to recognize: (a) that great research power resides in a diversity of health data, and (b) that privacy issues surround many kinds of data beyond those in primary medical records. Healt
Although definitions need not be belabored here, a few concepts and items of vocabulary are necessary. Data is taken to mean discrete bits of information. As one dictionary has it: "Data are facts or figures from which conclusions may be inferred." For most research now, data are converted into numerical form for processing by computers. D
Several current changes in the context within which health data are collected and used must be recognized. First, the boundaries between classical medical care and "public health" are becoming ever less distinct. Over the past decades the rubric, "health," has been broadened to include many matters—from hyperactivity in children, to teenagers' n
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.
Privacy has variously been cited as a rationale to cover a great many situations. 23 Here we can just note a few potentially relevant for health research. Among data-subject rights claimed have been:
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