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
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.
Several important legislative events are focusing attention on the issues.
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
For the U.S., it will be very important over the next few years to engage in high-level, broadly based dialogue with European leaders over the implementation of the E.U. Directive and the Council of Europe Recommendation. Discussions will have to be held with national governments and with intergovernmental organizations. Health care and health res
Versions of an omnibus "Medical Records Confidentiality Act" are being considered by the U.S. Congress, as is a "Genetic Confidentiality and Discrimination Act." Some States are revising their medical-privacy laws covering information on mental health, HIV–AIDS status, or genetics. All of these will have implications for research.
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
In October 1995 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." By October 1998 all fifteen E.U. Member States must bring their national laws into congruence with the Directive. In February 1997 the Council of Europe adopted a "
Personally identifiable health-research data are exchanged internationally every day, by governments, pharmaceutical firms, and others, and this will inevitably increase. Data on Americans are transferred, and American-based institutions do much transferring. Uniform international standards for protecting privacy, confidentiality, and security urg
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.
The Federal Common Rule and other laws and regulations require many protections for human subjects of research. The main social instruments are informed consent of the data- subject, and Institutional Review Board (IRB) supervision. Both of these mechanisms have served society well. But both now need to be renewed.
For many purposes researchers must potentially be able to trace back, even if through intermediaries, to the data-subject. Irreversible anonymization is not necessarily desirable. There are a number of important reasons why retaining personal identifiability—either openly labelled or via key-coding—may be essential:
Contemporary health research is generating a multitude of benefits for humankind, and the future benefits look at least as promising. As the above heading indicates, health research generates new data by observation and experiment, but also—in part because its questions are of such an "applied," practical nature—it often proceeds by analyzing
New approaches are being taken in providing health care, which is posing new research questions and changing the setting with which much research is conducted. Much more research now is being performed on data from private-sector managed-care organizations, for instance. Also, new approaches are being taken in research, such as elaborate compute
This Report examines how society can best pursue two very important goods simultaneously: Protect individuals' privacy; and at the same time, preserve justified research access to personal health data, to gain health benefits for society.
In September 1996 the U.S. Secretary of Health and Human Services, Dr. Donna E. Shalala, requested this study as background for policy decisions that her Department and American society, along with their counterparts in other countries, urgently must confront. The study was conducted by Dr. William W. Lowrance, an external consultant, who for ad