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 administrative purposes was appointed an interim government employee during the project. The project was supported by the Office of the Assistant Secretary for Planning and Evaluation.
The purposes of the study were to:
- Identify privacy issues surrounding research on personally identifiable health data, paying special attention to the international aspects.
- Review the ethical, legal, and general social context surrounding the privacy and confidentiality of health data.
- Describe relevant privacy-protection practices and problems, and identify emerging issues.
- Review the European situation, especially for American readers; and review the U.S. situation, especially for European readers.
- Analyze, especially, the implications for the U.S. of the new European Union Data Privacy Directive and related policy and legal changes.
- Recommend policy approaches and technical processes for ensuring that, as research proceeds to enhance the health of the public in general, the privacy of individuals is respected.
The author interviewed several hundred leaders in the U.S. and Europe, in government, academic, and private-sector research institutions; in government regulatory and public-health agencies; and in intergovernmental organizations. He also met with patient advocates, public policy experts, legal analysts, privacy advocates, and privacy commissioners. And he reviewed the relevant literature.
Everywhere, the author found deep interest in the issues, and unease about the present situation—concern that the very concept, "privacy," needs recasting; concern that health data are handled with too little respect for the people whose frailties they describe; and concern that research, disease prevention, and health care all will suffer if the current privacy, confidentiality, and security issues are not handled properly.