BOX 1-2

Selected Milestones in U.S. Efforts to Identify Effective Health Care Services


The U.S. Food and Drug Administration (FDA) is given authority to regulate the premarket review of new drugs for safety by the Federal Food, Drug, and Cosmetic Act (1938).


Technology assessment arises on the basis of the recognition that modern technology may have unintended, harmful consequences.

The Kefauver-Harris Drug Amendments expand the FDA’s responsibilities to include evaluations of safety and effectiveness. Effectiveness must be proved by “substantial evidence” (1962).


Congress gives the FDA significant authority through the Medical Device Amendments to regulate the testing and marketing of medical devices to ensure their safety and efficacy (1976).

ECRI (now the ECRI Institute) publishes its first monthly publication dedicated to assessing medical technologies (1971).

Congress establishes the U.S. Office of Technology Assessment (OTA) (P.L. 92-484) to perform objective analyses of technologies, including health care services, to aid policy making (1972). (Congress eliminated funding for OTA in 1995.)

Wennberg and colleagues document wide variations in physician practices, making evident that the style of U.S. health care practice is likewise variable (1973).

Congress establishes the National Center for Health Care Technology (P.L. 95-623) in 1978 to conduct medical technology assessments related to Medicare coverage decisions. (The program was dissolved in 1981 after Congress cut its funding.)


RAND Corporation researchers document that large proportions of the procedures that physicians perform are inappropriate, as judged by evidence-based decision criteria.

The American College of Physicians initiates the Clinical Efficacy Assessment Project and begins publishing clinical guidelines (1981).

The Veterans Administration institutes a Technology Assessment Committee to make recommendations on priority technologies for assessment and appropriate methods for technology assessment (1984).

The Blue Cross and Blue Shield Association (BCBSA) establishes the Technology Evaluation Center to assess medical technologies through comprehensive reviews of clinical evidence (1985).

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