Regulation of the health care industry and development of drugs, biologies and devices has developed, in part, to ensure public safety. There are numerous forces that promote regulatory efforts and those that work against formal regulatory measures. This presentation provides an overview of the following:
What is risk? What is risk assessment? What drives regulatory activity to ensure public safety? What are the issue areas surrounding cost benefit analysis? How is technology helpful in assessing and managing risks? How does health care reform drive new technologies which, in turn, must be assessed for risk and cost/benefit? A force field analysis model of factors contributing to regulatory activities and those that work against the promulgation of regulations is offered.