ABSTRACT
Clinical guidelines can enter the legal arena by two routes. Legislators may use them to assist in the regulation of clinical activities, and the courts may use them in resolution of civil disputes alleging medical negligence. This chapter considers how clinical codes and guidelines interact with legislation (statute law). In Europe and the USA statute law has played an important part in these developments. In the UK, greater reliance upon professional self-regulatory mechanisms has meant that there is still a relative paucity of statute in this area, although the situation is now beginning to change. Statute backed clinical guideline formulation and implementation has probably reached a higher degree of development and sophistication in the USA than in Europe. The range of US legislation in this area is indicated by three separate initiatives. The three separate initiatives are peer review organizations, agency for health care policy and research, and the maine 5-year medical demonstration project.
