ABSTRACT

Regulation is often narrowly understood as meaning the enforcement of administrative rules. Policy makers in the early twenty-first century have been galvanized into regulatory action by deaths from medical error, rising numbers of adverse event reports, and by influential patient safety overviews including from the United States and the United Kingdom. The restoration of public trust is cited by governments around the world as a key rationale for strengthening the regulation of health care. Patients want to feel confident that they can trust doctors and nurses and want to be assured that any problems that might occur will be fixed. An analysis of health care regulation requires a broad view of regulation and an appreciation of the potential range of policy instruments. John Braithwaite and others proposed responsive regulation as a new paradigm to transcend the regulation-deregulation dichotomy and to achieve win-win and just solutions through innovations in regulatory design.