The legal framework for health care quality assurance in Germany.

Like most industrialized countries, Germany's health care system is facing two major challenges. The first is to find a sustainable financing system for increasing health care expenditures. The second is to ensure - and improve - the quality of care provided. This article describes the status quo in quality assurance in Germany and analyses the changes introduced into the SHI (Statutory Health Insurance) system with the Modernization Act of 2004. First, a theoretical framework for quality assurance that is consistent with the logic of the German social market economy is outlined. The analysis then describes new actors and their duties in the field of quality assurance, highlighting improvements in regulation and the regulatory instruments applied. Although the strategy for quality assurance is still dominated by regulation and corporatist bodies, the latest reform acts of 2004 and 2007 focus on more and better information about the quality of services provided - an important prerequisite for more competitive elements in the German health care system.