1. Introduction : why regulate? 2. How safe is health care? 3. Regulatory actors : who governs health care? 4. Regulating the health professions 5. Safety cultures and safety systems 6. Regulating staff : internal management 7. Regulating organizations : external reviews 8. Regulation by enforcement : laws, money, and monitoring 9. Regulation by patients 10. Responsive regulation : trust and transparency.