The Healthcare Regulatory Ecosystem

Healthcare is a complex adaptive system, with considerable fragmentation between healthcare institutions and medical specialisations. The regulation of safety in healthcare involves both formal (legislation, accreditation procedures, policies, procedures) and informal (professional standards, ethical principles, accepted modes of care) components. These instruments are complemented by self-regulation by clinicians and by patients who invest in understanding their ailments and selecting desired treatment modes. In recent years, the Safety-II approach is increasingly recognised as an important regulatory paradigm.