2. Trust and transparency in the regulation of patient safety Judith Healy Regulatory Institutions Network Australian National University GovNet Health Governance Conference Brisbane, 10-11 December 2007

3. This talk Responsive regulation ideas Constellation of regulatory actors - networked governance Regulatory principles: trust and transparency

4. A broad definition of regulation 1.Governance: influencing flow of events OR 2. State as regulator OR 3. Compliance with rules and regulations. Responsive regulation –governance ranging upwards from soft to hard strategies in a regulatory pyramid. Braithwaite, Healy & Dwan (2005) The governance of health safety and quality Commonwealth of Australia, Canberra.

5. Responsive regulation: pyramids of sanctions and supports Pyramid of supports Pyramid of sanctions John Braithwaite et al (2007) Regulating Aged Care, Edward Elgar Softer regulation Harder regulation

6. Regulatory pyramid Market mechanisms Self-regulation Meta-regulation Command and control Voluntarism RegNet researchers: John Braithwaite, Neil Gunningham, Peter Grabosky Co-regulation

7. Regulatory strategies and mechanisms Examples of mechanisms Criminal or civil penalty License suspension Doctor re-registration External clinical audit Mandated adverse event reporting Funding agreements Clinical governance Hospital accreditation Performance targets Peer review Consumer complaints Performance payments Public reporting Clinical protocols Personal monitoring Continuing education Market Self-regulation Meta-regulation Command and control Voluntarism Co-regulation

8. Eras in safety and quality governance Voluntarism and professional self- regulation (19 th onwards) Information strategies (1970s -) Financial strategies (1980s -) Leadership and cultural change (1990s -) Co-regulation & meta-regulation (2000s -)

9. Institutional constellations “We conceive [institutional constellations] as entire sets of formal institutions and interconnected rules that shape public decision-making in a given regulatory arenas, including shared interpretative structures, affecting the patterns of interaction by decision- makers within that sector” (Jordana & Sancho 2004: 298)

10. Government Professions Community Market Institutional constellation of regulatory actors

11. Regulatory principles An abstract prescription that guides action Usually a high degree of generality Serve to mobilise others Europe stresses quality, Anglophone countries stress patient safety Trust and transparency are key regulatory themes internationally

12. Restoring public trust Patient-centred professionalism More accountability: move from self-regulation to co-regulation and meta-regulation Professional registration boards with external members, separation of powers, re-registration Hospital accreditation: voluntary to mandatory standards Adverse events reporting systems Health departments held accountable Performance agreements/contracts

14. Greater transparency Hospital performance indicators Hospital accreditation reports Adverse events public reporting Medical register – practitioner profile Confidential quality assurance (qualified privilege) versus open disclosure

15. In summary Safety and quality problems in patient care requires more regulatory attention from the state There is no single regulatory actor – requires networked governance Relevance of ‘responsive regulation’ to the health sector – being responsive to context, culture and conduct Stronger external regulation involves co-regulation and meta-regulation to monitor that quality systems are in place Principles of trust and transparency trump professional autonomy