Enhancing Sound Regulation and Strengthening Transparency Final Report
Trust and transparency in the regulation of patient safety
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Trust and transparency in the regulation of patient safety
Judith HealyRegulatory Institutions Network
Australian National UniversityGovNet Health Governance Conference
Brisbane, 10-11 December 2007
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This talk
• Responsive regulation ideas
• Constellation of regulatory actors - networked governance
• Regulatory principles: trust and transparency
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A broad definition of regulation
1.Governance: influencing flow of events OR2. State as regulator OR3. 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.
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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
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Regulatory pyramid
Market mechanisms
Self-regulation
Meta-regulation
Command and control
Voluntarism
RegNet researchers: John Braithwaite, Neil Gunningham, Peter Grabosky
Co-regulation
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Regulatory strategies and mechanisms Examples of mechanismsCriminal or civil penaltyLicense suspensionDoctor re-registration
External clinical auditMandated adverse event reporting Funding agreements
Clinical governanceHospital accreditationPerformance targets
Peer review
Consumer complaints Performance paymentsPublic reporting
Clinical protocols Personal monitoringContinuing education
Market
Self-regulation
Meta-regulation
Command and control
Voluntarism
Co-regulation
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Eras in safety and quality governance
• Voluntarism and professional self-regulation (19th onwards)
• Information strategies (1970s -)
• Financial strategies (1980s -)
• Leadership and cultural change (1990s -)
• Co-regulation & meta-regulation (2000s -)
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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)
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Government
Professions
Community
Market
Institutional constellation of regulatory actors
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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
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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
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Greater transparency
• Hospital performance indicators
• Hospital accreditation reports
• Adverse events public reporting
• Medical register – practitioner profile
• Confidential quality assurance (qualified privilege) versus open disclosure
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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