Trust and transparency in the regulation of patient safety

Judith HealyRegulatory Institutions Network

Australian National UniversityGovNet Health Governance Conference

Brisbane, 10-11 December 2007

This talk

• Responsive regulation ideas

• Constellation of regulatory actors - networked governance

• Regulatory principles: trust and transparency

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.

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

Regulatory pyramid

Market mechanisms

Self-regulation

Meta-regulation

Command and control

Voluntarism

RegNet researchers: John Braithwaite, Neil Gunningham, Peter Grabosky

Co-regulation

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

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 -)

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)

Government

Professions

Community

Market

Institutional constellation of regulatory actors

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

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

Greater transparency

• Hospital performance indicators

• Hospital accreditation reports

• Adverse events public reporting

• Medical register – practitioner profile

• Confidential quality assurance (qualified privilege) versus open disclosure

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