Julie King is the Company Director of Healthcare Regulation UK and an acknowledged expert in her chosen field. Julie is strongly committed to lifelong learning and self-improvement, something that informed her decision in 2018 to undertake a Masters in Law (LL.M) focused on healthcare regulation. 

Despite already holding a Law Degree (LL.B) and Bar Vocational Certificate (BVC), Julie was keen to deepen her understanding of healthcare regulation through advanced academic research. The Masters was a legal practice conversion programme that also enabled Julie to share her immense practical experience as registered nurse, regulator and non-practising barrister. 

In September 2019, Julie received confirmation that she had been awarded a Distinction having secured a mark of 92% for her 12,000 word Dissertation. It was a phenomenal achievement that again demonstrated why she is regarded as an expert in healthcare regulation. Julie graduates in November 2019, thereby adding another qualification to her considerable academic portfolio. 

The Dissertation was titled “Regulation in the Dock: The development of healthcare system regulation in England, its purpose and objectives and whether it is fit for purpose’. Here we share an edited version of Julie’s conclusion in which she puts forward her perspective on the topic… 

“Regulation is experienced in widely different ways and this informs differential perceptions of the discipline.  For ‘assurance’ regulators focused on adherence to explicit standards and rules, regulation is about deterrence tariffs and compliance strategies.  Correspondingly, for ‘improvement’ regulators the approach is driven through engagement and relationship building.  This inevitably shapes the experience of those being regulated, with the former not unsurprisingly viewing regulation as something that is done to them, and the latter as something that is participative. 

Meanwhile, the popular understanding of regulators is that of the archetypal ‘watchdog’, a body with punitive powers of sanction taken in the public interest.  This contrasts with the defensive instincts of some healthcare professionals who view regulation as an imposition, and the opinion of many providers that regulation constitutes a ‘red tape’ burden that merely adds cost and complexity. Furthermore, healthcare system regulation has struggled to disentangle itself from political control and interference, a form of administrative regulatory capture. 

These are competing demands, grievances and perceptions, and it is unrealistic to expect all parties to be satisfied.  However, the author believes that progress could be made through a more balanced and participatory style of regulation in which the various interests have both an investment and accountability for its design and development.  Regulatory neutrality should be the objective, an approach that embraces assurance and improvement hybridisation, but which takes this a step further towards a stakeholder model whereby the respective parties collaborate to arrive at a consensus concerning a common purpose and set of objectives for regulation.  

Such a regulator would still be underpinned by statute, but unlike at present, the regulations governing the healthcare system would not be imposed by the Department of Health (itself a proxy for State control and political capital), but rather developed and agreed by a regulatory council compromised of a representative membership of the constituent stakeholders.  Regulatory policy would be informed by contemporary academic research and practice based learning, and would have a ‘real time’ flexibility that can respond to changing circumstances. 

The devil would inevitably be in the detail, but it offers a more radical reimagining for regulation than a continuance of the State sponsored non-departmental arms length body which ironically only appears to unite uncommon interests in common dissatisfaction. 

Evidence also suggests that whereas quality ratings for social care providers have consumerist impact, this is not so for the NHS. Other than elective surgery or private healthcare, NHS patients have little choice in how their healthcare is provided (unlike social care).  Consequently, a conversation is required concerning the cost benefit of resource intensive NHS inspections in which a quality rating is the end product.  This is not to dismiss the value of inspections, but rather that their objectives are realigned to address safety and improvement.  There is also an opportunity to merge the hospitals focused inspection functions of CQC with the work of NHSI.  This would co-locate assurance and improvement approaches and promote hybridisation.  Whilst health and care service integration represents the direction of travel, there is a case for regulating the sectors differentially. 

If regulators are to place improvement on an equal footing with assurance, then leadership and sustainability will have to be addressed.  As a regulatory practitioner, the author is well versed in NHS providers who ratchet up investment in compliance in order to simply navigate the inspection process, but subsequently slip back into mediocrity.  Tackling this requires strong internal leadership and recognition that regulation is an ongoing and central facet of healthcare.  A hybridised approach in which leadership and sustainability are assessed domains would focus regulatory energy towards areas with the potential for promoting maximum gains across the healthcare system. 

An additional consideration is the need for CQC to invest in its resources to ensure it has the capacity, capability and competence to regulate emerging new models of care.  There is also a pressing need to introduce ‘contextual regulation’ whereby the performance is not only assessed against an agreed set of healthcare regulations, but that the outcome is then calibrated with regard to external factors that bear down on performance (e.g. patient demand volumes, staffing levels, funding etc.).  To regulate in a theoretical vacuum without regard to government policy, healthcare system economics and social demographics that impede provider performance is to ignore the obvious. 

Despite a shift towards specialism following Mid-Staffs, CQC remains essentially a generic regulator.  Hospitals are complex entities, and as such, inspectors require skills and abilities that can promote confidence in the regulatory process.  This is not only about clinical knowledge and familiarity with the medical profession, but also the ability to interrogate corporate governance and risk management arrangements.  Furthermore, the balance between data driven inspection frequencies and ground-based knowledge requires recalibration.  Whilst fiscal controls will inevitably inform the size of the regulatory workforce, the deterrence aspect of regulation requires visibility. 

Additionally, rather than construct a narrow regulator that meets prescribed financial modelling, it would be better to design a regulator that addresses the identified challenges, and then finesse that model to the fiscal imperatives.  Finally, there is the uncertainty of Brexit, which has derailed domestic policy and sidelined healthcare reform.  An extended withdrawal from the EU is likely to exacerbate the NHS staffing crisis and impact regulatory performance. 

In answering the central question as to whether healthcare system regulation is ‘fit for purpose’, the author has come to a view informed by both professional practice and the findings of this research.  Having carefully reflected upon the body of evidence, it is ventured that the purpose of regulation as defined by Selznick remains a useful benchmark by which to evaluate notions of ‘fitness’.  From this perspective it can be argued that regulation as currently configured indeed fulfils its conceptual purpose. 

However, where its specific objectives are concerned, both contemporary theoretical debate and the author’s practical experience suggest that the existing regulatory model lacks fitness.  This is partly to do with external factors over which CQC has no control (governmental policy, economics and demographics) and secondly because persistent political and media scrutiny has resulted in an organisation defensively focused on performance matters rather than regulatory innovation and system-focused improvement. 

Furthermore, public interest investment in the NHS means that the regulator’s strategies are significantly affected by reputational concerns and political activism.  Indeed, at the time of completing this research a further abuse scandal concerning an independent healthcare provider has once again questioned the efficacy of regulatory methodology and the approach of CQC specifically.  The regulator has since instituted an independent review to investigate allegations of failings on its part in an attempt to proactively limit the potential damage. 

Consequently, it can be said that whilst the purpose of regulation is relatively unchanging in its fundamental nature and characteristics, what it seeks to achieve is wholly sensitive to context and circumstances.  It is a constantly moving feast in which regulatory principles are prey to expediency and necessity.  Our present model of healthcare system regulation is informed by legislation and regulations shaped by the considerations of more than a decade ago.  To be fit for the future, an agenda for fundamental reform is now a pressing requirement.”