By Dominique Walcot, Consultant and Dan Donaghy, Director, Deloitte Consulting

Over the past few years, health regulators have been increasingly looking to use emerging technologies and new business models to reduce the burden of compliance and drive better efficiencies and regulatory outcomes. Recent changes to health legislation had been driving reform, and these changes were rapidly accelerated by the COVID-19 pandemic. Overnight, health regulators were unable to complete traditional face-to-face inspections or registration checks and had to rapidly evolve their models; deploying remote technologies and new ways of working to ensure key activities could be completed to keep patients and staff as safe as possible. For some regulators, this even meant moving into new areas of operations – such as vaccination monitoring. This blog discusses changes to the UK health regulatory system, growing trends in safety and quality regulation, and lessons learnt from the COVID-19 pandemic.

Why is regulation important?

The UK regulatory system (as a whole) is a national asset. The World Bank ranks the UK 8th among 190 economies for the ease of doing business in relation to regulatory performance; and the Organisation for Economic Cooperation and Development (OECD) gives the quality of our regulatory practices the highest overall country score.^1,2 Done right, regulation provides a wealth of benefits to society, from consumer protection and risk reduction, to stimulating trade through innovation and acting as a lever for government to achieve policy outcomes. When regulation doesn’t function effectively, we see seismic impacts – be that the financial crash of 2008, or the role of social media in elections. Given the velocity of new technologies and innovative developments, regulation is being driven to become increasingly agile, innovative, supportive, customer – centric, and digitally savvy.

Challenges facing health regulation today

The impact of the COVID-19 pandemic has forced regulators to change the way they monitor the healthcare industry. Face-to-face inspections and registration checks could no longer be completed in-person due to COVID-19 restrictions. This meant health regulators were under extraordinary time pressure to re-develop their model. This focused on inspecting and responding to whistleblowing and ‘at-risk’ providers, while trusting normally well-performing providers to continue to comply as usual with a lighter touch, more data informed, regime. However, even before COVID-19, risk-weighted and insight driven techniques were beginning to be seen as the future of regulation, with regulators shifting from a one-size-fits-all, timebound inspection driven regime, to a data-driven, segmented approach, prioritising support and oversight in areas of greatest risk. We are also seeing regulators beginning to grapple with becoming ‘improvement agents’ while keeping a watchful eye on the threat of regulatory capture by industry and providers.

These trends tie in with a move to implement recent UK policy initiatives around reducing bureaucracy in healthcare regulation. When talking to healthcare providers, a common issue we found was the amount of time spent preparing for inspections - time that could be spent providing care, managing risk, or developing innovative new ideas. Moreover, a Department of Health and Social Care report published in November 2020 identified six key issues with current healthcare regulation in the UK:³

• duplicative data requests
• overly complex regulation
• lengthy appraisals and repetitive mandatory training
• time consuming staff processes and information management
• out-of-date and overly prescriptive legislation
• time consuming procurement processes.

Based on these findings, the Department has suggested a number of changes that need to be made to healthcare regulation, including the increased use of ‘proportionate regulation’. The UK government are also currently carrying out a consultation⁴ to gain views on their proposals to reform the regulation of healthcare professionals with the same policy objectives in mind – releasing red tape, proportionate regulation and efficiency. We’ve have also recently seen the consultation and launch of a new organisational strategy for the Care Quality Commission.⁵

Lessons learnt, and the future of health regulation

With a rapidly changing health industry and against the backdrop of COVID-19, healthcare regulators need to be in front of the curve to do their jobs effectively. Although a strong understanding of the healthcare industry is paramount to the effectiveness of any healthcare regulator, we are beginning to see how innovations and changes across other industries, such as life sciences, are easily applicable to healthcare and can help regulators respond more effectively to a changing environment.⁶

Figure 1. How technology-based tools drive the economy, efficiency and effectiveness of regulatory operations

Increasingly, emerging technology is being incorporated into the ‘regulator’s new toolkit’ (figure 1)⁷. From conversations across the Global Deloitte network, we have seen the use of robotics and AI driven smart cameras, the combining of data and behavioural science to ‘nudge’ compliance, and the use of augmented reality in training along with exciting technological leaps in virtual inspections. We have also seen a shift to human centred design of services and a greater emphasis on culture and future skillsets needed to regulate in an era of shifting expectations from both citizens and authorising environments – particularly consumer / patient / user protection and the enablement of the “demand side” voice.

These are all trends that could be replicated in the UK, in healthcare regulation, and which could improve the efficiency of regulators while reducing the burden on those they regulate. For example, could smart cameras be used to aid inspections or detect abuse? Or big data be used to support proportionate regulation? Of course, with a changing toolkit, the skills and talent required by regulators is also changing. Increasingly, skills such as coding, behavioural science, and data management, analysis and visualisation are needed. Regulators are having to rethink their job specifications, where they attract talent from, and understand the competitive environment for that talent like never before. This in turn is driving new models of organisation and structuring of work as regulators experiment with contingent workforces, associate models, partner ecosystems and the sharing of scare human skills and capability.

Case study: creating an insight driven healthcare regulator

Recently, we worked with a prominent UK Healthcare regulator to develop a new, future-proof and strategy-aligned, operating model. A key part of this work was the development of an ‘Insight Driven Organisation’. This was a shift to align the organisation around the capability to collect, assimilate and analyse large amounts of data on a real-time basis, and use this to direct and prioritise regulatory activity (figure 2).

Figure 2. Analytics Maturity Curve - What does an Insight Driven Organisation look like?

The organisation wants to be able to use this to support real-time assessments of healthcare providers, risk-weighted regulation, and the review and incorporation of insights from across the industry – not just their own data but utilising cross government insight and, vitally, citizen reported outcomes in the future. The key aim is to reduce the burden and stress on regulated entities to free-up time for them to focus more on the things that matter, such as patient care, along with more targeted and joined-up regulation on-the-ground which looks at risk first instead of compliance. This is a journey that will take time but is shaped by the need for proportionality, the management of scare regulatory and provider resources and a want to target intervention, and importantly, support where it is most needed.

Conclusion

The world of regulation is rapidly changing – in terms of what we regulate, from wearable tech and social care apps now, to genomic technology and overseeing Net Zero in the near future, and also how we regulate, from using big data and analytics to being able to use predictive cognition to stop incidents before they happen. Significant innovation is required for regulators to keep up with this momentum, and to foster and encourage innovation in their regulated providers/ professionals. From our work, we are seeing regulators from a number of industries using emerging technologies and new techniques and methods to do this, whilst increasing their own efficiency and reducing the burden on those they regulate. To succeed in today’s environment, healthcare regulators must draw down from what is being seen in other industries, and from the host of exciting and innovative technologies, regulatory methodologies and tools at their fingertips. The data and technology revolution has created the optimum environment for regulators to experiment and push the boundaries of what they can do to develop ground-breaking new methods for keeping people safe.

Dan Donaghy - Director, Deloitte Consulting

Dan started his career with Deloitte in 2005 before moving to the General Medical Council, to implement a Target Operating Model for a new remote-working, regional service they were launching to work directly with doctors in healthcare environments in England. Dan subsequently worked directly with the GMC COO to lead and drive large-scale internal cost and delivery transformation programmes in addition to operational responsibility for business planning; regulatory reporting and performance assessment; and overseeing the corporate complaints environment including the delivery of ISO10002 accreditation. Dan re-joined Deloitte in March 2019 and has since led a number of pieces to develop Target Operating Models for UK Healthcare Regulators.

Email | LinkedIn

Dominique Walcot - Consultant, Deloitte Consulting

Dominique joined Deloitte in 2018 as a graduate in the financial advisory business, with a focus on health economics restructuring and transaction services. In 2019 she moved to the health enterprise consulting business, with a focus on supply chain and network operations. Since joining the firm, she has worked with a number of healthcare providers, from Trusts to Integrated Care Systems and government bodies. She has experience of supporting the development of a Target Operating Model for a major UK healthcare regulator, and during that time helped write a report looking at international trends in regulation.

Email | LinkedIn

_______________________________________________________________________

¹ Doing Business in 2020, Comparing Business Regulation in 190 Economies, World Bank Group, 2020.
² https://www.oecd.org/unitedkingdom/
³ ‘Busting bureaucracy: empowering frontline staff by reducing excess bureaucracy in the health and care system in England’, November 2020.
⁴ ‘Regulating healthcare professionals, protecting the public’, March 2021.
⁵ https://www.cqc.org.uk/about-us/our-strategy-plans/new-strategy-changing-world-health-social-care-cqcs-strategy-2021
⁶ A bold future for life sciences regulation, Predictions 2025, Deloitte UK, November 2018.
⁷ Ibid.