Controlling Risk

By - World Healthcare Journal
Controlling Risk

Balancing competing tensions in creating the most effective regulatory framework

There are many different systems in place to regulate the delivery of healthcare services across the globe. In the largest economies, these are invariably complex and can involve a regulatory maze of statutory oversight, licensing, professional standards and structures intended to provide a clear and consistent framework for the delivery of safe quality care.

Most jurisdictions agree that robust regulation of health and care provision, both in terms of provider entities and the healthcare professionals they engage, is essential to protect patients and maintain confidence in the profession. Policy debates on health, therefore, are centred largely not on whether regulatory oversight should exist, but instead on the way it should be best structured.

Most models aim for a balanced and reasonable level of control that aims to avoid any lack of oversight that could put patients at risk, while at the same time discouraging over-regulation or heavy-handed bureaucracy that might risk stifling innovation and/or create regulatory burdens which result in more time being spent on compliance to the detriment of providing safe and high quality healthcare itself.

Middle East healthcare

There has been a marked increase in the past year in new regulation governing healthcare and life sciences in the region. Alongside the relevant primary legislation sits a vast amount of regulatory codes of practice, guidance, and procedural documents to support the ever-increasing range of activities that need to be formally licensed and approved by the regulators.

“The many models of health regulation around the world are constantly under review because of political, social, economic and technological change”

As the pressure increases on Middle Eastern countries’ governments to control and reduce public spending on healthcare services, there are opportunities for the private sector to invest on a bigger scale. To facilitate that, governments are aiming to provide a stable environment to attract investment, as well as a solid regulatory framework that will govern health facilities and practitioners.

The region, therefore, has the benefit of time and precedent to establish, refine and embed an effective regulatory framework that balances the competing tensions between fostering innovation, having the right level of oversight with limited bureaucracy and ensuring safe and high-quality patient care.

Emerging regulatory risks

In introducing or revising structures for national health regulation, a number of challenges and issues exist:

Complexity and Clarity –  In some jurisdictions, over-regulation and competing interests of multiple agencies can create inertia, silo working, and regulatory gaps. Clear regulatory structures are therefore essential, not only in terms of efficiency but also promoting safety and quality.

The Changing Landscape of Provision – Perhaps the greatest challenge to regulation is the increasing ability of technology to enable new platforms to deliver care via new models, and frequently on a remote and cross-border basis including remote care – patients are gradually moving from being passive recipients of healthcare to active, button-pressing consumers, who research their symptoms, treatment options, risks and benefits – and remote dispensing from internet or international sites.

Expertise – Even within traditional models of care, technology is changing the way it is delivered and it is essential that regulators have the knowledge and skills to properly understand and evaluate services.

Streamlined Data Collection - Inspections of health services are a mainstay of regulatory performance, but factors affecting quality can also be assessed from data. However, multiple definitions and metrics of care quality are often used by different agencies, leading to inconsistencies and inefficiencies for providers in meeting information requests. There is a need to reduce the burden on providers with more streamlined systems that, for example, make use of shared datasets that address the needs of all stakeholders.

Qualitative Data Analysis - Technology has made it easier for people to leave instant feedback about services, and new tools to analyse data are constantly evolving. Regulators need to embrace how best to use this data to inform their own risk-based monitoring of services.

System Regulation – Many countries are aiming to break down boundaries between hospital care, primary care, community and other social care to provide more person and place-based services that are increasingly seamless. The challenge for regulators is to properly combine the task of carrying out system-wide reviews whilst ensuring the accountability of the individual players.

Staff Engagement – Over-regulation can discourage engagement of healthcare professionals. Regulators and providers need to work together towards a shared vision of high-quality care, encouraging their staff to innovate and engage in open, improvement-focused discussions.

Informing Choice – With a wide range of services available, regulation can better inform choice. But reports need to be current, intelligible and user-friendly for the patient to properly inform.

Alignment – With increased medical tourism and more global centres of expertise, regulators need to be able to work jointly on a cross-jurisdictional basis, sharing best practice and having a consistent approach to issues and emergencies.


The many models of health regulation around the world are constantly under review because of political, social, economic and technological change. Achieving better and more responsive healthcare professional regulation, therefore, will always be ‘work in progress. '

One size or structure doesn’t fit all, and each regulatory model will need to be moulded and legislated for according to national needs and demands. However, all governments will want to ensure sustainable, efficient and effective health service delivery that meets the public’s best interests, whilst protecting patients from harm.

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