In today’s global economy, a country’s ability to attract domestic and foreign investments is key for fostering economic growth, creating employment opportunities, and boosting competitiveness. One of the main pillars of the Kingdom’s Vision 2030 is a vibrant society and two main strategic objectives of the Health Sector Transformation Program are to facilitate access to and improve quality and efficiency of healthcare services. Accordingly, the Ministry of Health (MOH) — the main healthcare regulatory body in the Kingdom — is keen to ensure investment opportunities are realized within an agile auditing and compliance system.
Compliance plays a crucial role in overseeing the implementation of standards, increasing investor confidence and protection. This article aims to explore the significant contributions made by a regulatory agency compliance function in attracting investments and fostering economic growth, which includes guiding new market entries in adapting to the Kingdom’s healthcare regulations, helping protect investors from potential legal liability, and ensuring that market participants uphold ethical and professional standards.
Guide new market entries to adapt to the Kingdom’s healthcare regulations
The MOH uses an agile approach to regulating new services and ensuring that all new market entries are fully educated on the regulations and supported through the transition period. Upon identification of new service opportunities, the compliance function will assess existing regulations and identify any potential gaps in coverage. Compliance will propose legal tools to close the gaps utilizing the results of an extensive review of global best practices. Compliance then provides new entries to the market with the regulations and provides the training and tools to help new entries comply with the standards and time to adapt to new conditions. Our methodologies and guidance generally allow for new entries to take up to 90 days to adhere to regulations.
Protect investors from potential legal liability
The compliance function provides clear and fit-for-purpose self-assessment tools and training that ensure investors are knowledgeable on the healthcare regulatory requirements needed to operate within the sector. Self-assessment audit tools that cover hospitals, medical complexes, and different healthcare service standards are requested annually from providers to increase awareness and knowledge of regulations. The compliance function will then audit the assessment and provide corrective actions, where necessary.
MOH Inspection teams conduct approximately 50,000 routine audits per year, track the percentage of corrective actions implemented, and use these statistics to enhance our tools, methodologies, and communication strategies with practitioners.
Ensure that market participants uphold ethical and professional standards
The compliance function conducts routine inspections and gives corrective actions to help providers stay compliant with regulatory standards. Two types of inspections are usually carried out regularly. An annual inspection where inspectors will assess the providers’ compliance with all regulations and a second more focused inspection where inspectors will conduct visits to assess a specific service and the provider’s compliance with that specific service.
Additionally, inspectors will conduct a hybrid model of on-the-ground and digital tele-inspections of high-risk services with expert clinicians to assess compliance with clinical protocols and improve upon the quality of service.
Compliance also helps providers fulfill their obligation to ensure that they are overseeing the effective implementation of regulatory requirements in their organizations. There are different mechanisms used to enable organizations to do so — one such method is disseminating guidelines for implementing and overseeing a compliance program such as guidelines for developing a compliance risk register, hiring or appointing a compliance officer, and establishing a committee to review annual compliance plans. Ensuring an open channel of communication and continuous feedback between providers and regulators will ultimately improve investor climate and willingness to invest in the healthcare market.
In conclusion, compliance provides all investors in healthcare with a clear, practical, and fair framework for operation that helps uphold the highest standards and flexibility that is fit for purpose in the Kingdom of Saudi Arabia. The role of compliance and oversight cannot be overstated in facilitating investment opportunities within the Kingdom; by implementing and enforcing regulatory frameworks that foster investor confidence and protection, compliance units provide the necessary stability and security to attract investments.
Consequently, a thriving investment climate contributes to economic growth, job creation, and overall development of the health sector through fair and healthy competition.
Dr. Khaled Albassam is the Assistant Deputy Minister for Compliance at the Ministry of Health in Saudi Arabia. He is part of the panel discussion, “Development Opportunities for Investors in Radiology and Medical Imaging in the Kingdom”, under the Future of Radiology conference at the Global Health Exhibition on October 29.
