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Healthcare is both a service and an industry. As such it needs to be regulated so that the government’s requirements are properly enforced.

One paper defines patient safety regulation as “the processes engaged in by institutional actors that seek to shape, monitor, control or modify activities within healthcare organizations in order to reduce the risk of patients being harmed during their care.”

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Introduction

Regulation is an important entity in healthcare and healthcare insurance. The role of regulatory bodies is to protect healthcare consumers from health risks, provide a safe working environment for healthcare professionals, and ensure that public health and welfare are served by health programs. Regulation works at all levels, and the regulatory standards are developed by government and private organizations as well.

Regulations are necessary to standardize and supervise healthcare, ensuring that healthcare bodies and facilities comply with public health policies and that they provide safe care to all patients and visitors to the healthcare system.

Regulatory agencies thus monitor individual and corporate healthcare practitioners and facilities; inform the government about changes in the way the healthcare industry operates; ensure higher safety standards; and attempt to improve healthcare quality and follow local, state, cephalexin dosing instructions and federal guidelines.

Functions of a regulator

A regulatory system helps keep track of how well the healthcare system is complying with its contractual obligations and other legal requirements, protecting the public interest. It also lays down the standards for technical operations, safety and quality as required apart from the contracts themselves, and the penalties for non-compliance.

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Cost-effectiveness, performance analyses, tariff evaluations, and regular reviews, as well as setting up mechanisms for settling disputes between parties, are all part of regulation. The regulatory body also advises the government on private-public partnerships in healthcare, helping to shape policies and other related matters.

Statutory vs. non-statutory bodies

Statutory bodies thus publish quality standards, offer accreditation, and offer continuing education and training for healthcare professionals. Regulatory bodies of this sort may regulate services or professionals.

In contrast to such governmental oversight, accreditation agencies offer another level of oversight which is voluntary but offers quality certification and rankings, incentivizing efforts to improve the quality of healthcare and promoting best practices. These are more indirect in their approach but intend to enhance patient care.

The pros and cons

Regulatory activities are aimed at building appropriate motives and attitudes, policies, and healthcare protocols, within facilities and systems. Some regulatory activities include regular inspections and measures to enhance good practice and a better clinical culture.

The flip side is that slavish imposition of regulations could fail to address real problems of attitude and a non-professional approach to healthcare, is not flexible enough to cope with challenges and changes in the industry and may promote a bureaucratic pattern of complying with rules mechanically rather than seeking the patient’s welfare.

Some may perceive it as interference by an external authority that reduces the efficiency of work and intrudes on the smooth functioning of the clinical service, but regulatory oversight is designed to encompass a broader range of functions. This has led many individual and corporate observers to advocate for regulatory reform, leading to a simplified approach that clubs together regulations relating to similar services, and reduces the load on healthcare providers.

The main problems are multiple regulatory bodies that share the same aims; make for a complex and rapidly changing regulatory environment; and cause duplication of work, increasing the workload and creating frustration and negative relationships with the regulatory bodies.

Not only so, but the uncoordinated nature of the interactions between the various organizations and agencies that are involved in regulation can also both create confusion within the regulated body, and cause resources to be diverted from where they could be best used, to produce a semblance of improvement for the sake of the regulator.

Both the time and the energy, apart from the money spent, in producing a portfolio of the evidence required to satisfy the regulatory bodies, are concerning issues, detracting from rather than enhancing the quality of healthcare.

US healthcare regulators

Some important regulatory bodies in the USA include the State Offices of Health Care Quality which is responsible for certifying and licensing all the health care and community long-term care facilities. The Centers for Medicare and Medicaid (CMS) supervise and regulate the provisions linked to the healthcare system, providing care at a subsidized rate through different programs.

These include Medicare for older people and the disabled; Medicaid for the low-income individuals and families; and State Children’s Health Insurance Program (SCHIP) for the under-19 population. It also monitors compliance with the Health Insurance Portability and Accountability Act (HIPAA).

Another is the Agency for Healthcare Research and Quality (AHRQ), part of the U.S. Department of Health & Human Services (HHS), which works to boost the quality of healthcare and improve patient safety at a lower cost.

Non-profit watchdog organizations include the National Committee for Quality Assurance (NCQA), which monitors managed care, and the Joint Commission on Accreditation of Health Care Organizations (JCAHO) that ranks healthcare organizations by the quality of care. Such a ranking will affect insurance payments.

The HHS also heads other regulatory departments, including the Centers for Disease Control and Prevention (CDC) in Atlanta, that monitors public health for birth defects, disabilities, genetics, environmental health, injury, violence, and travel guidelines, among others. It also looks into possible infectious outbreaks.

The Food and Drug Administration (FDA) is a federal agency that oversees the drug supply to the USA for safety and efficacy. The Environmental Protection Agency (EPA) is a federal agency concerned with making and enforcing regulations that protect the environment, based on existing laws.

Regulators in the UK

The UK healthcare system is led and supported by the Department of Health and Social Care (DHSC), NHS England, and Public Health England (PHE). The National Health System (NHS) is regulated by ten service regulators including NHS Improvement and the Care Quality Commission (CQC), as well as the Medicines and Healthcare Products Regulatory Agency, the United Kingdom Accreditation Service, the Environment Agency, and the Human Fertilization and Embryology Authority.

The CQC is the primary healthcare regulator in England. It is responsible for registering, inspecting, monitoring, and rating healthcare services in England.

There are eight regulators of healthcare professionals, such as the General Medical Council, General Dental Council, General Optical Council, General Pharmaceutical Council, the Health and Care Professions Council, and the Nursing and Midwifery Council. These regulate the practice of healthcare by professionals, but also improve the education and training of these professionals, including revalidation, investigation, and sanctioning them as required. All eight regulators are overseen by the Professionals Standards Authority (PSA).

References:

  • Oikonomou, E. et al. (2019). Patient Safety Regulation in the NHS: Mapping the Regulatory Landscape of Healthcare. BMJ Open. https://dx.doi.org/10.1136%2Fbmjopen-2018-028663. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6615819/
  • Risso-Gill, I. et al. (2014). Assessing The Role of Regulatory Bodies in Managing Health Professional Issues and Errors in Europe. International Journal for Quality in Health Care, Volume 26, Issue 4, August 2014, Pages 348–357. https://doi.org/10.1093/intqhc/mzu036. https://academic.oup.com/intqhc/article/26/4/348/1789585
  • Grimm, N. et al. (2021). Healthcare Regulations: Who Does What? https://www.yourtrainingprovider.com/healthcare-regulations-who-does-what/. Accessed on October 18, 2021.
  • A Primer to Public-Private Partnerships in Infrastructure Development. 5.1. Functions of a regulator. Retrieved from: https://www.unescap.org/ttdw/ppp/ppp_primer/51_functions_of_a_regulator.html. Accessed on October 18, 2021.

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Last Updated: Dec 7, 2021

Written by

Dr. Liji Thomas

Dr. Liji Thomas is an OB-GYN, who graduated from the Government Medical College, University of Calicut, Kerala, in 2001. Liji practiced as a full-time consultant in obstetrics/gynecology in a private hospital for a few years following her graduation. She has counseled hundreds of patients facing issues from pregnancy-related problems and infertility, and has been in charge of over 2,000 deliveries, striving always to achieve a normal delivery rather than operative.

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