What Is Regulatory Compliance In The Healthcare Industry?

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In the United States, healthcare is among the most strictly regulated sectors, making healthcare compliance solutions an increasingly important and dynamic area of study.

Clinical facilities and organizations need healthcare compliance professionals to help them comply with the expanding body of government regulations meant to safeguard the confidentiality of patient information, promote high-level medical care, forestall fraud, and ensure the safety of healthcare workers.  

What Is Regulatory Compliance In Healthcare?

Healthcare is highly regulated, even in comparison to other sectors. In order to maintain high-quality patient care standards and combat fraud, all healthcare providers and facilities must adhere to these rules. These rules are all-encompassing, addressing every facet of running a medical practice.

1. Ensuring Privacy and Quality Patient Care

Patient identities, medical records, and financial information are all protected by strict privacy regulations that require healthcare providers to comply with regulatory compliance standards. It also specifies what must be done to prevent healthcare fraud and maintain high standards of treatment for patients.

HIPAA was enacted in 1996 but didn’t become law until 2003. It’s the benchmark by which other healthcare providers are measured. The document lays out the procedures that must be followed by all healthcare facilities and practitioners for collecting, storing, processing, and disseminating patient data. In order to ensure that these rules are followed to the letter, anyone who breaks them will face severe consequences.

2. Protection of Healthcare Workers

Compliance with healthcare regulations is also intended to safeguard the profession’s workforce. Healthcare facilities are subject to additional regulations under the Occupational Safety and Health Act (OSHA) of 1970. It covers numerous areas of the healthcare work environment, including, but not limited to, handling infectious agents and diseases, x-ray machines, and other safety standards.

3. Combating Fraud

Up to 10% of the value of the entire US healthcare industry is lost to fraud every year. Multiple laws and organizations have been created to prevent healthcare fraud.

In order to prevent accidental infractions, it is imperative that medical and healthcare workers be made aware of these regulations. The penalties could range from a monetary fine to the loss of your medical license.

In order to stay in accordance with the rules and regulations currently in place for your field, you need to pay special attention to the aforementioned details.

Why Is Healthcare Compliance Important?

Enhancing the quality of care for patients is the primary goal of healthcare compliance programs. When medical judgments are founded on relevant and up-to-date clinical standards, patient outcomes improve. Misguided patient care decisions are obviously not equivalent to high-quality treatment.

Healthcare compliance also helps facilities and practitioners stay out of legal hot water. A healthcare organization with a good compliance program can see issues and implement fixes long before a regulatory body does so. Sanctions, or monetary penalties, can be avoided altogether if a healthcare institution or provider implements an efficient healthcare compliance program. When healthcare facilities fail to implement sufficient compliance procedures, they are more likely to incur fines.

In response to issues discovered by their compliance programs, many healthcare organizations and providers have voluntarily reported them to regulatory bodies. When compared to the penalties and other sanctions handed out to organizations and providers who were prosecuted for their misbehavior, the penalties handed out to those who voluntarily disclosed their wrongdoings were much lighter.

The absence of malpractice claims against a healthcare organization or practitioner is just one more benefit of an efficient compliance program. Documentation of the organization’s or provider’s adherence to current clinical standards is a recurring theme in healthcare compliance. Most malpractice suits can be avoided if a healthcare provider or facility is following accepted standards of care.

Major Laws Related To Compliance

Helping to reduce the number of false claims submitted to healthcare insurers is what compliance in this field is all about (federal, state, and commercial). Combating such negative phenomena as fraud, waste, and misuse is the ultimate objective. What follows is a brief overview of some of the acts and statutes that pertain to healthcare compliance.

  1. False Claims Act (FCA): Under the FCA, anybody who intentionally submits or induces the filing of a fraudulent or false claim to the federal government is subject to civil liability. Having actual knowledge or acting in willful ignorance or heedless disdain for the truth or falsity of the information is what we mean when we use the terms “knowing” and “knowingly.” Without any premeditated scheme to cheat the system, a violation of the FCA is nevertheless a crime. For instance, the doctor is billing for services despite the fact that the patient was never seen.
  2. Anti-Kickback Statute (AKS): According to the AKS, it is prohibited to intentionally offer, give, or receive anything of value in exchange for generating new business that involves any product or service covered by a federal healthcare plan. Medical facilities need to check the AKS regularly for changes. As an illustration, a medical practice may offer gift cards to a local coffee shop to existing patients who bring in new customers.
  3. Physician Self-Referral Law (Stark Law): The Stark Law, or Physician Self-Referral Law, prohibits doctors from recommending themselves to patients. Except in limited circumstances, this legislation forbids physicians from referring patients to a business with which they have a financial relationship for the purpose of receiving “designated health services” that are reimbursed by Medicare or Medicaid. For instance, a doctor writes prescriptions for Medicare patients who can only fill them at the doctor’s own pharmacy.
  4. HIPAA (Privacy & Security): HIPAA directed the Secretary of Health and Human Services to form regulations that ensure the confidentiality of sensitive patient records. To meet this mandate, HHS made the HIPAA Privacy Rule and the HIPAA Security Rule. 

The Privacy Rule, or the Standards for Privacy of Individually Identifiable Health Information, is a set of mandatory federal regulations enacted to ensure the confidentiality of specific types of medical records. The Security Rule, also known as the Security Standards for the Protection of Electronic Protected Health Information, creates a uniform framework for safeguarding specific types of health information stored or transmitted digitally.


As healthcare regulations expand and alter over time, the need for compliance is only projected to increase. The advent of cutting-edge medical technologies has also resulted in the introduction of novel threats to the healthcare industry.

Investment in administrative responsibilities is the greatest strategy for keeping up with these rules. Successful compliance with regulations, an adaptive work style, and a culture of innovation is the responsibility of these positions. Staff compliance and the promotion of high-quality patient care will also benefit from ongoing training and education.




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