Regulatory Compliance in Healthcare

What is Regulatory Compliance in Healthcare?

Regulatory health compliance is a set of guidelines and laws that healthcare organizations and providers must adhere to. These compliance regulations must be strictly followed or else those who are in violation will be fined or penalized. So, what is regulatory compliance in healthcare? This guide details everything you should know to ensure the safety and privacy of your patients.

What is Regulatory Compliance in Healthcare?

The healthcare industry is one of the most regulated industries. All healthcare professionals and organizations need to follow these regulations to ensure the protection of patient information while upholding superior patient care and preventing fraud. These regulations are comprehensive and cover different aspects of the healthcare business processes.

1. Ensuring Privacy and Quality Patient Care

Regulatory compliance laws for healthcare organizations and professionals are developed to protect the private information of patients when it comes to personal, medical history, and payment information. It also outlines the requirements to ensure quality patient care and to combat fraud within healthcare organizations.

The HIPAA law passed in 1996 was implemented in 2003. It serves as the standard for all organizations in the healthcare industry. It defines the steps that every healthcare organization and professional must follow when collecting, storing, handling, and sharing patient information. Stiff penalties await those who violate these regulations to ensure strict compliance.

2. Protection of Healthcare Workers

Regulatory compliance in healthcare is also designed to protect healthcare workers and staff. The Occupational Safety and Health Act of 1970 was created to ensure safety standards within the healthcare workplace. It covers different aspects of the healthcare work environment including, but not limited to, handling infectious agents and diseases, x-ray machines, and other safety protocols.

3. Combating Fraud

The healthcare industry in the US alone is worth trillions of dollars and up to 10% of it is lost due to fraud (based on reports from the Federal Bureau of Investigation and the National Health Care Anti-Fraud Association). Fraud is a major issue in the healthcare industry, which is why several laws and organizations are formed to combat this problem.

Medical and healthcare professionals must be informed of these laws to avoid unintentional violations. Penalties could include fines and even revocation of your medical licensure.

The above-mentioned areas are what you must focus on to ensure compliance with the existing laws and regulations for the industry.

Regulatory compliance laws for healthcare organizations

Characteristics of an Effective Healthcare Compliance Program

You must develop a healthcare compliance plan and program to ensure that your business practices are aligned with the existing regulatory compliance standards. This program must also be evaluated regularly to stay abreast of the latest regulations.

The following are the characteristics that make a healthcare compliance program effective:

  • You must designate a chief compliance officer within your organization, along with a team with their respective roles. Each of these staff members will be responsible for the monitoring and implementation of your compliance program. The chief compliance officer will oversee the program and the individuals who have specifically designated roles to ensure everything is seamless.

  • You must develop a solid employee education and training program. This program will help your team stay updated on the current regulatory standards and expand their knowledge base.

  • You must have an effective communication system that makes it easy to report compliance concerns with anonymity. There should also be a plan of action developed on how to address a potential breach, or to prevent them.

  • You must have a process in place on how to respond to complaints and the necessary disciplinary actions for employees that break the codes of conduct.

  • You must have a corrective action in place to remedy any violations and to ensure that no similar compliance issues arise in the future.

Top Challenges in Regulatory Compliance in Healthcare

There is complexity in the regulatory compliance that governs healthcare organizations and professionals. It is important to identify the challenges that present a threat to maintaining compliance.

Here are the top three challenges that emerge and must be addressed accordingly.

1. Ensuring cybersecurity at all levels.

Healthcare organizations that collect, store, and manage patient information are a target for cybersecurity threats. It is important to implement updated security systems and infrastructure across all levels. Threats will target the weak points in your security systems. No matter how small the threat is, you must never take it for granted as any threat can damage the integrity of your organization.

There should be a tiered approach in managing cybersecurity so that the appropriate security measures are implemented based on the gravity and size of the threat. It is also best to conduct regular cybersecurity training for personnel and staff tasked with ensuring that your patient data are safe.

2. The advent of telemedicine.

Since the pandemic, many healthcare organizations and providers have switched to the telemedicine approach to delivering patient care and services. Regulating telehealth remains a big issue among compliance officers, mainly because it is new.

In connection with the above, telemedicine is also closely linked to the efforts of compliance officers to develop regulations that put cybersecurity as the main priority.

3. Acquiring talent using a more in-depth, yet ethically compliant screening process.

Hiring and retaining talent is one of the most pressing challenges faced by healthcare organizations. Aside from training them when they become part of your team, you can leverage the knowledge of talents that have an existing healthcare management knowledge base, especially when focused on healthcare compliance.

Make sure to intensify the screening process to find the most qualified individuals to join your team. Implement in-depth background checks, but make sure they are ethical and compliant. Their knowledge base will make it easier to implement policies that fit the regulatory standards in the healthcare industry.

Challenges in Regulatory Compliance in Healthcare

Tips to Stay on Top of Regulations

Healthcare compliance is expected to grow as regulations continue to evolve and change over the years. These changes are in response to the emergence of new technologies and new risks that healthcare organizations and professionals face.

The best way to keep up with these regulations is to invest in administrative roles. These roles are responsible for developing regulatory programs that ensure successful compliance, along with an agile work approach and a culture of innovation. Continuous staff training and education will also play a critical role in successful compliance and the promotion of quality patient care.


Chad Schiffman

Director of Compliance & Rick Management