The concept of compliance has undergone significant changes; the number of regulations, fines, penalties, and reporting requirements related to compliance and environmental, social, and governance (ESG) issues have also increased rapidly.
Compliance and risk management scope cover several areas, including data protection in human resources, tax and corruption guidelines in finance and sales, and website compliance in digital marketing. In today’s world, companies are influenced by numerous regulations, directives, and laws that internally and externally shape their day-to-day operations. The stakes are high because non-compliance can result in severe consequences like penalties, reputational harm, and public scandals.
Compliance has become a crucial aspect of operations for organizations across various industries. Compliance in healthcare carries greater importance than in other industries, given the sensitivity of patient health information and the potential risks associated with healthcare services.
In today’s healthcare business landscape, compliance remains an important concern. Healthcare organizations must continually adapt to changing regulations and standards to ensure the highest quality of care while upholding legal and ethical obligations. This article explores the pivotal areas of emphasis for healthcare compliance in the present day, shedding light on the critical aspects that demand the utmost attention.
The healthcare industry is a critical infrastructure, and government regulators will set higher expectations. To demonstrate compliance, organizations must provide evidence and proof of relevance in addition to documentation. The ultimate aim is to validate adherence to regulations.
Regulatory bodies will continue to enforce healthcare regulations and standards, leading to increased scrutiny of healthcare organizations. This underscores the importance of compliance programs and risk assessments to identify potential areas of non-compliance and address them promptly.
Organizations can adopt frameworks from respected bodies such as the National Institute of Standards and Technology (NIST) and the International Organization for Standardization (ISO) to establish an effective IT risk management program. These frameworks provide crucial controls, standards, policies, and guidelines.
Regulators will increase pressure on entities that receive federal funds via Medicare to prevent fraud, waste, and abuse. From 2023, scrutiny and oversight will intensify, necessitating the proper justification of billing processes supported by adequate documentation. Being proactive in scrutinizing business associates and implementing clear billing and coding procedures will help avoid fines and damage to reputation.
An important area of focus is the HIPAA Right of Access Initiative, which allows patients to access their medical records promptly without being inappropriately charged by the covered entity. Currently, a covered entity must provide access to medical records information within 30 days of a patient or representative’s request. In most cases, it may request a 30-day extension.
The proposed modifications to the HIPAA Privacy Rule include shortening the response time to “as soon as practical,” but in no case exceeding 15 calendar days from receipt of the request, with an optional extension.
Additionally, the No Surprises Act protects patients insured by certain health plans from receiving surprise medical bills when receiving care from out-of-network providers at in-network facilities. It established an independent dispute resolution (IDR) process to solve the legal challenges arising from the arguments between providers and customers regarding bills.
Finally, the Dobbs vs. Jackson Women’s Health Organization decision by the Supreme Court created confusion around the HIPAA Privacy Rule and what a healthcare professional can and cannot do moving forward, particularly in relation to disclosing protected health information (PHI) without patient authorization for non-healthcare-related purposes, such as disclosure to law enforcement. In response, the Department of Health and Human Services (HHS) issued guidance in June 2022 to clarify how the HIPAA Privacy Rule limits access to private medical information related to abortion and other sexual and reproductive healthcare held by HIPAA-covered entities.
Healthcare data is growing in high volume and value. Often, this data is duplicated and used by private healthcare agencies, insurance companies, government bodies, etc. In many organizations, this data is fragmented across various formats such as spreadsheets, scanned documents, pen and paper, images, databases, etc. Mostly, there are many sources of truth for medical data.
If the data is scattered, it results in data discovery challenges and makes it difficult to achieve regulatory requirements and timely audits. The most crucial factor is that the medical and patent data is sensitive. Fortified Health Security, a healthcare cybersecurity firm, has reported that over 19 million records were exposed in healthcare data breaches in the first half of 2022. Of all the breaches, 15% were attributed to unauthorized access and disclosure.
In the most regulated industry, healthcare organizations need to adhere to various government regulations related to data protection, such as USA Health Insurance Portability and Accountability Act (HIPAA), The Health Information Technology for Economic and Clinical Health (HITECH) Act, etc. HIPAA gives the power to customers over their data. If they change their health insurance from one company to another, they can do it without their Healthcare being compromised.
Unfortunately, healthcare providers face various challenges in establishing data governance. They are:
Telehealth services have become increasingly popular, particularly in the wake of the COVID-19 pandemic. As this trend continues, healthcare organizations must adapt their compliance strategies to encompass telehealth-specific regulations. Ensuring that remote consultations and data transmission comply with privacy and security standards is paramount.
Healthcare is about providing health services to people. Delivering a comfortable experience is very important in the healthcare business. Talent shortage can cripple compliance in a healthcare organization, which can cause quality issues, incidents, and medical staff unrest. One area of improvement for members of healthcare organizations would be sorting out talent and skill shortages. The healthcare industry is growing fast and facing acute staffing shortages.
Ensuring patient safety and security is of utmost importance for healthcare facilities, and this can be challenging due to the shortage of skilled nurses and practitioners. To mitigate risks, healthcare organizations must prioritize creating a culture that motivates workers to remain in their roles and provides them with the necessary tools and training to uphold patient safety. Improving the industry’s talent shortage requires redesigning the healthcare talent management model, investing in recruitment, and developing trust in the leadership team. The talent acquisition team needs to tackle the growing talent shortage challenge proactively. The training and development teams must implement training and development programs to grow talent. Address the skill gap with mentorships, training, and partner programs.
Proper documentation and record retention are fundamental to compliance. Healthcare organizations should establish clear policies for document management, storage, and destruction. This not only helps with compliance but also plays a crucial role in legal and liability issues.
Disasters, whether natural or cybersecurity-related, can disrupt healthcare operations and put compliance at risk. Developing robust disaster recovery and business continuity plans is essential for maintaining patient care and data protection during unforeseen events.
Ethical considerations in healthcare compliance extend beyond legal requirements. Organizations should focus on patient care and outcomes, striving for excellence in quality of care, transparency, and patient satisfaction. Ethical behavior should be an integral part of the compliance culture.
Even with the best intentions and rigorous compliance programs, human errors can still occur, leading to significant consequences. In 2023, healthcare organizations need to be aware of the risks associated with human errors in compliance and take proactive steps to mitigate them. Here are some of the most common human errors in compliance and solutions to minimize their impact.
Carelessness and negligence are common human errors in compliance that can have serious consequences. Employees may fail to follow established procedures or cut corners to save time or effort, leading to errors or violations. Misinterpretation of regulations is another common human error in compliance. Employees may not fully understand the regulations and standards, leading to unintentional violations or errors.
One of the most common human errors in compliance is a lack of communication and training. Employees may not be fully aware of the policies and procedures in place or may not have received adequate training to comply with them.
Carelessness and negligence are common human errors in compliance that can have serious consequences. Employees may fail to follow established procedures or cut corners to save time or effort, leading to errors or violations.
Healthcare companies must comply with various environmental regulations related to handling and disposing of hazardous materials and waste, including regulations set by the Environmental Protection Agency (EPA).
Timely and accurate regulatory reporting is essential for healthcare organizations. Failure to meet reporting requirements can result in fines and penalties. Therefore, organizations need to establish efficient reporting mechanisms to comply with regulatory agencies’ demands.
To ensure healthcare compliance, organizations should develop a comprehensive plan that includes documented policies and focuses on high-risk areas, as advised by the Office of Inspector General. Customizing the plan to their specific circumstances, drawing insights from internal audits and CERT data, is of utmost importance. The Department of Justice offers a valuable resource for crafting compliance plans. Continuous auditing, facilitated by healthcare compliance software, is a critical component, with regular audits serving as a cornerstone for maintaining vigilant oversight. Establishing and enforcing compliance through well-publicized disciplinary guidelines creates a culture of accountability, ensuring swift action against non-compliance.
Every healthcare provider and organization should implement a comprehensive compliance program, encompassing education, communication, and proactive measures.
To assist you in establishing a robust healthcare compliance framework, here’s a checklist:
Identify potential privacy and security risks in your digital health solution, ensuring alignment with relevant regulations and standards for software development and medical coding compliance.
Develop, distribute, and enforce written standards of conduct addressing vital compliance areas such as data privacy, informed consent, and reporting requirements.
Regularly educate and train employees on compliance policies, laws, and regulations while continuously assessing the effectiveness of your training initiatives.
Evaluate data security protocols, including encryption, access controls, and data storage, to ensure they meet industry best practices for healthcare IT compliance.
Establish channels for open communication to report compliance concerns, including anonymous reporting, and implement processes to address complaints and apply corrective actions.
Implement and routinely review internal monitoring and audit procedures to promptly address deficiencies.
Record audit findings, including noncompliance areas, to formulate an action plan.
Healthcare compliance demands continual vigilance to ensure adherence to regulations and standards. By following this checklist, you can create an effective compliance program that meets legal and ethical requirements.
Healthcare compliance programs should not merely focus on rule adherence but also aim to foster a culture that prevents, detects, and resolves non-compliance.
Achieving certification in healthcare compliance for your organization is a significant milestone for professionals in the field, demonstrating a deep understanding of the complex regulatory landscape and a commitment to upholding ethical and legal standards. Certification programs typically cover topics such as healthcare laws, regulations, privacy and security, and compliance management strategies, ensuring that individuals are well-prepared to navigate the intricacies of healthcare compliance.
Healthcare organizations need to take proactive steps to minimize compliance risk, including prioritizing communication and training, establishing a culture of compliance, providing clear guidance on regulations and standards, and promoting employee wellness. Healthcare organizations can protect patients, employees, and their bottom line by doing so.
Many healthcare organizations are turning to automation and digitalization to overcome these challenges and improve compliance. Technology can help reduce costs by reducing manual tasks, minimizing errors, and increasing efficiency. Automated systems can also help reduce administrative costs by streamlining processes.
Pick a cost-effective GRC system that allows you to establish internal controls to alleviate your digitalization risks. Map each of your risks to internal controls. It also helps you streamline your compliance and governance processes.
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