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According to the HIPAA Journal, from 2009 to 2023, there were 5,887 reported healthcare data breaches involving over 500 records. Hacking was the leading cause of these breaches, resulting in the exposure of over 519 million medical records.
These statistics highlight the increasingly volatile situation within the healthcare sector, impacting patient safety and privacy, as well as the credibility of healthcare organizations.
The question is, how can institutions safeguard their data and protect themselves from fraudulent activities and breaches?
In this article, we will explore the concept of healthcare compliance management, discuss its benefits and challenges, and provide 11 steps to implementing a healthcare compliance management system in your organization.
Healthcare compliance is a set of measures taken by a healthcare institution to prevent fraudulent acts and abuse within an organization. These measures are typically ongoing and involve sticking to legal and professional requirements that are clearly communicated and accepted within the organization.
The cornerstone of regulatory compliance in healthcare is an organized plan, documented within the company’s policies, consisting of specific components and requirements.
Here is an overview of several key acts and statutes related to healthcare compliance:
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) requested the HHS (US Department of Health & Human Services) Secretary to develop regulations aimed at protecting the privacy and security of certain types of health information.
This led to the creation of the HIPAA Privacy Rule, which sets national standards for the protection of individually identifiable health information, and the HIPAA Security Rule, which establishes security standards for protecting health information.
The AKS criminalizes the act of knowingly and willfully offering, paying, or receiving any remuneration to reward patient referrals for services reimbursable by a federal healthcare program. It also criminalizes the initiation of business involving any item or service payable by federal healthcare programs (e.g., healthcare services, supplies for Medicare/Medicaid patients).
The FCA is a federal law that demands civil liability on individuals who knowingly submit or cause the submission of false or fraudulent claims to the federal government. A violation of the FCA can occur even without a specific intent to defraud.
Commonly known as the Stark Law, this statute prohibits physicians from referring patients for designated health services payable by federal healthcare programs to entities with which they or their immediate family members have a financial relationship.
The US Food and Drug Administration (FDA) is a federal agency within the HHS. The FDA is responsible for protecting and advancing public health through the control of a wide range of products, including food safety, caffeine, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, as well as vaccines, blood transfusions, and veterinary products.
The FDA’s primary focus is the enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), which aims to ensure the safety of food, drugs, cosmetics, and medical devices.
Implementing a robust organizational compliance program offers significant benefits to healthcare institutions. An effective compliance program aids in many ways, including but not limited to the following.
Healthcare compliance management helps identify problems such as medical coding and billing errors, allowing for timely corrections.
Healthcare compliance management guarantees that both leadership and employees are committed to ethical practices.
In the highly regulated healthcare industry, to truly benefit from a compliance program, healthcare organizations must actively engage with it and adopt regular practices and compliance analytics within their monitoring processes to enhance the quality of care and reduce costs.
The implementation of healthcare security and compliance solutions brings a plethora of benefits to healthcare organizations. Below are some examples.
Correct and up-to-date information contributes to more accurate procedures and treatment. Additionally, relevant data is crucial for quality analysis, providing the necessary information to improve business processes and care provision.
Healthcare data management tools boost coordination among doctors and various departments within a healthcare organization.
These tools reduce costs by enabling the sharing of medical history, which speeds up diagnosis and eliminates unnecessary tests.
Healthcare security and compliance solutions eliminate the need for manual data entry and contribute to the safety and security of data storage.
While compliance management software can streamline many processes within an organization, it also may come with some challenges.
The accuracy of compliance management software is based on the quality of the data input. Incorrect and irrelevant data can significantly affect the efficiency of the software and the implementation team efforts. Moreover, the software may produce false positives, which can lead to wasted time and resources.
For optimal functionality, it is crucial to integrate compliance management software with other tools used within the institution. Depending on the specific situation, this process may take months or even years. Additionally, the organization will need a dedicated team or specialist to assist with the integration.
Compliance requirements can vary depending on the industry, country, and state. This makes it challenging to find an out-of-the-box solution that meets the wide range of legal standards applicable to your organization.
Implementing and maintaining compliance management software requires technical knowledge. Even if your organization has a well-experienced IT department, specialized training is often necessary to maintain the system effectively.
Compliance regulations are subject to constant changes. Failure to adapt may have negative consequences causing potential compliance issues for your organization.
Healthcare compliance is supported by a range of solutions, each designed to address specific aspects of compliance management.
Below are five essential categories of healthcare compliance management tools along with their functionality and benefits.
This software handles the comprehensive provider data lifecycle. It covers verification, credentialing, payer enrollment, privileging, peer review, quality improvement, and risk management.
Key benefits:
This software ensures all vendors meet your organization’s specific requirements prior to credentialing. It may feature real-time tracking dashboards for on-site and virtual access.
Key benefits:
This tool manages access to healthcare facilities with secure, efficient check-ins and customizable visitor limits and requirements.
Key benefits
This software guides users through HIPAA compliance, covering Privacy, Security, Breach Notification, and Omnibus Rules. The main goal is to help with the HIPAA risk assessment process in identifying, tracking, and mitigating risks.
Key benefits:
Available in various forms, this software may use automation and AI compliance tools to review medical records for compliant billing, and supports computer-assisted coding and documentation.
Key benefits:
Below are 5 of the most popular healthcare compliance management platforms with their primary focus, key features, pricing, and pros and cons.
Primary Focus: All-in-one healthcare compliance solution
Key Features: Full HIPAA compliance, knowledge base, employee training tools, customizable forms and checklists, employee messaging, task tracking
Pricing: Free-for-life plan, premium plans from $29, 14-day free trial
Pros: Centrally and securely stored compliance documents, support compliance with real-time employee communication, easy training for employees, notification on upcoming certification expiration dates
Cons: More integrations on the way
Primary Focus: Employee health benefits compliance
Key Features: Compliance communications, exposure analytics, functional data, concierge services
Pros: Comprehensive benefits management, bilingual support
Cons: Pricing not public, limited to employee benefits
Primary Focus: Workplace inspections
Key Features: Automated inspection and audit reminders, compliance analytics dashboards with customizable insights, branded checklists and reports, task tracking
Pricing: Starts at $19/user/month
Pros: Multi-device support, 24-hour support
Cons: Not HIPAA compliant, per-user pricing adds up
Primary Focus: Medical chart auditing
Key Features: Customizable platform, audit management, compliance management, mobile app
Pricing: Starts at $500/month
Pros: Healthcare-specific, consultancy services
Cons: Separate pricing for tools
Primary Focus: Cybersecurity
Key Features: Cybersecurity training, document tracking, HIPAA risk assessments, employee training records
Pros: Comprehensive HIPAA support, continuous training
Cons: Web form support only, pricing not public
Implementing healthcare compliance management software requires substantial investments of time and resources. However, when approached wisely and gradually, it will inevitably lead to positive outcomes.
Follow the steps below to achieve success in your healthcare compliance management software efforts.
Step 1. Define goals and requirements
Step 2. Elaborate written policies, procedures and standards
Step 3. Select members of a compliance committee and a compliance manager
Step 4. Set stakeholder engagement activities
Step 5. Select the right platform
Step 6. Develop training and education programs
Step 7. Set effective lines of communication
Step 8. Develop an implementation plan
Step 9. Create internal monitoring and auditing plan
Step 10. Communicate the guidelines to the company
Step 11. Set procedures for prompt response to detected breaches and relevant actions
The successful implementation of healthcare compliance management software requires the time and effort of several designated teams. Most of these steps are easy to follow, especially if your organization is accustomed to setting clear guidelines and plans for enhanced efficiency.
However, there are still parts that may raise concerns and cause obstacles, particularly when it comes to the technical aspects of the process, such as training the IT team, selecting the right platform, integrating with existing legacy systems, and ongoing software updates and improvements to meet the growing needs of the organization. In such cases, a better solution would be to collaborate with a team of experienced professionals who can assist at every step of this laborious process, or to build a custom software solution.
Kanda Software is your trusted partner for the successful development and/or implementation of healthcare compliance management platforms.
Whether you’re dealing with HIPAA Privacy and Security Rules or FDA requirements, our 25+ years of software development and deployment experience will come in handy in finding the optimal and scalable solution to address your business needs.
With a highly qualified team of professionals specializing in compliance automation, AI compliance solutions, data management, and engineering, among a large clientele of healthcare vendors, Kanda is here to help with your compliance needs.
Talk to our experts today to find the easiest path to achieving your compliance goals. Start saving time on mundane tasks and free up your team to provide improved care and treatment with the help of Kanda.
