Key Takeaways
1. The three core rules of HIPAA— Privacy, Security, and Breach Notification—are essential for protecting Patient Health Information (PHI) and achieving compliance.
2. Regular risk assessments and updating HIPAA policies are critical for identifying vulnerabilities and ensuring compliance.
3. I.S. Partners specializes in guiding organizations through the complexities of HIPAA compliance.
What Is the HIPAA Compliance Checklist?
A HIPAA compliance checklist is a set of guidelines that organizations can use to align their operations according to the rules of the HIPAA framework.
It covers key areas such as risk assessments, employee training, and implementing administrative safeguards to protect patient data. Adhering to this checklist helps organizations avoid penalties and maintain trust with patients.
Now, here is a comprehensive HIPAA checklist you can use to achieve compliance effectively.
Step 1. Understand the Risks
First things first, take a good look at your organization’s current setup and understand the risks. What are you doing right, and where could you improve? Have you implemented the three rules of HIPAA?
For context, the three rules of HIPAA are the Privacy Rule, the Security Rule, and the Breach Notification Rule.
- The HIPAA Privacy Rule protects the confidentiality of individuals’ medical records, allowing controlled use and disclosure of protected health information (PHI) while giving patients rights over their data.
- The HIPAA Security Rule safeguards Electronic Protected Health Information PHI (ePHI) through required administrative, physical, and technical measures, such as encryption and security controls.
- The HIPAA Breach Notification Rule mandates that organizations notify affected individuals and authorities if unsecured electronic PHI is breached, ensuring transparency and timely response.
Now, as a business, you need to grasp the purpose behind these requirements and carefully examine the necessary technical specifications. This understanding is paramount so that you perform the next steps smoothly.
Step 2. Appoint a Leader
Choose someone to take the lead on HIPAA compliance. This person will be your main contact for anything HIPAA-related and will be designated as the privacy officer.
For instance, covered entities and business associates must designate a privacy or security officer. These individuals are responsible for ensuring HIPAA regulations are followed within their organizations.
Again, you cannot just about pick anyone from the team; it requires someone with a strong understanding of federal, state, and local laws, as well as other compliance standards like those needed for Medicare.
Sometimes, a multidisciplinary compliance team handles this, with leaders from different departments as privacy or security officers. If these leaders don’t have the necessary knowledge or resources, you might need to hire a new team member or outsource the task to a third-party expert in the HIPAA compliance program.
I.S. Partners is a leading auditing firm that will help you get HIPAA compliant in no time. We have the credentials and experienced auditors who will guide you along the way. Get on a call to know more.
Consulting a healthcare compliance professional can guide your organization if you’re unsure who should take on this role.
Step 3. Assess Your Risks
A HIPAA risk analysis is necessary for spotting and managing potential cybersecurity risks in your organization. It’s more of an internal checkup that looks at how your PHI is stored and protected, helping you find weaknesses and boost your information security.
Here’s how to do it:
- Consider every possible risk to your PHI—where it’s stored electronically and physically, and the devices it’s on. Make sure you document all these details.
- Look at past projects, talk to your team, and check your records to find any vulnerabilities that could lead to security incidents.
- Review your technical safeguards and compare them to HIPAA requirements. If you find any gaps, reassess and strengthen them.
- Determine the likelihood of each threat’s occurrence and the severity of its impact. Use a simple scale to keep things clear.
- Once you’ve rated the risks, rank them by importance and document how you’ll address them.
- To ensure your security measures stay up to date, regularly review and update your security risk assessment, ideally once or twice a year.
Step 4. Create Policies and Procedures
HIPAA policies and procedures are in place across three key areas: administrative, technical, and physical. These cover how your facility processes, uses, and shares health data. So, what specific documentation should your facility have for HIPAA compliance?
While this isn’t an all-inclusive list, it provides a solid starting point for building your policies and procedure strategy:
- Training Records
- Privacy Official and Contact Person
- Complaint Records
- Notice of Privacy Practices
- Access Control Policy
- Security Management Policy
- Incident Response Policy
- Data Backup and Disaster Recovery Policy
- Training and Awareness Policy
- Physical Safeguards Policy
- Breach Notification Policy
- Authorizations
- Business Associate Contracts
- Designated Record Sets
- Amendment Requests
- Accounting of Disclosures
- Restriction Request Agreement
- HCC and Affiliated Covered Entity Designations
- Group Health Plan Document Amendment
These examples should help you get a headstart on creating a documentation approach. Learn more about HIPAA Privacy & Security Regulations.
Step 5. Establish Physical Safeguards
Physical safeguards are essential for protecting your organization’s electronic information systems from environmental threats and unauthorized access. As part of the HIPAA Security Rule, these safeguards are critical for maintaining the security of sensitive data.
Here are key examples of physical safeguards:
- Facility Access Controls. This includes lockable doors, security alarms, key cards, biometric or integrity controls, visitor management systems, access logs, and storage locks to ensure only authorized personnel have access.
- Workstation Use. To prevent unauthorized use, protect workstations with physical security, access control measures, encryption, and inventory tracking.
- Device and Media Controls. Implement encryption, password protection, multifactor authentication, and inventory tracking for mobile devices and media. Ensure proper disposal procedures are in place to remove data securely.
- Workstation Security. To prevent unauthorized use, protect workstations with physical locks, access control measures, encryption, and inventory tracking.
Here’s how you can do it:
- Start by assessing what needs to be physically protected and how to do it effectively.
- Design your facility with security in mind, including environmental controls.
- Clearly define methods for controlling access and ensure continuous monitoring, even if done remotely.
- Apply the principle of least privilege and categorize data into restricted, internal, and public levels to limit access based on necessity.
Step 6. Create Protocols For Breach Notification
When a breach of unsecured protected health information occurs, HIPAA-covered entities must notify those affected to the Secretary of HHS and, in some cases, the media. Business associates must also inform the covered entities they work with if a breach happens on their end.
It’s important to note that the breach notification process differs for CEs and BAs. CEs are required to report a breach to the HHS within 60 days of discovering it, while BAs must notify the CEs they work for within 60 days.
After receiving the report, the CE will determine whether the incident qualifies as a breach and decide on the appropriate next steps.
Step 7. Train Your Employees
As required by law, anyone handling PHI must undergo HIPAA compliance training. This training is mandatory for all roles—doctors, nurses, administrative staff, even front desk personnel—essentially, anyone who interacts with patient information.
Compliance is not just for large healthcare systems; it’s equally critical for smaller practices and solo practitioners.
Moreover, HIPAA doesn’t dictate the length of the training but focuses on the content that must be covered. At a minimum, your training should include:
- What qualifies as PHI under HIPAA? Patient names, Social Security numbers, and health records are all considered PHI and need to be protected.
- Staff members should grasp the significance of protecting PHI. Explain how potential breaches harm patients and lead to hefty fines and legal consequences for the larger organization.
- Training should cover how to secure PHI. This includes teaching employees how to create strong passwords, recognize phishing attempts, and ensure that electronic devices storing PHI are secure.
- Employees should know the steps to take if they suspect a breach. This might include whom to notify, how to document the incident, and immediate actions to minimize damage.
Step 8. Find the Right Security Provider
According to a 2023 report by the Healthcare Dive, Healthcare continues to be the most expensive industry for data breaches, with costs increasing 53% since 2020. These breaches often result from unauthorized access to PHI, underscoring the need for robust security measures.
Continuous monitoring allows organizations to detect and respond to potential threats in real time, reducing the risk of breaches by up to 90%
If managing everything in-house isn’t feasible for your organization, consider partnering with a compliance vendor. Companies like I.S. Partners specialize in HIPAA compliance and can offer expertise and support tailored to your specific needs. Contact us to learn more.
Who Needs HIPAA Compliance?
If you work in healthcare, HIPAA compliance is a must. However, it’s a common mistake to think that only CEs need to follow HIPAA rules.
The truth is anyone handling PHI, including Business Associates (BAs), must be compliant. These groups include a wide range of businesses, all of which need to adhere to HIPAA security standards based on their interaction with PHI.
- Covered Entities: CAs are individuals or organizations that handle identifiable health information and must comply with HIPAA regulations. They fall into three categories:
- Healthcare Providers. Any provider who transmits PHI electronically, regardless of the size of the practice, must be HIPAA compliant.
- Healthcare Plans. This includes health insurers, employers offering health insurance, HMOs, and government healthcare programs. Notably, small group health plans covering fewer than 50 individuals and administered solely by the employer are exempt from HIPAA.
- Healthcare Clearinghouses. These entities process and check electronic claims between healthcare providers and insurers, ensuring accurate processing and payment. As they handle PHI, they must also comply with HIPAA.
- Business Associates: Business associates are individuals or entities that perform services for or on behalf of covered entities and handle PHI.
Examples include consultants, billing companies, shredding services, and lawyers who work with covered entities. Despite not always being in the healthcare industry, they are required to be HIPAA compliant due to their access to PHI.
Why Is It Important to Prove HIPAA Compliance?
HIPAA is mandatory for all organizations handling patient information. In a time when data breaches are at an all-time high and rising, it’s more important than ever to provide assurances when it comes to protecting ePHI. Remember that the healthcare industry suffers more data breaches than any other industry in the U.S. Plus, attacks are currently on the rise.
“Healthcare accounts for 79% of all reported breaches in 2020; Reports show a 45% spike in attacks against healthcare providers since November,” according to Health IT Security.
The risk of exposing a patient’s ePHI puts the reputation and financial stability of your business, its stakeholders, vendors, and other third parties on the line.
Therefore, you want to be able to let those relying on your organization know that you are committed to protecting ePHI. HIPAA is the gold standard for strengthening your organization’s control over patient data.
This framework can further be strengthened by creating a compliance pathway connecting it and other security frameworks, such as SOC 2. By understanding the differences between SOC 2 vs HIPAA, organizations can ensure they address both data security and healthcare-specific privacy requirements effectively.
What Is HIPAA Certification, and Is HIPAA-Certified Equal HIPAA Compliant?
HIPAA certification simply means that an organization has participated in a training course with the information needed to steer the organization toward achieving HIPAA compliance. Certification is not a recognizable measure of HIPAA compliance.
The certification does not attest to the company’s compliance with those regulations. Nor does the certifying company bear any responsibility for a company not implementing the necessary measures.
Therefore, HIPAA certification does not equal HIPAA compliance. Does that make HIPAA certification worthless? No. Organizations can certainly take the sensitive information learned via HIPAA certification training to help achieve compliance.
Also Read: HIPAA Compliance & Cell Phones: Staying Compliant While Staying Connected
How Can You Easily and Effectively Prove HIPAA Compliance?
Healthcare organizations must rely on the goods, services, and expertise of businesses not fundamentally associated with the healthcare industry. That is just the way of today’s world, as healthcare companies—like businesses in any other industry—try to find the best resources for the best financial value.
The following are three ways to prove that your organization has achieved HIPAA compliance. These will show your clients, business associates, and stakeholders that your organization is dedicated to privacy and security.
1. Self-Assessments
This is the least expensive option in terms of upfront costs. However, costs in terms of staff hours and effort can add up quickly.
Compiling all the security policies and security procedures on your own—without the assistance of an experienced HIPAA auditing team—can be a big undertaking.
Businesses need to craft reports that thoroughly document the path to HIPAA compliance. This means reviewing mountains of supporting documentation, including screenshots of settings and links to policies, to illustrate an organization’s compliance. Not surprisingly, self-attestation can become a long and arduous process for everyone involved.
2. Third–Party Audits and Attestations
Another option is relying on an external auditing firm to conduct a compliance assessment. This covers the measures in place to ensure patient privacy and patient data security. It looks at how your organization collects, stores, processes, and transmits ePHI and can provide attestation that it complies with HIPAA regulations.
At the end of the audit, your auditor will provide an attestation, which is verifiable proof of your organization’s full compliance. Top auditing firms will also provide an official badge or seal to add to your website, demonstrating HIPAA compliance.
This may be the easiest way to prove HIPAA compliance. Even with a somewhat greater initial cost, the expertise and guidance make it highly attractive to busy healthcare organizations. In the end, it often saves these organizations both time and money.
3. Purchase Software to Achieve HIPAA Compliance
If the first method of proving HIPAA compliance is too risky and the second method is too expensive, consider investing in software.
There are programs available to streamline and automate the process of ensuring HIPAA compliance. Software programs provide minimal guidance in completing the HIPAA compliance documentation.
Penalties for HIPAA Non-Compliance
Noncriminal HIPAA violations of the Security Rule are managed by The Department of Health and Human Services Office for Civil Rights (OCR). On average, fines for violations run from 100 to 50,000 dollars based on the tier level:
- Tier 1 indicates the organization was unaware or could not have avoided the violation.
- Tier 2 states the organization was likely aware of but could not have avoided the violation
- Tier 3 is for violations that occur due to willful neglect, but an attempt is made to correct the problem
- Tier 4 refers to violations due to willful neglect where no attempt is made to correct the problem
Companies that violate HIPAA rules may also be held criminally liable if they disclose personal information or obtain it under false pretenses for commercial or criminal purposes.
Although developing the means to remain compliant can seem extravagant, the cost is much less than a breach.
As of 2020, the average healthcare data breaches cost $7 million beyond the HIPAA fines. Organizations typically face civil lawsuits from patients whose privacy has been violated, as well. Considering the epic results from a data breach, the cost of things like a SOC 2 assessment makes sense.
Take Control of Compliance! Ensure HIPAA Success with I.S. Partners
HIPAA compliance isn’t just about avoiding penalties—it’s about protecting what matters most: your patients’ trust and the reputation you’ve worked hard to build. A single misstep can lead to fines, data breaches, or even the erosion of confidence in your care. You need more than just a checklist; you need a solid strategy to safeguard your organization.
That’s where we come in. At I.S. Partners, we understand the unique challenges healthcare organizations face. With years of experience in healthcare auditing, we’re here to help you navigate the maze of HIPAA requirements with clarity and confidence. Our team works alongside you, ensuring your systems and processes aren’t just compliant but fully aligned with the standards that keep your patients and organization safe.
What Should You Do Next?
Start reviewing your operations today and leverage our expertise with healthcare compliance. Perform these critical steps to ensure HIPAA success.
Assess Your Current Compliance Posture. Conduct a comprehensive review to identify risks and areas that need immediate attention.
Strengthen Your Security Measures. Update policies, procedures, and systems to address vulnerabilities before they become problems.
Engage I.S. Partners. Work with our experts to simplify compliance and stay ahead of regulatory changes while protecting your organization from risks.
Don’t wait until it’s too late. Contact I.S. Partners today and let us help you achieve HIPAA compliance with confidence. Together, we’ll protect your patients, your reputation, and your future.