In this blog, we will lay out our HIPAA compliance checklist so that you can use it to benchmark your current HIPAA compliance efforts. First things first, let’s just briefly look at what HIPAA compliance actually is.
What is HIPAA Compliance?
HIPAA compliance is the adherence to rules established by the Health Insurance Portability and Accountability Act, which aims to safeguard confidential patient information. Entities responsible for storing, handling, or processing protected health information (PHI) must implement an array of security measures to ensure they are HIPAA compliant. These measures include physical, network, and procedural security safeguards. Healthcare providers, contractors, or manufacturers handling PHI are all obligated to meet HIPAA compliance standards.
HIPAA Compliance Audit Challenges
HIPAA compliance audits are essential to ensure that healthcare providers are implementing the necessary safeguards and controls to meet HIPAA requirements. However, compliance audit teams face significant challenges that must be addressed to ensure that healthcare providers remain compliant with HIPAA regulations and standards.
One of the major challenges of HIPAA compliance audits is understanding the complex regulations and standards. Compliance audit teams need to have a thorough understanding of the regulations and standards to identify and address potential vulnerabilities and non-compliance issues. This can be especially challenging for teams without the necessary expertise and experience.
Another challenge is keeping up with changing regulations. HIPAA regulations and standards are constantly evolving, and compliance audit teams need to keep up with these changes to ensure that their healthcare provider remains compliant. This can be difficult for teams that do not have the resources or time to devote to staying up to date with the latest changes.
A lack of resources is another major challenge. HIPAA compliance audit teams may not have the necessary resources, such as staff and funding, to conduct thorough audits and address potential compliance issues. This can lead to a limited scope of the audit, which can result in overlooked vulnerabilities or non-compliance issues.
Technical challenges also pose a significant challenge. HIPAA compliance audit teams may face technical challenges in auditing the security and privacy controls of electronic systems that store and transmit ePHI. For instance, they may encounter difficulties in identifying vulnerabilities in third-party software or in securing mobile devices. Without the necessary technical expertise, these challenges can be difficult to overcome.
Human error is another challenge that can be difficult to mitigate. HIPAA compliance audit teams may encounter the human error, such as accidental disclosure of ePHI, despite implementing robust security measures. This can be especially challenging for teams that do not have the necessary resources to provide ongoing education and training to employees.
Native auditing or auditing without the use of a Data Security Platform can also pose a significant challenge. Without the use of a Data Security Platform, compliance audit teams may not have access to real-time monitoring and analytics, which can make it difficult to identify potential vulnerabilities and non-compliance issues. Additionally, native auditing may not provide the necessary reporting capabilities, which can make it difficult to provide evidence of compliance during an audit.
To overcome these challenges, healthcare providers should invest in training and education, allocate resources, and conduct regular audits. Utilizing technology, such as automated tools and software, can also help streamline compliance audits and identify potential vulnerabilities. Finally, fostering a culture of compliance can help ensure that HIPAA regulations and standards are a priority for all employees at all levels of the organization.
Now, it’s time to get into our HIPAA compliance checklist.
HIPAA Compliance Checklist
Below is a HIPAA compliance checklist to help you protect your PHI and comply with HIPAA:
1. Conduct HIPAA Compliance Audits and Assessments
The first step towards HIPAA compliance is performing security audits and risk assessments for systems storing ePHI. Assessments should be carried out on a regular basis, in accordance with the NIST recommendations. Results should be documented, and a risk management policy should be implemented to evaluate the likelihood and potential impact of a data breach. The policy should also include information about the security protocols required to protect ePHI.
2. Implement Policies and Procedures
To comply with HIPAA regulations, it’s important to have policies that cover the HIPAA Privacy Rule, the HIPAA Security Rule, and the HIPAA Breach Notification Rule. This will include policies relating to passwords, remote access, and email. You will also need a Business Associate Agreement (BAA), and an Incident Response Plan (IRP) to help you respond to security incidents in a timely and coordinated manner.
3. Designate a Security Officer
All covered entities are required to appoint a HIPAA Security Officer who is responsible for the development and implementation of policies and procedures to ensure the integrity of ePHI. The ideal candidate would be someone who is confident, communicable, organized, and has a profound understanding of the HIPAA requirements.
4. Understand the Breach Notification Rule
A vital step in the HIPAA security checklist is adhering to the HIPAA Breach Notification Rule, which states organizations are legally obligated to notify the authorities and all relevant stakeholders within 60 days of discovering a data breach. Notifications can be sent by snail mail, email, telephone, or some other agreed method of communication. If the organization doesn’t have contact details for over 10 persons, they can post a clear notice on their website, or notify those affected via a relevant news outlet.
5. Introduce Safeguards to Protect ePHI
Ensure that you have the necessary technical, physical, and administrative safeguards in place to ensure data integrity, availability, and confidentiality.
- Authentication & authorization: To ensure secure access to data, it is recommended to enforce a robust password policy and implement multi-factor authentication if feasible. Additionally, careful access controls must be established to grant users access only to the data that is required for their job responsibilities.
- Real-time auditing: The ability to detect and respond to anomalous user activity is necessary to prove that you know who is accessing what data, and when. Administrators should receive real-time alerts when critical ePHI is accessed, modified, shared, or deleted.
- Encryption: ePHI should be encrypted according to NIST recommendations. This includes data at rest and in transit.
- Perimeter security: As with any IT environment, AV software, a commercial-grade firewall, or an intrusion prevention system (IPS) should be installed and maintained to protect against external threats.
- Additional technologies: Other solutions such as mobile device management, automated patch management, penetration testing, and vulnerability scanning software can also help to keep your system secure and safeguard ePHI.
- Security awareness training: To ensure data security, all relevant parties should undergo security awareness training. This includes teaching users to identify and report suspicious emails that may distribute malware or obtain login credentials through social engineering. Users should also be trained to identify suspicious email attachments or links and check for spelling and grammar errors in email domains. Additionally, all individuals must understand HIPAA compliance requirements and the consequences of failing to abide by them.
- Incident response: Healthcare service providers will need to ensure that they have a tried and tested Incident Response Plan (IRP) in place. A typical IRP will document the protocols relating to incident preparation, identification, containment, eradication, recovery, and post-incident activity.
- Secure data removal: To ensure data security, sensitive paper documents should be shredded when no longer needed. For hard drives containing sensitive information, wiping the data via a desktop utility doesn’t guarantee that it will be unrecoverable. Additional disposal methods such as disk encryption, degaussing, digital shredding, or even physical shredding/crushing can be considered for extra safety.
- Secure workstations: To prevent unauthorized access to sensitive data on desktop computers, do not leave them unattended when logged in. Instead, set them to automatically log out when inactive. Additionally, secure the server room with locks, alarms, ID badges, and CCTV cameras.
How to Achieve HIPAA Compliance
Understanding HIPAA’s three rules is crucial to implementing the right compliance controls. The Privacy Rule and Security Rule outline the necessary safeguards to protect PHI and ePHI, while the Breach Notification Rule specifies remediation requirements in case of a breach. Businesses must understand these requirements and review technical specifications to establish the appropriate safeguards, procedures, and policies. In addition to the above checklist, below are some additional tips to help you achieve HIPAA compliance.
Tip 1: Determine which rules apply to your organization
Firstly, you will need to determine if your organization qualifies as a covered entity. Covered entities are required to safeguard all PHI, including non-electronic data. If your organization is exempt or a business associate, you may still be obligated to comply with some Privacy Rule requirements if you have agreements with covered entities.
Tip 2: Conduct a risk analysis
To become HIPAA compliant, it is important to identify gaps in existing data security practices and assess how they align with HIPAA requirements using the Security Risk Assessment Tool, from HealthIT.gov. Audit current privacy and security policies and update outdated systems to maintain data security for PHI. Use the analysis to create a personalized HIPAA risk assessment checklist and develop a compliance plan to close security gaps and maintain HIPAA standards.
Tip 3: Identity which data needs extra protection
This includes protected health information, but not all of an organization’s data. The organization needs to determine what data (both digital and physical) is collected, stored, and used. They should review how much of it is protected health information, and how it is collected, retrieved, and deleted. It is also essential to note who can access the data, and how it can be accessed.
Tip 4: Establish accountability in your compliance plan
To ensure HIPAA compliance, it’s important to assign responsibility and establish accountability within your organization’s compliance plan. This enables clear communication and streamlines the process of monitoring, audits, technology maintenance, and training. Assigning responsible parties early can help maintain compliance.
Tip 5: Maintain comprehensive documentation
To comply with HIPAA guidelines, it is important to maintain detailed documentation of all data privacy and security improvements. This includes keeping track of policy revisions, attendance at compliance training sessions, and entities with whom PHI is shared. In the event of an OCR audit, certain documentation may be mandatory. However, it is better to document as much of the HIPAA compliance process as possible to quickly identify and address any security vulnerabilities.
Tip 6: Don’t hesitate to report security incidents
Organizations are mandated to report security incidents by submitting a breach report within 60 days of discovering the breach, as well as notifying all persons affected. Notification is mandatory for breaches impacting more than 500 individuals, and instructions for notification to local media should also be adhered to. The reported breach would then trigger an investigation by OCR, and it is advised that the organization conducts its investigation and documents its findings, which together with OCR’s investigation, can close security gaps and restore HIPAA compliance.
How Lepide Helps to Achieve HIPAA Compliance
The Lepide Data Security Platform helps you detect and respond to threats involving ePHI. Firstly, the built-in data classification solution will scan your repositories, both on-premise and cloud-based, and classify the ePHI as it is found. This will make it easier to assign the relevant access permissions to keep it secure. The Lepide platform uses machine learning techniques to identify anomalous changes to your ePHI, and when discovered, will send real-time alerts to your inbox or mobile app. You can also generate pre-defined reports that are customized to meet the HIPAA compliance requirements, thus enabling you to easily demonstrate your compliance efforts to the relevant authorities.
Risk Analysis and Management
Lepide helps organizations conduct accurate and thorough risk assessments of the potential risks and vulnerabilities to ePHI. With the Lepide platform, you can identify the risks and vulnerabilities so that you can make more informed decisions about which security measures need to be implemented.
Human Resources Security
When workforce members join, move or leave the company, it’s likely that their access to ePHI will need to be modified. Lepide enables proper security management processes by helping you identify what data your employees have access to, and how they are getting that access, and allows you to modify permissions from within the Platform itself.
Isolate Healthcare Clearinghouse Functions
If a healthcare clearinghouse is part of a larger company, the clearinghouse needs to implement policies and procedures that protect ePHI from unauthorized access by the larger organization. Using the access governance and user behavior analytics functions of the Lepide Data Security Platform will help you to implement this with confidence.
Lepide enables you to identify and respond to suspected or known security incidents. The platform also enables you to mitigate the potential damages of security incidents through risk assessment and threat surface reduction.
With Lepide, you can find out what ePHI you have, where it is located, how much of it you have, and who has access to it. You can also identify which of your users have excessive access to this data based on how they are using it. Lepide can also detect and alert you when permissions change that might affect your compliance.
Logging, Monitoring, and Alerting
Lepide keeps a detailed audit log of all changes being made that affect your ePHI. These audit reports are easily filterable, searchable, and sortable to aid your security investigations.
With Lepide’s advanced threat detection and detailed auditing, you can ensure that your ePHI is adequately protected and that you are aware of any changes being made that might affect the integrity of your data.
HIPAA Compliance FAQ
Who must comply with HIPAA?
HIPAA-covered entities in the US must adhere to all HIPAA laws. This includes medical insurance companies, healthcare providers, and healthcare clearinghouses. External organizations handling PHI data, such as accountants and lawyers, or exempt entities like life insurance companies or on-campus health centers, must also adhere to certain HIPAA compliance requirements.
How do you verify HIPAA compliance?
HIPAA compliance is verified and enforced by the Office for Civil Rights (OCR) within the U.S. Department of Health & Human Services through routine compliance check-ups and investigations into complaints.
What happens if you fail a HIPAA audit?
If an organization fails a HIPAA audit by the OCR, they will need to create a corrective action plan that includes tasks like data risk analysis and training employees. Even after completing the plan, the organization may still be fined for violations and individuals could face criminal charges.
What is the Minimum Necessary Standard?
The Minimum Necessary Standard is a part of the Privacy Rule that instructs covered entities to make reasonable attempts to limit access to PHI to the bare minimum needed to complete a task. Compliance with this standard can be achieved by identifying necessary roles, setting up role-based permissions, and conducting regular audits.
What are the Data Retention Requirements under HIPAA?
The HIPAA Privacy Rule does not dictate how long medical records must be kept, as each state has its own guidelines. However, HIPAA-related documentation (such as risk assessments, disaster plans, and business associate agreements) must be kept for at least six years.
Is employee training required under HIPAA?
Yes! It is essential for both covered entities and business associates handling PHI to undergo HIPAA training.