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What is HIPAA Compliance Testing and how to perform it on Healthcare Software?

hipaa compliance testing
Today, the healthcare industry is monitored and driven by various standards and rules created and implemented around the world. HIPAA compliance is one such standard that deals with the healthcare data and ensures the data’s protection and security. After monitoring over the past few years, the market trends of HIPAA compliance are now predicted to grow by 3.56 billion dollars during 2020-25.

HIPAA guidelines enforced by the US government revolutionized handling and protecting the data in the healthcare industry. The organizations dealing with healthcare data need to comply with HIPAA requirements. Such organizations need to administer a strict internal protocol and invest significant efforts to ensure their healthcare software system’s soundness.

This article discusses HIPAA compliance, covering all of the following points in detail:

What is HIPAA compliance?

HIPAA (Health Insurance Portability and Accountability Act) is a set of standards and rules defined and implemented by the US Department of Health and Human Services in 1996 to handle sensitive healthcare data security. Companies dealing with PHIs (Protected Health Information) and ePHIs (electronically Protected Health Information) must have their systems compliant with HIPAA. Entities dealing with payments, providing treatment and operations in healthcare; and business associates who have access to patient’s information, payments, treatments or operations, all must meet HIPAA compliance.

Why is HIPAA compliance important?

HIPAA compliance brings numerous benefits to the healthcare industry. It helped in:

  • the transition from paper records to electronic health records,
  • administers healthcare functions,
  • ensures the secure sharing of PHIs and
  • improves the organization’s overall efficiency.

The most significant benefit of HIPAA compliance is for patients. HIPAA establishes rules that limit the access and control of health data. It applies restrictions on the sharing of data, manipulation of data and who can view the information. Patients are also given control over with whom their data can be shared. Patients who wish to take more control over their healthcare can obtain a copy of their records. The facility of obtaining copies of healthcare information helps patients in migrating from one healthcare provider to another. The information of treatment and test reports can be passed on; tests do not need to be repeated and new healthcare providers get the complete history of the patient’s health. Such benefits make HIPAA compliance essential for all healthcare organizations.

What are the steps to achieve and maintain HIPAA compliance in your healthcare software?

steps to achieve and maintain HIPAA compliance

While implementing HIPAA compliance, you must ensure that the documentation, policies and procedures are pulled together in your facility. Here are the steps required to achieve HIPAA compliance:

  1. Update old policies and procedures. The changing rules and standards require updating the policies and procedures of the organization. It is necessary to update according to the prescribed criteria to be compliant with HIPAA.
  2. Check for compliance with business partners.. With the increase in digitization, healthcare organizations are going online and storing data electronically. Every company dealing with electronic healthcare data needs to be compliant with HIPAA.
  3. Identify a security officer. A person who can take charge of the HIPAA compliance program must be appointed. The individual would be responsible for checking the regular updates, tracking patients’ data and managing the HIPAA compliance system.
  4. Train and educate employees on keeping data safe. Staff training and educating employees is a part of the HIPAA compliance system. The compliance committee needs to make sure that everyone knows and is updated with the current compliance system.
  5. Keep regular track of data for its safe storage and transfer. It is strongly suggested to have an audit trail to follow the data entered by patients and workers to detect and eliminate any potential breach.
  6. Recognize the breach. A breach may occur anytime when PHI falls into the wrong hands. The encountered breach and the reason for the occurrence of that breach must be reported and addressed carefully.
  7. Plan for handling the breach.The first and foremost action to be taken is Risk analysis when a violation has occurred. The administration is responsible for conducting the risk analysis for security compliance. This analysis can help identify the security gaps and your IT experts will figure out how to handle those gaps.

What is the process of HIPAA Compliance Testing?

Whenever a HIPAA compliance defect occurs, it must be treated with high priority by correctly indicating them in a bug tracking system. It must be visible to the whole team, including the project leader and must be fixed with the highest priority. However, it is always beneficial to test the system and ensure that it is HIPAA compliant. Some of the practical testing strategies are:

Sanity Testing

Conduct sanity testing as early as possible in the development phase to detect the significant defects in the application’s HIPAA compliance. A high-level Sanity Testing must be performed in the following areas:

Verify the following for high-risk roles:

  • A specific role-based user can authenticate the login successfully and is granted all the accesses required (view, modify, add and delete).
  • Every action performed, including viewing, modifying, user authentication, etc., must be tracked and recorded in the audit trail.

Verify encryption in areas mentioned ahead:

  • ePHI (electronic Protected Health Information)
  • Audit trail entries.

Create Roles Matrix

Since the HIPAA compliant applications allow role-based access, the foremost task in HIPAA compliance testing would be to identify the roles and their accesses. The role identification is made with customer consultation, who then approves the risk associated with each component and operations relationship. The factors on which the level of risk depends are information disclosure, probability of errors, frequency of use and impact on the customer in case of error.

To develop a role matrix table, associate the colors with the risk level and indicate the roles that have access to perform operations (view, add, delete and modify). Colors displaying risk level are:

Red indicates high risk,

Yellow indicates medium risk and

Green indicates no/ low risk.

An example described ahead would explain it better. Suppose an administrator performs operations like view, add, delete and modify an appointment. In the role matrix table, the actions that involve security risks will be mentioned in red. In this case, all the administrator’s activities involve high-risk exposure, so all the administrator’s tasks will be mentioned in red.

Create Test Cases

HIPAA compliance is supported by traceable records of what is tested and every test case is written with explicit detail. The executed steps are broken into low-level actions with specific expected results of that action.

What areas should be considered for HIPAA compliance testing?

Five main areas need specific consideration while HIPAA compliance testing:

factors to consider for hipaa compliance testing

User Authentication

Testing of user authentication ensures successful login for each role. User authentication to applications is generally one of the following:

  • Ownership-based; example: ID cards
  • Biometric-based: example: fingerprints
  • Knowledge-based; example: user id and password.

Besides, the negative path test also needs to be covered. Test cases such as:

  • Login failure for an invalid password, incorrect password, invalid user-id, empty password/user-id and expired/ blocked account.
  • Lock account after repeated failing logins
  • Login idle timeout
  • Login success after password change

Information Disclosure

  • Role-based access (RBA): It groups users into specific classes based on their levels of access to particular components.
  • Patient allocation (PA): The patient allocation supervisor is responsible for assigning patients to a specific healthcare provider for a fixed duration, such as a shift in a hospital on a particular floor.

Audit Trails

Analysis of audit trails is conducted to have more thorough testing. A comparison study is done to verify that the entries produced are similar to the expected entries. Verify the following:

  • Verify that all audit trail entries related to every operation performed on ePHIs exist. Use Role Matrix to ensure that no action is missed while writing detailed test cases. It is also essential to test and ensure that all entries are created for operations performed on all types of devices.
  • Verify that all entries consist of required information such as date and time of action, user access level, details of activities performed, user information, and other related details.
  • Test and verify that audit trail entries cannot be removed.
  • Verify that audit trail entries are accessible to specific and authorized users only.
  • Verify that audit trails are encrypted.

Data Transfers

Along with primary encryption verification performed on databases and audit trails while sanity testing, it is essential to use a network analyzer tool (e.g., Wireshark) to ensure that all ePHIs are encrypted when:

  • Data is accessed between all mobile devices using the application and all workstations.
  • Information is transferred to any external location.
  • Data is moved to any offline storage space.

Information on correct data use

Ensure that each page on the application has a help link to explain correct data use. It must also contain information related to each specific operation that involves ePHI.

What are HIPAA compliance risk assessment tools?

hipaa compliance assessment tools

While there isn’t an official toolkit available for risk assessment, HHS provides guidelines to ensure that risk assessment meets its ultimate goal of eliminating breaches and keeping data safe. Following methods must be considered for conducting risk assessment:

  • Vulnerability assessments: It is a simple process of identifying, quantifying, and prioritizing vulnerabilities in the system.
  • Penetration tests: It is a testing process that checks a computer system, a network or a web application for any security gap. It can be automated with software applications as well as can be performed manually.
  • External Perimeter tests: During external testing, the assessor trying to gain internal network entry is detected. This testing keeps a continuous check on externally facing assets for the organization.
  • Wireless security tests: Wireless testing examines wireless devices such as gateways to exploit and disclose any vulnerability.
  • Internal assessments: It differs from vulnerability assessments because it exploits what data is being exposed.


In the healthcare industry, the stakes are very high. Non-compliance to HIPAA may lead to various disastrous consequences, from bad reputation to loss of patients’ trust. Besides, non-compliance may be considered a criminal act and lead to a lawsuit. Therefore, compliance with HIPAA is not a choice but a necessity to safeguard patients’ health.

No healthcare organization would like to jeopardize their patients’ health in the name of noncompliance. Now, if you’re asking yourself, “Is my healthcare software HIPAA Compliant?”We have the answer for you.

We can perform HIPAA compliance testing to ensure that your healthcare software complies with HIPAA and your system is safe and secure. Besides, if you’re looking to build HIPAA compliant healthcare software from scratch, we can also build a custom HIPAA compliant healthcare software based on your requirements. Get in touch with our experts and convert your idea into reality.

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Author’s Bio

Akash Takyar
Akash Takyar
CEO LeewayHertz
Akash Takyar is the founder and CEO of LeewayHertz. With a proven track record of conceptualizing and architecting 100+ user-centric and scalable solutions for startups and enterprises, he brings a deep understanding of both technical and user experience aspects.
Akash's ability to build enterprise-grade technology solutions has garnered the trust of over 30 Fortune 500 companies, including Siemens, 3M, P&G, and Hershey's. Akash is an early adopter of new technology, a passionate technology enthusiast, and an investor in AI and IoT startups.

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