HIPAA Compliance Testing in Software: How to Comply With HIPAA in 2024

HIPAA has been governing the healthcare software market for almost three decades now. But, as ubiquitous as it is, not every healthcare organization is either willing to make sure their application is compliant with HIPAA, or has the skills and resources to develop HIPAA-compliant software. As a result, over 231 million US citizens became victims of a healthcare data breach.

In many cases, companies lose money in settlements due to failing to comply with HIPAA regulations, and in 100% of the cases, companies sacrifice their reputation among patients and partners. One of the most effective ways to ensure compliance with HIPAA requirements and subsequent safety of the patient data is through HIPAA compliance software testing, and that’s precisely what we’ll talk about today.

What Is HIPAA and What Are the Key HIPAA Requirements?

HIPAA, which stands for Health Insurance Portability and Accountability Act, is a legal document outlining the ways healthcare providers need to manage the data of their patients. HIPAA was enacted for multiple reasons, but most importantly, to keep patient health information secure and ensure complete access control only for authorized parties. Moreover, HIPAA became instrumental in the switch from paper to digital when it came to managing and transferring patient records.

HIPAA is divided into five sections, or titles, each having to do with different aspects of sensitive patient data protection and management. The titles include the following segments of software in the healthcare industry.

1. Security

Under the security section of HIPAA requirements, there are three safeguard types: technical, physical, and administrative.

HIPAA technical safeguards include the following points:

• There must be a strategy for safely releasing patient data in case of an emergency
• Data must be encrypted at the point where it leaves the internal firewall
• All users accessing patient information must be regularly logged out on their devices
• There should be a technical ability to know when the data has been tampered with by a third party

Here are some physical safeguards outlined by HIPAA:

• There must be a regularly updated list of locations where sensitive data can be accessed
• Each hardware device dealing with healthcare data must be accounted for
• If an employee can access the data from their mobile device, the data must be wiped after the employee leaves the organization
• There should be a set of clearly outlined policies for users with access to data

Finally, these are the administrative safeguards to consider:

• Risk assessment and risk management policies should be in place
• If any third parties have access to the data, a business associate agreement must be signed
• There needs to be a security and privacy officer at the organization
• There must be a contingency plan detailing the company’s security efforts

2. Privacy

• You must obtain the customer’s consent before using their data for marketing or research purposes
• There needs to be an NPP (Notice of Privacy Policy) and an additional policy in case someone did not comply with the NPP
• Your privacy principles need to be outlined and open to the public
• If a customer requests a copy of their record, you must be able to provide it within 30 days

3. Enforcement

• There must be access and authentication protocols in place
• Encryption must be used to protect PHI (Protected Health Information)
• You must ensure that any third-party tech partner helping develop or test your software is also HIPAA-compliant
• Security risk assessments must be performed regularly

4. Breach notification

• The responsible parties should be able to quickly identify a breach
• There must be a clearly defined procedure to deal with a data breach
• Users, partners, and authorities must be notified in case of a breach
• If more than 5,000 patients are affected by the breach, the media should also be notified

5. Omnibus

• A HIPAA Privacy and Security Awareness Training Program should be made available to all employees
• You must provide an electronic copy of the patient’s record should they request it
• The breach notification compliance plan should be regularly updated
• Your ePHI must always comply with the newly introduced standards

Why Does Healthcare Software Need to Be HIPAA Compliant?

To prevent data loss, the US Department of Health has introduced fines for companies whose products do not meet HIPAA compliance. The fines can range from $100-$50,000 for organizations that did not know about the data breach to up to $1.5 million when the company willingly did not comply with HIPAA requirements. There are known cases when the company reached a settlement with the victims amounting to $16 million. However, the chance of getting fined is certainly not the only reason to align your software with HIPAA guidelines.

The main reason to prepare your software for HIPAA compliance is that a software product meant to help people in the most sensitive subjects should have their complete trust. And gaining trust is never easy, but regaining it after a security breach is harder than anyone can imagine. This is the part of HIPAA that is not outlined in the official documentation but has an immediate impact on the present and future of your application.

Who Is Required to Be HIPAA Compliant?

Historically, health and human services in the US have a long and often complicated supply chain. This is why the HIPAA guidelines are applicable not only to the immediate healthcare providers, including hospitals and individual doctors, but also to a variety of other individuals working in the healthcare field:

• Health insurance companies
• Health plan providers
• Software service providers (developers, QA engineers, cloud storage providers)
• Medical billing companies
• Transcriptionists

Who Should Do Testing to Ensure HIPAA Compliance?

Defining the testing in the HIPAA segment of QA is one thing, but an equally important question is: “Is testing healthcare software difficult, and who should do it?” To answer the first part of the question, HIPAA software testing is usually more complex than other QA activities because there are so many regulations to take into account and so many different but equally important, detailed test cases to prepare. Therefore, the best HIPAA software testing engineers are the ones who have not only deployed healthcare apps before, but are also familiar with the specifics of testing for HIPAA compliance. This is why most companies prefer to work with QA teams who are HIPAA-certified.

Team Composition for HIPAA Compliance Software Testing

The exact composition of the team will depend on a number of factors, including the size of the application, the end goal of testing, the specifics and amount of test data used, and so on. The type, purpose, and logic of the application matter as well.

Let’s take a closer look at all the specialists involved in the HIPAA testing process:

• Chief Compliance Officer. This is the person in charge of the whole operation. Their job is to plan all the HIPAA compliance-related activities, coordinate the team’s efforts, and act as the link between the organization and the regulatory bodies.
• Privacy Officer. The job of a Privacy Officer is centered around the protection of customer data and ensuring complete confidentiality across the board. This line of work is governed by HIPAA’s Privacy Rule and deals with all things privacy.
• Security Officer. The Security Officer ensures the security of electronic protected health information (ePHI). This job heavily leans on the Security Rule of HIPAA and can involve activities ranging from security risk assessment to proper response to security incidents.
• Project Manager. The Project Manager plans and executes the HIPAA compliance testing process. Unlike a CCO, who deals with the big picture, the PM focuses on the nitty-gritty of the testing process, planning the activities and getting the team through the milestones.
• Testers. These are the people performing the largest chunk of the work when it comes to HIPAA testing. They go over the testing tasks, document the results, report to the management team, and maintain the integrity and efficiency of the testing process.
• IT Personnel. In addition to testers, a HIPAA testing project may require additional IT-related roles to deal with building the project infrastructure, implementing security measures, managing data encryption and access, and ensuring secure ePHI transmission.
• External HIPAA Consultant. In some cases, the project also needs to be overseen by an external HIPAA consultant. This should be a person with no relation to the project but with extensive knowledge of HIPAA rules and guidelines, so that they can conduct independent audits and provide recommendations.

When to Do HIPAA Compliance Testing?

Given the sensitive nature of patient information protected by HIPAA and the many examples of companies suffering financial and reputation losses due to failure to comply with the regulations, the importance of HIPAA compliance software testing is not to be argued with. However, there are three situations where HIPAA testing proves to be particularly integral:

1. When you are about to release a new healthcare application into the market.
2. When there are significant changes to the existing application, i.e., new functionality.
3. When HIPAA regulations have recently been updated.

How to comply with HIPAA with the help of software testing

In an ideal scenario, healthcare applications must follow HIPAA regulations already at the software development stage. However, HIPAA compliance should become a continuous work in progress: as the software changes due to updates or enhancements, and as HIPAA requirements get more sophisticated, HIPAA compliance testing in software applications dealing with healthcare becomes a standard part of developing and testing software. But how exactly do you develop a HIPAA compliance testing plan, and what should you include in one?

It’s worth noting that there cannot be a universal testing and QA strategy for HIPAA compliance in software testing because the products themselves can be very different, and there can be different amounts of HIPAA testing done previously. This is why it’s vital to check the software documentation first to find out what has already been done in the HIPAA compliance software testing areas. Here is what else your healthcare software testing strategy needs to include if you want to ensure that the product is compliant with HIPAA.

1. Functional and non-functional testing

When you are getting ready to release a new software product or an updated version of an existing product, HIPAA compliance is not the only area that needs your attention. The compliance of the application with both non-functional and functional requirements has an immediate impact on the way the audience interacts with the product and whether the users are likely to turn into loyal customers. This, in turn, influences both the company’s reputation in the market and its revenue. So whether you do functional testing and non-functional testing simultaneously with HIPAA-related testing activities or have them precede HIPAA compliance testing, this step is not to be missed.

This stage is strongly linked to sanity testing, where the team covers major HIPAA compliance software roles and functionality to make sure they’re all there and ready for further testing.

2. Roles matrix

One of the principles of a HIPAA-compliant application is role-based access, where different categories of authorized users have different access levels. To make it happen and to test it with maximum efficiency, there needs to be a role matrix. For each role, there should be a risk analysis, which is then displayed in the matrix using color coding. Typically, red means high-risk operations, yellow indicates medium risk, and green means low risk. The healthcare software development team will usually look at a few factors to determine the risk level, including the need for information disclosure, the likelihood of errors, and how much the customers are going to be affected in the negative scenario.

3. Security Testing and Penetration Testing

By its nature, security testing is at the heart of software compliance and is one of the most major HIPAA compliance software testing components. Security testing is meant to verify that the product has all the protection from unauthorized use and data breaches it needs. It’s also a good idea to invest in penetration testing — as an advanced subsection of security testing, penetration testing helps find even the smallest flaws within the software. The technique where QA engineers pose as hackers also helps identify security bottlenecks and prevent breaches in the future.

4. Test Cases

A test case is a valuable piece of test data that tells the team exactly what needs to be tested. In terms of test cases, HIPAA software testing must cover five key areas:

• Information disclosure — primarily, this includes role-based access to different types of information and patient allocation to a specific provider for a specific amount of time.
• User authentication — an area that deals with positive login scenarios (including username and password, fingerprint, or ID cards), as well as negative scenarios (login timeout, password change, repeated failed attempts)
• Audit trails — an operation meant to make sure that audit trail entries are the same or close to the expected entries. Moreover, the audit trails need to be encrypted and impossible to remove for specific access levels.
• Data transfer — in HIPAA compliance, not only audit trails and databases need to be encrypted, but also PHI when it’s transferred between mobile devices, sent to a different location, or moved to an offline storage facility.
• Correct data use information — every page within the application needs to include a link to a source where correct data use is explained, in addition to describing the operations linked to ePHI.

5. Testing Automation

While some of the aspects of HIPAA compliance testing can only be done manually, automated testing tools can significantly enhance the testing project and help obtain more reliable results. Automation testing can be particularly useful in security and penetration testing, when the team needs to use a variety of scenarios to make sure the testing process is complete. It can also come in handy with regression testing, saving the team time and resources on repeated tasks.

Best Practices to Achieve and Maintain HIPAA Compliance

We’ve already talked about the areas you need to check when ensuring the compliance of your application with HIPAA rules. However, there are some additional guidelines that will help you make sure your app is fully ready to be scrutinized by the most demanding HIPAA compliance officer.

• Appoint a responsible individual. You may have a large testing and QA team, but there needs to be one person (i.e., a security officer) who will oversee the entire process and be aware of all the changes and the subsequent steps the team needs to take to ensure compliance.
• Keep track of data movements. Whenever patients or providers enter healthcare data, or it’s transferred to another physical or cloud storage location, or any other significant or minor changes occur, the changes need to be recorded and the data management strategy needs to be adjusted.

• Train and update your employees. In addition to the security officer or a person in a similar management position, the day-to-day tasks of ensuring compliance with HIPAA will be done by your employees. This is why they need to have a complete idea about HIPAA and what they personally can do to ensure it.
• Make sure your business partners are compliant too. These days, healthcare software products rarely exist in isolation, as software development companies have come to rely on third-party partners for infrastructure, additional services, and so on. It’s vital to ensure that the partners are also HIPAA-certified.
• Have a breach reaction policy. Security breaches seem to be almost inevitable, but the way you react to them will greatly impact your business reputation. It’s also one thing to react properly to a breach, but even being aware of a recent breach is not always easy. This is why your breach-related policies need to be robust and regularly reviewed.

Factors Influencing the Cost of HIPAA Compliance Testing

Before we talk about the cost of testing your software for HIPAA compliance, we need to answer one question: Who is going to test the software application and see if it complies with HIPAA rules? There are several directions your project can go in terms of the team. First, you can entrust the work to your in-house QA department, provided that there is one and that the members of your testing team are familiar with the ins and outs of HIPAA compliance.

Another option is to create a HIPAA testing department from scratch, hiring only the most knowledgeable engineers with relevant healthcare experience. The downside of this method is that it takes a lot of time and money to establish a brand new department, so it may be a while before you start getting results. Plus, it doesn’t always make sense to hire an entire new team when you only need to test one application and may not need long-term commitment.

This is why many companies that want to be HIPAA-compliant now prefer to outsource their testing needs to an outside vendor. This method has multiple benefits for a project:

• Cost-effectiveness — you don’t need to take care of hiring, office space, equipment, or onboarding.
• Niche expertise — you get to choose specialists who are experts in exactly the right field.
• Flexibility — you can hire a team for a limited time and scale the cooperation up and down as needed.

Of course, before you make any commitment, you need to make sure that the QA engineers are equipped to tackle the challenges specific to your project. At the very least, you need to make sure that they have experience with healthcare applications and HIPAA regulations. It’s also a good idea to work only with engineers who are HIPAA-certified: this is the main sign that they know their way around HIPAA compliance.

Now let’s move on to the question of costs. While keeping your budget lean is not the only reason to consider outsourcing, it’s still one of the main reasons why companies do it at all. And there can be a significant difference in the prices: an in-house Junior Software QA in the US can cost you around $60 per hour, while an engineer with similar qualifications in Eastern Europe costs only $20-30 per hour. In the case of more experienced engineers with niche expertise, the price difference can be even more stark. In addition to that, the following factors typically influence the cost of a HIPAA compliance testing project:

• The nature and complexity of the application
• The current state of HIPAA compliance
• The relevant technical testing safeguards
• The required types of testing
• The number and complexity of the test cases
• The need for testing automation and its scale
• The use of paid testing tools (including security and penetration)

Challenges of Ensuring HIPAA Compliance in Software Testing

Testing healthcare applications for HIPAA compliance is a complex and resource-intensive task. Even with careful planning and an experienced team at hand, the project stakeholders can still face certain challenges when trying to ensure full HIPAA compliance. Here are the most common challenges teams may encounter along the way.

Complexity of Regulations

As evidenced by the previous parts of this article, HIPAA regulations are extensive and highly intricate. Without any prior experience, grasping the entire scope of HIPAA rules can be very challenging. And even with some experience in the field, the sheer number of rules and regulations stipulated by HIPAA may prove downright impossible for one person to master.

Presence of Legacy Systems

It’s not at all uncommon, even for established healthcare software solutions, to at least partially rely on legacy systems. These systems may do the job well, but they are not always compliant with modern industry guidelines, including HIPAA. Bringing these legacy systems up to modern standards can be a costly endeavor that also requires a lot of time.

Constantly Evolving Security Threats

Just as healthcare software is constantly getting more functional and more advanced, the elaborateness of security threats is also rapidly increasing. This means that the testing team should not only stay on top of the current security threat landscape, but also be able to predict where it can go from there. Also, the emergence of new technologies, including both software solutions and physical devices, creates an additional challenge of accounting for more potential threat origins.

Resource Limitations

HIPAA compliance software testing is an essential step in releasing healthcare software, which means it’s not something companies can skip. This also means that small and medium organizations may not have enough financial and human resources to go through every single step. Moreover, HIPAA testing is a race against the clock, as new healthcare software is released regularly, the competition is getting more and more fierce, and releasing an application that is not HIPAA-compliant is not really an option..

Training the Team

HIPAA testing is a subject that requires continuous training and education for the team, and not just for the people directly involved in the testing process, but also for every employee at any level who may in any way be connected to the organization’s HIPAA and other compliance-related policies. Timely and comprehensive training takes time and effort, but it can prevent many subsequent challenges, including complications that stem from human error.

Third-Party Vendor Management

Working with third-party vendors and other business partners is a common practice for healthcare organizations. But, as much as these practices can enrich the application and its functionality, they can also create an additional challenge, since it’s important to ensure that every provider and business partner is also HIPAA-compliant. Otherwise, the security of PHI can be under threat.

Maintaining HIPAA Testing Documentation

Testing documentation is incredibly important for any development and QA project, but it’s absolutely integral for HIPAA compliance testing. Extensive documentation not only provides current and future employees with the information they need but also serves as the basis for any audits and inspections the company may undergo. At the same time, creating and maintaining the documentation on the necessary scale may be challenging when there is limited administrative support.

Current Trends in Testing HIPAA-Compliant Software: Where Do We Go From Here?

Both healthcare regulations and quality assurance are two rapidly developing industries, which means that HIPAA testing transforms year after year, right before our eyes. 2024 promises some interesting developments in the HIPAA compliance testing field, and these are the key trends that deserve your attention.

Continuous Monitoring Practices

HIPAA testing is not a one-and-done activity, as effective threat control and risk prevention are only possible when security and compliance monitoring are done on a regular basis. This is exactly what organizations are now trying to achieve with dynamic dashboards, which integrate various types of security and compliance metrics from different sources, presenting the real-time state of the application and alerting the team when anything requires their attention.

Automation and AI-Based Testing Strategies

Both automation and Artificial Intelligence play an increasingly important role in the task of HIPAA testing. Automation helps process large data volumes faster and without the risk of human error skewering the results, as well as enhances the vulnerability scanning and threat prevention process. AI, in turn, can successfully analyze patterns and behaviors to detect abnormalities, identify security threats, predict security breaches, and maximize the efficiency of threat detection processes — something that is impossible to ensure with manual techniques alone.

Introduction of Enhanced Security & Encryption

In 2024, we are witnessing a rise in the use of end-to-end encryption for ePHI and other sensitive data, both in storage and in transit. In addition to strong encryption algorithms, this trend also includes the implementation of secure key management practices. Another security technology trend is Data Loss Prevention, which aims to monitor the flow of sensitive information, preventing unauthorized access and data breaches.

Shift of Focus to Risk-Based Compliance

The current approach to ensuring HIPAA compliance is designed to be proactive rather than reactive, and one of the crucial components of this approach is risk-based compliance. According to this approach, the most critical areas of the application and infrastructure are prioritized based on their risk level, and high-risk processes are put at the center of the team’s compliance testing efforts. This trend is also all about personalization: a customized plan and tailored approach will always generate more comprehensive results than a one-size-fits-all procedure.

Increased Attention to Patient Rights

The focus on patient rights and patient data security is understandably a big part of ensuring HIPAA compliance. Right now, it includes not just implementing advanced security tactics to ensure the integrity of the data, but also making it easier for patients to access and manage their data. This trend also includes informing patients about how their data is used, where it is stored, and what they can do with their PHI. In other words, transparency is becoming just as important as security and breach prevention.

Final Thoughts

If you work in the healthcare software domain, making your product compliant with HIPAA is not just an option to consider — it’s what your business requires to occupy a decent place on the market and ensure a decent reputation among customers, business partners, and authorities. It’s important to continuously think about HIPAA requirements already at the development stage and regularly engage in HIPAA compliance test efforts to protect the application from preventable security issues and subsequent revenue and reputation losses.