Healthcare Software Testing: All You Should Know in 2026

Only two years ago, an average software data breach cost US medical businesses $8.64 million (source ). Failure to establish app interoperability may cost such companies more than a billion (source ). Finally, poor performance can turn 53% of users from your medical website. How can you avoid such losses (source )?

Healthcare application testing becomes a solution to these and many other problems. QA specialists help you detect and fix the most significant vulnerabilities of your software. Therefore, you will launch a secure, efficient, and user-friendly product that brings real value to patient care services.

Do you need more detail on QA healthcare services? Check our new material to understand the value and the essentials of software testing in the healthcare domain. With our relentless expertise in healthcare application testing, Binariks is ready to help you with quality assurance services for your business.

Quality assurance in healthcare: 6 Essential considerations

There is no universal pattern for QA medical services. Phases of a healthcare software testing project completely depend on software requirements and may differ from project to project. Besides, such demands determine the tech stack required for quality assurance in healthcare. In some projects, QA specialists manually review an app with tools like Postman and Apache JMeter . Meanwhile, other healthcare software testing tasks require using automation software, such as Jest .

Even though medical software testing is very diverse, there are some essential app features you must review to deliver a quality medical product. Let's proceed with the most valuable considerations of software testing for medical devices.

1. Security and compliance testing

The medical technology industry is shaped by diverse regulations, such as HIPAA . According to HIPAA Rule , a healthcare provider takes responsibility for private health information (PHI) stored in their medical software. Even minor app vulnerabilities can lead to massive data leaks. Meanwhile, businesses that fail to secure PHI can be fined up to $1.5 million or face liability (source).

Healthcare testing is the right solution for securing your medical software from data leaks. Automated medical software testing will help you determine whether all app endpoints are fortified with authorization and access permissions. In addition, healthcare application testing specialists determine whether your software keeps up with the Transport Layer Security (TLS) . The latter is a common protocol established to encrypt the communication between web applications and servers.

If you build an AWS-based healthcare app, you can use numerous tools from the AWS tech stack for healthcare testing. For example, you can create specific software rules with AWS Config . After that, AWS will automatically check your software for compliance with these rules. Another AWS tool relevant to quality assurance in healthcare AWS tool is IAM Access Analyzer . It allows you to detect and delete odd software permissions that make your app more vulnerable.

2. UI/UX healthcare application testing

Even if your product runs well and has no security or connectivity issues, a poor UI/UX design can ruin everything. This problem is especially relevant in the medical industry. Many of its clients are senior citizens that are often uncomfortable with using new technologies. Therefore, to make your patient app work efficiently, you should create an intuitive design devoid of any user inconveniences. UI/UX healthcare testing helps you determine any challenges the users can encounter while navigating your application.

UI/UX healthcare IT testing can be roughly divided into two stages.

1. Static healthcare application testing. It involves a general review of a non-dynamic app design created with Figma or a similar platform. At this stage, QA specialists review whether the app's design fits user requirements and its business logic.

2. Dynamic review phase of software testing in the medical industry. Here you get an opportunity to see how your app design deals with various requests and runs in dynamic conditions.

There are numerous approaches to designing healthcare application testing. Here are the most popular ones.

In sum, design healthcare testing helps you develop a highly usable application that suits a broad range of clients.

3. Medical device testing

IoT systems have become an integral part of the medical industry. Practitioners rely on them so much that an IoT system fault can disrupt the entire process of care. Focus on medical device software testing as the right way to secure your IoT systems from data inconsistencies and other problems.

An app sees a device but cannot connect to it? A wearable is connected to the system but fails to communicate data? software testing for medical devices brings solutions to all such problems and many more.

At this stage of software testing for medical devices, you will review the work and the connectivity of medical device databases. A tried and trusted solution is to apply InfluxDB , an open-source time-series database that empowers building IoT systems. QA specialists review the implementation of this database at the stage of medical device software testing. Hence, they ensure that no medical device data is lost.

4. Interoperability healthcare IT testing

Interoperability gains momentum in healthcare. As medical systems grow bigger and more complex, their connectivity and smooth data exchange become vital. Major industry influencers, such as ONC and CMSs, introduce provisions facilitating the development of healthcare interoperability. Meanwhile, the failure to comply with such regulations can prevent your business from participating in insurance programs bringing attractive incentives. For many companies, it is the main reason to remember the importance of quality assurance in healthcare.

Healthcare software testing helps you indicate any issues disrupting the interoperability of your apps and platforms. QA specialists use manual requests to check your software's data exchange instances and review them for compatibility with the FHIR standard. In addition, a medical software testing specialist applies different testing scenarios to examine your app's connectivity with various third-party services. After reviewing the interoperability of medical software solutions, you will be able to make the most complex healthcare IT systems run smoothly.

5. Performance testing

Performance review is one of the most essential phases of software testing. When it comes to healthcare, where speed and efficiency are a must, performance medical software testing is vital. It is the right way to determine any glitches that disrupt the app's work. Besides, performance healthcare IT testing helps determine whether an app complies with the essential productivity requirements. The key point is to understand how such variables as location, device, connection quality, or the number of simultaneous users affect the app's speed. This helps developers build highly scalable apps that run smoothly regardless of conditions or data loads.

Typically, performance healthcare testing is arranged according to different scenarios. Functional behavior review tools, such as Apache JMeter , measure the app's productivity in different conditions. Besides, QA specialists use manual testing software, such as Postman , to create requests sent to the app endpoints or connected third-party services. Such requests emulate different data loads, operating systems, and other variables affecting software performance. Hence, such medical software testing helps you determine situations in which your app may struggle to work properly.

6. Other types of testing

The five types of software testing for medical devices outlined above are part of every healthcare software testing project. However, other types of testing are possible depending on the project specifications. After all, medical apps need to be tested from multiple angles to ensure their success.

• Functional testing confirms that the app performs as expected, even in uncommon scenarios, by testing the system against its intended functional requirements.
• Cross-browser testing ensures consistent performance of the applications across phones and operating systems (Android, iOS).
• Verification of the mobile version focuses exclusively on whether the app performs well on the mobile device.
• System integration testing aims to identify how different components of the medical software app interact with one another. The purpose is for the components to integrate seamlessly and work smoothly.
• Positive and negative testing involve testing the applications with valid and invalid inputs to check whether it performs as expected in both scenarios.

Why should you implement quality assurance in medicine?

A minor technical issue can turn a client away from your product. However, in the healthcare industry, the outcomes of such problems are even more significant, as the price of a mistake can be a patient's health. Surely medical software faults do not necessarily ruin the entire process of patient care. However, they may be damaging to healthcare businesses in many other ways. Here are the most common medical software implementation issues:

• Failure to comply with ONC or CMS-initiated medical interoperability regulations that prevents businesses from participating in profitable insurance programs;
• Security breaches that can lead to significant fines under HIPAA compliance requirements;
• Medical data glitches leading practitioners to wrong decisions;
• Data inconsistencies that delay the release of new software or disrupt the work of the existing applications;
• UI/UX design issues that make an app inconvenient for its users;
• Situations when your software runs differently on distinctive devices or operating systems;
• Issues with medical device software connectivity, which disrupt patient monitoring.

Particular implementation issues that might occur with your medical software depend on many factors, and the exact type of healthcare software is one of them. Regardless of the type of software, the best course of action is to prepare for as many outcomes as possible before starting QA testing in healthcare.

What categories of healthcare software should you test?

The healthcare software market is diverse, and there are various types of software for testing. Depending on the type of software, the content of the test plan can vary a lot. Overall, common categories of healthcare software are:

• Healthcare mobile apps: Mobile applications used on the go, such as telemedicine apps, personal health management apps, medical reference apps, and others. The convenience of use and UI/UX design matter a lot for a great experience with such apps, as non-professionals tend to interact with them the most. User experience is even more important for testing healthcare applications of this type than for other medical software.
• Healthcare web apps: Web-based applications, including electronic health records, medical reference databases, patient portals, and others. These applications are more complex and have more features than mobile apps.
• Healthcare desktop software: Software used on desktops and laptops, for example, clinical decision support systems or practice management software. Healthcare desktop software is mainly meant for professionals. Patients and casual users do not use it in most cases. The healthcare software testing process of desktop software should have an extra focus on interoperability with other systems used in a professional setting.
• Medical device software: Type of software integrated with medical devices directly. This includes software integrated into the device's hardware, such as insulin pumps, diagnostic software for devices like MRI machines, or software used to control the delivery of drugs. This is, by far, the most complex type of software that goes through the most rigorous QA. Medical device software is designed for real-life situations, and the process and outcome of the treatment directly depend on it.

Ultimately, all types of medical software have to go through software as a medical device quality assurance. Quality assurance in healthcare includes compliance testing, app performance analysis, medical devices security testing, and many more. While implementing this stage of medical app development, you secure your business from many reputation threats, non-compliance fines, and even liability. Here are some stats that highlight the importance of medical device testing and quality assurance in medicine.

Challenges in healthcare app testing

Software as a medical device quality issues in healthcare corresponds with the types of testing discussed in the previous section of this article, such as UI/UX issues, security, and compliance. Ultimately, there are many unique challenges caused by intricate systems involved in the development of medical apps and elevated data sensitivity.

1. Security and data privacy

According to the study that assesses the ratings of mobile health apps among users, most applications receive the lowest scores when it comes to security and privacy. At the same time, users remain satisfied with the transparency, health content, and technical content of most applications. Such contrast is caused by the fact that security and privacy are significant concerns for the healthcare industry and apps in particular. Security is a key issue to focus on with the amount of sensitive personal information in medical apps, many regulations affecting the industry, and the high probability of breaches that still occur.

Mobile app ratings according to different criteria source

2. Complexity of testing healthcare applications

Software as a medical device quality testing medical apps is more complex than many other types of software due to the highlighted interoperability, need for compliance, data accuracy concerns, and other issues. Because of so many varying goals, apps often need specialized expertise not provided by your in-house team. Turning to outsourcing is a solution that helps efficiently manage such complexities. Regardless of how well your in-house team navigates the testing process, it may be efficient to consult software QA experts at Binariks .

3. Clinical accuracy

Healthcare applications face an additional demand for clinical accuracy on top of other testing-related challenges. The accuracy of medical apps finding is the subject of skepticism among patients and medical professionals alike. Regardless, studies confirm positive outcomes for many healthcare apps. In particular, recent research demonstrated that symptom-assessment apps could give urgent advice on safety similar to GPs, and there is room for improvement with technology development. Clearly, there should be extra efforts to ensure that the advice provided by healthcare apps is reliable from the medical perspective.

Accuracy of urgency advice across apps source

Typical healthcare software testing team

The composition of the healthcare software QA team varies greatly depending on the size, scale of the project, and budget. Some healthcare software testing process roles are unique to the healthcare software industry, while others are just like in any other software testing. Here are the common crucial roles encountered in most healthcare testing teams:

• QA manager: The team manager responsible for supervising the testing process, ensuring that the purpose is met within the expected deadline, and that the result is up to all requirements. The manager selects quality assurance tools in healthcare.
• Test engineer: A professional involved in manual and automated testing. A test engineer designs and executes test cases, analyzes test results, and reports defects.
• Test automation engineer: Responsible for developing and implementing automated tests to ensure that results meet expectations. Unlike a general test engineer, a test automation engineer is not involved in manual testing.
• Compliance consultant. A unique actor in healthcare app testing, a compliance consultant ensures the software and all testing processes adhere to relevant regulations and standards in the healthcare industry, such as HIPAA, HITECH, and FDA.
• Test lead: A leader of the particular testing project who develops a testing plan and oversees the testing schedule.

Binariks provides healthcare app testing services

Previous expertise is essential when selecting a software as a medical device quality testing team because healthcare apps pose challenges not found across other software development sectors. Binariks has expertise across all stages of quality assurance services for medical software, including automated and annual testing. Our team has created solutions for all types of healthcare software, including mobile apps, web apps, desktop software, and medical device software.

We focus on all stages that matter the most for medical software, including UX audit, security and compliance evaluation, and performance testing in different environments. What is more, Binariks is a healthcare application testing company that offers software maintenance across the entire lifespan of the product to make sure that the software is up to date with the latest healthcare market trends.

What affects the cost of healthcare software testing?

The factors affecting the cost of healthcare software quality assurance directly correlate with all factors discussed in other sections of this article, including:

• The complexity of the application: The more complex the software, the more time it will take to develop it, leading to higher costs.
• The size of the team and specific roles: More team members lead to higher costs. However, assigning the roles efficiently enough may result in saving resources instead.
• Interoperability with other systems and apps: The more integrated the software is with different types of software and healthcare systems, the more costly the process will turn out.
• The implementation of testing tools: The more testing tools the team uses, the greater the final cost of testing. Automation tools, in most cases, are the most costly ones because of the complex, innovative technologies behind them.
• The balance between outsourcing and insourcing: The final price may depend on how much work is assigned to in-house and outsourcing teams.

Final thoughts

A clear understanding of healthcare domain testing essentials and the importance of quality assurance in healthcare matter a lot. Unfortunately, it is nothing without QA medical specialists that can review your app and determine all its vulnerabilities. The best solution is to outsource medical software testing to reputable software engineering professionals.

That is when Binariks QA medical testers come into action. We have solid expertise in developing and testing healthcare software. For example, our healthcare domain testing specialists reviewed the quality of a primary care platform designed for remote patient monitoring. We thoroughly examined its interoperability with third-party services and eliminated any issues pertaining to medical device connectivity. Our healthcare software testing specialists also fortified the application to comply with HIPAA rules. Check our case study to get more information on this project. Make sure to review our portfolio for more information about our QA medical expertise.

Contact us if you want dependable professionals to handle your healthcare domain testing. Remember that there is no place for faults and vulnerabilities in medical software development.