Digital health refers to the use of technologies to simplify access to healthcare services and enhance patient experiences. It covers everything from monitoring and managing health conditions to providing remote consultations and facilitating communication between healthcare providers and patients.

It’s important to note that the popularity of healthcare software is on a steady rise, gaining significant traction in 2020 and following an upward trend ever since. A recent analysis shows that the use of telehealth services today is 38 times higher than before the COVID-19 pandemic. Other factors contributing to the rising popularity of digital health is the shortage of healthcare workers as well as easier access to healthcare. The World Health Organization predicts a shortage of around 10 million health workers by 2030, while a recent survey reports that 86% of people using telemedicine have agreed that it has made it easier for them to get the care they need.

Additionally, with the global digital health market forecast to hit USD 780.05 billion by 2030 with a CAGR of 16.1%, more and more healthcare software providers are looking to strengthen their position and get ahead in the market. This brings us to our topic of focus—testing healthcare software.

The main goal of digital health is to achieve three things—greater efficiency, improved patient care, and reduced healthcare costs. But to achieve this goal, companies developing healthcare software must conduct comprehensive software testing to ensure the software meets all requirements—or face severe repercussions. This, however, is not always simple and straightforward.

How is healthcare software testing different from standard software testing?

Healthcare software testing presents unique challenges due to the intricate nature of the services provided in the healthcare industry. There is simply no room for error. As a result, it’s important for companies to take extra caution when testing their healthcare software products to ensure that they work as intended and do not fail users.

In the race to release new healthcare software, however, many companies tend to overlook critical aspects of their software, like security, accessibility, interoperability, and regulatory compliance. Such oversights can lead to legal trouble, increased costs, and prolonged development times, which is why following efficient quality assurance practices when testing healthcare products is pivotal.

In this blog post, we will explore the key challenges of healthcare software testing, investigate how they can be overcome, and look at some of the most common issues encountered by our QA engineers when testing healthcare software.

#1 Challenge: Security testing

Close-up of a stethoscope and person using a laptop

Healthcare software deals with highly sensitive data, including patient medical records, making security a crucial factor for patients who use or plan to use such software. In fact, a recent survey showed that 30% of people would be more likely to adopt digital health if they had more confidence in data security and privacy.

However, performing security testing on healthcare software can be challenging. Quality assurance teams must ensure that data is not exposed or compromised during testing. This requires a thorough understanding of the system, regulatory requirements, and potential vulnerabilities. Furthermore, QA engineers must consider the complexity of the software, integration with other systems, and different use cases, which can all impact security testing.

The main challenges of security testing for healthcare are related to:

Complexity of the software. Healthcare software is often complex and includes multiple layers of functionality. This complexity can make it difficult to test for security vulnerabilities, as the interactions between various components, like patient portals and electronic health records, can be difficult to predict and replicate.
Limited access to live patient data. Accessing real patient data can be challenging due to privacy concerns and regulatory requirements. This can make it difficult to test the software in real-world scenarios and may require additional measures to ensure the security and privacy of patient data during testing.
Compliance with regulations. Healthcare software is subject to a wide range of regulations and standards for data security and privacy, including HIPAA, GDPR, and PIPEDA. Testing must ensure compliance with these regulations, which can add additional complexity and constraints to the testing process.
Integration with other systems. Healthcare software often needs to integrate with other systems, such as medical devices and hospital management systems. This integration can introduce new security vulnerabilities and require additional testing to ensure the security of the overall system.
Unexpected user scenarios. Healthcare software is used by a wide range of users: healthcare providers, patients, and administrative staff. Each of these user groups may have unique needs and use cases, which can lead to unexpected scenarios that may not have been fully anticipated during the design and development of the software. Testing must be comprehensive and include a wide range of user scenarios to ensure the security and reliability of the software in real-world use.

Thoroughly testing the security of healthcare software requires quality assurance teams to have a deep understanding of the system, regulatory requirements, and potential vulnerabilities, along with technical expertise and attention to detail.

“When testing the security of healthcare software, we focus on testing multiple user scenarios where patient data and security may be at risk. For example, we thoroughly check authentication procedures with various methods such as bankID, eID, and smartID. Additionally, we inspect the security of all other features to ensure that the software is fully secure.”

—Sintija Dereumaux, QA Engineer @ TestDevLab

#2 Challenge: Accessibility testing

Person using assistive technology to access healthcare software

Accessibility testing is crucial when testing healthcare software because it ensures that individuals with various disabilities, including those with visual, auditory, or motor impairments, can use the software effectively.

And while 86% of patients using telehealth have said it has made it easier for them to get the care they needed, a recent WHO study has found that digital health is not accessible to everyone equally, especially to people with underlying health conditions. By testing for accessibility, healthcare software can be made more inclusive, ensuring that all types of users can use it effectively, regardless of their abilities.

Based on our experience, the main challenges of accessibility testing for healthcare are related to:

Lack of accessibility testing expertise. Accessibility testing requires specialized knowledge and expertise. Many QA teams do have the necessary training and experience to effectively perform accessibility testing.
Compatibility with assistive technologies. Testing for accessibility requires the use of assistive technologies, such as adaptive switches, screen readers and magnifiers. However, many QA teams do not have access to such technologies, so they are unable to test all use case scenarios, resulting in incomplete testing.
Compliance with accessibility regulations. Healthcare software must comply with various accessibility regulations and guidelines, like WCAG and Section 508 of the Rehabilitation Act. Ensuring compliance with these regulations can be complex and time-consuming, so QA teams should have sound knowledge of these regulations in order to perform accessibility testing in detail.

To overcome these gaps in accessibility testing, it’s important to have a dedicated team of QA engineers who have the knowledge and expertise in conducting comprehensive accessibility testing.

“Accessibility testing is a top priority for our clients within the healthcare industry, which is why at TestDevLab we have a dedicated team of accessibility QA engineers who are able to perform comprehensive accessibility tests to ensure healthcare software is inclusive and accessible.”

—Elīna Šiškeviča, Accessibility Testing Lead @ TestDevLab

#3 Challenge: Hardware integration testing

Healthcare software often requires integration with a variety of hardware devices, such as medical equipment, sensors, and monitoring devices. Hardware integration testing ensures that the software is compatible with these devices, and that they can communicate and interact with each other effectively.

When performing hardware integration testing for healthcare software, QA teams can come across multiple challenges:

Access to hardware devices. In many cases, QA teams do not have access—or have limited access—to medical devices that need to be connected with other devices for testing. This can complicate the testing process and produce unreliable and incomplete results.
Compliance with regulations. As healthcare solutions are subject to various standards and regulations, QA teams need to be extra cautious when performing hardware integration testing to make sure that strict privacy and security protocols are in place, which may require additional resources and expertise.
Limited interoperability. Some healthcare hardware devices may have limited interoperability with other devices. This can make it difficult to test the software's ability to communicate and interact with them.

“It’s not uncommon to find hardware issues when testing healthcare solutions. We have come across various issues stemming from faulty hardware or poor integration.”

—Aiga Dejus, QA Engineer @ TestDevLab

#4 Challenge: Interoperability testing

TestDevLab QA engineer performing interoperability testing for healthcare software

Interoperability testing is important for healthcare software, as healthcare systems rely heavily on the exchange of information between different software systems, devices, and organizations. Therefore, healthcare software needs to be able to work together seamlessly with other systems to ensure patient data is secure while providing high-quality care.

According to a study published in the Cureus Journal of Medical Science, approximately 80% of serious medical errors are the result of miscommunication during patient care transitions. Such errors are usually the result of poor interoperability, which can be detected—and avoided—earlier with interoperability testing.

Performing interoperability testing for healthcare software can present several challenges for QA teams as a result of:

Complex systems. Healthcare software systems are usually complex and are dependent on multiple components, devices, and third-party systems working together seamlessly. Testing the interoperability of these systems requires QA engineers to have a deep understanding of how they interact with each other.
Different technologies. Healthcare software systems are often built using different technologies, languages, and platforms. This variety can make it challenging for QA engineers to test the interoperability of different systems, as it means that QA teams should also have diverse technical knowledge and experience.
Large volume of (sensitive) data. Healthcare software systems need to be able to handle a large volume of data and users. Testing the interoperability of these systems at scale can be challenging as QA teams need to have a comprehensive testing strategy and follow strict security practices—this applies even more so to remote QA teams—to ensure sensitive data is safe during testing.

“Issues that have the greatest impact in healthcare testing are the result of data not being transferred or data not transferred correctly. We test a lot of devices—blood pressure monitors, scales, sleep analyzers, thermometers, watches, and so on—so it is important for us to ensure that these devices communicate effectively and accurately with one another.”

—Vera Jerihova, QA Engineer @ TestDevLab

#5 Challenge: Audio and video quality testing

Doctor providing telemedicine services to patient

Many doctors and patients are taking advantage of telehealth to schedule appointments and have their medical examinations or checkups over the phone or video chat. Doing so reduces office wait times and patient costs. Patients that prefer using telehealth to access various health services list convenience, speed of care, and easy access to health information as the main reasons behind their preference.

A poll conducted by the American Psychiatric Association (APA) showed that 38% of U.S. adults have used telehealth services to meet with a medical or mental health professional, with 69% of those using a video format to do so.

The rising popularity of telehealth services means that audio and video testing is particularly important for companies offering such services, as patients and doctors rely heavily on audio and video communication. Poor audio and video quality can lead to misinterpretation of symptoms, inaccurate diagnosis, and a bad user experience.

However, audio and video testing for healthcare software solutions can be a challenge for QA teams for several reasons:

Variable network conditions. Telehealth services rely on stable network conditions, which can vary widely depending on factors such as location, network infrastructure, and device capabilities. This is why it is important for QA teams to be able to test such solutions under different network conditions that simulate real-life scenarios to ensure a stable audio and video connection. However, testing audio and video quality across a range of network conditions can be time-consuming and resource-intensive, so QA teams need to be well prepared on both fronts.
Complex use cases. Telehealth solutions can be quite complex. QA teams need to dedicate enough time to learn and test the different features available, as well as prepare an efficient testing strategy that will cover different user scenarios that reflect real-world usage. This, however, is often easier said than done.
Hardware integration. Telehealth software is often intended to be integrated with other hardware devices and medical equipment, like digital otoscopes, special headsets and tablets, as well as cameras, microphones, headphones and speakers. As a result, a frequent challenge QA teams may face when testing audio and video quality is accessing and testing the solution on all relevant hardware.
Limited testing resources. Often QA teams may not have access to different hardware devices, testing equipment, or an isolated testing environment. This can limit the scope and accuracy of audio and video quality testing.

#6 Challenge: Regulatory compliance

Healthcare software solutions need to comply with various regulations for data security and privacy:

HIPAA (USA)

The Health Insurance Portability and Accountability Act (HIPAA) is a federal law that protects sensitive patient health information, including electronic health records, from being disclosed without the patient’s consent or knowledge. Failure to comply with HIPAA can cost healthcare companies millions in penalties. For example, healthcare company Aetna had to pay a $1 million fine for three separate healthcare data breaches after violating HIPAA regulations.

The General Data Protection Regulation (GDPR) is a regulation applicable inside the European Union. It sets standards for the collection, processing, and storage of personal data, including health data. Healthcare companies must obtain consent from patients to collect and use their personal data. Patients should be able to access, correct, and delete their personal data at any time. In 2022, French healthcare software solution provider, Dedalus Biologie, was fined 1.5 million euros after a massive health data leak.

PIPEDA (Canada)

The Personal Information Protection and Electronic Documents Act (PIPEDA) is a Canadian federal law that applies to the collection, use, and disclosure of personal information, including electronic health records, by private sector organizations. It includes provisions related to the protection of personal health information and requires healthcare providers to obtain patients' consent to collect, use, and disclose their personal information.

OAIC (Australia)

The Office of the Australian Information Commissioner (OAIC) is an independent regulator that is responsible for overseeing privacy protection and information access in Australia. Specifically, it governs how healthcare service providers can collect, use and disclose health information.

Ensuring regulatory compliance can be a challenge when testing healthcare software, as QA engineers must have specialized knowledge and expertise to ensure that the software meets relevant regulatory requirements.

Read our case study: How Doktor.se Implemented an Efficient QA Process with Support from TestDevLab

Most common healthcare software issues

Having worked with numerous clients from the healthcare industry, like Koa Health, Doktor.se and others, we have tested many different types of healthcare software and applications:

Electronic Health Records (EHR)
Hospital Management Systems (HMS)
Remote Patient Monitoring (RPM)
Telemedicine software
E-prescribing software
Healthcare CRM software
Patient portals
Medical billing software
Health tracking apps

To better understand exactly what companies are doing wrong—and how their current testing practices can be improved—we asked our QA engineers to share some of the most common issues they come across when testing healthcare software.

Functionality issues. The software does not work as specified in the requirements.
Accessibility issues. The software is not inclusive and cannot be accessed by people with various disabilities.
UI/UX issues. The software has various issues related to layout, design, buttons, and other elements that influence the user experience.
Hardware issues. The hardware is faulty, cannot be integrated with other devices, or does not communicate well with other devices.
Tight testing schedule. The software provider wants to release multiple features without leaving enough time for proper testing.

Read our case study: TestDevLab Helps Koa Health Set Up Device Matrix and Improve Testing Efficiency

How to overcome challenges and ensure high-quality healthcare software?

Testing healthcare software solutions requires specialized knowledge and expertise due to the complexity and critical nature of the healthcare industry. To overcome the key challenges of testing healthcare software, implementing the best quality assurance practices and working with experienced QA engineers is essential.

At TestDevLab, we have an accomplished team of QA engineers who have ample experience in testing healthcare software products and can make sure your healthcare software meets the highest quality standards. We also have access to a wide range of testing devices and unique testing laboratories.

Do you have a healthcare solution you need help testing? Reach out to us with your project details and we’ll let you know how we can be of service.

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