13 min gelezen

Expert guide to healthcare software testing: everything you need to know

Gezondheidszorg

To put it bluntly: healthcare is a very demanding industry when it comes to software safety, security, and quality. That’s why rigorous testen is not only an industry best practice but also a must according to many healthcare regulations, such as FDA and MDR requirements, and IT standards, like ISO 13485 and ISO 9001.

Some may be tempted to cut corners with QA to lower project expenses. But is it worth the risk? We at Innowise are all for in-depth, thoughtful testing of healthcare apps, and I will make a case for it in this article. Stick with us and learn more about healthcare software testing types, processes, and expected results.

Why testing healthcare applications is absolutely necessary

Many industry experts agree that software testing in the healthcare domain should not only be done but it should be done right. Here’s what a mindful and meticulous approach to testing helps achieve.

Software quality

Carefully testing all aspects of healthcare applications and addressing the detected issues inevitably leads to better quality. Testing is paramount to detecting bugs early, avoiding costly post-deployment fixes and user dissatisfaction.

Results you achieve:

Smooth healthcare software operation
Minimal error rate of the application
High satisfaction of clinicians & patients

Patient safety

Both providers and regulators in the healthcare domain focus on software safety for end users, especially when it comes to SaMD and SiMD. Ensuring patient safety starts with rigorous testing to catch issues that could affect clinical decision-making or patient care.

Results you achieve:

No software use risks for patients
Accurate data handling for patient care
Flawless clinical accuracy of the healthcare app

Naleving van de regelgeving

During testing, neglecting the strict compliance requirements of HIPAA, GDPR, or FDA is a dead end. When planned right, the testing approach is tailored to identify compliance gaps, maintain patient data confidentiality, and prevent costly violations or software launch delays.

Results you achieve:

Audit-proof healthcare software compliance
Smooth regulatory clearance of SaMD
No violation fees & reputational risks

Databeveiliging

As patient data is one of the most sensitive types of information, testing is another safeguard for protecting it. Testing helps validate encryption, access control, and data transfer methods, identifying vulnerabilities before malicious actors can exploit them.

Results you achieve:

Robust security mechanisms in place
No security loopholes for attackers to employ
Timely security patch management

Prestaties

When certain aspects of patient care rely on software, it must perform flawlessly under heavy workloads. A well-planned and executed testing strategy helps ensure that healthcare apps can handle large volumes of queries, maintain a reasonable speed, and avoid downtime.

Results you achieve:

High availability of the healthcare app
Minimal response time
High healthcare software throughput

Data accuracy

If testing is done right, healthcare providers can be sure that data handled by the software is fully accurate and processed without fragmentation or losses. This way, any data handling errors are eliminated proactively, without ever disrupting the patient care workflows.

Results you achieve:

No data loss, duplication, or inconsistencies
Smooth data flow with other IT systems
Data interoperability (using HL7, FHIR, etc.)

“Healthcare software quality can never be compromised, and we don’t take it lightly. At Innowise, we make sure that every line of code meets the highest standards. With our ISO 13485, ISO 9001, and ISO 27001 certifications, we’re not only experts at developing high-quality software but also at spotting bugs early and delivering software that’s both reliable and compliant.”

Aleh Yafimau

Leveringsmanager

Designing an effective healthcare software testing roadmap

Merely testing an app is not enough if you want to detect the defects and keep up with the project pace and budget. You should have a clear roadmap of how you will test the app without delaying the deployments or compromising quality.

As a part of Innowise’s team, I’ve helped deliver many successful healthcare projects. Let me spill the beans and share with you Innowise’s healthcare app testing process that proves to be efficient time and time again.

Eisen analyse

Innowise begins by diving deep into your medical software testing needs. Our team cooperates with stakeholders to understand the software scope, functionality, documentation, and applicable regulatory requirements. This ensures that we align the testing strategy with your project objectives, security, safety, and compliance thresholds.

Stage deliverables:

Healthcare software requirements outline, featuring functional and non-functional requirements that should be met.
Testing project scope, objectives, and deliverables.
Compliance requirements (e.g., HIPAA, HITECH, GDPR, FDA, MDR).

Testplanning

During this stage, we devise the healthcare application testing strategy. We assess the software complexity, identify key risks, and create a testing roadmap in line with the development plan. Also, Innowise’s team establishes testing goals, timelines, and plans resource allocation so that every step of the process is executed efficiently.

Stage deliverables:

Healthcare software testing strategy, including the testing tools, testing metrics, defect reporting, tracking practices, etc.
Detailed healthcare software testing plan, including timelines, test approach, features to test, and so on.
Testing risks outline and risk mitigation plan.

Ontwerp van testcases

Here, Innowise creates detailed test cases based on the requirements and test plan. We design scenarios that cover functional and non-functional aspects of the healthcare solution, making sure we test all potential use cases and eliminate potential issues.

Stage deliverables:

Healthcare software test cases, covering all the functionality, security, compliance, and usability requirements.

Testomgeving instellen

Then, we prepare a testing environment that simulates real-life production conditions. This includes configuring necessary hardware, software, and network settings. Our team ensures that the environment accurately simulates real-world conditions to uncover any issues with healthcare solutions before deployment.

Stage deliverables:

Test environment descriptions that take into account test entry and exit criteria.
Fine-tuned test environment for simulation of different production conditions.

Testuitvoering

Innowise’s QAs run the test cases, carefully documenting results. Depending on the healthcare software specifics and constraints, our team uses both manual and automated methods to assess functionality, performance, and security. Here, it’s important to make certain that the issues are identified and resolved early in the process.

Stage deliverables:

Test case results.
Automated test suite pass rate metrics.
Healthcare software testing status updates.

Compliance audit

While we check healthcare software during the whole testing process, we conduct a final audit when the software is ready for launch. The audit involves reviewing the software and its documentation to validate adherence to the requirements of HIPAA, GDPR, FDA, or other regulations. Our team identifies any gaps in data handling and security to ensure full compliance with the standards.

Stage deliverables:

Comprehensive compliance audit report.
Resolution recommendations for detected compliance issues.

Reporting test results

When the testing is complete, we provide detailed reports highlighting software defects, inconsistencies, and areas for improvement. Our team communicates findings clearly and suggests fixes so the developers can have a detailed picture of required changes moving forward.

Stage deliverables:

Quality reports highlighting the most critical defects, overall software quality metrics, defects distribution, etc.
Defect list highlighting issue severity and priority for the team.
Team effort reports with performed tasks breakdown.

Need a testing vendor who knows the intricacies of healthcare?

Types of healthcare software testing

Depending on the way the software is being assessed and what aspect is evaluated, experts distinguish the following types of testing in healthcare.

Functioneel testen

Functional testing ensures that the core features of the healthcare software work as intended. It includes compatibility testing to verify that the software works across different devices, browsers, and operating systems. Here, QAs also run regression tests to verify that new updates don’t break already existing functionality.

Expert tip: Creating detailed functional test cases might seem overwhelming at first, but they’re the foundation of your software’s long-term success. High-quality test cases make future updates significantly easier, streamlining both maintenance and software upgrades. Better yet, they provide confidence in your test coverage and ultimately ensure the overall quality of your healthcare application.

Automatisering testen

Automated software testing in healthcare is vital for efficiency. Here, QA engineers use automated scripts to test repetitive tasks, such as data input or UI interactions, to reduce errors and speed up the process. This type of testing is especially useful for large-scale, complex healthcare solutions like records management systems or comprehensive hospital apps.

Expert tip: Healthcare applications have evolved into sophisticated ecosystems with complex business logic, extensive databases, and intricate data flows from multiple integrated systems. Automating tests for every aspect can quickly become prohibitively expensive. Instead, adopt a strategic approach by prioritizing automation for your business-critical workflows while handling less crucial functions through manual testing.

Veiligheidstests

Essential for the safety of protected health information, veiligheidscontrole identifies vulnerabilities within healthcare software to prevent unauthorized access or data breaches. Penetration testers simulate potential attacks to check how well the solution protects sensitive patient data and validates privacy safeguards in place.

Expert tip: According to Microsoft, hospitals on average lose $1.9M per day of downtime following a ransomware attack. These numbers give chills, right? However these losses can be avoided if you prioritize security testing and go with a testing team proficient in OWASP, SOC 2 best practices, as well as ISO 27001, ISO 27017, and ISO 27018 requirements.

Prestatie testen

The success of care often depends on its speed, and slow-performing software is a no-go in these scenarios. Performance testing evaluates how the software works under high load and assesses its response time and stability. This type of testing ensures that healthcare solutions, especially those tracking data in real time, can handle peak loads without issues affecting user experience.

Expert tip: In healthcare, speed is critical, and this urgency extends to your software’s performance. Don’t relegate performance testing to the final stages of development. Instead, conduct thorough performance assessments on your healthcare application’s first working versions. Being proactive helps you identify potential bottlenecks early and address them at the architectural level when resolutions are still relatively straightforward and cost-effective.

Interoperability testing

Healthcare software needs to communicate with other IT systems, like EHR or EMR, CRM, LIMS, and others. Interoperability testing checks whether the app can exchange operational and care-related data with external systems seamlessly using appropriate data standards, like FHIR, HL7, DICOM, and others. In doing so, it helps achieve accurate data transfer between platforms.

Expert tip: When your healthcare system needs to share data with solutions using different exchange standards, data integrity during format transformation becomes paramount. You must verify that information transforms flawlessly between systems without any losses or corruption. Include a comprehensive suite of test cases specifically designed to validate data transformation in your testing plan.

Integratie testen

Unlike interoperability testing, this type of testing aims to verify the actual integration of the app and other systems, not its ability to exchange information. QA engineers check if data flows correctly between the software and other internal systems and third-party apps. This process ensures that the healthcare software works harmoniously with other apps and provides a complete view of data in real time.

Expert tip: When integrating your healthcare application with an out-of-the-box IT solution, it’s tempting to skip testing because “the platform has a ready-made API”. This assumption can be dangerous. Even established APIs can behave unexpectedly in unique environments, potentially compromising critical medical data and patient outcomes. At Innowise, we never leave it to chance — we rigorously test every integration to ensure data flows seamlessly between systems.

Testen op naleving

Healthcare apps must meet stringent regulatory standards. During compliance testing, project teams audit the software to verify it aligns with the legal and security requirements, such as HIPAA, GDPR, or FDA guidelines, and follows applicable industry standards.

Expert tip: If you need to develop and test software as a medical device (an app that requires regulatory clearance according to FDA and MDR), it’s a must to document all project activities according to ISO 13485 or IEC 62304. This applies to testing as well, so make sure to choose a testing partner with appropriate certifications.

Bruikbaarheidstests

Usability testing ensures that patients, doctors, and nurses can use the healthcare software with ease. QA engineers assess the app interfaces and UX, confirming they’re intuitive enough. Testers can also validate accessibility — check if users with visual and motor impairments are able to interact with the healthcare app without external help.

Expert tip: While healthcare apps are often made to promote access to care, not all of them are easy to use for people with special needs. That’s why we encourage our QA engineers to put themselves in users’ shoes and look beyond the software requirements to find ways to make the software more convenient for, say, color-blind people or those with limited finger mobility.

Lokalisatie testen

When healthcare software is intended for a multilingual audience, localization testing checks software interface adaptation to multiple languages and the overall respect for cultural differences. Here, QAs usually test translations, date formats, and regional preferences to make sure the software feels native to each user.

Expert tip: To make sure your healthcare app looks natural for the international audience, we suggest hiring business analysts with relevant cultural and linguistic backgrounds at the software planning stage. And, later, choosing QAs proficient not only in healthcare specifics but also in the target languages.

Need to be 100% sure your healthcare software functions right?

Innowise’s healthcare application testing services

Handling healthcare software testing in-house may be a tiresome task. You’ll need to plan the testing process, hire QA engineers with relevant experience, coordinate their daily tasks, sync testing with development, and make sure the team meets the expected KPIs. Sounds like a whole lot of trouble, right?

On the other hand, to make the healthcare application testing easier, you can outsource the whole process and save yourself a headache. In my experience, many of Innowise’s healthcare clients felt much more relieved when they had almost instant access to a scalable team of QAs with expertise in specific technologies or solutions they needed. Here are the most common scenarios of how our testing team can lend a hand in a healthcare IT project.

Healthcare software testing

Innowise’s testing services range from functional to performance and security testing and can match your needs to a T. We apply both manual and automated techniques to ensure optimal test coverage and a balanced project budget. With years of experience in both healthcare and testing, our QA engineers are team players: they proactively collaborate with your in-house developers and leave no stone unturned.

Healthcare software development + testing

If you work with Innowise on ontwikkeling van software voor de gezondheidszorg projects, be sure we’ll handle the testing as well. At the same time as planning the future app, we take time to carefully map the testing. During the development stage, our QA engineers work closely with developers to identify and tackle issues early on, from code-level bugs to system integration challenges.

Healthcare IT consulting + testing

When you hire Innowise as an IT consulting partner for your healthcare app upgrade and evolution projects, we can engage our testing teams as well. They will assess the code quality, app performance blockers, check the security measures, and detect vulnerabilities. Then, based on the QA findings, our consultants with deep healthcare expertise will draft a plan with suggested improvements and changes.

60+

Interne QA-ingenieurs

18+

years in the industry

85%

senior & mid-level specialists

Inpakken

In healthcare, testing isn’t just another formality — it’s an essential step to safeguard software security, compliance, and quality. From functional checks to performance validation, each test ensures that the software works reliably in real-world healthcare settings.

If you’re looking for reliable, high-quality healthcare software testing services, feel free to reach out. We’re here to help you navigate the complexities of healthcare software testing and be certain your app works as you expect it to.

Deel:

Anastasia Ilkevitsj

Portfolio manager in Gezondheidszorg en Medische Technologieën

Date: Apr 23, 2025

Deel:

Anastasia Ilkevitsj

Portfolio manager in Gezondheidszorg en Medische Technologieën

Date: Apr 23, 2025

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