You’re not just delivering features. You’re handling patient records, clinical decisions, and systems that can’t afford to fail.
If your software breaks, it’s not just inconvenient. It can be dangerous.
And that’s why testing healthcare software is crucial.
It’s an ongoing job that demands precision and clear thinking from the start.
In this article, we’ll discuss everything you need to know about testing healthcare software: why it’s important, the biggest challenges you’ll face, the types of testing you should do, and more.
Let’s dive in!
Table of Contents
Why is testing healthcare software essential?
Because it’s not just software. It’s also a medical tool.
Healthcare software can:
Help diagnose illnesses
Track patient records
Schedule surgeries
Share sensitive data across systems
And when it fails, people can get hurt.
One wrong data point, one untested feature – and it snowballs.
A patient could receive the wrong dosage. A diagnosis could be delayed. A provider could lose access to critical info mid-operation.
It’s not theoretical. A software bug in a UK NHS screening program led to 450,000 women missing breast cancer screenings, with estimates that up to 270 women had their lives shortened because of it.
So, in a nutshell, bugs in healthcare software can have catastrophic results.
And strong QA processes and thorough testing are key to preventing them.
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Testing ensures your software always behaves exactly as expected – in every possible condition, every possible input, and across every user role.
Also, bug-free software is key to building trust with your users.
Doctors have to trust it to show accurate, real-time patient data. Patients have to trust it to keep their medical history private. Admins have to trust it to run without a hitch at scale.
And rigorous testing is the only way to earn that trust.
Plus, it’s also about responsibility. Healthcare software is often regulated like a physical medical device. That’s how serious it is.
Under HIPAA, any software handling patient data must meet strict privacy and security standards. In the EU, GDPR and MDR raise the bar even further.
If you fail to meet those standards, it’s not just bad PR. It’s legal trouble.
And testing is your first line of defence.
Top challenges in healthcare software testing
Next, we’ll cover the main challenges in healthcare software testing.
Handling sensitive data
Healthcare software almost inevitably touches sensitive data.
Patient names. Diagnoses. Medications. Test results. Mental health notes.
Too many teams use production data in test environments. That’s a direct breach of HIPAA or GDPR, depending on where you’re operating.
It doesn’t matter if it’s “just for internal use.” If that data leaks, the damage is done.
Your test data must be synthetic, anonymized, or fully scrubbed. That’s non-negotiable.
But generating synthetic or scrubbed data takes work:
You need to remove or replace personal identifiers.
You need to maintain relationships between data sets (e.g. patients, appointments, records).
You need realistic values and formats to avoid breaking your tests.
You need tooling or processes to keep generating new data over time.
It’s harder to do right, sure. But it’s the only option that fully protects privacy and meets compliance requirements.
You need to think about access, too. Who can see what?
Even within your QA team, not everyone needs admin-level data permissions. Fewer people with access = lower risk.
Also, don’t forget logs. Logging is great for debugging, but logs often include personal data – you should always mask or remove that data.
Remember, handling sensitive data isn’t just a technical issue. It’s a trust issue.
And one breach is enough to break that trust for good.
Integration with legacy systems and medical devices
Healthcare doesn’t run on shiny new systems. It runs on a mix of old, older, and ancient tech.
Some hospitals still use software built in the early 2000s. Others use custom devices with proprietary protocols. And your software has to play nice with all of it.
Integration is one of the biggest testing challenges in healthcare software. You’re not just connecting APIs, you’re connecting across decades of technology gaps.
HL7 v2. FHIR. DICOM. Custom XML. No two systems behave the same way, even when they follow the same “standard.”
Let’s say your product pulls patient vitals from a monitoring device. What happens if that device sends a malformed value? Or drops connection? Or runs out of battery mid-stream?
You need to test for all of that.
Integration testing in healthcare means testing for data consistency, timing issues, and fail-safes.
A delay in syncing a lab result can delay a diagnosis and a mismatch in units (mg vs. mcg) could cause a dosage error. This is not just technical debt, it’s a clinical risk.
Versioning matters too. One hospital might be on HL7 2.3 while another runs 2.6. Your QA team has to test against multiple versions, not just the latest one.
Plus, integrating with devices like glucose meters, heart monitors, and imaging tools is another major headache.
Many come with their own SDKs, but don’t count on them to be simple, clear, or complete. You might just spend more time reverse-engineering than actually building software.
In short, testing in isolation isn’t enough.
Your software has to be tested within the system it’s meant to live in.
Maintaining compliance
Compliance isn’t a one-time checkbox. It’s a moving target.
Regulations change, new laws get passed, and standards get updated. And your software needs to keep up without missing a beat.
You need to know which regulations apply to your product:
HIPAA in the US
GDPR in the EU
ISO 13485 for medical devices
IEC 62304 for health software lifecycle safety
MDR for products distributed in the European Union
If you don’t follow these regulations, the consequences are serious.
Fines. Legal action. Loss of market access. And most importantly, a loss of trust from the people who rely on your product to work safely and ethically.
Some of these laws require full documentation of your development and testing processes. Others expect automated audit trails. Some mandate traceability from user needs to product features to validation results.
And your testing strategy must be built with all this in mind.
Start by mapping each user story or feature to relevant compliance checkpoints. For example:
Is patient consent captured and logged?
Can users request data deletion under GDPR?
Is all PHI encrypted according to HIPAA guidelines?
Then test each of those checkpoints. Every time.
This is where continuous compliance testing becomes essential. Integrate compliance checks into your pipeline and validate them with every release.
You also need clean documentation. Not just for auditors, but for your team, so you know what was tested, how, and why.
That kind of transparent data can save you weeks during a certification process.
Regulations aren’t there to slow you down. They’re there to keep patients safe.
And staying compliant means you’re building something that meets both technical and ethical standards.
Types of healthcare software testing
Next, we’ll cover the main types of testing you need to use when building healthcare software.
Functional testing
Functional testing answers one question: Does the software do what it’s supposed to do?
Functional testing checks that every feature works according to spec. Every input, output, and user action. It’s the foundation of quality assurance.
In healthcare, that question carries weight. Because if it doesn’t, the result isn’t just a bad UX, it can lead to clinical errors.
And that foundation needs to be bulletproof.
Take an EHR system. When a doctor updates a patient’s medication, that update must:
Save correctly
Sync across platforms
Show the latest info to other clinicians
Trigger relevant alerts if there are known drug interactions
That’s four different systems working together for one action. And every one of them needs to be tested.
Functional testing also ensures role-based access works as intended.
A nurse doesn’t need to see what an administrator sees. A patient shouldn’t be able to edit clinical data. If access controls fail, privacy fails.
There’s also the risk of silent failures. For example, a lab result doesn’t load due to a timeout but the app doesn’t show an error.
That’s a failed test case. The user didn’t get critical information, and they weren’t even told something went wrong.
Also, you need to cover every edge case.
What happens if a required field is skipped? If a clinician clicks “Save” twice? If the same record is opened on two devices at once?
That’s why your test cases need to go deep.
Functional testing in healthcare isn’t just about pass/fail. It’s about clinical reliability.
Security testing
When people use healthcare software, they’re trusting you with their most private information.
You don’t get a second chance with that kind of data.
A single breach can do irreversible damage.
And healthcare has the highest average cost of a data breach of any industry:
Security testing checks how your system handles attacks before someone tries it for real. That includes:
Broken authentication
Insecure session handling
SQL injection
Unencrypted data storage
Access control failures
It also covers more subtle risks.
Can one patient view another’s data by changing a URL? Can an admin export a full patient database without a warning? Do error messages leak technical details?
You have to think like an attacker – and test like one, too.
But healthcare software adds extra layers.
Many apps handle data across multiple devices and networks. Some sync with wearables or diagnostic tools. Others integrate with cloud providers.
Every one of those entry points needs to be secured and tested.
And don’t forget mobile.
A patient portal on a phone is convenient – but it also brings new risks. What happens if a phone is stolen? Can notifications reveal sensitive info? Does the app require two-factor authentication?
Security testing needs to cover all of it.
It’s not just about blocking hackers. It’s about earning trust.
If your product can’t protect data, users won’t care how many features it has. They’ll just stop using it.
Compliance testing
Healthcare software can’t just work. It has to work within strict regulatory frameworks.
And that’s exactly what compliance testing validates.
Whether it’s HIPAA, GDPR, ISO 13485, IEC 62304, or MDR, these aren’t optional checklists.
They define what your software must do, how it should behave, and how it needs to be tested.
Interoperability testing makes sure your product can exchange data correctly, consistently, and in real-world conditions. That means:
Sending lab results from one system to another.
Pulling patient history into a new platform.
Syncing with wearables or connected medical devices.
Displaying third-party data without distortion.
Sounds simple, right? It’s not.
Even “standardized” formats like HL7 or FHIR can vary wildly in implementation. One system might require custom extensions or weird field mappings.
You need to test for those gaps. And test what happens when things go wrong.
What if the external system goes down? What if it sends malformed data? What if there’s a delay or partial sync?
You can’t assume anything here. You have to validate everything with test cases that simulate:
Real-time data flow
Out-of-order events
Mismatched schemas
Legacy system responses
This also applies to devices, too. Medical hardware has its own quirks.
Some send continuous data streams. Others only sync once per day. Your QA team must know how each device behaves and test accordingly.
If your product is meant to integrate with a third-party API, mock it and test it under stress. What happens if it times out, sends an empty response, or returns outdated data?
Interoperability testing is what connects your product to the rest of the healthcare world.
When it works, it feels invisible. When it breaks, people notice fast.
Performance testing
Performance testing isn’t just about load times or fancy dashboards.
It’s about how your product holds up under pressure during peak usage with thousands of concurrent users. And all the while processing large datasets and syncing across systems.
Performance testing answers key questions like:
Can the app handle 10,000 users logging in at once?
What happens when hundreds of lab results are pushed in real-time?
Does the system crash under load?
You’re not testing for perfect conditions. You’re testing for reality.
Think of a telehealth app during a national emergency. If your backend can’t scale, appointments will fail and patients will lose access and trust.
That’s why you need to simulate real-world loads. Use tools to mimic user behaviour at scale and test:
Server response times
Database query performance
Network latency
API throughput
Resource usage under stress
Don’t forget mobile performance either. A slow mobile app is a dealbreaker, especially for patients who rely on it daily.
Then there’s uptime. Healthcare systems don’t get to take breaks.
A hospital management app going down at 2 AM is still a potential crisis.
Performance testing should cover stability over time. Can your app run for days without memory leaks? Can it recover from a failed service without human intervention?
And remember, performance issues are hard to fix post-launch.
And that’s why you need to start performance testing early.
Usability testing
A feature no one can use is as good as a bug.
Usability testing makes sure your product works for real people, in real situations, under real pressure.
And that pressure is constant in healthcare.
Doctors don’t have time to guess what a button does. Patients might be older, stressed, or managing a condition – they won’t read a user manual.
Your interface needs to remove friction and be simple and intuitive.
Usability testing puts your design in front of the people who’ll actually use it – clinicians, admins, patients – and observes what works and what doesn’t.
It asks:
Can they complete tasks without getting stuck?
Do they understand what each screen is telling them?
Are important actions easy to find and hard to mess up?
This isn’t about aesthetics. It’s about outcomes.
A good test session can uncover:
Confusing navigation
Overloaded screens
Poor contrast or font sizing
Missing feedback after key actions
Accessibility is part of this too. Many users may have visual, motor, or cognitive impairments.
Ask yourself: Can your app be used with a screen reader? Are buttons large enough for users with limited dexterity? Do error messages explain what went wrong – and how to fix it?
Usability testing doesn’t just polish your product, it protects your users.
It proves your app is built for the real world.
And when it comes to healthcare, that’s what matters most.
Key tips for effective healthcare software testing
Finally, we’ll share some essential tips to help you get healthcare software testing right.
Start testing early
If you wait until the end to start testing, you’re already too late.
Early testing catches the issues that cost the most to fix later.
Not just bugs, but bad assumptions, missed edge cases, and unclear requirements.
Start testing from day one. From the moment you write your first line of code or even before that.
This will save you a lot of time and money. Fixing bugs right at the start can be up to 100x cheaper than fixing them post-deployment:
Don’t think of QA as a final phase. It should be a core part of your development process from the beginning.
When you involve your QA engineers early, they will ask the right questions:
What happens if the data is missing?
What if two people edit the same record?
Who can see this screen – and why?
That insight leads to stronger designs and smarter decisions. It will even prevent you from building entire features the wrong way.
And this means better software.
Set up a CI/CD pipeline
Continuous integration (CI) and continuous delivery (CD) will help you ship faster without cutting corners.
CI/CD automates what used to be manual. Every time your team pushes code, automated tests run.
And the result? You catch bugs early and your deployments become predictable.
That consistency is essential in healthcare – you can’t afford surprise bugs in production.
With a CI/CD pipeline, testing becomes default, not an afterthought. Here’s what that looks like:
Developer commits code.
Pipeline runs unit, integration, and security tests.
Test results are visible to the whole team.
If everything passes, the build is approved for deployment.
If not, the feedback loop is instant.
This workflow works especially well when you have frequent (weekly/daily) releases.
CI/CD reduces human error and gives you clear audit trails. And in healthcare, where regulations demand repeatability, that structure is gold.
You also get confidence. Confidence that your app will behave the same way in staging, production, and every environment in between.
If you’re serious about quality, CI/CD is non-negotiable.
Thoroughly test for edge cases
Edge cases are where software breaks. They’re rare, unpredictable, and often ignored.
But in healthcare, ignoring them is risky.
You need to test what happens when things go wrong. Because they will.
Here’s what edge cases look like:
A user enters a birthdate from 1895
A wearable sends corrupted data
Two clinicians update the same record within seconds
A patient loses connection mid-telehealth session
A file upload is interrupted, then retried
These aren’t theoretical. They can and will happen. And if you aren’t ready, you’ll see bugs in production.
You can’t test for everything, of course. But you can plan for chaos.
Start by identifying high-risk areas:
Inputs from users, devices, or external systems
Network connectivity and timeouts
Sync issues across roles or devices
Rapid, repeated actions
Then build test cases that push those limits.
What happens when the app is offline? When a user taps the same button 10 times? When the API returns partial data?
Your product should fail gracefully. No crashes and no silent errors, but clear messages and safe fallbacks.
Remember, you’re building software for real people. And real people don’t use software perfectly.
They forget passwords, tap the wrong thing, and make typos – you need to be ready for that.
Testing edge cases takes time and effort.
But it gives you confidence that your product will hold up in messy, real-world situations.
Healthcare software testing: FAQs
Because the stakes are higher.
A bug in a social app might be annoying. A bug in a healthcare app could put someone’s health, or even life, at risk.
You’re also working under strict regulations like HIPAA, GDPR, MDR, and IEC 62304.
That means testing isn’t just about catching bugs. It’s about proving your product is safe, reliable, and compliant.
Testing only the happy path, i.e. not digging deep enough.
Too many teams focus on ideal user flows and forget what happens when things break – network drops, invalid data, unexpected inputs.
But that’s exactly where real-world issues happen.
If you don’t test for edge cases, concurrency issues, or integration failures, those bugs will show up in production.
Right from the start.
Testing isn’t a final phase. It’s a core part of the development process.
Involve QA during discovery. Let them challenge requirements, flag risks, and plan early test strategies. The earlier they’re involved, the better the product.
Early testing will reduce future rework and help you ship faster with fewer surprises.
Looking for a reliable development partner?
Do you want to build high-quality healthcare software but can’t seem to find a development partner that can actually pull it off?
Well, you’re in the right place.
We’re an EU-based software development company with 12+ years of experience building complex custom software solutions.
And we’re deeply committed to building high-quality software.
If you want to learn more, feel free to reach out and our team will be happy to set up a meeting to discuss your needs in more detail.
Mario makes every project run smoothly. A firm believer that people are DECODE’s most vital resource, he naturally grew into his former role as People Operations Manager. Now, his encyclopaedic knowledge of every DECODEr’s role, and his expertise in all things tech, enables him to guide DECODE's technical vision as CTO to make sure we're always ahead of the curve.
Part engineer, and seemingly part therapist, Mario is always calm under pressure, which helps to maintain the office’s stress-free vibe. In fact, sitting and thinking is his main hobby. What’s more Zen than that?
