And the costs will keep rising in the coming years, as more and more healthcare providers switch to digital solutions.
So, you can’t afford to be reactive if you’re building healthcare software. Security has to be built in, not bolted on.
Start by asking yourself: Who could attack this? How could they get in? What would they want to steal?
Then, plan defenses like it’s going to happen. Because eventually, someone will try.
Start with the basics:
End-to-end encryption
Role-based access control (RBAC)
Multi-factor authentication (MFA)
Activity logs for every sensitive action
But don’t stop there.
If your system integrates with external services or providers – hospitals, insurance APIs, wearables – you’re also inheriting their risks.
Every new connection is another surface for attack and APIs are often the weakest link.
In healthcare, that’s a serious liability. If one integration exposes patient data or fails to authenticate properly, it’s not just their breach – it’s yours too.
Use strict authentication, validate every request, and limit access to only what’s necessary. .
Also, remember that security isn’t just technical. It’s cultural. Everyone on your team needs to understand why it matters.
Your users trust you with their most sensitive information.
And you need to earn that trust with airtight security from day one.
Build with compliance in mind
Regulatory pressure in healthcare is intense.
And that’s not just because of the laws. It’s because of what’s at stake.
You’re dealing with people’s health, private records, and personal lives.
And mistakes don’t just lead to downtime – they lead to lawsuits.
In the US, HIPAA (Health Insurance Portability and Accountability Act) sets the bar. In the EU, it’s GDPR.
HIPAA explicitly regulates protected health information (PHI) and you can’t dodge it. Here’s how it affects software development in particular:
Key HIPAA rules that impact software development: overview
HIPAA Rule
What it covers
Why it matters
Privacy Rule
Sets standards for how PHI can be used and disclosed.
Determines what data you can collect, who can access it, and under which circumstances.
Security Rule
Requires administrative, physical, and technical safeguards for electronic PHI.
Directly affects how you build your product, including encryption, access control, and system monitoring.
Breach Notification Rule
Defines what to do when PHI is compromised or exposed
Requires you to quickly and transparently detect, document, and report breaches.
If you have a catastrophic breach and you’re not compliant with HIPAA, you could be on the hook for an 8-figure sum – the record HIPAA settlement was $16 million.
So, if you want to target the U.S. market, your software needs to be HIPAA-compliant.
Then, there’s GDPR.
While it’s not healthcare-specific, health data, genetic data, and fitness and wellbeing data are explicitly protected:
Here’s the catch: compliance isn’t something you can just add later.
That’s where a lot of companies go wrong. They treat compliance like a separate layer. Like something the legal team will “handle later.”
But the reality is, you need to design it into your architecture from the beginning.
That means:
Collecting only the data you absolutely need.
Managing consent the right way.
Creating detailed audit trails.
Protecting every data transaction with encryption
Every user action should be logged, every access point controlled, and every device verified.
A compliant product isn’t just safer – it’s also easier to sell.
Hospitals, insurers, and public health systems will ask about your data protection measures on day one.
Being able to say “We designed for that from the start” makes all the difference.
So here’s the rule: build for compliance before a single line of code is written.
That’s how you protect your users and build a successful product.
Focus on patient-centric design
A well-designed product helps users take action.
A poorly designed one? It adds friction, confusion, and unnecessary delays. And when someone’s health is on the line, delays are dangerous.
That’s why patient-centric design is non-negotiable.
Start by listening and not guessing. User interviews, surveys, and contextual research will tell you what users are really dealing with, not what you think they need.
Here’s the mistake a lot of companies make: they overbuild for the doctor, and underbuild for the patient. Both need attention.
But if patients can’t (or won’t) use your app, it fails.
Need a partner who gets healthcare software? Let’s talk →
You’ll be talking with our technology experts.
Let’s say you want to build a mobile app for diabetes management.
You can make a design full of complex graphs and medical terms that looks impressive – but it probably won’t work.
Why? Diabetes rates increase with age, so a huge chunk of your users will be older and have limited tech experience.
And they need just one thing: an easy way to log their blood sugar.
Accessibility matters too.
Your users might have vision issues, motor limitations, or cognitive impairments. Design with that in mind. This means:
Readable fonts
High contrast
Voice input
Simple navigation
Accessibility standards like WCAG 2.2 are a great place to start.
And if you’re targeting the EU market, you’ll have to comply with the European Accessibility Act (EAA) which comes into force in June 2025.
Also, don’t forget to test it all. Not just on a test device in your office. Put it in front of real users.
Watch how they move through it, where they pause, and what confuses them – that feedback is gold.
In short, design isn’t fluff or just aesthetics. It’s how users experience your product.
And in healthcare, experience is the product.
Clearly define requirements to avoid scope creep
Just adding another feature here or making a small change there sounds harmless.
Changes to your original scope are perfectly fine and they happen in almost every project.
But, you have to be careful. Too much wiggle room and you risk scope creep derailing your entire project.
Scope creep is one of the biggest project killers out there. It can delay your launch, break your budget, and wreck your team’s focus.
If you’re interested in a deeper dive on scope creep, DECODE co-founder and CEO, Marko Strizic, joined us on The Roadmap and discussed how you can prevent it:
The tricky thing about scope creep is that it doesn’t happen all at once.
But, it usually starts with vague requirements.
“We just need a basic dashboard.” That’s not a requirement. That’s a placeholder for endless revisions.
This is a real requirement: “We need a dashboard that displays a patient’s upcoming appointments, prescription refill reminders, and recent lab results, updated in real time through an EHR integration.”
Here’s the key takeaway: your requirements need to be clear, specific, and to the point.
Strong requirements keep you grounded and keep everyone on the same page.
That means you have to write:
Clear product goals
Specific feature definitions
User stories that reflect real workflows
Known constraints and dependencies
Every change to the original scope should earn its way in. And it needs to have a clear, measurable impact.
If you don’t control the scope, it will control you.
So, strong requirements aren’t a nice-to-have – they’re non-negotiable for successful development.
Design for interoperability and integration
In healthcare, no product stands alone.
It always has to talk to something else, whether it’s an EHR, a lab system, a wearable, or a billing platform.
That’s why integration isn’t an extra feature. It’s a foundation.
If your software can’t reliably connect to a customer’s wider ecosystem, it won’t last.
Hospitals and clinics don’t want tools that create more data silos. They want tools that fit into their existing workflows.
And that means building with interoperability in mind from the start.
Don’t treat QA as just another phase in development.
It should be a core part of your development process from start to finish.
From day one, your QA engineers should be involved.
They should sit with your developers, read the requirements, and ask questions.
Because the sooner you catch bugs or defects, the cheaper (and easier!) they are to fix.
Fixing them at the start can be up to 100x cheaper than fixing them post-deployment:
So, how do you get this right?
Start with the essentials:
Unit tests for every critical component
Integration tests for key data flows
Manual testing for edge cases
CI/CD pipelines to catch issues before deployment
Also, document everything.
Clear test cases, reproducible bug reports, and version histories make it easier to spot patterns, track down issues, and keep improving.
And that will speed up every future release.
In a nutshell, QA isn’t just about catching bugs. It’s about building trust – patients trusting your product will work and clinicians trusting that your data is accurate.
So test early. Test often. And never treat it like a checkbox.
Healthcare software development best practices: FAQs
You’re working with sensitive data, under strict regulations, and in high-stakes environments.
Mistakes can cost more than money – they can impact lives.
And that’s why security, compliance, and reliability are critical from day one.
Healthcare systems are deeply interconnected.
Your product will need to work with different types of data and integrate with tools and systems like:
EHRs
Wearables
Lab systems
Billing platforms
And if your software can’t do that, it won’t be adopted
It’s non-negotiable.
If your product handles patient data, you need airtight security. And not just for compliance, but to build trust.
This includes encryption, secure coding, strong authentication, and support for industry standards like SOC 2 or ISO 27001.
Need a reliable development partner?
Building healthcare software takes more than just good code. It takes a team that understands security, compliance, and real-world complexity.
And that’s where we come in.
We’re an EU-based, high-caliber software development company with 12+ years of experience delivering secure and scalable software solutions for a wide range of industries, including healthcare.
If you’re ready to turn your idea into a reliable product that both users and regulators can trust, feel free to reach out and our team will be happy to see how we can help you make it a reality.
Damir knows how to build partnerships that last. With 20+ years of experience in sales leadership, business development, and tech consulting, he’s helped companies grow, scale, and adapt - whether by leading teams, building businesses from scratch, or driving digital transformation. He started with a degree in history and archaeology before adding an MBA and training in negotiation, web development, and more. That mix of curiosity and drive is what makes him great at what he does.
Outside of work, you’ll find him on the trails, pushing his endurance limits, or at home keeping up with his three kids. And when he's not on the move, he's diving into the latest and greatest history books and documentaries.
