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The 2023 Truepill data breach is a good example of what can happen if you partner with a vendor lacking robust security practices.
That data breach compromised over 2.3 million patient records due to inadequate data security measures, specifically the failure to encrypt sensitive healthcare information.
The biggest red flags when picking a development partner? No clear security practices and vague answers when you ask about data protection.
If they can’t explain how they’ll keep your product safe, walk away. Companies with authentic expertise will be able to discuss:
Specific regulatory challenges
Integration complexities they’ve solved
Measurable outcomes
Healthcare standards/regulations liek HIPAA, HL7, and FHIR
The right partner won’t just understand healthcare. They’ll have the track record to prove it, too.
Ask the tough questions. The ones who’ve done it before will have the right answers.
How well do you understand clinical workflows?
Building effective healthcare software requires really understanding how medical professionals actually work.
Clinical workflows are complex and involve multiple stakeholders, strict protocols, and life-or-death decisions most software developers just don’t encounter in their regular work.
You don’t want to deal with constant software crashes, financial nightmares, and workflow disasters because a vendor promised more than they could deliver without truly understanding real-world clinical needs.
The best healthcare software development companies will actually invest in UX research and usability testingto ensure your software actually works in a clinical setting.
And, if they’re close to you, they could even spend time in your practice to watch how doctors, nurses, and other staff interact with software.
When talking to potential partners, ask about workflow analysis.
They should talk about how they map existing workflows, spot bottlenecks, and design software that makes clinical work easier, not harder.
Watch out for red flags like vendors who don’t seem familiar with common clinical processes or those who brush off the importance of end-user feedback.
And be wary of vague responses like “We’ll design something clean and modern” if they can’t show they understand your specific needs.
How do you ensure compliance with relevant healthcare regulations?
Regulatory compliance should never be just a final checkbox in healthcare software projects.
Your development partner should show a compliance-first approach with clear processes for meeting regulatory requirements.
They need to understand how to build HIPAA-compliant software if you’re in the US, plus regulations like GDPR in the EU.
Here are the key HIPAA rules they need to be aware of:
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.
Be cautious if you hear vague answers about regulatory requirements or statements like “We plan to address HIPAA compliance and data security in a future phase”.
Good healthcare software development companies will have ready answers about their data retention policies, anonymization methods, and how they handle security incidents from the get-go.
What specific security measures and protocols do you follow?
Healthcare data protection demands the highest levels of security, both from technical and legal perspectives.
So, don’t take chances on a company with poor security practices.
Also, ask them about specific security measures they will implement, like:
End-to-end data encryption at rest and in transit
Role-based access controls
Multi-factor authentication (MFA)
Regular security audits and penetration testing
Automated threat detection systems
Data backup and disaster recovery protocols
Session timeouts and automatic logoffs
Critical red flags include vendors who treat security as an afterthought or those who can’t comply with essential healthcare security frameworks.
Ask them how they handle data, respond to breaches, and plan for disasters.
Look for companies that regularly check their security and have clear steps in place to deal with incidents.
Their development process should build privacy into your software from the start, not just tack it on later to satisfy regulations.
Which technologies and programming languages do you use?
The tech stack your development partner chooses significantly impacts your project’s success, scalability, and long-term maintenance requirements.
In healthcare software development, some languages and frameworks are particularly valuable for meeting the unique demands of medical applications.
Python is a top choice in healthcare tech due to its simplicity, versatility, and powerful libraries for data science, with approximately 48% of developers in health tech using it for AI, machine learning, and large-scale data analysis.
The tech stack shouldn’t be a one-size-fits-all decision.
Your development partner should justify their choices based on your specific requirements, including factors like integration needs, scalability requirements, compliance, and long-term maintenance.
They should balance proven, stable technologies with new, innovative frameworks.
And they should have the experience to avoid trendy tools that introduce unnecessary risk while still staying up to date with technologies that bring real, long-term value.
Red flags include vendors who can’t explain their technology choices or those who default to whatever stack they’re most familiar with regardless of your requirements.
Can you discuss your development methodologies?
Healthcare software development needs methods that balance agility with the strict documentation and validation requirements of regulated industries.
Your partner’s approach can make or break project success and timeline, especially considering how complex requirements usually are in healthcare projects.
Scrum, for example, breaks development into short (2-4 week) iterations called sprints, which act as mini development cycles.
This allows you to quickly pivot if and when you need to and is a life-saver if requirements change mid-development.
Many healthcare projects that work well use hybrid approaches – they mix Agile’s flexibility with elements of Waterfall for regulatory documentation and compliance.
But, what really matters is having structured processes with clear phases, regular feedback from users, and documentation standards.
Your development partner should also use modern project management tools and have dedicated roles like product managers who understand healthcare requirements.
Watch out for vendors who push back on regular project updates or don’t have clear contacts you can reach out to.
And be on alert if they seem reluctant to schedule regular check-ins or just give you vague updates along the lines of “Everything’s fine, don’t worry about the details.”
How do you manage project updates and client feedback?
When choosing a healthcare software development partner, ask them how they handle project updates and client feedback.
It’s a window into how your whole relationship will work.
Healthcare software deals with sensitive patient info, compliance rules, and workflows that directly affect care.
Getting regular updates keeps you in the loop about progress and challenges, which is extremely important when patient safety or regulatory compliance is at stake.
A good feedback system shows they’re committed to working with you, not just following a rigid plan.
Healthcare needs change constantly, with evolving requirements from all sides. Your partner needs to be able to incorporate ongoing input from your clinical staff, administrators, and tech teams.
Their answer also reveals how mature their project management really is.
Watch for structured communication methods, dedicated channels, consistent update schedules, and clear processes for handling feedback. These things show they’ve dealt with complex projects before.
Here’s what they should offer from day one:
Regular check-ins with clear action points
Transparent project dashboards
A clear feedback process
Multiple communication channels
Willingness to adapt to your preferences
Partners who take communication seriously are much more likely to deliver solutions that actually fit what your organization needs.
This leads to better adoption, smoother implementation, and fewer expensive fixes later.
In the end, how they manage updates and feedback is a pretty reliable indicator of whether they can successfully deliver your project.
How do you handle changes in project scope?
When choosing healthcare software development partners, pay close attention to how they handle scope changes.
Healthcare projects rarely stay static – regulations change, clinical workflows get updated, and stakeholders change their priorities mid-development.
How a company manages these changes will directly affect your project’s timeline, budget, and success.
Companies without solid change management typically fall into one of two traps: either stubbornly sticking to initial requirements or letting the scope constantly expand until you’re dealing with budget overruns and delays.
The best partners in healthcare development have formal change management processes that strike a balance between flexibility and accountability.
They’ll document change requests, figure out how they impact timelines and resources, and make sure you approve before implementing anything.
Also, they’ll create clear channels where you can discuss possible changes and help you understand what those changes really mean for your project.
This keeps scope creep in check while still allowing for necessary adjustments.
Taking a closer look at how a company handles scope changes tells you a lot about their expertise, transparency, and whether they can handle the moving parts that come with building real-world healthcare software.
How is your pricing structured?
Understanding costs upfront helps you avoid blowing your budget and makes sure you’re getting your money’s worth.
But healthcare software development still has a major transparency problem. Many company end up facing surprise expenses that they could have avoided if they’d just asked the right questions at the beginning.
The first question, of course, is: how much does healthcare software development cost?
Also, things like integrating AI, machine learning, and voice features typically adds 20-40% to your total budget.
This jump comes from needing specialized experts and beefing up your data infrastructure.
A good development partner won’t hide this – they’ll be straight with you about things that might affect pricing, like changes in project scope or when you need specialized talent.
On top of that, you need to know which pricing model they use – fixed price or time and materials. Here’s a breakdown of their key differences:
Fixed price vs. time and materials: overview
Category
Fixed-price
Time and materials
Best for
Small, well-defined projects
Long-term, evolving projects
Budget control
High, costs are agreed upfront
Varies, costs depend on hours worked
Flexibility
Very low, changes require renegotiation
High, you can adapt the scope as needed
Development speed
Usually slower because of more rigid planning
Faster, teams can adapt as new priorities emerge
Scope changes
Costly and difficult to implement
Easy to accommodate
Example project
Patient intake form app with fixed fields and workflows
Custom EHR platform
A major red flag is when a vendor’s cost structure is incomplete or murky.
Steer clear of any company that can’t give you a clear, detailed breakdown of what you’ll pay upfront and down the road – things like licensing fees, maintenance costs, upgrade charges, and support expenses.
Watch out for responses like “We can figure out the costs as we go along” or when they don’t want to explain exactly what might trigger extra fees.
Your development partner should be upfront about how they charge, with pricing that matches what your project needs.
Fixed-price deals make sense when you know exactly what you want, while time-and-materials or hybrid pricing gives you more wiggle room for complex solutions that might evolve as you go.
How do you handle ongoing software updates and maintenance?
Healthcare software requires continuous maintenance to remain secure, compliant, and effective.
Regulatory requirements change, security threats evolve, and your clinical workflows adapt over time.
Your development partner should offer comprehensive ongoing support, not just initial development.
Corrective maintenance – Finding bugs and errors post-launch.
Adaptive maintenance – Updating your product to work with new hardware and software environments.
Perfective maintenance – Improving features and performance based on user feedback.
Preventive maintenance – Updating security measures and optimizing code.
Avoid vendors who only provide vague commitments for post-launch support, like “Your staff can learn as they go” or “We’ll provide documentation, but training is extra.”
That kind of ambiguity won’t help you when real issues come up.
Look for companies who offer structured maintenance plans that include proactive monitoring, regular security assessments, and prompt response to issues.
Your Service Level Agreements (SLAs) should outline response times and support availability, providing clarity and accountability for ongoing support.
How do you handle intellectual property concerns?
When hiring a healthcare software development company, you really need to understand how they handle intellectual property (IP) concerns to protect what matters to your business.
This question gets at the heart of who fully owns your ideas, code, andsystems that might give you an edge over competitors.
Healthcare software often includes your own proprietary algorithms, unique workflows, or clever ways to tackle clinical problems.
Without clear IP agreements, you might lose control of your innovations or get stuck in expensive legal battles.
The risks are especially high in healthcare, where your solutions might include patentable processes or represent years of research investment.
Plus, healthcare apps typically deal with sensitive patient data, which adds another complicated layer to IP considerations.
A good development partner will be upfront about who owns the source code, whether they’ll reuse parts of it elsewhere, and how they’ll keep your confidential information safe.
Asking about IP upfront helps you make sure everything gets properly documented through solid contracts that spell out who owns what, confidentiality requirements, and licensing terms.
This kind of planning prevents headaches down the road and builds a foundation for a good working relationship where everyone understands their rights and responsibilities from the start.
What steps do you take to ensure accessibility?
Accessibility in healthcare software isn’t just about looking good. It’s about ensuring your solution serves all users effectively, including those with disabilities.
And it’s slowly becoming a legal requirement, too.
And thenew HHS regulations mean that accessibility standards extend to all third-party digital services, including telehealth solutions and scheduling software.
It’s not just the U.S., either. The EU Accessibility Act came into full force in June 2025 and set common accessibility requirements across the EU.
Your development partner needs to get these requirements and bake accessibility right into their development process from day one. But, what does that mean, exactly?
When designing for users, they need to focus on making interfaces intuitive, navigation straightforward, and keeping mental effort low.
This helps everyone, not just people with disabilities, and can really boost how many people actually use your software while cutting down on mistakes that might affect patient care.
Make sure your partner tests usability with all kinds of users, including healthcare workers and patients with different abilities.
They should know accessibility standards inside and out and have ways to check compliance throughout the entire development journey, instead of just tacking accessibility on at the end as an afterthought.
Need a reliable development partner?
Do you have a new project in the works for your practice but you can’t seem to find a reliable partner who handle it?
Well, you’re in the right place.
We’re an EU-based, high-caliber software development company with 13+ years of experience building enterprise-grade custom software solutions.
And we’d be happy to help you get your project over the line, whether it’s a custom solution tailor-made for you or a health tech product you want to go to market with.
If you want to learn more, feel free to reach out and our team will be happy to set up an intro call to discuss your needs in more detail.
A seasoned software engineering executive, Marin’s role combines his in-depth understanding of software engineering processes (particularly mobile) with product and business strategies. Humbly boasting 20+ years of international experience at the forefront of telecoms, Marin knows how to create and deliver state of the art software products to businesses of all sizes. Plus, his skills as a lifelong basketball player mean he can lead a team to victory.
When he’s not hopping from meeting to meeting, you’ll find Marin listening to indie rock, or scouring the latest IT news.
Here, we give you practical guide to testing healthcare software that holds up in the real world while meeting clinical, security and compliance standards.
