Healthcare Software Testing
Since 2001, IT Craft has been testing and building software, including healthcare IT solutions for medical software vendors and healthcare providers.
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Healthcare Software Testing Explained
Medical software testing verifies that a healthcare application works as specified, meets FDA and HIPAA requirements, exchanges data via HL7 and DICOM, and keeps patient information secure. Testing can account for up to 40% of software development costs, and outsourced QA with automated regression suites brings that share down.
Key steps:
- Software requirements verification.
- Risk evaluation.
- Test planning and design.
- Test execution.
- Results reporting.
Team structure: a QA manager, a test lead, test engineers, test automation engineers, a compliance consultant, and an information security specialist.
Healthcare Software Testing Costs
Healthcare software testing services typically cost $30,000 to $150,000+, or roughly 15–40% of the total software development budget. Where a project lands in that range depends on application complexity and how strict the applicable regulations are.
Cost Breakdown by Product Type
- Mobile health apps: $30,000–$60,000.
- Telehealth solutions: $50,000–$120,000.
- EHR/EMR systems: $100,000–$250,000.
- Regulated medical device software (SaMD): $150,000+ (driven by FDA, ISO 13485, and IEC 62304 requirements).
Specific Testing & Compliance Add-Ons
- Security code review or data protection audit: $15,000–$25,000.
- QA code review (incl. root cause analysis): $8,000–$16,000.
- Penetration testing: $5,000–$15,000 per round.
- One-time performance testing of a mobile health app: ~$5,000.
- QA process audit and recommendations: $24,000–$72,000.
- Continuous managed testing of 3–5 healthcare apps: ~$20,000 per month.
Key Cost Drivers
Healthcare solution-related factors:
- Solution type and complexity (e.g., a patient app vs. an EHR module).
- Security and compliance requirements (e.g., HIPAA, GDPR).
- Number of user roles (e.g., medical staff, admins, patients) and the intended user count.
- Number and complexity of integrations with other healthcare IT systems (EHR, RCM, CRM, practice management systems, patient apps, etc.).
Client Pain Points & QA Solutions
Challenge
Solution
- It may be hard to keep healthcare software in line with FDA and HIPAA requirements when test results are not documented for an audit.
- Our QA engineers implement compliance controls at every level of testing, from requirements traceability and validation protocols to defect logs and audit reports.
- Integration with Epic or Oracle Health (Cerner) is often limited by unstable data flows from labs and pharmacies.
- Our team reproduces EMR/EHR data flows and connects the test environment with lab and pharmacy systems via HL7 FHIR APIs and mock services. Lab orders, e-prescriptions, and insurance pre-authorizations are then tested without real patient data.
- Patient safety cannot be ensured once and for all, as each new release, such as a dosage calculation or alert update, adds risks of clinical errors.
- In addition to risk-based testing, automated regression, and strict verification, IT Craft isolates dosage calculations, clinical alerts, and patient matching from other functions and performs clinical logic testing before releases.
- “Our QA team tests features, not clinical workflows.”
- Our test engineers build workflow-first test scenarios in line with HL7, FHIR, and DICOM, with end-to-end paths for medication orders, lab results, and patient record matching.
Healthcare Software Testing Process
A healthcare software testing plan depends on the software type (e.g., EHR/EMR, HIS, medical imaging and lab software, telemedicine solutions, SaMD) and the standards it must meet (e.g., HIPAA, GDPR).
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Software requirements analysis and planning
Depending on the complexity of the healthcare software and the project’s scope, a test lead or a QA manager:
- Analyzes the healthcare software requirements to make sure they are clear, complete, and testable.
- Identifies the risks of a healthcare software testing project (e.g., resource shortages, budget overruns, etc.) and creates a risk mitigation plan.
- Outlines the healthcare software testing plan, which covers: testing objectives and types of testing to perform; testing schedule; required specialists and team structure; test automation share; testing metrics.
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Test design
After verifying the healthcare software requirements and defining the testing strategy, test engineers:
- Prepare the relevant test environment and test data. Best practice: During healthcare software testing, IT Craft uses mock data sets instead of real patient information to prevent sensitive data leakage.
- Design test scenarios and test cases.
- Prepare the testing toolkit (defect management and tracking software, communication tools, etc.).
- Set up and configure test automation tools and frameworks; write automation scripts (where test automation is feasible).
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Test execution and reporting
The healthcare software test engineers:
- Run and maintain manual test cases and automated scripts.
- Report the defects found.
- Conduct re-testing and regression testing to confirm that defects are fixed and existing healthcare software functions are not affected.
- Submit regular reports on test execution and the fulfillment of testing KPIs.
Main Types of Healthcare Software Testing
To help you choose the testing types your project needs, we have summarized the ones most often requested by our clients in the healthcare domain.
Functional testing
The functionality of healthcare software is tested against the software requirements to make sure the solution works exactly as planned (functionality verification). Where feasible (e.g., regression testing), test automation is used to significantly reduce testing cost and time.
Performance testing
Testers check the healthcare solution stability under normal load and in stress conditions.
Security & compliance testing
For healthcare software, security and compliance testing are closely tied: patient data security is essential for compliance with regulations like HIPAA and GDPR. Testing activities include penetration testing, vulnerability assessment, security code review, etc.
Compatibility testing
Test engineers run compatibility testing to make sure a healthcare application works on different devices and is fully compatible with the required range of operating systems and browsers.
Interoperability testing
Test engineers check whether a healthcare solution supports reliable medical data exchange in line with major data transfer standards such as HL7, FHIR, DICOM, and more.
Integration testing
Testers check whether combined healthcare software modules or connected applications (e.g., EHR, RCM, patient apps, medical devices, imaging and lab software, etc.) work together smoothly.
Usability testing
With healthcare rules and regulations in mind, test engineers develop user scenarios for each user role (e.g., medical staff, admins, patients, etc.) to cover every procedure a specific user performs and make sure the solution offers a convenient user experience.
Our Services
In software testing since 2001, IT Craft checks medical applications for application functionality, security, and regulatory compliance.
Consulting
Our consultants will:
- Run requirements analysis for your healthcare solution.
- Recommend a sourcing model that fits your testing needs and budget.
- Design a testing plan for your solution type.
- Select testing frameworks and tools.
- Build a risk mitigation plan.
- Break down testing costs and suggest cost optimization options.
Software testing outsourcing
What our QA team takes over:
- Testing strategy and plan.
- Test environment setup and healthcare test data generation.
- Test case development, execution, and maintenance.
- Automation script development (if required).
- Testing for regulatory compliance (e.g., HIPAA, FDA).
- Testing documentation and regular progress reporting.
IT Craft as a Healthcare Software Testing Company
- Since 2001 in software development and testing.
- Medical software testing since 2001.
- 330 experts on staff, incl. QA engineers.
- 4.9 rating on Clutch.
- Experience with healthcare regulations (HIPAA, HITECH, ONC, MACRA, MIPS, CEHRT, SAFER), data exchange standards, and clinical terminologies (HL7, ICD-10, CPT, XDS/XDS-I, SNOMED CT).
Success Stories
End-to-End Testing of an AI Workforce Management Platform for the Largest US Healthcare Staffing Company
Over an eight-year partnership, IT Craft’s QA engineers performed functional, integration, and regression testing of Workforce AI, a platform for nurse staffing, predictive scheduling, and workforce planning built for Aya Healthcare. Automated regression within CI/CD pipelines helped the team ship new modules while the platform’s integrations with EMR, HRIS, and VMS systems kept working without disruption.
Security and Performance Testing of a SaaS Platform Processing Tens of Thousands of HIPAA-Aligned Requests Daily
IT Craft tested Arctrieval Legal’s SaaS platform, which US personal injury firms use to request medical and billing records, for PHI security, audit trail accuracy, and stability under high request volumes. Integration and API testing covered the external API for law firms’ case systems and native integrations with legal practice management software, helping the platform scale across the US legal market.
Functional Testing of a Claims Audit Platform for Healthcare-Focused Insurers
Functional Testing of a Claims Audit Platform for Healthcare-Focused Insurers IT Craft’s QA team verified the custom audit algorithm that checks diagnosis and procedure codes in medical claims, along with SSIS-based import of remote claims data. Security testing of role-based access and document upload helped deliver a HIPAA-aligned platform that serves multiple insurance firms.
Roles in Our Healthcare Testing Team
Team composition depends on the type and complexity of your healthcare application testing project. These are the common roles on IT Craft’s healthcare testing teams.
QA manager
Turns requirements into testable requirements, identifies the compliance policies and regulations that apply, builds the testing strategy, selects test management tools, and guides the QA process setup.
Test lead
Handles test planning for the solution’s type and complexity, picks testing frameworks and tools, takes care of team management, and controls test design and execution.
Test engineer
Covers test case design and maintenance, runs manual testing, handles defect reporting, and performs fixed defect validation.
Test automation engineer
Selects scenarios worth automating (automation scenario selection), designs the test automation architecture, handles tool configuration, develops and maintains automation scripts, and validates fixed defects.
Compliance consultant
Reviews requirements, the testing process, testing tools, and project documentation against healthcare standards (e.g., HIPAA, GDPR), and keeps sensitive data handling compliant during testing.
Cybersecurity specialist
Runs vulnerability assessment and penetration testing, finds security loopholes, advises on security issue mitigation, and reinforces existing security controls.
Engagement Models
Each model trades control for cost and speed in its own way. Here is what you get and what you risk with each.
H3: In-house Testing
- (+) Full process control over testing.
- (−) Testing skills and domain competence gaps in the team.
- (−) High spend on training, salaries, taxes, and licensed tools.
- (−) Low team scalability.
Outsourced Testing
- (+) Optimized testing costs.
- (+) Scalable healthcare testing teams.
- (+) Transparent KPI-based approach.
- (−) Vendor selection risks: a vendor without healthcare experience can cost you an audit.
Hybrid Testing
QA management stays in-house; the testing team is fully or partly outsourced.
- (+) Balanced costs and process control.
- (+) Fast access to specialized talent with healthcare solution expertise (a specific software type or standard).
- (−) Possible communication issues between in-house management and the outsourced team.
Technology Stack
In healthcare testing projects, IT Craft usually works with:
Contributor
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Healthcare IT Expert & Consultant
