01
Before a health system go-live
Interface and workflow testing against the hospital's test environment.
Healthcare / Quality Assurance
Healthcare quality assurance for clinical and patient software
A missed defect in healthcare software can put a result in the wrong chart or lock a patient out of their care plan. Agnotic Technologies tests and validates healthcare software before each release, from HL7 v2 and FHIR interfaces to accessibility and FDA validation evidence, using synthetic data instead of patient records.
HL7 v2 and FHIR
Interface testing
Synthetic data
No patient records
WCAG 2.2
Accessibility checks
Trusted by global innovators
Industry Overview
What is healthcare quality assurance?
Healthcare quality assurance is the testing and validation that shows clinical and patient software is safe to release: functional and regression tests, HL7 v2 and FHIR interface tests, accessibility and security checks and, where FDA rules apply, documented system validation. Agnotic Technologies plans and runs this testing with synthetic data, never real patient records.
Industry Challenges
What goes wrong when healthcare software is tested like any other app?
General QA catches broken buttons. Healthcare releases fail in places a general test plan never looks.
Interfaces are tested with a handful of clean sample messages, then real HL7 v2 feeds arrive with optional segments, repeats and local Z-segments.
FHIR APIs pass a quick smoke test but fail profile validation or terminology bindings when a partner connects.
Test environments are loaded with copies of production data, so PHI ends up on laptops and in vendor tools.
Accessibility is checked once by eye, so screen reader users meet unlabeled form fields in the patient app.
An EHR upgrade on the hospital side changes a message or an API, and nobody reruns the interface tests.
Software that holds FDA-regulated records ships without the validation evidence an auditor will ask for.
Decision table
Which tests does each kind of healthcare release need?
We start every test plan from this table, then adjust it to the risk of the specific release.
| Release type | Must-have tests | Evidence to keep | Common miss |
|---|---|---|---|
| Patient-facing web or mobile app | Functional, accessibility, security, device and browser coverage | Test results per release, accessibility report | Screen reader and keyboard paths |
| HL7 v2 interface | Message conformance, edge cases, error and retry handling, volume | Message test sets, interface sign-off | Optional segments and repeating fields |
| FHIR API or SMART on FHIR app | Profile validation, OAuth scopes, paging, error responses | Validator output, conformance test results | Terminology bindings and scope edge cases |
| EHR upgrade on the provider side | Interface regression, workflow regression in the EHR | Before and after test runs | Changed fields nobody announced |
| Software holding FDA-regulated records | Validation against requirements, audit trail and signature tests | Validation plan, traceability matrix, summary report | Traceability from requirement to test |
| AI or analytics feature | Accuracy on held-out synthetic cases, bias checks, fallback behaviour | Evaluation set, results, model version | Behaviour when the input is out of range |
Our Approach
How does Agnotic approach healthcare QA?
Three principles run through every test plan we write for a healthcare client.
Test by clinical risk
The tests that protect patient safety and data, such as result routing and access control, run on every build. Lower-risk areas get lighter coverage.
No PHI in test environments
We generate synthetic patients and messages that look like real traffic, so testers and tools never need production records.
Test where the integration lives
Interface and API tests run against the partner's test environment or sandbox, not only against our own mocks.
Capabilities
What does our healthcare QA cover?
Testing and validation work we plan, automate and run for healthcare software teams.
Test strategy and risk assessment
A test plan built from the release's clinical and data risks, with clear entry and exit criteria for each test level.
HL7 v2 interface testing
Message sets for ADT, orders and results, with edge cases, malformed messages, acknowledgements and retry behaviour.
FHIR conformance testing
Resources checked against FHIR R4 profiles with the FHIR Validator, and APIs exercised with conformance test kits such as Inferno.
Synthetic test data
Generated patients, encounters and messages that cover your edge cases, with no real patient identifiers.
Accessibility testing
Automated checks plus manual screen reader and keyboard testing against WCAG 2.2 success criteria.
Regression for EHR upgrades
Automated interface and workflow suites rerun before and after an EHR upgrade, with the differences reported.
Security and privacy testing
Access control, session, audit log and data exposure tests tied to the HIPAA Security Rule safeguards the product relies on.
Computer system validation
Validation plans, traceability matrices and summary reports for software that holds FDA-regulated electronic records.
Engineering Stack
Tools and standards we test with
Chosen to fit your stack, your CI pipeline and the systems you integrate with.
Automation
Playwright and CypressAppium, XCTest and EspressoAPI test suites in CIContract tests
Interfaces
HL7 v2 message simulatorsInterface engine test channelsFHIR ValidatorInferno test kits
Test data
Synthetic patient generatorsCustom message buildersMasked reference valuesSeeded sandboxes
Accessibility and security
axe and LighthouseVoiceOver, TalkBack and NVDAOWASP ZAPDependency and container scanning
Measured Impact
What should a healthcare QA program report?
Measures we report each release and review with your engineering and clinical leads.
Escaped defects
Found after release
Defects found in production, by severity and by the test level that should have caught them.
Interface coverage
Messages and resources tested
Which message types, segments and FHIR profiles have automated tests.
Accessibility
Open WCAG issues
Open accessibility issues by success criterion and by screen.
Traceability
Requirements with tests
Requirements linked to passing tests, where validation evidence is needed.
My Lauren Maternal Health Platform | Built by Agnotic
A HIPAA-ready maternal health platform enabling remote patient monitoring, care coordination, and personalized engagement from pre-pregnancy through postpartum.
Case Study
LERA Health: Compliant Women’s Health App Platform
A women’s health product experience focused on guided care journeys, education, and compliance-aware workflows to support long-term engagement.
Case Study
Use Cases
When do teams bring in healthcare QA?
The moments that most often start a healthcare quality assurance engagement.
02
Before an EHR upgrade
Regression suites run before and after the upgrade window.
03
Before FHIR API certification testing
Profile validation and conformance testing ahead of formal test runs.
04
Before an FDA submission or audit
Validation plans and evidence for systems that hold regulated records.
05
After a production incident
Root cause tests added so the same defect cannot return.
06
When manual testing slows releases
Automation for the regression tests your team repeats every sprint.
Integrations
Which systems do we test against?
The environments and partners our test suites run against.
Clinical record
EHR sandboxes (Epic, Oracle Health (Cerner), others)
HL7 v2 routing
Interface engines
APIs
FHIR servers
X12
Payer and clearinghouse test endpoints
SSO and SMART on FHIR
Identity providers
Automation
CI and device clouds
Self-assessment
Is your healthcare release ready to ship?
Tick what is true for your next release. Every gap is a question we would ask on the scoping call.
Compliance-First Development Services Backed by Global Standards
We build secure, scalable products designed for privacy, interoperability, and regulatory readiness from day one across every sector we serve.
Health Insurance Portability and Accountability Act
Protect PHI with privacy-first architecture, encrypted storage and transmission, and strict access controls.
Fast Healthcare Interoperability Resources
Enabling standardized health data exchange through standards-based API mappings.
Health Level Seven International
Supporting enterprise-grade interoperability for clinical messaging and record workflows.
Our Edge
Why Global Leaders Choose Us
We combine deep technical expertise with industry-specific knowledge to deliver solutions that aren't just functional, but transformational.
Enterprise-Grade Security
We implement rigorous security protocols and compliance standards (HIPAA, GDPR, SOC2) across all industrial solutions to protect sensitive data.
High-Performance Scaling
Our architectures are built to handle massive data loads and user bases, keeping performance steady whether you're serving ten or ten million.
Accelerated Time-to-Market
Using our suite of internal tools and proven frameworks, we reduce development cycles and get your product to market 40% faster.
Embedded AI Integration
Beyond simple wrappers, we build deep-learning integrations and predictive analytics directly into the core of your industry-specific workflows.
Engagement Model
How does a QA engagement work?
We start with the release that carries the most risk. Timing depends on scope; we agree a fixed first release of the test suite on the scoping call.
01
Scoping call
We review the product, the integrations, the regulatory context and the next release date.
02
Test strategy
Risks, test levels, environments, synthetic data needs and evidence to keep are agreed in writing.
03
First test suite
Automated tests for the highest-risk flows and interfaces, running in your CI pipeline.
04
Release testing
Manual, exploratory and accessibility testing alongside the automated suite for each release.
05
Ongoing support
Suites kept current as interfaces, EHR versions and regulations change.
Facts and sources
Standards behind healthcare software testing
Short facts we test against, each linked to its primary source.
The HL7 FHIR R4 specification describes several ways to validate resources, from XML and JSON schema checks to the FHIR Validator, which tests structure, cardinality, terminology bindings, invariants and profiles.
Source: HL7 FHIR R4, Validating ResourcesInferno is an open source tool for automated FHIR conformance testing, and ONC's public Inferno host runs the (g)(10) Standardized API Test Kit, an approved test method for the 170.315(g)(10) certification criterion.
Source: ONC (ASTP), Inferno on HealthIT.govWCAG 2.2 is the W3C Recommendation commonly used as the technical benchmark for accessible web and mobile interfaces.
Source: W3CFor closed systems that hold FDA-regulated electronic records, 21 CFR Part 11 requires validation of systems to ensure accuracy, reliability, consistent intended performance and the ability to discern invalid or altered records.
Source: 21 CFR 11.10(a) (eCFR)HIPAA allows two ways to de-identify health data: expert determination, or the safe harbor method, which removes 18 categories of identifiers.
Source: 45 CFR 164.514(b) (eCFR)
Voice of success
We don't just build products; we forge lasting partnerships. See how we've helped industry leaders transform their vision into technical reality.
“I can clearly see how Agnotic has a unique way of handling end-to-end development. They are always active on quick chat and provide support quickly.”
Aaron Phelan
Founder, Benchmark
“Agnotic combines deep technical expertise with strong domain knowledge. They understand the business context, anticipate challenges, and make collaboration smooth and effective.”
John Pasmore
Founder, Latimer
“Agnotic is the best technical team we evaluated. Their engineering excellence made our work dramatically easier and allowed us to stay focused on what matters most for maternal care outcomes. They took full ownership of the technical execution, and we are always happy to continue working together.”
Kim Smith
Founder, My Lauren
Related pages
Related testing and integration services
This page covers testing for healthcare software. These pages cover the build and integration work it protects.
QA and testing services
Our general software testing and automation services across industries.
HL7 v2 integration services
Building and running the HL7 v2 interfaces our tests exercise.
FHIR integration
FHIR APIs and apps built to the profiles we validate against.
FDA SaMD compliant software development
Software as a medical device built with design controls and validation evidence.
DevOps for healthcare
Secure delivery pipelines where automated tests run on every build.
More in Healthcare
More Healthcare Solutions
Explore other production-grade engineering platforms we deliver across healthcare.
Cross-Industry Reach
The Same Engineering Patterns, Across Other Industries
The technical patterns behind this platform translate naturally into adjacent verticals.
Frequently Asked Questions
The number of interfaces and platforms to cover, how much is automated, whether validation documentation is needed, the accessibility scope and how often you release. We explain these drivers on the scoping call instead of quoting a fixed price.
It depends on scope. We agree a fixed first release, usually automated tests for the highest-risk flows and interfaces, on the scoping call, then grow coverage release by release.
No. We use synthetic patients and messages built to match your edge cases. If a test truly needs production-derived data, it must be de-identified under HIPAA first, and Agnotic signs a business associate agreement before any PHI is shared.
It means testing the safeguards the product relies on, such as access control, audit logs, encryption and session handling, and keeping PHI out of test tools. HIPAA has no certification for software, so we report test evidence, not a compliance badge.
Yes. We build HL7 v2 message sets with edge cases and error paths, validate FHIR resources against their profiles with the FHIR Validator, and run conformance test kits such as Inferno against FHIR APIs.
Yes, for software that holds records under FDA rules such as 21 CFR Part 11. We write the validation plan, trace requirements to tests and produce the summary report. Your quality team approves the validation.
Yes, scaled to the stage. Healthcare quality assurance for startups usually starts with automated tests for login, consent and data flows, synthetic test data and an accessibility check, because health system buyers ask about all three.
Industries