Accelerate QE with AI to Ensure HIPAA, FDA, & HL7/FHIR Compliances

AI-Powered Automation Healthcare
Software Testing Services

From seamless functionality and regulatory compliance to data privacy and security, QASmartz
covers it all! Leverage our AI-augmented healthcare software testing solutions
to unlock the full potential of your healthcare software.

Why Does Healthcare Application
Quality Assurance Matter?

Industry Highlights & Statistics

of healthcare apps fail to meet HIPAA compliance during initial audits.
0 %
of healthcare organizations experience data breaches every year.
0 %
million is the average cost of a healthcare data breach.
$ 0
The failure of software can be a matter of life and death in healthcare. From telehealth to EHRs, every single digital touchpoint
must function with precision and no errors. QASmartz ensures your healthcare app is aligned with
data security and regulatory compliance. We help deliver an optimal patient experience
through AI-powered digital healthcare quality engineering (QE).

Healthcare Software Testing Challenges & Solutions

Addressing Modern Hurdles in Healthcare IT

Industry Challenges

Meeting strict HIPAA, FDA, HITECH, MHRA, and ISO standards
High-risk data security and PHI privacy
Ensuring interoperability across EHR, EMR & medical systems
Handling large volumes of sensitive patient data
Telehealth traffic spikes causing latency
Frequent regulatory & clinical workflow updates

QASmartz’s AI-Powered Solutions

Automated compliance testing with audit-ready logs, risk-based reporting
Continuous vulnerability scanning, security testing, and PHI masking
API, integration & HL7/FHIR interoperability testing
AI-driven data validation, integrity checks & audit trail testing
Real-world load & stress testing for patient portals & telemedicine apps
Multi-region cloud load & stress testing
Adaptive QA automation with continuous compliance checks

Our Healthcare App Testing Capabilities

AI-Powered Digital Healthcare Quality Engineering

Our healthcare software testing solutions will take your application to the next level. Whether it’s security, performance,
or compliance, we make testing smarter and faster with AI/ML implementation so your team can do more with less.

Our QA professionals ensure that your healthcare or life science software product does all that it is designed to accomplish.

Use case: Ensuring e-prescription dosage calculation works correctly for pediatric vs. adult patients.

We carry out different types of performance and load tests that check the behavior of software in various situations.

Use case: Testing telehealth platforms for concurrent video calls without latency.

We use a variety of techniques to ensure the security of sensitive patient data, helping you make your software impenetrable.

Use case: Validating that patient portals don’t expose lab results through broken access controls.

Make sure that your healthcare app is accessible to any user with any accessibility needs, providing a smooth UX to everyone.

Use case: Screen reader testing for visually impaired patients booking appointments.

Let us test your software against a wide variety of healthcare standards and regulations, from HL7 to HIPAA compliance testing for telehealth apps.

Use case: Ensuring audit trails can’t be modified or deleted in an FDA-regulated clinical trial app.

Leverage our automation testing tools and solutions, fine-tuned based on the requirements of your project.

Use case: Automating workflows such as “Order Lab Test → Receive Result → Update EHR.”

Our Healthcare & Life Sciences Software Testing Services

Transforming the Way Digital Healthcare is Delivered 
Our healthcare application testing services let organizations innovate safely and within the regulations. We offer
AI-enabled automated testing solutions that accelerate the digital transformation of each health
system and make every touchpoint reliable.

EHR &
EMR Testing

We provide interoperability testing, data consistency, and secure transmission among healthcare systems, ensuring fluency in the workflow of doctors, patients, and insurers alike.

Ideal for EHR/EMR software solutions providers to ensure patient records align with HL7/HIPAA standards.

Telemedicine & mHealth Testing

Our quality assurance team provides connectivity, video/audio performance, and device compatibility while ensuring the protection of patient data in telemedicine or mHealth apps.

Ideal for healthcare startups or a telehealth platform for the extension of patient care remotely.

Life Sciences
App Testing

We offer expertise in life sciences app testing for reliability across clinical trial platforms, laboratory systems, and pharma ERP modules.

Ideal for biotechnology, pharmaceutical, and clinical research organizations that need compliant systems.

Medical Device &
IoT Testing

Our QA engineers test integrated, connected medical devices and sensors with digital dashboards for device accuracy, reliability, and compliance.

Ideal for IoT-driven healthcare device makers and digital health innovators.

Frameworks and Methodologies We Follow

Trusted, Scalable, & Compliant

QASmartz integrates AI-powered digital healthcare quality engineering with the shift-left continuous testing
approach to ensure zero compliance violations and perfect patient experiences.

Compliances for Healthcare QA:

HIPAA (USA): Protection and confidentiality of patient data
GDPR (UK/EU): Data privacy and consent compliance for users
OWASP: Web & API security compliance
FDA 21 CFR Part 11 (USA): Validation for electronic records, signatures
ISO 13485 (Global): Quality management for medical devices
HL7/FHIR (Global): Standards for health care data interoperability
WCAG (Global): Accessibility standards for differently abled users
OWASP Top 10: Web and API Security Best Practices
SOC 2 Type II (North America): Operational and data security controls

Our Framework Includes:

End-to-end automation integrated into CI/CD pipelines
AI-driven predictive analytics for risk-based testing
Continuous monitoring and performance benchmarking
Advanced test environments that are scalable and reusable
Automated reporting dashboards and compliance validation

API Testing Tools We Have Expertise In

Fail-Proofing Your Complete APIs

Why Choose QASmartz for Healthcare and Life
Science Quality Assurance Testing Solutions?

Ensuring Next-Gen, AI-First Quality Engineering 
We ensure that your healthcare applications are not only functional but also always compliant, highly scalable,
and secure with our skilled testing professionals, intelligent automation frameworks, and deep domain expertise.

Certified Experts

Our testing team holds certifications in QA, test automation, and regulatory compliance, including HIPAA and ISO 27001.

AI-Powered Accelerators

Reduce up to 40% of your testing effort thanks to our proprietary AI and RPA accelerators. 

Strategic Tool Partnerships

Integrate with Tricentis Tosca, UiPath Test Suite, and major healthcare automation platforms.

Faster Release Cycles

Shorten the product release cycles by up to 50% and ensure the reliability of applications by up to 90%.

Driving Measurable Value

healthcare software engagements completed
0 +
certified operations
ISO 0
certified experts in life sciences software QA
0 %
compliance testing
0 %

Experience QASmartz –
Free 40-Hour QA Trial

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Frequently Asked Questions

Healthcare software testing is all about verifying that health-related software applications function properly and securely. Since healthcare apps deal with sensitive patient data, they need to meet strict industry regulations like HIPAA or GDPR. This is why testing is necessary to:

  • Avoid system failures
  • Maintain data privacy
  • And protect patient safety

Generally, healthcare application quality assurance includes a series of tests put in place to ensure the software is of the required standard and functions properly. The major tests are functional testing, performance testing, automation testing, compliance testing, and security testing.

Software applications in healthcare include sensitive information about patients and must be very reliable, as well as comply with very strict international standards, such as HIPAA, FDA, and ISO 13485. These are some of the unique risks that generic QA does not consider.

For more than 25 years, QASmartz has been offering end-to-end QA and testing solutions to healthcare and life sciences ventures in the US, UK, North America, and the MENA regions. Our key services include:

  • Regulatory compliance testing (HIPAA, GDPR, FDA, MHRA)
  • Interoperability testing (HL7, FHIR)
  • Performance and security testing
  • AI-supported test automation
  • Accessibility testing

Yes! At QASmartz, we have a dedicated team that relies on proven automation tools and platforms to speed up regression testing, reduce human error, and ensure consistent QA results. We also provide test coverage for critical user flows, APIs, and integrations under strict compliance regulations.

Because the Healthcare & Life Sciences TCoE provided by QASmartz combines domain knowledge, regulatory knowledge, and AI-based testing accelerators. We rely on certified QA engineers, automated frameworks, and compliance-driven methodologies through which every healthcare product that we test is safe, accessible, and internationally compliant.

QASmartz continuously conducts compliance audits, deploys secure test environments, and confirms workflows via AI-driven compliance automation frameworks. We strictly follow QA processes aligned with HIPAA, FDA, and ISO regulations, including:

  • Data security
  • Audit trails
  • And compliance validation.

Simply fill out the form or contact us at 1-888-661-8967. You can also email us at sales@qasmartz.com. Subsequently, our experts will arrange a quick FREE consultation for life sciences software testing services.

Experience QASmartz –
Free 40-Hour QA Trial

Contact Form

Get in Touch                 Call Us: +1-888-661-8967  Email Us: sales@qasmartz.com                                         ©QAsmartz All Rights Reserved 2025-26

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