Blog Summary:

This post provides a comprehensive insight into strategizing the QA process for healthcare software development with. From basic details, we explain the types of QA tests, including manual and automation testing, along with best practices and challenges of Healthcare Application Testing.

Imagine a scenario where your healthcare app is suffering a data breach or fails a clinical audit. Could you imagine what will happen? According to the HIPAA Journal, 725 cases of data breaches were reported in 2023, resulting in approximately 133 million records being compromised. This situation creates repercussions, including financial penalties, HIPAA violations, and lawsuits. These all reflect compromised patient safety.

healthcare data breaches

Not to mention, healthcare is a sector where trust is everything – even a small QA insight can lead to a major fall in reputation. It necessitates rigorous healthcare quality assurance, which has become mandatory rather than optional. Your healthcare apps should meet high-performance standards while adhering to interoperability requirements, privacy, and regulatory requirements.

A well-defined QA process is essential for any IT team or small business to avoid risks that fall short of user expectations and compliance. In this guide, we discuss a complete QA methodology for healthcare app development. Let’s explore now.

Understanding QA in Healthcare App Development

QA in healthcare app development is much more than preventing bugs. It involves maintaining reliability, protecting lives, and ensuring regulatory compliance. The entire process requires a compliance-based and rigorous approach that adheres to both clinical and legal consequences.

What is QA in Healthcare?

QA is a process that checks whether healthcare apps perform as expected. It verifies the software works with accuracy, safety, and full compliance within the context of patient privacy and clinical workflows.

QA in the healthcare app development process differs significantly from general app development, which focuses on functionality, user experience, and cross-device consistency. Healthcare QA focuses on the following important elements;

  1. Data Integrity
  2. Workflow Accuracy
  3. Fail-Safes

You need to understand that even a minor bug in your healthcare app leads to major issues. It could expose various issues, ranging from exposing personal health details to delaying urgent care.

Compliance Foundations

When it comes to compliance, it’s pivotal for QA in the healthcare sector. Ensure that every phase of your QA process incorporates all relevant regulations, such as GDPR, HIPAA, and FDA guidelines, among others. Let’s explain each of them in-depth.

  1. HIPAA: It requires foolproof protection of personal health information (PHI), which impacts cloud architecture, login flows, and more.
  2. GDPR: It’s another regulation that necessitates explicit data portability and user content.
  3. FDA: It becomes necessary when apps are classified as medical devices, which requires enforcing traceability, validation, risk management, etc.

Check out our detailed guide on HIPAA compliance app development, which will help you navigate and mitigate complex regulations.

App Types

Varieties of healthcare software require fully customized QA strategies.

  1. Telemedicine Apps: These are apps that require enhanced performance under various network conditions, real-time data sharing, and encrypted video calls, among other features.
  2. Electronic Health Record (EHR) Systems: It must prioritize role-based access controls, data consistency, and integration with legacy systems.
  3. AI Diagnostic Tools: They require complete validation against accuracy benchmarking, medical datasets, and exploitability testing to match EMA/FDA criteria.
  4. mHealth Apps: These are mainly patient-facing apps that require complete usability testing across multiple demographics and devices. Additionally, they must also follow the FDA’s mobile health guidelines.

Why Does Healthcare App QA Testing Process Matter?

What is QA Process?

A strategy-driven QA testing process provides great value to healthcare organizations. Let’s consider it from the different points of view of various stakeholders.

  • For Founders: A trustworthy QA process is essential for developing investor trust, minimizing launch delays, and enhancing market readiness.
  • For IT Managers: QA offers interoperability, system stability, uptime, and more. These help them avoid emergency patches or last-minute surprises.
  • For Compliance Officers: Comprehensive QA minimizes the overall risk of audit failures, regulatory violations, legal liability, and many other related issues. These protect the organization’s reputation.

Manual Testing in Healthcare QA

Manual testing plays a crucial role in determining complex user workflows that involve patient interactions, clinical logic, variable conditions, and other factors. For instance, a medical professional who deals with medication charts, patient vitals, and alerts should experience an intuitive and smooth flow. It’s something that automated scripts cannot replicate in real-world use cases.

It’s indeed highly important in accessibility testing, especially for patients with disabilities or the elderly who rely on voice-based navigation. Manual testing and human observation often require analyzing the way visually impaired users interact with mobile health apps.

Techniques

An effective and result-driven software testing in healthcare includes the following important points:

  • Exploratory Testing: Testers use the software as real users would, discovering various unexpected issues in live workflows.
  • Usability and Accessibility Assessment: For persons with disabilities or older patients, many factors determine usability and accessibility. These factors include color contrast, font sizes, ease of use, and screen reader compatibility, among others.
  • Test Case Documentation: Every manual test is thoroughly documented, including expected outcomes, clear steps, and detailed notes on observed behaviors. These help ensure repeatability and audit-readiness.

Automation Testing in Healthcare QA

Automation testing is crucial for ensuring consistency, speed, and scalability. It’s highly important for today’s advanced healthcare QA strategies.

Automation is ideal for high-volume, repetitive, or time-sensitive tasks that require implementation across multiple platforms and builds. Let’s understand important areas where automation brings value, including;

  • Regression Testing: It involves verifying whether existing features remain unaffected by new code implementation.
  • Performance Testing: It simulates a large number of concurrent users to verify load handling, whether for scheduling or telemedicine apps.
  • Bulk Data Validation: This involves processing data with accuracy and displaying larger datasets, including patient histories and lab results, without requiring manual overhead.
  • Repetitive Security Checks: It automates the entire process for common vulnerabilities like token expiry, sanitization, encryption protocols, etc.

Recommended Tools

Healthcare QA teams mainly depend on various top-notch automation tools, which are as follows:

  • Appium: It’s apt for mobile apps across iOS and Android.
  • Selenium: It’s apt for cross-browser web app testing
  • Cypress: This tool is apt for advanced JavaScript-based end-to-end testing.
  • Custom Frameworks: These have the potential to handle a variety of healthcare-related workflows and also compliance validations.

Integration

Automation works smoothly when integrated with a CI/CD pipeline. It triggers test suites with every code pull or push request. It offers;

  • Early bug detection
  • Fast regression cycles
  • Scalable test environments that ensure future app growth

When you integrate automated QA with DevOps, it ensures healthcare apps remain high-performing, audit-ready, and deployment-friendly.

Security and Penetration Testing

Security is not to be optional for healthcare development. It is, in fact, critical, especially with the rising number of data breaches. Therefore, security testing has become indispensable for quality assurance in healthcare.

Criticality of Security

It cannot be denied that healthcare data is the primary target of cyber attackers. We have already seen various examples, whether it’s ransomware attacks or the theft of patient records. These are real and an increasing threat.

Many reputable regulatory bodies, such as GDPR and HIPAA, often impose heavy fines for non-compliance. You need to understand that even a single data breach can cause millions of dollars in costs and permanently damage trust.

Approach

A security testing strategy consists of multiple approaches that are as follows;

  • End-to-End Security Assessments: It involves determining every point related to storage, data entry, transmission, and third-party integration.
  • Penetration Testing: It aims to identify vulnerabilities before attackers can exploit them.
  • Vulnerability Scans: It detects security flaws in APIs, libraries, and configurations.
  • Encryption Validation: It ensures the proper encryption of data at rest and in transit using industry-standard protocols.

Best Practices

  • Secure Authentication: For this, you can utilize advanced practices such as session timeouts, multi-factor authentication, and role-based access control.
  • PHI Protection: This includes various activities such as anonymizing datasets for testing, masking sensitive fields, and preventing the storage of unwanted data.
  • Threat Modeling: It involves simulating real-world attacks to strengthen defenses.

 Checklist for Security Test Before Launch

Let’s explore an important checklist for quality assurance testing before you conduct a thorough security test.

  • Complete penetration testing
  • Verify data encryption
  • Implement secure logging and audit trails
  • Review PHI access controls

Ensure Your Healthcare App Meets Highest QA Standards

Wondering if your app’s QA process truly covers all compliance and security bases? Let our specialists review your workflows and identify key improvement areas.

Book a QA Consultation

Healthcare Application Testing Lifecycle and Tools

Healthcare App QA Tools Landscape

Implementing the top practices and tools makes your QA process more advanced and streamlined. Let’s explore various emerging trends and tools to improve speed, quality, and compliance.

QA Lifecycle

QA lifecycle offers regulatory alignment and consistent delivery. It includes multiple phases.

  1. Planning: This phase involves determining the major objectives of QA, which are aligned with compliance and clinical objectives.
  2. Recruitment Analysis: It involves collaborating with app owners and other stakeholders to discover regulatory and functional test conditions.
  3. Test Design: This phase involves creating traceable and detailed test cases mainly for user flows, PHI handling, and edge cases.
  4. Test Execution: This phase involves a combination of both automated and manual strategies for complete coverage.
  5. Defect Tracking: To achieve this, you need to leverage tools such as TestRail and Jira to focus on and resolve various issues with higher efficiency.
  6. Reporting: It provides detailed insights into compliance risks, severity levels, resolution timelines, and more.
  7. Closure involves conducting post-release reviews to document learning and enhance future cycles.

Collaboration

The QA process in healthcare app development needs to be cross-functional by design. It also requires perfect collaboration between developers, testers, clinicians, compliance officers, and others for various purposes.

  1. Intuitiveness of UI/UX, be it for professionals or patients.
  2. Align features for data safety and medical accuracy.
  3. Verify that workflows align with legal and clinical standards.

Trends

Modern healthcare QA teams should adopt the following important practices to stay compliant and competitive;

  1. Synthetic Data: HIPAA-safe options for real patient records, providing scalable and secure testing.
  2. AI-Assisted Testing: These tools generate test cases automatically and identify anomalies using historical data.
  3. Agile/DevOps QA Integration: It advocates for continuous testing, properly integrated into development pipelines, for error-resistant and fast releases.

Challenges in Healthcare Application Testing Challenges

The development of healthcare apps presents several QA challenges that can lead to audit failures, stall releases, and compromise patient safety. Let’s explore those challenges one by one.

  • Integration Chaos: Healthcare apps are designed to be integrated with wearables, EHR systems, lab platforms, and third-party apps. Therefore, any communication lag or misaligned data structure can cause serious functionality issues.
  • Fragmented User Data: Any fragmented or inconsistent data across various systems can lead to clinical inaccuracies, test failures, compliance violations, and other issues.
  • Ever-Evolving Regulation: With changing regulatory guidelines and industry standards, QA teams face numerous challenges in keeping up.
  • Device Fragmentation: A healthcare app should be functional on a range of devices with varying screen sizes, operating systems, and other specifications. Each comes with its own set of variables to test.

Mitigation Strategies to Overcome These Challenges

  • Continuous Training: It’s crucial to regularly upskill your QA team on the latest tools, regulatory standards, and healthcare-specific testing scenarios.
  • Regulatory Monitoring: To stay up-to-date with the latest regulatory updates, it is essential to subscribe to relevant organizations, such as HIPAA, the FDA, and the GDPR. And adjust your QA protocols accordingly.
  • Robust Documentation: Always work with a version-controlled and clear record of test cases, compliance checks, and outcomes.
  • Cross-Team Communication: Ensure that developers, clinicians, and QA are properly aligned through shared weekly stand-ups, dashboards, and feedback loops.

Real-world Story: Babylon Health

Babylon Health, a telemedicine company, faced major software issues in 2020. The affected software was the UK app.

What were the issues?

An app update introduced a bug that allowed users to browse consultation recordings that didn’t belong to them.

What was the risk?

It posed risks, including breaches of confidentiality and the disclosure of sensitive PHI, which constituted a clear violation under GDPR/HIPAA-like regulations.

What was the impact?

Although the issues were not malicious, they still posed significant privacy risks and became a major threat to the company’s reputation and compliance.

QA Intervention

The QA team acted fast and unveiled a vulnerability by focusing on privacy scenarios and edge cases. They identified and resolved the glitches within a couple of hours, thereby successfully mitigating a large-scale data breach.

Why Choose Moon Technolabs for QA Testing Processes?

A robust QA process is essential for healthcare app development for several reasons, including compliance, security, and user-friendliness. At Moon Technolabs, our QA experts ensure that your healthcare apps meet the latest QA standards, encompassing user safety, regulatory compliance, and data security.

Our deep expertise as a top software testing services company spans manual, automated, and advanced security testing, ensuring every application is robust, reliable, and fully compliant with global standards, including HIPAA, GDPR, and 21 CFR Part 11. We have a proven track record across diverse digital health solutions ranging from telemedicine, mental health, EHRs, medical IoT, and pharmaceutical apps.

FAQs

01

What is the QA process in healthcare?

The QA process in healthcare serves its core purpose of verifying the safety of medical apps. It also ensures compliance with and adherence to performance standards.

02

What are the methods of quality assurance in healthcare?

QA in healthcare encompasses various methods, including peer reviews, clinical audits, accreditation, performance benchmarking, patient feedback, and evidence-based guidelines.

03

What are the main stages and steps in the QA Process?

The entire QA process consists of multiple steps like requirement analysis, test execution, test design, defect reporting, test closure, and more.

04

How to automate QA testing?

You can automate QA testing in several ways, such as selecting the right tools, test cases, and creating scripts for repetitive tasks. You need to integrate the testing into CI/CD pipelines for higher efficiency.
About Author

Jayanti Katariya is the CEO of Moon Technolabs, a fast-growing IT solutions provider, with 18+ years of experience in the industry. Passionate about developing creative apps from a young age, he pursued an engineering degree to further this interest. Under his leadership, Moon Technolabs has helped numerous brands establish their online presence and he has also launched an invoicing software that assists businesses to streamline their financial operations.

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