Healthcare Software Testing

Functional testing involves verifying medical software for compliance with established requirements to ensure its correct operation. This primarily concerns testing the core functionalities of the solution, such as patient registration, access to medical records, doctor support, prescription processing, and more. Automated tools, including regression tests, are widely used in this type of healthcare software testing, significantly speeding up the process. Automation of repetitive processes and checking whether new code disrupts existing functionalities help maintain high standards of performance and reliability. Verification of diagnostic accuracy also plays a crucial role: testing artificial intelligence systems and algorithms that may be used for medical solutions.

Compliance testing is a key tool for protecting patient confidential information and ensuring adherence to industry regulations. Medical software typically processes electronic protected health information (ePHI).

During testing, we check whether the solution meets all security requirements, specifically:

• HIPAA: The level of data privacy protection concerning patients in the U.S;
• GDPR: Personal data security in Europe, if the solution has users in the EU;
• FDA: Standards for medical devices and industry software;
• ISO 13485: International standard for quality management in medical devices;
• IEC 62304: Standard for the development of medical systems.

During this type of testing, our medical QA analyzes the correctness of data encryption transmitted over the network or stored on servers. Specifically, we check how effectively access control and audit monitoring are performed to ensure complete protection and compliance with regulations. We also apply penetration testing, assessing the system for vulnerabilities that could be exploited for unauthorized access to medical data.

Performance testing ensures the software's resilience under various loads. During load testing, hospital quality analysts check the system's performance under high traffic to ensure it operates reliably under pressure. We also apply stress tests — under extreme loads — to evaluate stability.

The system is also checked for speed, scalability, availability, and response time under load. The assessment of response times to requests, throughput, resource utilization, and overall operational efficiency completes the performance testing process.

The team verifies whether the medical software correctly transmits and receives data according to key information exchange standards, such as HL7, FHIR, and DICOM. For instance, ensuring compatibility with medical devices and other third-party systems (e.g., cardiac monitors, MRI or ultrasound processing systems).

Testing covers two main areas: functional and technical compatibility.

Functional compatibility ensures accurate and complete data exchange. This includes careful verification that data transmitted from one system is correctly interpreted and received by another system, minimizing the risk of errors that could lead to incorrect diagnoses or therapeutic decisions.

Technical compatibility involves checking that different systems use the same data formats and standardized protocols. Testing in this area identifies possible format incompatibilities that could cause data loss or communication breakdowns, hindering effective information exchange.

Usability testing assesses the clarity of the user interface (UI) and ease of use (UX) beyond simple functionality checks. The main goal is to evaluate how easily and effectively users, such as doctors and patients, can interact with the medical software and complete necessary tasks. Specialists check how intuitive the interface is and how effective the workflows are to reduce the risk of potential errors that could impact the quality of care.

UX testing focuses on user satisfaction with the application. Patients should easily manage their appointments, access medical data and prescriptions, encouraging them to engage more actively in their health care. High-quality UX also enhances service delivery efficiency, reduces stress for healthcare providers, and improves treatment outcomes.

Interoperability in healthcare is the ability of different digital platforms and medical institutions to interact and transmit clinical data using unified information exchange standards. It is crucial that data can be transmitted and used without errors.

Compatibility with other solutions elevates performance speed and drives digital transformation in the healthcare sector. It opens opportunities for medical institutions to create integrated hospital systems by combining software from various providers for data exchange between them.

Quality assurance and healthcare specialists manually perform queries to check the data exchange process in the software, evaluating its compliance with Fast Healthcare Interoperability Resources (FHIR) standards. They also apply various testing scenarios to verify the application's interaction with external services. Ensuring that the solution is compatible with necessary and common medical systems and devices is essential.

Accessibility testing in medical applications is a key aspect of ensuring that all users, regardless of their abilities, can easily access services and derive maximum benefit from the programs.

This not only complies with ethical norms and legislative requirements and standards such as the Web Content Accessibility Guidelines (WCAG) but also fosters the creation of effective and accessible solutions for a broad audience.

Such tests should be conducted to ensure inclusivity and equal access, meeting the medical needs of patients of different ages and individuals with disabilities, preventing discrimination, and generally enhancing the user experience.

Testing backup and recovery solutions is mandatory when it comes to protecting IT infrastructure and patient data. The primary goal is to create copies of medical data and store them securely.

This applies to both structured and unstructured medical data.

Structured data, such as demographic information, vital signs, test results, and medications, are organized and easily formatted for analysis. These are specific conclusions that medical personnel can quickly interpret.

Unstructured data, Unstructured data, on the other hand, is disorganized and requires additional analysis and visualization for understanding. This includes X-rays, medical images, videos, audio recordings, and physician notes. Due to the variety of formats of this information, it is challenging to control, track, and protect it. This makes backup solutions even more critical for ensuring reliable protection.

The frequency and volume of healthcare data backups are influenced by several key factors, such as regulatory compliance, including the Health Insurance Portability and Accountability Act (HIPAA), Personally Identifiable Information (PII), and the ability of systems to perform automatic backups.