The revenue of the global digital healthcare market is projected to reach $549.7 billion by 2028 according to the National Library of Medicine.
This projection illustrates the demand for quality healthcare software healthcare software testing strategies. Such rigorous testing not only ensures patient safety and the proper functionality of software but also contributes to a more efficient and reliable healthcare ecosystem.
The following blog will provide you with many invaluable insights into software testing in healthcare, including examining various testing types, step-by-step guidance for a well-defined testing plan, and key factors to consider when building a testing team.
What Is Healthcare Software Testing?
Healthcare software testing is an important process that focuses on verifying and guaranteeing the quality, functionality, performance, and security of software applications used within the industry. Tested applications in this case can range from electronic health records (EHR), and telemedicine platforms to medical imaging systems and clinical decision support tools.
The importance of testing healthcare software is to ensure that the software meets the demands of the end-users, including patients, healthcare providers, insurers, regulators, and researchers. In addition, testing can validate whether the software complies with relevant standards and regulations, such as HIPAA, FDA, GDPR, HL7, and DICOM or not, thereby safeguarding the security of patient data and healthcare institutions.
Types of Testing for Healthcare Software
Healthcare software testing processes involve assessing various perspectives of the final products. Therefore, acknowledging different types of testing is the key to develop the appropriate testing plan to best evaluate the software performance. Some common types of healthcare software testing include:
- Functional testing
- Performance and scalability testing
- Security and compliance testing
- Interoperability testing
- Usability and user experience testing
1. Functional Testing
Functional testing involves evaluating healthcare software against specified requirements to verify that the new software solutions function precisely as intended. Automation tools, like regression testing, are also leveraged in this testing type to significantly reduce testing costs and time. By automating repetitive tasks and verifying that new code changes do not negatively impact existing functionality, healthcare software can maintain high standards of quality, efficiency, and reliability.
2. Performance and Scalability Testing
Performance and scalability testing within the healthcare sector is crucial to ensure that software can effectively meet the care delivery demands. This testing guarantees smooth operation and reliable outcomes for both medical professionals and patients.
In particular, performance testing evaluates the software’s responsiveness under varying load conditions, such as its speed during peak hours in a hospital when numerous healthcare providers access patient records simultaneously, to ensure its stability.
Meanwhile, scalability testing examines how well the software can handle the expanded scope of work, especially as healthcare networks expand to include new clinics or hospitals.
3. Security and Compliance Testing
Compliance testing serves as a critical shield safeguarding sensitive patient data and ensuring strict adherence to regulations within the healthcare sector. Specifically, healthcare software frequently manages Electronic Protected Health Information (ePHI), necessitating stringent safeguards as outlined by regulations such as HIPAA or GDPR.
Through compliance testing, the software is meticulously evaluated to verify its alignment with these mandated security standards. Moreover, testers will also examine the software’s security functionalities, with a particular focus on aspects like access controls, data encryption, and audit controls to ensure comprehensive protection and regulatory compliance.
4. Interoperability Testing
In this form of healthcare software testing, test engineers ensure that a healthcare solution consistently shares medical data according to key data transfer standards such as HL7, FHIR, DICOM, among others. The testing will concentrate on two primary areas, including functional and technical interoperability.
Functional interoperability will involve engineers ensuring the accurate and complete exchange of data. Particularly, within this type of testing, the engineers can diligently confirm the receiving system’s correct interpretation of data from the originating system. The process will minimize the incidents of omissions or misinterpretations that may result in incorrect diagnoses or treatment errors.
Technical interoperability meanwhile focuses on the technical aspects of communication. Testers ensure the systems involved use compatible data formats and protocols like the aforementioned industry standards. The aim of this field is to identify any incompatible formats that can lead to data corruption or communication failures, hindering information exchange.
5. Usability and User Experience Testing
Usability and User Experience (UX) testing extends beyond routine functionality assessments. Particularly, usability testing aims to evaluate the ease and effectiveness with which users, such as doctors and patients, navigate and accomplish tasks within healthcare software. Engineers analyze the intuitiveness of the interface, and efficiency of workflows to diminish any likely errors that could compromise patient care.
Meanwhile, user experience testing focuses on user satisfaction with software. User-friendly interfaces empower patients to manage appointments, records, and prescriptions independently, hence encouraging proactiveness over fostering their health. Besides, effective UX also supports streamlining care delivery, therefore reducing stress for healthcare professionals and improving treatment outcomes.
4 Steps to Design An Effective Healthcare Software Testing Plan
Developing a solid testing plan for healthcare software means thinking about the type of software (like EHR/EMR, HIS, telemedicine solutions, SaMD, etc.), how complex it is, what testing methods are needed, and the regulations it must follow (such as HIPAA in the US or GDPR in the EU). While plans can vary based on a solution’s features and testing methods, some key stages of any medical software testing project will involve:
- Software requirements analysis
- Test planning
- Test design
- Test execution and results reporting
1. Software Requirement Analysis
The software requirement analysis process is a strong foundation for any testing plan. Therefore, To ensure drafting out a clear, complete, and most importantly, testable plan, healthcare organizations should:
- Scrutinizing Requirements: The analyst should meticulously examine the documented requirements to identify any ambiguities, inconsistencies, or missing details.
- Ensuring Testability: Each requirement is evaluated to determine if it can be effectively tested. Unclear or immeasurable requirements need to be refined to facilitate proper testing.
- Risk Identification and Mitigation: Identify potential risks associated with the project, such as resource limitations or unclear requirements. A plan is then formulated to mitigate these risks and ensure project success.
2. Test Planning
After having a thorough understanding, healthcare entities can go on with the test planning. Overall, the test plan is like a roadmap, assisting in outlining the testing strategy and approach. A well-defined test plan typically includes:
- Testing Objectives: Clearly define goals for the testing process, including ensure regulatory compliance or achieve specific functionality features.
- Testing Types: Outline different types of testing, such as functional, usability, and security testing for an optimal testing plan.
- Testing Schedule: Draft a realistic timeline for each testing phase to ensure all of the important timestamps are met.
- Resource Allocation: Identify the personnel required for testing, including their roles and responsibilities.
- Test Automation Strategy: Assess automating feasibility in certain test cases to improve efficiency and consistency.
- Testing Metrics: Define metrics for measuring the effectiveness of testing, such as defect rate or test case coverage.
3. Test Design
Based on the comprehensive testing strategy, test engineers will then embark on the crucial stage of test preparation. Some key steps involve:
- Preparing the Test Environment: Hardware and software setup is required to ensure compatibility and simulate the production environment. This also includes generating realistic test data and simulating the healthcare facility’s network infrastructure for software deployment.
- Crafting Test Scenarios and Cases: Test engineers will translate the testing strategy into actionable test cases. Particularly, general scenarios are detailed into specific test cases with user actions, expected system behavior, and assessment criteria.
- Assembling the Testing Toolkit: Effective communication and defect management are vital for successful testing. Test engineers ensure they have the necessary tools at their disposal, including defect management and tracking software as well as communication tools between different stakeholders.
- Harnessing the Power of Automation (Optional): Automation can significantly improve efficiency in repetitive or regression testing. When feasible, test engineers can leverage test automation tools and frameworks or write test automation scripts to mimic user actions and verify expected outcomes.
4. Test Execution And Results Reporting
With the test fully designed, the engineering team will proceed to execute the final phases, in which testing results will be generated for the healthcare software assessment. This stage of healthcare software testing typically entails:
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- Executing and Maintaining Tests: This involves manually carrying out testing to identify issues like incorrect calculations, missing functionalities, or confusing user interfaces; otherwise automation testing is an alternative.
- Defect Detection and Reporting: The process requires the engineer to catch any bugs, glitches, or errors in the software that could potentially harm patients or hinder medical care. They should also document these defects clearly, including the steps to reproduce the issue and its potential impact.
- Validating Fixes and Regression Prevention: Once a defect is fixed, engineers re-run the test case(s) to confirm the issue is truly resolved. They also conduct broader testing to ensure that new changes or fixes do not unintentionally introduce new problems in other functionalities of the software.
- Communication and Reporting: Finally, the results of the testing efforts should be communicated through reports. These reports detail the number of tests conducted, defects found, and the overall progress of the testing process. The KPIs, including defect detection rates, test case coverage, or time taken to resolve critical issues, should be tracked as well.
Factors To Consider When Building A Test Engineering Team
When it comes to conducting software testing, there are several critical factors that must be taken into account. Specifically, to ensure the effectiveness and efficiency of the testing process, healthcare organizations should pay attention to:
- Tools and techniques
- Testing costs
- End-user mindset of testers
- Experience and expertise of testers
1. Tools and Techniques
When engaging in software testing, the careful selection of tools and techniques is paramount to ensuring optimal performance. Testing tools play a crucial role in streamlining test cases, data management, and report generation, while techniques empower testers to uncover latent defects that can impact product quality.
It is advisable to consider employing emerging methods such as cloud-based testing solutions, which enable teams to access virtual environments from any internet-connected location. These services provide cost-effective scalability, as they charge users based on usage, eliminating the need for significant investments in server hardware and reducing overall expenses.
2. Testing Costs
Healthcare software testing is crucial as it directly affects patient lives and well-being, but ensuring the quality and safety of such software comes at a price.
The testing process handles a mass volume of data, requiring specific testing tools to verify encryption protocols and data integrity. These tools, however, are expensive to purchase or license. Moreover, test engineers with healthcare-specific knowledge are in high demand, leading to incurring costs when hiring them compared to other general testers.
Not to mention, in healthcare, even minor flaws can cause life-altering threats, therefore testing must be way more thorough and all-encompassing. This means more test cases, extended testing periods, and possibly the need for extra staff or tools. These steps can lead to a more complex and time-consuming process, hence inevitably increasing costs. That is the reason why the expenses involved in this process can make up a significant portion, possibly reaching up to 40% of software development costs.
3. End-User Mindset
One of the winning points of making a successful software testing project is to choose testers who tailor their approach to the product and user base. They should think like end-users, go beyond scripted testing, and proactively suggest improvements to enhance user experience.
For instance, testers should thoroughly understand how busy doctors or non-tech patients will actually interact with the systems. That way they can ensure the solution is intuitive and efficient to navigate in a fast-paced healthcare environment.
4. Experience and Expertise
Healthcare software testing requires both expertise in core testing methodologies, tools, and working experience in the healthcare domain. This includes an understanding of medical terms, HIPAA regulations, and healthcare workflows for effective test case design. Besides, experience with HL7, FHIR, and interoperability testing is also crucial to navigate through various systems.
However, training testers in this case can be a challenge, both in terms of incurring costs and staffing quality, regarding the complex requirements and regulations imposed on healthcare software. Besides, the ongoing economic downturn and the prolonged situation of staff burnout are hindering organizations’ financial and human resources capabilities and adding a layer of difficulty to ramping up a testing team.
In such scenarios, outsourcing to a reliable vendor can effectively address these concerns. Not only does the vendor assist healthcare organizations in reducing training and hiring expenses, but they also provide the requisite expertise for a complex and repetitive testing process.
KMS Technology: Your Software Testing Partner of Excellence
The demand for reliable healthcare software, the growing complexities of business operations, and the emergence of new technologies are driving healthcare organizations to cut down on unmanaged testing practices. They rightfully require more agile, well-defined, and all-encompassing testing plans to be adopted before making any decision.
KMS Technology, with our 15-year presence in the healthtech sector, is more than familiar with most industry-standardized quality assurance and testing practices. We leverage market-leading frameworks and open-source tools to offer end-to-end testing services, including test management, test design, test execution, test automation, and even test consultation with our global experts.
Let us help create testing solutions that optimize test coverage and accelerate time-to-market.
