Medical Software Testing 101: Advice to Consider for Upgrading Patient Experiences

Aiming to improve patient experiences and deliver accessible services of the highest quality, medical institutions rely on sophisticated software and groundbreaking approaches, such as AI, AR/VR, bioprinting, digital therapeutics, and even medical robots. No wonder patients worldwide are embracing modern digital health solutions - the number of users of online doctor consultations is expected to grow by 13.7 million people in just 4 years. Due to the high intricacy of such systems and sensitive patient data that needs to be securely stored, the operation of medical software must be meticulously verified. This helps eliminate any malfunctions, prevent harm to people’s lives, ensure compliance with pervasive regulations, and prevent severe penalties that can reach up to $1,5 million. eHealth quality assurance helps cope with these priority tasks and ensure that solutions fully meet both functional and non-functional requirements. In this article, I’ll focus on the most common aspects associated with rolling out top-tier medical IT products and fit-for-purpose verifications. Specifics That QA Teams Should Consider While Testing Healthcare Software It’s almost impossible to define a universal approach to scrutinizing diverse systems ― a lot depends on the solution itself, the know-how that lies at its core, and, of course, the industry. Healthcare software testing is rather unique and has peculiarities for QA teams to consider. Such software: Has a safety class according to the possible effects on patients because of the hazard the system can pose for life. Is highly intricate ― HIMS, IoMT systems, CRM solutions, data warehouses, just to name a few. These have complex logic, architecture, and dependencies. Must meet a myriad of stringent rules and standards ― HIPAA, FDA, HITECH, GDPR, PCI DSS, PIPEDA, OAIC, and others. Any violations of set requirements result in financial and reputational losses for companies and possible harm to patients. Is often part of an interconnected ecosystem of diverse solutions integrated with one another ― RPM systems, data analytics software, EHR systems, and many others. Is often related to sophisticated hardware, such as laboratory equipment, MRI, CT, X-ray machines, defibrillators, ultrasonography equipment, angiography tools, and more. Their smooth interoperability must be established, otherwise, people may suffer because of a minor glitch. Must be inclusive, as people with disabilities must have access to the opportunity to work with digital health software and obtain quality treatment. Stores impressive amounts of private patients’ data that need to be secured to prevent any exposure and reach compliance with safety standards. Is used to support patients during critical situations and must deliver error-free operations within peak usage periods, which means their performance comes to the fore. Paramount Factors Increasing the Odds of Success for QA in eHealth Considering the overall complexity of the industry and software solutions, I suggest that QA teams pay attention to building strong domain knowledge, upskilling, and even creating a healthcare QA CoE. It helps standardize QA processes, ensure that every aspect of a complex IT product is covered with tests, confirm that QA processes are supplemented by detailed test documentation necessary for passing regulatory demands, and continuously improve approaches for high efficiency. Next, I will mention planning. When done properly, it allows QA teams to correctly estimate financial and time resources, consider probable risks, establish accurate objectives and expectations, create a detailed guideline of the entire QA process, and ensure more effective communication between project members. Finally, I’d highlight detailed test documentation, as it provides a clear description of a test execution scope, any changes made to the software, and in-depth analytics on detected issues. It helps new team members quickly delve into the current testing stage and software specifics. Holistic QA Support for Top-Tier Operation of Medical IT Products With all that’s said, I’d like to focus on the most vital aspects of testing in eHealth that can detect software glitches and prevent harm to patients. Accessibility testing WHO states that 1.3 billion people all over the globe have disabilities of diverse kinds which means that the software they use must be adjusted in the proper way to ensure effective access to medical services. QA engineers need to test products based on WCAG 2.2 and ADA standards for accessibility, apply assistive technologies, such as screen readers and magnifiers, and verify different formats of software representation (e.g., audio, and diagrams). Involving disabled people in the testing process is also a good idea as they can share valuable insights into the most challenging aspects of using software for them personally. Cybersecurity testing Big data is one of the major characteristics of medical software ― patient disease registries, administrative data, health surveys, and more. In addition, such IT products are often integrated with diverse devices or other systems, which means that the number of potential security loopholes is only rising. If not addressed, they can lead to phishing and DDoS attacks that result in data theft, fines imposed by regulatory bodies, and loss of patient trust. Hence, QA specialists should perform a comprehensive security assessment focusing on penetration testing as it simulates the attacks of malicious intruders and thus highlights the weakest points in the system that should be taken care of. Compliance testing Meeting requirements of international standards, such as FDA or GDPR, plays a pivotal role, as it contributes to protecting patient privacy, data security, preventing information loss and hefty penalties, and obtaining improved opportunities for entering the market. During testing, QA engineers verify the software in accordance with diverse requirements outlined in a particular standard, for instance, data storage, access controls, user authentication protocols, IT product's adherence to set design, user consent, data breach notification, and other aspects. Usability testing Usability is a vital aspect of any software as it allows doctors to perform their intended tasks in an easy and streamlined way, which frees up valuable time, especially in the case of an emergency. In addition, user-friendliness is critical for patients, including the elderly, who aren’t so tech-savvy and require a very simple and straightforward interface to receive the treatment they need. Therefore, QA teams perform usability testing paying special attention to verifying navigation, logical structure of the pages, search, buttons, and other high-priority aspects ― all to make sure that different user groups can seamlessly leverage all software functions. API testing EMR/EHR systems, leveraged by hospitals, often work in close cooperation with different external solutions, to provide doctors with improved capabilities. They also must exchange extensive data amounts without any disruptions. It’s important for the QA engineers to perform diverse types of API testing and ensure that requests send and receive correct and full information on time, all the data is secured due to properly working encryption and authentication mechanisms, speed of requests doesn’t decrease despite the peak loads, and confirm that errors during random input of incorrect data are detected. Testing software interaction with hardware Medical software often must work in conjunction with sophisticated hardware, such as diagnostic, treatment, life support, or laboratory equipment. Their cohesive interaction must be established to provide smooth functioning round-the-clock. Therefore, QA engineers should verify that all eHealth software features work as intended after merging with hardware, thus ensuring they operate as one and minimizing the risk of malfunctions. Performance testing IT products often have to deal with high loads ― emergencies, planned appointments, processing of big data, constant boosts of user bases, and more. These situations mustn’t negatively influence software performance, as a lot is at stake when it comes to well-being and saving lives. To prevent deterioration of software response time, any outages, or data losses, QA teams focus on end-to-end performance testing or one-time diagnostics. They fulfill server-side verifications to determine the system’s load capacity, scalability capabilities, and detect performance issues. Client-side testing helps identify elements with low loading speeds and make sure updates haven’t decelerated software operation. Functional testing Be it a telehealth system, EMR solution, imaging solution, medical equipment management software, billing system, or any other software, it's characterized by high complexity of internal modules and sophisticated business logic. In addition, such systems often fall under the FDA’s classification of probable risks to patients. Without detailed testing, it’s hardly possible to confirm its failsafe operation. Thus, depending on a business's need, QA engineers perform the required functional testing type (from requirements to acceptance testing) to check every software feature and detect fluctuations from requirements and issues before the software is released to the production environment. This way, companies can avoid budget overruns and missed deadlines because of late or post-production fixing of bottlenecks. Test automation Within the healthcare industry, software releases are time-sensitive, and no delays are allowed when it comes to upgrading systems for saving or prolonging people’s lives. Therefore, to speed up testing cycles, companies can opt for introducing test automation. Automated testing procedures applied at the earliest software development stages simplify overall QA processes, contribute to a more accurate search for defects, broaden test coverage, accelerate testing, and free up the time for team members to perform other priority project activities. Afterword Medical software is known for its complicated architecture, multiple integrations with third-party services, and extensive amounts of data it leverages and stores. Its operation must meet strict compliance regulations set by the FDA, HIPAA, and other worldwide standards. Therefore, companies can opt for comprehensive medical application testing ― from functional QA to test automation. Done as early as possible, it contributes to cheap defect fixing, meeting user and business requirements, and avoiding issues with regulatory authorities. Aiming to improve patient experiences and deliver accessible services of the highest quality, medical institutions rely on sophisticated software and groundbreaking approaches, such as AI, AR/VR, bioprinting, digital therapeutics, and even medical robots. AI, AR/VR, bioprinting, digital therapeutics, and even medical robots. No wonder patients worldwide are embracing modern digital health solutions - the number of users of online doctor consultations is expected to grow by 13.7 million people in just 4 years. 13.7 million 13.7 million Due to the high intricacy of such systems and sensitive patient data that needs to be securely stored, the operation of medical software must be meticulously verified. This helps eliminate any malfunctions, prevent harm to people’s lives, ensure compliance with pervasive regulations, and prevent severe penalties that can reach up to $1,5 million . sensitive patient data prevent harm to people’s lives, $1,5 million $1,5 million eHealth quality assurance helps cope with these priority tasks and ensure that solutions fully meet both functional and non-functional requirements. In this article, I’ll focus on the most common aspects associated with rolling out top-tier medical IT products and fit-for-purpose verifications. meet both functional and non-functional requirements. Specifics That QA Teams Should Consider While Testing Healthcare Software It’s almost impossible to define a universal approach to scrutinizing diverse systems ― a lot depends on the solution itself, the know-how that lies at its core, and, of course, the industry. Healthcare software testing is rather unique and has peculiarities for QA teams to consider. Such software: Has a safety class according to the possible effects on patients because of the hazard the system can pose for life. Has a safety class according to the possible effects on patients because of the hazard the system can pose for life. a safety class Is highly intricate ― HIMS, IoMT systems, CRM solutions, data warehouses, just to name a few. These have complex logic, architecture, and dependencies. Is highly intricate ― HIMS, IoMT systems, CRM solutions, data warehouses, just to name a few. These have complex logic, architecture, and dependencies. highly intricate Must meet a myriad of stringent rules and standards ― HIPAA, FDA, HITECH, GDPR, PCI DSS, PIPEDA, OAIC, and others. Any violations of set requirements result in financial and reputational losses for companies and possible harm to patients. Must meet a myriad of stringent rules and standards ― HIPAA, FDA, HITECH, GDPR, PCI DSS, PIPEDA, OAIC, and others. Any violations of set requirements result in financial and reputational losses for companies and possible harm to patients. a myriad of stringent rules and standards Is often part of an interconnected ecosystem of diverse solutions integrated with one another ― RPM systems, data analytics software, EHR systems, and many others. Is often part of an interconnected ecosystem of diverse solutions integrated with one another ― RPM systems, data analytics software, EHR systems, and many others. interconnected ecosystem of diverse solutions integrated with one another Is often related to sophisticated hardware, such as laboratory equipment, MRI, CT, X-ray machines, defibrillators, ultrasonography equipment, angiography tools, and more. Their smooth interoperability must be established, otherwise, people may suffer because of a minor glitch. Is often related to sophisticated hardware, such as laboratory equipment, MRI, CT, X-ray machines, defibrillators, ultrasonography equipment, angiography tools, and more. Their smooth interoperability must be established, otherwise, people may suffer because of a minor glitch. sophisticated hardware, Must be inclusive, as people with disabilities must have access to the opportunity to work with digital health software and obtain quality treatment. Must be inclusive , as people with disabilities must have access to the opportunity to work with digital health software and obtain quality treatment. Must be inclusive Stores impressive amounts of private patients’ data that need to be secured to prevent any exposure and reach compliance with safety standards. Stores impressive amounts of private patients’ data that need to be secured to prevent any exposure and reach compliance with safety standards. private patients’ data Is used to support patients during critical situations and must deliver error-free operations within peak usage periods, which means their performance comes to the fore. Is used to support patients during critical situations and must deliver error-free operations within peak usage periods, which means their performance comes to the fore. peak usage periods, Paramount Factors Increasing the Odds of Success for QA in eHealth Considering the overall complexity of the industry and software solutions, I suggest that QA teams pay attention to building strong domain knowledge, upskilling, and even creating a healthcare QA CoE. It helps standardize QA processes, ensure that every aspect of a complex IT product is covered with tests, confirm that QA processes are supplemented by detailed test documentation necessary for passing regulatory demands, and continuously improve approaches for high efficiency. strong domain knowledge, upskilling, and even creating a healthcare QA CoE. Next, I will mention planning. When done properly, it allows QA teams to correctly estimate financial and time resources, consider probable risks, establish accurate objectives and expectations, create a detailed guideline of the entire QA process, and ensure more effective communication between project members. planning. Finally, I’d highlight detailed test documentation, as it provides a clear description of a test execution scope, any changes made to the software, and in-depth analytics on detected issues. It helps new team members quickly delve into the current testing stage and software specifics. detailed test documentation, Holistic QA Support for Top-Tier Operation of Medical IT Products With all that’s said, I’d like to focus on the most vital aspects of testing in eHealth that can detect software glitches and prevent harm to patients. Accessibility testing Accessibility testing Accessibility testing WHO states that 1.3 billion people all over the globe have disabilities of diverse kinds which means that the software they use must be adjusted in the proper way to ensure effective access to medical services. 1.3 billion 1.3 billion QA engineers need to test products based on WCAG 2.2 and ADA standards for accessibility, apply assistive technologies, such as screen readers and magnifiers, and verify different formats of software representation (e.g., audio, and diagrams). Involving disabled people in the testing process is also a good idea as they can share valuable insights into the most challenging aspects of using software for them personally. WCAG 2.2 and ADA Cybersecurity testing Cybersecurity testing Cybersecurity testing Big data is one of the major characteristics of medical software ― patient disease registries, administrative data, health surveys, and more. In addition, such IT products are often integrated with diverse devices or other systems, which means that the number of potential security loopholes is only rising. If not addressed, they can lead to phishing and DDoS attacks that result in data theft, fines imposed by regulatory bodies, and loss of patient trust. Hence, QA specialists should perform a comprehensive security assessment focusing on penetration testing as it simulates the attacks of malicious intruders and thus highlights the weakest points in the system that should be taken care of. penetration testing Compliance testing Compliance testing Compliance testing Meeting requirements of international standards, such as FDA or GDPR, plays a pivotal role, as it contributes to protecting patient privacy, data security, preventing information loss and hefty penalties, and obtaining improved opportunities for entering the market. During testing, QA engineers verify the software in accordance with diverse requirements outlined in a particular standard, for instance, data storage, access controls, user authentication protocols, IT product's adherence to set design, user consent, data breach notification, and other aspects. data storage, access controls, user authentication protocols, Usability testing Usability testing Usability testing Usability is a vital aspect of any software as it allows doctors to perform their intended tasks in an easy and streamlined way, which frees up valuable time, especially in the case of an emergency. In addition, user-friendliness is critical for patients, including the elderly, who aren’t so tech-savvy and require a very simple and straightforward interface to receive the treatment they need. an easy and streamlined way, a very simple and straightforward interface Therefore, QA teams perform usability testing paying special attention to verifying navigation, logical structure of the pages, search, buttons, and other high-priority aspects ― all to make sure that different user groups can seamlessly leverage all software functions. API testing API testing API testing EMR/EHR systems, leveraged by hospitals, often work in close cooperation with different external solutions, to provide doctors with improved capabilities. They also must exchange extensive data amounts without any disruptions. external solutions, exchange extensive data amounts without any disruptions. It’s important for the QA engineers to perform diverse types of API testing and ensure that requests send and receive correct and full information on time, all the data is secured due to properly working encryption and authentication mechanisms, speed of requests doesn’t decrease despite the peak loads, and confirm that errors during random input of incorrect data are detected. Testing software interaction with hardware Testing software interaction with hardware Testing software interaction with hardware Medical software often must work in conjunction with sophisticated hardware, such as diagnostic, treatment, life support, or laboratory equipment. Their cohesive interaction must be established to provide smooth functioning round-the-clock. Therefore, QA engineers should verify that all eHealth software features work as intended after merging with hardware, thus ensuring they operate as one and minimizing the risk of malfunctions. work in conjunction with sophisticated hardware, work as intended after merging with hardware, Performance testing Performance testing Performance testing IT products often have to deal with high loads ― emergencies, planned appointments, processing of big data, constant boosts of user bases, and more. These situations mustn’t negatively influence software performance, as a lot is at stake when it comes to well-being and saving lives. processing of big data, To prevent deterioration of software response time, any outages, or data losses, QA teams focus on end-to-end performance testing or one-time diagnostics. They fulfill server-side verifications to determine the system’s load capacity, scalability capabilities, and detect performance issues. Client-side testing helps identify elements with low loading speeds and make sure updates haven’t decelerated software operation. server-side verifications Client-side testing Functional testing Functional testing Functional testing Be it a telehealth system, EMR solution, imaging solution, medical equipment management software, billing system, or any other software, it's characterized by high complexity of internal modules and sophisticated business logic. In addition, such systems often fall under the FDA’s classification of probable risks to patients. Without detailed testing, it’s hardly possible to confirm its failsafe operation. fall under the FDA’s classification Thus, depending on a business's need, QA engineers perform the required functional testing type (from requirements to acceptance testing) to check every software feature and detect fluctuations from requirements and issues before the software is released to the production environment. This way, companies can avoid budget overruns and missed deadlines because of late or post-production fixing of bottlenecks. (from requirements to acceptance testing) Test automation Test automation Test automation Within the healthcare industry, software releases are time-sensitive, and no delays are allowed when it comes to upgrading systems for saving or prolonging people’s lives. Therefore, to speed up testing cycles, companies can opt for introducing test automation. no delays are allowed Automated testing procedures applied at the earliest software development stages simplify overall QA processes, contribute to a more accurate search for defects, broaden test coverage, accelerate testing, and free up the time for team members to perform other priority project activities. Afterword Medical software is known for its complicated architecture, multiple integrations with third-party services, and extensive amounts of data it leverages and stores. Its operation must meet strict compliance regulations set by the FDA, HIPAA, and other worldwide standards. Therefore, companies can opt for comprehensive medical application testing ― from functional QA to test automation. Done as early as possible, it contributes to cheap defect fixing, meeting user and business requirements, and avoiding issues with regulatory authorities.