Whatever approach you select for managing your software development workflow, you cannot test a healthcare app the same way you test general-purpose applications.
Any desktop or mobile health application is subject to more requirements and regulations as compared to the average app. The app validation process can be longer and more complex, so you need to plan in advance how the app will iterate and how to secure successful completion of each development stage. Moreover, a health app comes under scrutiny throughout its entire life cycle, and software testing is in fact a continuous process when you develop healthcare apps and gadgets.
Ensuring Compliance with Healthcare Regulations
Health treatment and health records are subject to specific and strict regulations all over the world, especially when it comes to online data transfer and treatment suggestions. Regulations, such as HIPAA, cover security, compatibility, and reliability, which means you need to be aware in advance what testing methods you will need to implement. You can perform app testing internally or opt for web testing from a reputable expert service.
Usually, software testing of health apps must guarantee compliance with the international standard IEC 62304, which is adopted in both the European Union and the United States. This standard stipulates requirements related to software planning, software architecture, implementation and verification. It is also mandatory to perform integration testing of healthcare software.
Overview of Software Development Processes for Medical Software
IEC 62304 provides the framework for many testing parameters in order to secure compliance with basic safety requirements and risk mitigation.
Meticulous Performance Testing
Testing a health app or a heath monitoring wearable for performance requires more efforts than usual. Such solutions require extra testing to meet the acceptable standards of accuracy, measuring vitals, and overall capabilities. Software testing should also include checks for intended versus unintended use, which is a critical component of any health app functionality. Quality assurance testers should assess all risks related to app degradation and mitigate them in advance.
Furthermore, you need to carefully test integrations and performance of any third-party software. Most healthcare web applications need to connect to external databases, protocols, and interfaces to perform within the limits of its intended use. Hence, you should achieve seamless and error-free integration and communication.
Additionally, some of these external resources may be subject to further regulations for your app to comply with. All APIs you employ must pass thorough testing for compatibility and reliability before you even consider releasing a beta version of your product or service.
A web developer can easily perform A/B testing of an app intended for general use. Testing of health apps usually used for treatment suggestions or for monitoring of a condition requires a different approach. You need to test such applications in the field and get as much feedback as possible.
Related to the previous point, user experience is of utmost importance when medical software is concerned – users should operate the app in the easiest way possible and get straightforward and comprehensive measurements or suggestions. High-level user experience testing can guarantee all required features are integrated and all the obsolete functions are removed during early testing stages. Then you can move on to release an official version of your health app.
Field tests do not involve testing with real data, though. Regulators ban software testers from using real health records and data for patients, so you need to mock data or sub-data to test if the software functions correctly.
Accuracy and Usability Testing
The growing popularity of health wearables and self-diagnosis apps requires ultimate usability and 100-percent accuracy for an application to be considered viable. All regulations and data access authorisations aside, you need to provide easy access to all the critical information with minimum input from the user and make the interface as easy to use as possible. This requires a lot of testing of specific functions and their display methods, as well as continuous testing for accuracy of measurements. Usability testing should also include tests for fool-proof protection, i.e. elimination of any possible human errors that can result in degraded performance or incorrect operation.
Self-diagnosis App Usage in the US
Crowd Testing and Other Methods
Crowd testing is a testing method that involves all the stakeholders in testing your health application. Whether you choose iOS, Android, or Windows as an operating system for your app, you need it to be tested by patients, healthcare practitioners, and legal experts alike. Thus, you test the app against all technical, functional, and compliance requirements in place.
By implementing crowd testing, you can also target a specific subset of prospective users, thus getting more accurate results. Crowd testing may involve various types of tests: performance testing, functional testing, security testing, compliance testing, etc. Usually, these tests are run manually although you can also run some automated tests during crowd testing.
You can also use emulators to test the basic functions and interfaces of your health app, but testing it on a physical device is mandatory since a viable healthcare solution should have a mobile version. Unless you develop a wearable health device, you must test the software on numerous physical devices by different manufacturers. Slight differences in the device design and operating system may produce significant errors or malfunctions, so testing on a diverse set of devices is mandatory.
Finally, it’s highly recommended that you stick to a well-defined plan when testing. Start with drafting an overview of the app, then describe all the features you need to test and areas that do not need testing. Make a list of all the dependencies between the testing activities you will perform.
After you define the scope of testing, specify which aspect of your health app will undergo a specific testing method: for security, performance, usability, or any other area. Select a testing approach, for example, black box testing or grey box testing, and only then schedule your tests. And never forget to document everything about the methodology as well as all the results collected during testing of your health application.