Healthcare professionals are probably some of the busiest people in the world, and with the pressure to provide accurate care to their patients, the reliance on apps and medical software began. Through EMRs or Electronic Medical Records, PDAs or Personal Digital Assistants, CDSSs or Clinical Decision Support Systems and similar applications, the market for medical software is growing at a rapid pace.
The quality requirements for healthcare, medical applications are highly strict, specific and stringent. There can be no room for error-absolutely at all because lives are at stake. Quality Assurance vendors have pushed the bar for safety and accuracy for medical application testing to ensure that there is no inaccuracy, infiltration or hacks.
The IT industry too is under tremendous pressure, because they have to provide error-free apps to their customers, and with the surge in demand, the need for quality apps went several notches higher. As per the IDC Health Insights, about 40% of the healthcare professionals relied on medical software, thereby increasing IT investments in 2016, and brought in 5 billion dollars. So we are looking at huge figures here, in terms of returns, and the figures keep growing.
Given below are some areas that the QA team must peruse before they are ready to release an application in the market:
Data security
Quite understandably, healthcare is one of the primary targeted areas for hackers. According to a research conducted by Identity Theft Resource Centre (ITRC), about 23.7% of all the data breaches in the US happens within the healthcare sector.
Image Credit: ITRC
To overcome this, all the areas of vulnerability should be identified and focused. Data encryption makes it secure, so the data has to be encrypted, both when in motion and when at rest. This is usually done through Transport Layer Security (TLS) and this makes it easier to validate.
However, it could be a bit tricky to verify data that's at rest. Usually, these applications are downloaded on mobile devices, either permanently or on an intermediate basis. Hence, it is important for the encryption to work optimally, and this should be stringently checked in web and hybrid applications.
Data privacy
Who has access to the data that is there in mobile apps? Strict authorization and access control can make the application more focused and result-oriented. Certain boundaries should be set so the information reaches only the people who are authorized to receive it. According to the QA perspective, if there is no need for a particular user to have access to a certain patient's information, then it should be masked. And alerts should be set so if anyone tries to hack the masked fields, there will be notifications running through the system.
While the patient information is shared across people, care should be taken to ensure that it reaches only the members of the caregiving team and not the entire facility, so boundaries should be set from that level.
Usability
Usability is a critical aspect of QA testing, especially in healthcare. There cannot be absolutely any room for error of any sort because lives are at stake. Usability issues can lead to clinical issues, and the patient can suffer through an adverse event. Imagine machines looking after the task of administering medicines to patients. Suppose, there has been a usability error, and the machine wrongly suggests medicine to the patient? That would have been a fatal error.
Conformance
Interestingly, conformance comes in different forms. The entire healthcare system runs on certain rules and regulations. So, naturally, when an app is released on the healthcare front it will have to comply with the rules of the authoritative organization. And based on this scenario, there are different kinds of compliance like regulatory compliance, functional completeness and interoperability.
Regulatory compliance - wherein there are certain rules and regulations mandated under HIPAA, US Food and Drug Administration (FDA), data security regulations and more. Healthcare entities can also abide by the Common Security Framework (CSF) prescribed by HITRUST (Health Information Trust Alliance) to prove their security standards.Functional completeness - wherein the application should be functionally complete under the rules of concerned authoritative organizations.Interoperability compliance - wherein two participating healthcare entities should have some sort of semantic and syntactic interoperability agreement.
Performance
The performance aspect of a healthcare application is extremely important. Social media platforms are meant to handle millions of transactions per second. Fortunately, medical applications do not have to handle such a huge volume because they cater to a limited user group. Nevertheless, when you look at the implications of a medical application, performance becomes a critical aspect.
Information should be procured at command, so the caregiver/patient/doctor can have clinical data readily. Performance testing must also include aspects like local data size, scalability, archival strategy and so on.
For example, if the application stores data locally or is called to do any CPU intensive tasks, then the performance factor must not be affected in any manner. Hence, there should be a thorough evaluation of performance.
Put special emphasis on mobile apps
There is nothing to rival a fully functional mobile app for healthcare professionals because apart from providing a world of opportunities in the form of advice and tips on addressing common healthcare challenges, it saves a lot of time as well.
But with the advantages come certain disadvantages too because performance and load testing must be checked thoroughly. While testing the software app, it is important to simulate real conditions to ensure the app functions well and doesn't succumb to internet connectivity challenges and signal quality.
Testing types
These are the different testing types of a strong QA team:
1.Functional testing- To test the functional capabilities of the application
2.Medical imaging testing - Specialized test automation is done for medical imaging applications like MESA, DVTK, Mirth, etc.
3.Platform testing - To test the app on different platforms, and to check for cross-browser compatibility.
4.Conformance testing - to check whether the app conforms to security requirements like HIPAA, FDA requirements, Meaningful Use, and VA requirements.
5.Load and performance testing - Checking the load and performance benchmarks of the application.
Conclusion
It is important to test the medical software for functionality at different levels - including patient level, doctor level, and even the insurance provider. There are hundreds of healthcare apps in the market, but why is it that only a few make it to the top? The secret lies in testing. So before releasing an app into the market, make sure it conforms to the different challenges and gives accurate results.