Healthcare Software Testing
Healthcare Software Testing
The second half of 2016 has witnessed the second highest rate of recalls for medical devices since 2000. With 650 medical devices being recalled in the U.S. alone; and the major culprit for this is: Software Errors. Although the U.S. FDA’s Office of Science and Engineering Laboratories regulations has been enforcing stricter rules on medical and healthcare software testing and quality assurance since 2012, the high competition and expanding global healthcare market is pushing the boundaries of technologies and making way for new innovations that better support the medical community and patients as well. But with one caveat: more complex software and system designs, which are breeding more errors.
The benefits to using latest technological trends to enhance healthcare service are quite evident, but the data involved to produce these capabilities is not quite appreciated; for one small wrong data bit can shift results from good to bad diagnosis or from data privacy to data breach. So, what does that mean to the world of healthcare software testing?
Software Quality Assurance organizations and Top tier testing professionals are inevitably required to play a strategic role throughout the development cycle to simplify the complexities, ensure compliance to industry regulations, and avoid unnecessary business risks. This is one way to ensure high quality products are introduced in timely fashion to the market with peace of mind that these devices do what they are supposed to do: save people’s lives.
The two high level questions that comes to mind when asking the healthcare software testing community about a products health are:
- Is the data of the product validated?
- Is integrity and privacy of patient data assured?
That is where software testing comes into play but on a more technical capacity than perhaps some of the more commonly used web based applications. But there are also multitude of challenges that the SQA need to overcome to deliver on the success of the discipline.
With innovations in healthcare, software complexity is the only constant, as medical and healthcare devices need to inter-operate and share data between multiple applications, platforms (IOS, Android, Azure, Amazon EC2, Google, etc.) and devices. As such, understanding the data flow requirements in the industry, its purpose, and the different stakeholders involved is a must to be able to provide the high quality assurance needed. In addition, stricter regulatory standards requires different certifications and regulatory framework under which the medical devices need to be compliant to in the U.S. and abroad and analyzed for any potential risks relevant to data, security, privacy, and process breach. These include interoperability standards (HL7, NCPDP, CCD/CDA, etc.), conformance standards (HIPAA, FDA requirements, etc.), and healthcare work-flows (IHE, HITSP, etc.).
To overcome these challenges, it is important to recognize that healthcare software testing and quality assurance cannot be a last milestone in a medical device development, but should be actively integrated in the overall development process beginning from the strategy setting session and evolving with the product development to deliver a reliable and risk mitigated product at the anticipated product launch date. This is the agile testing process that we subscribe to here at AwesomeQA. Our experience shows that such a holistic agile approach for product development enables organizations to increase the number of releases of a product by five folds during any given week, at the same time enhance the reliability and customer experience of the product.
Testing in the healthcare industry is becoming a top requirement for testing professionals that are more experienced, more agile and more data integrity savvy than the average tester. They must be stringent and experienced in regards to data scrubbing, data integrity, and database queries, in addition be able to leverage automation to generate data and AI to mitigate the risks associated with testing in the heath-care industry. But that is not enough, for finding the attributes of great testing candidates for the complex medical and healthcare systems is as important as the innovation of the product itself, and can mean the difference between reliable and recalled product.