Healthcare Software Testing Methodologies for HIPAA Compliance
When conducting healthcare application testing, there are many government regulations that the tester must be aware of. These regulations are automatically a part of any requirements, even if not explicitly stated. These regulations will be the same for all healthcare web applications so it is incumbent for any testing organization to not only thoroughly understand these regulations but have established healthcare domain knowledge to also ensure that the test strategy and test plan accommodates them. For the healthcare industry in the United States, the main law for these regulations is HIPAA.
HIPAA stands for the Health Insurance Portability and Accountability Act of 1996. It has two major components.
- Health insurance coverage is protected for workers and their families when they change or lose their jobs.
- National standards are established for the Security and Privacy of private health data while allowing the flow of health information needed to provide and promote high-quality health care and to protect the public’s health and well-being.
Security and Privacy of private health data are the main concerns for healthcare software testing and are applicable to all healthcare applications.
To test your product for HIPAA compliance, the five following areas must be covered:
- User Authentication – Using verification methods to ensure that those logging on are who they say they are and to deny access to all others.
- User Authorization – Authorizing access to information is based on user role and patient limitations.
- Audit trail – All transactions and all attempts of data access with a proper set of audit trail information are recorded.
- Data transfers – Ensure data encryption at all transfer points according to ANSI 5010.
- Help Information – Help information on the correct and incorrect uses of data.
There are many other specific regulations that may or may not apply depending on the purpose of your software product. A few of these requirements include:
- When a breach of security is discovered, notification to the consumer affected must be within 60 days.
- Rules for a pre-existing condition are many and complicated. For example, the exclusion period for pre-existing conditions can be 6, 12, or 18 months, depending on the circumstances. These rules are complicated, but compliance must be tested.
- Rules concerning family members are also varied and complicated.
It’s important for the test strategy and plans to include which parts of the regulations apply and to ensure that the right rules are included in the test case design to guarantee proper test coverage. Without this kind of specific domain knowledge, it is difficult to test healthcare software and ensure its quality.
Pharmacy Management Software Testing
We have been testing healthcare software, managing healthcare software quality assurance, and focusing on pharmacy management software systems for years and wanted to share a few notes from our testing experience during that time.
- First of all, data needs to be precise. Since the software deals with medicine, incorrect data could result in a wrong dosage and have serious consequences, even death. So, we have to pay a lot of attention to data verification.
- Second, usability testing is a very important part of the QA testing process. Some features or user scenarios are executed by pharmacists or nurses hundreds or thousands of times per day. So, any inconvenience in these scenarios is critical. In addition, pharmacists don’t want to use a mouse for frequently executed tasks. They expect to use only a keyboard with lots of shortcuts.
- Predictive text input is also a powerful function in pharmacy management systems, so efficiency is very important. People always want to type as few characters as possible and then have the expected result appear in a list.
- Devices play a big role in pharmacy management systems. For example, barcode scanners and printers. They all need to be tested because medicine can’t be delivered to patients without them. Mobile healthcare application testing will become more and more important as functionality is migrated to mobile.
- For overall system testing, pharmacy management systems also need to communicate with other systems, e.g. insurance systems and welfare systems. These systems will confirm or reject the transaction, so the communication needs to be stable and reliable.
Finally, you need to be familiar with their business and what pharmacy software is intended to do. Healthcare domain knowledge is a necessity. Otherwise, you are just pushing buttons.
Healthcare Domain Testing
XBOSoft’s healthcare domain testing services and quality assurance consulting is based on years of experience working with our clients to understand and improve the quality of their life-critical products, including Software as a Service (SaaS) products and electronic health records (EHR), and electronic medical records systems along with mobile applications. In addition to EHR, our healthcare domain expertise and experience goes deep and broad, from automated drug dispensing machines to pharmacy management, EMAR, and EPCS with mobile apps syncing in the field.
Over the last ten years, we’ve been serving healthcare software clients, working on their healthcare domain projects for testing, and have gained the expertise to provide comprehensive healthcare software testing. Our healthcare software quality assurance and software testing services enable you to focus on your business while we worry about test coverage, cross-platform, multi-device, and multi-browser compatibility.
For healthcare software testing with zero tolerance for error and a total focus on quality, contact us or visit our website for tips on quality assurance and QA testing.