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At its heart, quality assurance (QA) testing is quality assurance testing. A company wants its applications to pull accurate and relevant data when requested, do it quickly, perform the requested action and do it all in an environment that safeguards data and respects business rules. Regardless of industry, those are basic functionality goals that software applications should meet.

As you’ve seen in previous blogs, the financial services and insurance industries have particular QA testing considerations, including business intelligence, a focus on mobile and adherence to general business and industry-specific standards and practices.

Healthcare is another industry where enhanced QA scrutiny is required to adequately protect data while pushing it out to an increasingly wide array of devices that reflect how providers, payers and partners to healthcare companies get their work done. In order to grow, providers must keep service quality high and protect patient data while staying current with regulatory requirements, evolving technologies and competitive threats.

At Pyramid Consulting, we work directly with healthcare providers and healthcare independent software vendors (ISVs) to integrate clinical data, modernize legacy systems, build patient care portals and provide a host of targeted solutions to help our clients thrive in this disruptive market

Life sciences companies, in particular, need to pay attention to FDA validation testing. Title 21 CFR Part 11, commonly referred to as Part 11, refers to federal regulations that give the Food and Drug Administration oversight for electronic records and electronic signatures. Specifically, it defines the criteria by which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Part 11 applies to industries regulated by the FDA, including pharma and medical device manufacturers, biotech companies, biologics developers, contract research organizations (CROs) and others. Ensuring compliance goes well beyond “basic” QA testing, and requires that your QA staff or selected partner have specialized knowledge in this area.

It’s no surprise that security testing ranks high for healthcare companies. Privacy regulations, including HIPAA, mandate that patient information be encrypted on servers, in the cloud and in transit between providers. What’s more, HIPAA regulations also encompass business associates of those entities covered under HIPAA. Think third-party billing agencies or software developers that work with patient data. Penalties for security breaches can be steep, and there are strict reporting requirements, depending on the size of the breach.

A recent survey from KPMG showed that 81% of healthcare execs say their organizations have been compromised by at least one malware, botnet or other cyber-attack during the past two years. What’s more, only half of execs believe they are adequately prepared to prevent future attacks.

The prevalence of technology in the healthcare workplace has placed increasing importance on mobile testing. Many facilities have bring-your-own-device (BYOD) policies, where caregivers transmit and share protected health information about patients to speed diagnoses, the administration of medications, transmittal of critical lab results and other information. But that data must be encrypted at the source, while in transit and at the device. Provisions must also be made to wipe remote data should a device be misplaced or stolen.

Because of the sheer amount of data that healthcare companies leverage, automated testing solutions allow healthcare organizations to leverage modular testing methodologies to reduce the need for manual processes while creating a competitive advantage.

Healthcare companies also should pay close attention to business intelligence reporting and the ETL process (extract, transform, and load). Like financial services firms, healthcare companies utilize a variety of data sources, including legacy systems that must be tested if applications require data from those sources. Likewise, ETL tools verify data sources, the correctness of data and its proper movement.

Healthcare is a complicated business, and successful QA testing requires specialized knowledge of widely different systems, applications, testing methodologies and industry regulations. If your QA testing staff can’t keep pace, Pyramid Consulting can.

Carl Johanson

About the author

Carl Johanson

Practice Director, QA & Testing

Carl has been creating custom, forward-focused and effective QA solutions for Pyramid Consulting since 2012. Implementing the latest tech and thought leadership delights Carl just as it does clients. In his personal life, Carl focuses on doing things right and doing the right things—an important distinction—as efficiently as possible. If you need Carl urgently, check out your local drumming scene or the closest beach, otherwise you can find him at home with his beautiful and ever-growing family.

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