As bioinformaticists, we regularly get asked to develop apps or websites which are HIPAA compliant, connect to an EHR, or are ready for FDA regulation.

Regarding the last, the FDA has built up best practices over the past 40 or 50 years regarding "validation and verification" testing. Without going into a lengthy history of FDA regulations, suffice it to say that there are two important distinctions about validation and verification testing - the first of which is that there has to be more than one testing methodology, so that manufacturers or developers don't get a sort of biased tunnel vision; and the second is that at least one of the testing methodologies has to be user-centric. So, it's not enough to test the engine of a car, a manufacturer also must have crash test dummies.

In the world of software written for hospitals and clinical environments, we interpret the verification and validation testing requirements in terms of requiring more than one testing framework, one of which is an end-to-end testing harness using a technology like Selenium. It's not enough to have unit testing, but we also need e2e acceptance testing. Selenium has traditionally been the only game in town, and has been a struggle to work with at times. But it's a tank, and keeps on rolling. We particularly like recent incarnations using Chromedriver and WebDriver protocols, which is slowly reducing the reliance on the legacy Java server.

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