Novel standards for unregulated health software consider human factors

Novel standards for unregulated health software consider human factors

Press releases may be edited for formatting or style | September 15, 2020 Health IT
In this digital age, health software is becoming increasingly important for the delivery of healthcare. Unlike medical devices, unregulated software has not had the benefit of tried-and-true standards to help promote patient safety and health. Now, the Association for the Advancement of Medical Instrumentation (AAMI) has released the provisional standard HIT 1000-4, Application of Human Factors Engineering. It’s the latest in a suite of provisional standards designed not only for health software developers, but also for vendors, healthcare delivery organizations, end-users, and everyone in-between.

“Standards for medical device software already exist, but these are focused on compliance with medical device regulations. Much of health software in the U.S. does not fall under those regulations and much of that software is modified by the users when it is incorporated into their larger health IT systems,” said Joe Lewelling, senior advisor on content and strategy at AAMI. “What makes this whole suite of provisional standards different is that we’re acknowledging that the end users, especially in a clinical setting, have an important role to play.”

“For medical devices, the standards tend to focus mostly on what manufacturers need to do to create a safe product. By comparison, software is more complicated,” added Neil Gardner, a health IT consultant who was instrumental in creating the suite. “Because of the degree to which software is customizable and integrated into health IT systems at a local level, we really had to look at the full life cycle of health IT software and systems and address these new standards to all the various players that need to be involved to ensure the health IT solutions being implemented are safe and effective.”


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The first of the suite, HIT 1000-1, Fundamental concepts, principles, and requirements, debuted as a provisional American national standard in 2018. It outlines the need for standardized quality systems, risk management, and usability in the largely unguided wild west that is software development.

“As someone who works in information technologies for a hospital system, I can’t say ‘show me the IT safety standards.’ There aren’t any,” explained David Classen, MD, co-chair of the AAMI Health IT Committee. “For the most part, we are really creating these standards from the ground up.”

HIT 1000-3, which debuted in late 2019, focuses on risk management. The risks that come with improperly curated medical records are crucial for developers to understand; while those who implement, use, and modify the software need to know the best routes for mitigating risk. The new HIT 1000-4 touches on a complimentary side of this ecosystem. It outlines how a software’s developers and the parties installing it should work closely with end users, such as clinicians, to ensure the products are easy to use and understand. This is important because risk management practices only work if a product is implemented and used correctly.

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