A primary goal of Health IT software is to improve the overall quality, safety, and effective delivery of healthcare. However, despite widespread implementation and use of health IT software, these safety and quality benefits have not been fully realized, as software vendors and users must balance innovation with the ability to mitigate risk in these highly valuable systems.

Though developing safe and reliable software has long been a focus of health IT companies, well-established and overarching standards for regulating or assessing the safety and effectiveness of such products throughout the software development life-cycle are still under active development.

A milestone in this process was recently reached when the Association for the Advancement of Medical Instrumentation (AAMI) published a provisional standard for review and feedback. The Standard, HIT1000-1(PS):2018, Safety and effectiveness of Health IT software and systems—Part 1: Fundamental concepts, principles, and requirements, forms the basis of a 4-part series and lays the foundational requirements for all stakeholders in health IT development and use in creating and managing safe and effective software and systems. The standards intentionally facilitate shared responsibility and cooperation among all involved parties and place safety at the forefront of health IT software development.

Quandary Peak Research actively tracks the development of these and similar standards as part of its Health IT and regulatory consulting services for its Health IT software clients, including software vendors, clinical content companies, and government agencies.