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ANSI/AAMI HIT1000-1:2022
Safety and effectiveness of health IT software and systems - Part 1: Fundamental concepts, principles, and requirements
The AAMI HIT1000 series of standards and provisional standards provides a framework for managing the safety and effectiveness of health IT (HIT) software and systems, for the purpose of promoting better patient outcomes. AAMI HIT1000, Part 1: Fundamental concepts, principles, and requirements, identifies the core concepts and principles needed to maintain safe and effective health IT software and systems. It also identifies roles and defines responsibilities, activities, and best practices that are necessary for managing that safety and effectiveness. This standard applies throughout the whole lifecycle of health IT software and systems and to all sizes and types of actors involved with that system—from developers and system integrators who create the systems, to healthcare delivery organizations (HDOs) who own, configure, implement, and use the systems, and to those responsible for operating and ultimately decommissioning health IT systems or health IT system components.
Association for the Advancement of Medical Instrumentation [aami]