AAMI HIT1000-1: 2022

AAMI HIT1000-1 – 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.