AAMI has filed a Project Initiation Notice with ANSI for a new standard on Application of Quality Management Principles and Practices to Health IT. The notice was published in the ANSI Standards Action publication on January 23. The notice is reproduced below.
BSR/AAMI HIT2000-201x, Application of Quality Management Principles and Practices to Health IT (new standard)
Stakeholders: Health IT producers, vendors, and manufacturers; healthcare providers; healthcare IT professionals; patient advocacy organizations; government representatives; and health-IT associations.
Project Need: There is need for the application of QMS principles and practices for health software and other HIT products that pose only moderate risk to patients and that are not regulated as medical devices. HIT products differ from medical device software in that HIT complexity comes primarily from the domain content, has a very different product life cycle and tends to evolve over the life of the product. Therefore, a QMS for such HIT needs to emphasize different quality management principles.
This standard will detail the application of Quality Management System (QMS) principles and practices for health IT software to improve patient safety.