AAMI HIT Risk Management Standard

AAMI has filed a Project Initiation Notice with ANSI for a new standard on HIT risk management. The notice was published in the ANSI Standards Action publication on December 19. The notice is reproduced below.
BSR/AAMI HIT1000-201x, Risk Management for Heath-IT (new standard)
Stakeholders: The primary stakeholders are health IT producers and manufacturers, healthcare providers, HIT experts from healthcare delivery, and other healthcare IT professionals. Other stakeholders would include patient advocacy organizations, government representatives and health-IT associations.

Project Need: The need for a risk-based framework to help deliver consistent, high-quality clinical health IT and to ensure its safe implementation and use has been identified by various organizations and government agencies Clinical software systems health IT is creating risk for a myriad of reasons across product life cycle. The safe functioning of health IT is highly dependent on a common understanding of each point in the life cycle by all vendors and providers of care. A standardized risk-management process for clinical software systems health IT will promote safety while avoiding the burdensome impact of stringent regulation. For this reason, such a risk management process must include all stakeholders involved in the creation, implementation and use of this type of health IT.

This standard will provide a process for managing risks to patients posed by clinical systems health IT. The roles and responsibilities of those involved in creating, implementing, and using health IT will be defined. Methods for identifying and quantifying risks will be outlined and guidance will be provided for establishing mitigation strategies.

Upcoming Training

Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

Email training@softwarecpr.com for more info.

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