AAMI News August 2015

AAMI Launches Health IT Standards Initiative

AAMI has launched an initiative to develop American National Standards applying to health service provider organizations and vendors that develop, implement, or use health information technology (HIT) software and systems. AAMI HIT1000, Risk Management Practices for Health IT, will define a process to identify the patient safety hazards associated with health IT, to estimate and evaluate the associated risks, and to control or mitigate these risks. AAMI HIT2000, Application of Quality Management Principles to Health IT, will identify and prioritize the appropriate quality system principles necessary to create, deliver, and utilize health IT safely and effectively.

The work will commence with an invitation-only meeting on Oct. 20 with key stakeholders to seek input and explain the plan of work. The open inaugural meeting of the new AAMI Health IT Committee will follow the next day.

Several recent studies and reports by patient safety organizations and government agencies have called for the application of risk management practices and quality management principles to manage and mitigate risks and deliver consistent, high-quality, HIT products and services. While general quality system and risk management principles are covered in many existing standards, these standards do not offer the sector-specific detail needed for the HIT sector or provide the requisite focus on patient safety, health, and security. On the other hand, well-developed quality systems and risk management standards for medical devices—such as ANSI/AAMI/ISO 13485 and ANSI/AAMI/ISO 14971—are intended for use in a highly regulated environment, which does not exist in the United States for nonmedical device HIT. In addition, the latter standards do not take into account the very different life cycles of HIT or the special risk conditions created when such IT is custom implemented and configured in the field.

According to Joe Lewelling, AAMI’s vice president of emerging technology and health IT, the creation of HIT sector-specific standards and guidance is not intended to supplant existing quality management systems or risk management frameworks; rather it is intended to establish consistency and consensus on the minimum requirements for such frameworks and practices, enabling HIT vendors to assess their existing systems and improve them if necessary. “In the absence of defined minimum standards, the industry will be judged by its worst actors,” Lewelling said.

The AAMI work is being pursued alongside a related effort to develop a body of standards for HIT software and systems under the joint auspices of ISO/TC 215, Health Informatics, and IEC/SC 62A, Common aspects of electrical equipment used in medical practice. Lewelling noted that domestic standards are needed to address specific conditions of the U.S. market, but said he hoped they can be developed faster and then be used as source documents in international efforts.