The use of IT systems to support healthcare delivery promises to make that care more efficient and accessible, and to achieve better patient outcomes. But health IT systems are not without risk—poor design, incorrect configuration, or improper use can hold back this technology’s benefits and create hazards to patient safety and health.
In order to help promote the safety and effectives of health IT systems, AAMI has published a provisional standard: HIT1000-1(PS):2018, Safety and effectiveness of health IT software and systems—Part 1: Fundamental concepts, principles, and requirements. It was developed to help healthcare vendors, delivery organizations, and clinicians identify and minimize patient risks to health IT systems so they remain safe and effective from design and development through implementation, use, and ultimately retirement.
HIT1000-1 is intended as the first in a four-part series, with subsequent editions focusing on quality systems, risk management, and usability principles as they relate to health IT.
Envisioned to “not reinvent the wheel,” the HIT1000 series is built upon existing standards from other industries, adapting them to the particular characteristics of health IT software and systems.
Mark Segal, PhD, co-chair of AAMI’s Health IT Committee and principal at Digital Health Policy Advisors, LLC in Chicago, said that HIT1001-1 “sets the stage” for the further work that will be published throughout next year by defining high-level concepts, principles, and terms intended to help orient those who are involved in developing, implementing, or using health IT.
“Most current health IT software is not regulated by the Food and Drug Administration, and the current standards used for the medical device industry just aren’t a good fit for health IT software,” Segal said.
Current health IT standards for quality and safety are used only by the vendors as they develop their health IT software. However, much of the impact on the safety and usability of software is determined by the actions of those who implement and customize it, said co-chair David Classen, chief medical information officer at PascalMetrics.
The development of the HIT1000 series represents a major step in realizing the recommendations of the Institute of Medicine’s 2011 report, Health IT and Patient Safety: Building Safer Systems for Better Care, which called for a shared responsibility between developers and users in ensuring the safety of health based on longstanding aviation industry practices.
HIT1001-1 is available for free download at http://my.aami.org/store/detail.aspx?id=HIT10001PS2018.
