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.

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 community stakeholders (vendors, healthcare 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.

“This provisional standard, HIT1000-1, lays down the fundamental requirements and concepts for managing the safety and effectiveness of health IT systems and software,” says Joe Lewelling, vice president of standards strategy and emerging technology at AAMI. “Our goal with these standards is to facilitate shared responsibility and cooperation among all the stakeholders and entities involved with health IT.”

HIT1000-1 is the product of AAMI’s Health IT Committee, which was established to address the absence of needed standards in this area for health IT systems. 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 the 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.

“The healthcare system is increasingly being digitized, and the associated health IT is generating data relied upon through the healthcare system by providers, patients and consumers, researchers, and payers. That’s led to an increasing desire to make sure that the use of this technology is safe and effective for its intended purpose,” Segal says. “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. We encourage all stakeholders to test drive HIT1000-1 and provide their feedback.”