The authors emphasize that there is no “one size fits all” for health IT systems. Digital medical records help aggregate and organize patient history. Other programs may be used to network the constantly changing collection of medical devices in a hospital. Trouble arises when the expectations of health professionals do not align with the know-how of developers or even the IT staff integrating the system. Additionally, when a program needs to be modified to meet new needs, developers are often involved only after a problem arises.
“Imagine if an airline decided to modify the programming of a Boeing 747, and never once worked with Boeing engineers to do so,” said Classen. “It’s inconceivable! And yet, for medical software, this happens all the time.”
HIT 1000-4 helps to remedy this by assigning responsibility throughout a program’s life cycle. During the development stage, business owners, users, and implementers are expected to work together to outline expectations for the software. Similarly, when an acquired program is being added into a system, the professionals integrating it are expected to communicate with users and developers. Even during the end of an obsolete program’s life cycle, business owners, IT staff, and users are expected to be equally aware of the hazards that come with decommissioning the software.
“Human factors—the way that clinicians and patients use and potentially misuse software—is an aspect of health information technology that U.S. authorities are particularly interested in,” added Lewelling.
He explained that the end-goal is for HIT 1000-4 and its sister documents to serve as foundations to build more comprehensive standards on an international stage. Gardner, who served for more than 25 years in a provincial Ministry of Health in Canada, is looking forward to this future.
“Just like medical device providers, health IT systems providers are becoming international in scope,” Gardner said. “If we can move to more consistent standards across the world, we’ll all be able to more effectively learn from one another to make these products and their implementations as safe and effective as possible.”
About AAMI
AAMI is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for health technology and sterilization professionals.
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