A new watchdog agency to monitor health information technology safety problems?
That’s what the Institute of Medicine has proposed so that safety incidents tied to health IT tools including health records and health information exchanges can be effectively investigated.
The IOM, in a report commissioned by the Office of the National Coordinator for Health, said the Food and Drug Administration should not necessarily oversee health IT applications since it lacks funding, resources and the investigative capabilities necessary, according to a FierceHealthIT report.
The FDA is responsible for approving device-related applications already and new regulations may expand the group’s authority. The IOM voiced a few qualms over the FDA’s missing expertise as well as its ability to handle regulation of mobile health and IT apps.
The answer according to IOM: the Department of Health and Human Services should create and fund a new agency of which health IT vendors are required to report incidents to.
In addition, IOM suggests vendors should be required to register their products with said agency. The group demanded criteria for EHR safety be both established and enforced and amidst this all, the HIMSS’ Electronic Health Record Association formed a partnership with the iHealth Alliance, an action that seems non-coincidental.