As concern over health IT-related safety issues mounts, the Institute of Medicine (IOM) has proposed the creation of a new watchdog agency to monitor these problems. This agency would investigate safety incidents tied to the use of health IT tools such as electronic health records, personal health records, and health information exchanges.
In a report commissioned by the Office of the National Coordinator for Health IT (ONC), the IOM recommends against having the Food and Drug Administration (FDA) oversee health IT applications. The report notes that the FDA lacks the funding, human resources and investigative capabilities necessary to police the health IT area. Moreover, it says, FDA oversight could seriously hamper innovation and, by doing so, actually could increase the number of potential safety issues.
The IOM's take on FDA's lack of expertise raises some questions about its ability to regulate mobile health and professional IT applications, including decision support tools. The FDA already must approve many device-related applications, and proposed new regulations may expand its authority in this area.
IOM suggests that the Department of Health & Human Services (HHS) create and fund the new health IT regulatory agency. Health IT vendors would be required to report safety incidents associated with their products, and healthcare providers also could report such events voluntarily.
Among other things, IOM also recommends that vendors be required to register their products with the new agency, that criteria for EHR safety be established and enforced, and that a study should be conducted to quantify the number of deaths and injuries associated with health IT.
This week, HIMSS' Electronic Health Record Association announced a partnership with the iHealth Alliance to develop practical and effective reporting tools to track EHR-related medical errors. Could the timing of this announcement be a coincidence? Probably not.