This week, a pair of HIT organizations — including a HIMSS-backed group and an alliance focused on HIT safety — came together to help track HIT-related patient safety problems. The two groups have broad-based vendor support, and they seem to have the right goals. Unfortunately for them, though, the HIT safety ship may have already sailed.
Participants in the current linkup include the iHealth Alliance, part of the EHR safety group EHRevent.com run by the publishers of the Physicians’ Desk Reference, and the HIMSS EHR Association, a collection of 44 EHR vendors working together to work on key industry issues.
The safety group, which offers a quick form allowing people to report EHR-related safety concerns, is an official, federally-certified Patient Safety Organization. That gives providers the chance to report such events in a privileged, confidential manner.
That being said, regulators seem to have gotten the jump on the software folks. As some of you may know, regulators are already preparing to begin, well, regulating HIT safety results. The FDA, which issued draft guidance on mobile medical apps this summer, may cast its eye on EHRs at some point.
Another possible angle comes from the Institute of Medicine, which recently issued a report recommending that HHS create a new watchdog agency investigating health IT safety issues. National Coordinator for Health IT Farzad Mostashari recently told reporters that his agency, the ONC, has already begun developing an EHR safety and surveillance plan which should be out within the next 12 months.
(If you want this process to be as painless as possible, you’d better hope that the IOM gets its way; vendors, you don’t want to face the kind of FDA struggles pharmaceutical companies do, right?)
Honestly, someone who’s watched regulators do their thing for decades, I’m betting this latest industry effort will be too little, too late.
Folks, as I see it the only way you’ll get the agencies off your back is to start reporting on safety issues with EMRs/EHRs and other health IT tools aggressively. But given that many organizations aren’t even at the stage where their EMR installation is stable, good luck!