EMR-EHR Safety Watchdog Unlikely To Emerge Soon

Yesterday, we at HealthcareScene.com got a letter from the organization behind EHREvent.org, a patient safety organization allowing people to anonymously report EMR-related safety events, stating that the site was shutting down.  PDR Secure LLC gave little information on the closure, other than to say that it was relinquishing its PSO status.

Curious, John and I took a closer look at the matter. The only other organization which seemed to allow for reporting of EMR-related safety incidents, EHREventS.org (“S” capitalized for clarity), seems to have disappeared since it was first launched late last year.

So while Google searches aren’t perfect, it does appear that at the moment, there’s no official source to which providers, hospitals or other interested parties can report patient safety incidents related to problems with an EMR/EHR.

It’s worth noting that the FDA seems quite concerned about establishing EMR safety regulations. In fact, agency members have been in discussion for years on the topic, spurred by reports of HIT-related malfunctions. “Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist,” Dr. Jeffrey Shuren of the agency’s Center for Devices and Radiological Health told Congress in 2010.

But so far, the agency hasn’t issued any regs. My feeling is that FDA leaders are stalling (prompted in part, I’m guessing from indirect lobbying pressure) on getting such a system started, as it’s definitely going to irritate some very deep-pocketed HIT players out there.

As FierceEMR editor Maria Durben Hirsch noted in an excellent recent column, there’s more than one way the private sector could take up the role of EMR safety watchdog, such as:

*  Creating a one-stop site where users and others can report on their experiences with EMR systems, a step the AMA has apparently considered

*  Launching a new watchdog agency, run by HHS, which would oversee EMR registration, monitor for health IT-related mistakes and investigate adverse event reports.  According to Durben, Congress likes this idea — which was proposed by the Institute of Medicine — but that there’s been no action yet.

Bottom line, it seems that reporting on adverse EMR events is a very unpopular idea in many quarters, or at least a political hot potato.  I suspect someone, perhaps HHS or even the POTUS, is going to have to hammer EMR reporting into place if it’s going to happen anytime soon.

About the author

Anne Zieger

Anne Zieger

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

7 Comments

  • Thanks for the clarification, Carl. But if I understand what I’ve read correctly, if an EMR is buggy and *almost* causes harm, that’s not a reportable incident. If so, I’d say we have a loophole here.

  • Anne,

    Yep, it is. The debate in the FDA is whether software is a device. If it is, then there are scads of products that would be covered much less our babies.

    If software is not then they will have to take it program by program. Either way it’s a tough question. I don’t think creating another federal agency or a private one is the way to go. It would take them a long time to build the systems, experience and knowledge of adverse events that the FDA has.

  • In February, the HIMSS EHRA published a Patient Safety Statement of Commitment:

    http://www.himssehra.org/docs/20120221_EHRA_PatientSaftetyPressRelease.pdf

    “The EHR Association Patient Safety Workgroup and the Executive Committee have worked diligently to gain consensus on our commitment to support a larger “learning system‟ in which potential safety issues in healthcare environments are reported and analyzed, including those associated with health information technology, in an effort to foster continuous system-wide improvement,” said Leigh Burchell, Vice President of Government Affairs for Allscripts and Chair of the Association‟s Public Policy Leadership Workgroup. Burchell went on to say, “We are committed, as an association, to partnering with the Office of the National Coordinator and other stakeholders in healthcare to standardize best practices in health IT safety, including definitions and processes, and we hope that our statement sets the stage for collaborative action around this issue.”

    The statement, available on the EHR Association web site at http://www.himssehra.org/ASP/index.asp, , describes the Association‟s objectives to identify and implement best practices that enable the safest possible development, adoption and use of health IT as an essential component of improving overall healthcare quality and safety, and promoting the use of health IT to identify and reduce areas of safety and/or quality risks.

    What, if anything, came of this?

    QA

  • Who would have thunk that the HIMSS EHRA’s “Patient Safety Statement of Commitment” was empty and meaningless!

    Seems like they’re trying to force the government to get involved in regulatory ways (which will happen after enough high profile deaths / vendor incompetence).

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