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Initial Impressions from the IOM report: Health IT and Patient Safety: Building Safer Systems for Better Care

Despite some of the alarmist responses to the report, I want to assure anyone reading this that using better technology to improve healthcare is a necessity. Trying to pull back from adoption by saying that health IT has safety problems would be like saying that because there are automobile accidents we should ban cars. Health IT can improve patient safety and the quality of care we provide.

But a few things stand out from my first reading of the report. First is this:

"The current state of safety and health IT is not acceptable; specific actions are required to improve the safety of health IT. The first eight recommendations are intended to create conditions and incentives to encourage substantial industry-driven change without formal regulation. However, because the private sector to date has not taken sufficient action on its own, the committee believes a follow-up recommendation is needed to formally regulate health IT.

If the actions recommended to the private and public sectors are not effective as determined by the Secretary of HHS, the Secretary should direct the FDA to exercise all authorities to regulate health IT."

And then looking back at some of the recommendations, one that immediately caught my eye:

"The committee considered a number of potential organizations that could objectively analyze reports of unsafe conditions, as well as conduct investigations into health IT–related adverse events in the way the committee envisions, including the FDA, ONC, AHRQ, and the private sector. The committee concluded that investigating patient safety incidents does not match the internal expertise of any existing entity, as the needed functions are under the jurisdiction of multiple federal agencies and efforts are generally uncoordinated and not comprehensive.

The committee believes development of an independent, federal entity could perform the needed analytic and investigative functions in a transparent, nonpunitive manner. It would be similar in structure to the National Transportation Safety Board, an independent federal agency created by Congress to conduct safety investigations. The entity would make nonbinding recommendations to the Secretary of HHS. Nonbinding recommendations provide flexibility, allowing the Secretary, health care organizations, vendors, and external experts to collectively determine the best course forward."


"Recommendation 8:

The Secretary of HHS should recommend that Congress establish an independent federal entity for investigating patient safety deaths, serious injuries, or potentially unsafe conditions associated with health IT. This entity should also monitor and analyze data and publicly report results of these activities."

We have been using an EHR for over seven years. There is no doubt that the quality of care has improved, that safety is increased, and ultimately costs are also lowered through the proper implementation of health IT. But it is this proper implementation that is so key, and sadly, sometimes so lacking.

I think the report is a solid start and I look forward to HHS action. I was happy to see +Farzad Mostashari's post today, which stated, "ONC will lead an HHS planning initiative to develop a comprehensive EHR safety action and surveillance plan well within the 12-month period recommended by IOM. In formulating this plan, ONC will work with the FDA, AHRQ, NIH, and CMS as well as the broader healthcare community and industry."

I have absolute confidence that the measured and thoughtful response by HHS to the issues raised in this report will help alleviate many of the concerns raised. But I also believe that it is our responsibility in the healthcare and technology communities to help make this happen...
Nick Genes's profile photoKeith Boone's profile photoDirk Stanley's profile photoBrian Ahier's profile photo
I don't want to minimize the impotance of safety concerns. I have seen some examples where alert fatigue has led to potential safety issues. There could also be instances where a software glitch causes an inaccuracy, that is then scaled across potentially thousands of records.
Brian -- Thanks for sharing your thoughts on this. I think it's important to note that ONC commissioned this report (as Farzad noted in his post) and is seeking to use the gravitas of the IOM (which, of course, has issued the epochal patient safety reports ten years back or so). Unfortunately, those reports (To Err Is Human & Crossing the Quality Chasm) haven't really changed the bottom line. We have more preventable deaths in the health care system now than we did then. So ONC has effectively thrown down the gauntlet -- to itself and to a sister agency -- by invoking the IOM and entering into a turf battle with the FDA over EHR regulation. Good luck, Farzad & team! We hope you can pull this off.
Yes, +Jeff Brandt but the current hold harmless clauses with EHR vendors absolve them of any responsibility for adverse effects of failures in their systems. What the IOM is recommending is that these specific clauses with EHR vendors be removed. Since many EHR vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”), IOM found these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety and these clauses should be eliminated for EHR vendor contracts.
Nice summary and perspective. My thoughts are here:

I'd love more sunshine in hospital-vendor contracts and more standardized reporting. But in general, I worry that these calls for greater safety and monitoring of health IT, especially when folks are despondent about MU and ICD10, will tend to preserve the status quo in a lot of places.. Keeping a paper-based system is much harder to monitor or study, but is probably less safe than electronic records.
+Dirk Stanley made a great comment from a physicians perspective on this thread (but posted it on Facebook :)
Dirk Stanley I think a lot of the complexities and confusion stems from the limited definitions of some of our most used tools in healthcare - Orders, order sets, protocols, guidelines, etc... EMRs are necessary because they force us all to look at these definitions, but there are no good standards with regards to these definitions, and so, it makes training about these tools (in medical school) somewhat challenging. Once we agree to these basic tools (I call it the "Informatics Toolbelt"), the training could be much more standardized and the implementation of #EMRs would be much easier.
Tangible things like hammers are easier to understand - you can see them, touch them, and when you hit your thumb with one you learn quickly about how to use them safely. Orders, order sets, and documentation are conceptual and harder to understand and so it helps to have better definitions.

(Just my two cents worth.) :) 
I love this: "Tangible things like hammers are easier to understand - you can see them, touch them, and when you hit your thumb with one you learn quickly about how to use them safely. Orders, order sets, and documentation are conceptual and harder to understand and so it helps to have better definitions."
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