Friday, January 08, 2016

Yet another observation that known health IT-caused injuries and deaths are "the tip of the iceberg"

I've noted a new observation of the limited data available on health IT harms being the (quote) "tip of the iceberg."

This statement appears in "Electronic Health Record–Related Events in Medical Malpractice Claims", Gruber et al., J. Patient Saf 2015, (PDF available free from link on right side of page.)

From the abstract:

Background: There is widespread agreement that the full potential of health information technology (health IT) has not yet been realized and of particular concern are the examples of unintended consequences of health IT that detract from the safety of health care or from the use of health IT itself. The goal of this project was to obtain additional information on these health IT-related problems, using a mixed methods (qualitative and quantitative) analysis of electronic health record-related harm in cases submitted to a large database of malpractice suits and claims.

Methods: Cases submitted to the CRICO claims database and coded during 2012 and 2013 were analyzed. A total of 248 cases (less than 1%) involving health IT were identified and coded using a proprietary taxonomy that identifies user- and system-related sociotechnical factors. Ambulatory care accounted for most of the cases (146 cases). Cases were most typically filed as a result of an error involving medications (31%), diagnosis (28%), or a complication of treatment (31%). More than 80% of cases involved moderate or severe harm, although lethal cases were less likely in cases from ambulatory settings. Etiologic factors spanned all of the sociotechnical dimensions, and many recurring patterns of error were identified.

Conclusions: Adverse events associated with health IT vulnerabilities can cause extensive harm and are encountered across the continuum of health care settings and sociotechnical factors. The recurring patterns provide valuable lessons that both practicing clinicians and health IT developers could use to reduce the risk of harm in the future.

Note the statement at pg. 5:

... The actual incidence of harm cannot be reliably estimated from this data; nonetheless, it is generally agreed that safety events represented in malpractice claims are the ‘tip of the iceberg', insofar as the vast majority of cases, even cases that involve harm, do not result in suits.

I've heard claims that up to 95% of potential meritorious medical malpractice suits never make it to the lawsuit stage due to difficulties in, and costs of, prosecution.  Anecdotally, the latter observation corresponds to my own family's experience; several attorneys would not take my mother's EHR-related medical malpractice case initially, due to her age and concerns about expenses.

I note at my post today "Repeated crushing by alligators and crocodiles: ICD-10 has you covered. Harmed by bad health IT? No codes for that" at that repeated attacks and crushings by creatures of Order Crocodilia are well-covered by ICD-10, but health IT harms do not appear to be covered by the same mandatory coding system.  My view is that this is likely by design, not due to lack of knowledge of these events by ICD-10 experts involved in creating this coding system.

Below is a checklist of such failure modes causing patient harms from the May 2012 AHRQ Health IT Hazard Manager Report (  These should be represented in ICD-10 so that the issues can be further known and studied:

AHRQ Health IT Hazard Manager Report - Hazard Modes of Health IT (click to enlarge)

Other taxonomies exist, such as in the 2010 FDA Internal Memo on Health IT harms, "not intended for public use" and unearthed by investigative reporter Fred Schulte.  See my post at and the memo itself at the link below.

Internal FDA Memo ("not intended for public use") on potential dangers of health IT.  Download the full PDF by clicking here.

  • Other use of that same "tip of the iceberg" phrase of which I have written:

FDA CDRH Director Jeff Shuren MD, JD's statement that the known risks are "the tip of an iceberg" was made at the HIT Policy Committee, Adoption/Certification Workgroup on February 25, 2010, where the topic was "HIT safety" (The text is available at

... In the past two years, we [FDA] have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.

For more on these issues, see my April 9, 2014 essay "FDA on health IT risk: "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" at


ECRI Institute:

HIT Errors 'Tip of the Iceberg,' Says ECRI
Cheryl Clark, for HealthLeaders Media , April 5, 2013

Healthcare systems' transitions from paper records to electronic ones are causing harm and in so many serious ways, providers are only now beginning to understand the scope.

... Karen Zimmer, MD, medical director of the institute, says the reports of so many types of errors and harm got the staff's attention in part because the program captured so many serious errors within just a nine-week project last spring.  The volume of errors in the voluntary reports was she says, "an awareness raiser."

"If we're seeing this much under a voluntary reporting program, we know this is just the tip of the iceberg; we know these events are very much underreported."

On the ECRI Deep Dive study of health IT risk, see my Feb. 28, 2013 essay "Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI 'Deep Dive' Study of Health IT Events" at

Tip of the iceberg:  ignore it at your peril

 -- SS

1 comment:

Anonymous said...

The care and caring that is given to patients when doctors and nurses are answering to their EHR master, is the TIP OF THE ICEBERG of what the patients need.