Health Care: Is There a Safety Issue with EHRs?

Electronic Health Records (EHR) are touted as being more efficient than paper record keeping systems.  They should be more capable of reducing errors due to illegible handwriting, avoiding misfiled documents, and in spotting problems like identifying possible dangerous drug interactions in prescriptions.  But are they really?  The ECRI institute actually ranked Health Care Information Technology as number five on their list of the top 10 health technology hazards for 2011.  The ECRI Institute identified potential problems with EHR as:  “lead to data being lost (e.g., overwritten, unsuccessfully transmitted) or being associated with the wrong patient, which in turn can lead to misdiagnosis, inappropriate treatment, or the need for repeat testing.”

The Institute of Medicine (IOM) questions the safety of Electronic Health Records, or at least want to be reassured that the move to technology doesn’t bring along with it unexpected health risks.  Late in December, the IOM formed a committee with a charter of investigating Patient Safety and Health Information Technology.

One of the recommendations of the study may be that the FDA regulate EHR and Health Information Technology.  Already some hospitals voluntarily report IT malfunctions and other problems to the FDA.  The FDA has received 260 reports of malfunctions during the years 2008 and 2009 that resulted in 44 injuries and 6 deaths.

The work is being sponsored by the Office of the National Coordinator for Health Information Technology that funded the study with $989,000.  Dr. David Blume, national Health IT coordinator and sponsor for the project, commented that “at the same time, any time you change the world, you create risks.  We want to make sure that implementation is as safe as it can be and all safety benefits are realized.  If the IOM concludes that some sort of regulation is necessary, we will want to balance regulation and innovation as we do in every marketplace.”

Vendors of Electronic Health Record systems are worried that FDA regulations may make their lives difficult.  They argue that more regulation will stiffle innovation.   Miami bioethicist Kenneth Goodman countered this line of argument by saying that “we value innovation, but we don’t value it more than safety.”  Striking the right balance between innovation and safety will be important to make sure that EHR systems are function correctly.