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Tag: American Recovery and Reinvestment Act

Why the Electronic Medical Record Needs to be Viewed as a Medical Device

In our rush to establish a national electronic medical record (EMR) system as part of the American Recovery and Reinvestment Act of 2009, powerful silos of independent EMR systems have sprung up nationwide.

While most systems are being developed responsibly, like the Wild, Wild West, many have been developed without an objective eye toward quality and the potential  harm they may be causing our patients.

As most readers of this blog are aware, since 2005 the medical device industry in which I work has had widely publicized instances of patient deaths splashed all over the New York Times and other mainstream media outlets from defibrillator malfunctions that resulted in a just a few patient deaths.

The backlash in response to these deaths was significant: device registries were developed, software improvements to devices created, and billions of dollars in legal fees and damages paid to patients and their families on the path to improvement.  In addition, we also learned about the limits of corporate responsibility for these deaths thanks to legal precedent established by the Reigel vs. Medtronic case.

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Bringing Medicine into the Age of Computers, Finally

The economic stimulus package passed in 2009 contained billions of dollars designed to encourage hospitals and doctors to install electronic health records (EHRs).  At the time, an exceptionally small number of health care providers had computerized medical records.  It is hard for those of us who are used to dealing with credit card companies, airlines, automobile service departments, utility companies, and the like to imagine that the medical world was living in the Dark Ages.

Here was an industry that hadn’t even arrived in the 20th century – much less the 21st century — in terms of computerization.  Accordingly, the idea of the legislation was to both create jobs and also pull the industry up by its bootstraps.

Everyone understood that this would not be an easy task, but it was the right thing to do.  Without EHRs, if you show up at a new hospital and the doctor there needs your medical history from your home institution, the file of paper records needs to be extracted from the archives.  Then, believe it or not, it is faxed a page at a time to the doctor who is treating you.  That’s if you are lucky.  Many times, the process is just too burdensome and time-consuming.  If you are waiting in an emergency room, chances are they will not even try to obtain this information.  The result is that tests you might have had recently will have to be repeated, a high cost, when you enter the new facility.

But not having EHRs is a problem even if you go to your regular hospital.  There, too, your doctor needs to put in a request for someone to dig up your files and have them delivered or faxed to his or her office.  Not only does this create delays, it offers a high probability that your doctor will not have key information about you as he or she begins to diagnose and treat you.

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