The Legalities of the Electronic Medical Record: Choose Your Vendor Wisely

The Patient Protection and Affordable Care Act (PPACA), also known as “Obamacare” has become law.  Whether you agree with it or not is your business.  My business as a clinically active nurse and as a Legal Nurse Consultant (LNC) is to try to understand it and how it will affect my practice and the work of my attorney clients.  One piece of this legislation involves the mandate that all patients’ medical records be electronic by the year 2015 (this date keeps changing–it used to be 2012, then 2014, now 2015).  An enormous amount of money has been set aside to help health care organizations make the transition from paper medical records to electronic medical records (EMR) or electronic health records (EHR).

Let’s assume we’re talking about a hospital.  “Good Hospital”  uses the money appropriately, selects a vendor and a product, and initiates the conversion to electronic documentation.  This is exactly the point where medical malpractice issues may begin.  According to Ronald B. Sterling, CPA, MBA, and author of Keys to EMR Success (Greenbranch Publishing; Phoenix,Maryland; second edition, 2010), “Every aspect of EHR selection, implementation, and use may be examined in the course of medical malpractice discovery to uncover the source of the incident, or undermine the records that are being presented in defense of the malpractice claim.  Anything could be a malpractice issue, from the product itself, the way it was set up, or how you’ve been using it.”

A 2010 report by Conning Research and Consulting found that the increased use of the EMR will drive up the cost of medical liability insurance.  The researchers believe that documentation errors and software flaws will lead to a rise in medical liability claims.  In 2009 $36 billion dollars was provided by the ARRA stimulus legislation for Health Information Technology.  This understandably encouraged many software companies to develop their own version of the EMR.  There are more than 700 vendors selling EMR products in the US.  As of October 2011, there were 499 ONC (Office of the National Coordinator for Health IT) certified products.  This certification is very basic. CCHIT (Certification Committee for Health Information Technology) also certifies these products.  It’s estimated that only 10% of the available EMR products would pass this more strenuous certification.  Bear in mind that the certification is voluntary at this point, and there is no regulatory agency that monitors the software for quality control.

You would think that a design flaw would be the responsibility of the vendor and clinicians would not be held liable for any error that occurred as a result of the product.  However, most vendors’ contracts basically say that they do not practice medicine and it’s up to the clinician to be sure the product is being used correctly.  In addition, there are gag clauses, which prohibit the vendor’s clients from publicizing information about software flaws that may cause patient error.  The irony of this is that part of the ARRA HIT (health information technology) legislation was to improve patient care!  A poor EMR product may lead “Good Hospital” to a corporate negligence claim, as ”Good Hospital” has a responsibility to provide a safe place for patient care and a responsibility to choose a vendor that provides a reliable EMR. 

Health care organizations should discuss with their liability carriers the potential risks of conversion to the EMR and develop protocols to reduce that risk.  Vendors need to commit to a product that meets clinical, legal, and record management needs while protecting the patient.  Finally, clinicians need to demand functionality that enhances their practice and makes quality patient care the priority.