Medical Malpractice and Personal Injury Law Blog

How Gag Clauses Involving Electronic Health Record Systems Can Create Potential Malpractice Liability

Posted by Briggs Bedigian | Apr 10, 2019 | 0 Comments

Dr. David Bates is a chief in internal medicine and a researcher at Brigham and Women's Hospital. He is very familiar with the system of electronic health records (EHR) at the medical center; however, he is unable to demonstrate the capabilities of the system due to policy.  He explains that showing the software to others is prohibited due to potential liability. He is unable to create and share screenshots or any video footage of the system. This is viewed as a patient safety concern among the staff.

Sharing EHR Information

These restrictions are commonly referred to as “gag clauses” that are part of the contract between the hospital and the EHR vendor. These are legal requirements designed to protect the EHR vendor's software from access by competitors. Bates is unable to even share potential formatting concerns with third-party IT providers. Darrell Ranum is a vice president with the Doctors Company, a company that provides medical malpractice insurance. He explains that these gag clauses are estimated to be the source of approximately 1 to 2% of all claims of malpractice.

Potential for Problems

Dr. Raj Ratwani is the director of the MedStar Health National Center for Human Factors in Healthcare in Washington D.C. Says that restrictions create an inability to properly train users and leads to errors that ultimately compromise patient safety. He explains that the EHR systems are increasingly confusing and users are prone to errors. For example, when he wants to order Tylenol for a patient, a window opens that contains “86 different possible” dosages.

Governmental Measures

The federal government has been made aware of the problem. The Office of National Coordination of Health Information Technology is in the process of implementing some new rules. Many of the proposed solutions seek to eliminate gag clauses. Dr. Andrew Gettinger, the chief clinical officer, says that “prohibiting or restricting communication regarding health IT software does not promote safety.” Gag orders have apparently been a standard in the EHR market for several years. The risk to the companies is that competitors who access the software can reverse engineer their technology.

New Proposal

The U.S. Department of Health and Human Services is seeking to implement a more “seamless and secure” way of accessing and exchanging electronic health information. They want the market to adopt a standard (common) interface and also allow for access via mobile devices. Their proposal is being leveraged on the basis that a patient should be allowed access to their medical records at no cost.

Impact on Pediatrics

A recent report suggests that pediatric patients are specifically at risk from the problems associated with EHRs. Children are particularly vulnerable to errors involving medications. A study was conducted that analyzed 9,000 patients during the span of time from 2012 to 2017. Their results showed the following:

  • Roughly 36% of medication-related errors involved problems with system “usability”
  • Nearly 19% of system usability problems likely caused harm for a patient
  • These results were similar across three separate healthcare facilities that were analyzed independently
  • The majority of the problems involved an inability to provide feedback on the system, particularly about problems with the visual display

About the Author

Briggs Bedigian

H. Briggs Bedigian (“Briggs”) is a founding partner of Gilman & Bedigian, LLC.  Prior to forming Gilman & Bedigian, LLC, Briggs was a partner at Wais, Vogelstein and Bedigian, LLC, where he was the head of the firm's litigation practice.  Briggs' legal practice is focused on representing clients involved in medical malpractice and catastrophic personal injury cases. 

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