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Are EHR Vendor Contracts Hindering Patient Safety Research?

By Sara Heath

Adhering to patient safety standards is of vital importance when using an EHR, which is why proper review and research among different systems are critical for innovation. However, are supposed gag clauses in EHR vendor contracts inhibiting this kind of review and research?

A recent Politico article written by Darius Tahir presents considerable research into the matter. According to Tahir, EHR users are being completely prohibited from sharing adverse events and negative feedback regarding their EHRs. This stems from different gag clauses included in EHR vendor contracts, and seriously affects innovation that can help improve patient safety.

But HealthAffairs article by Kathy Kenyon, JD, MA, tries to clarify many of the legal implications of EHR vendor contracts, and discusses the realities of the “gag clauses.”

According to Kenyon, gag clauses in EHR vendor contracts do not necessarily prohibit users and researchers from offering negative feedback regarding their EHR systems. However, as soon as users or researchers include a screenshot of an EHR screen in their critique, they are breaching the “gag clauses” that actually deal with protecting intellectual property.

Kenyon states that many EHR vendor contracts include clauses that prohibit users from publically sharing screenshots of the EHR while reviewing the product without vendor permission. These clauses exist to protect the intellectual property of EHR vendors.  However, they are actually quite vague and unclear, giving vendors the power to prohibit potentially vital research that could improve the EHR for patient safety.

The true ‘gag clause’ problems with EHR vendor contracts appear to be related to the confidentiality and intellectual property terms, which are overbroad and unclear, and limits on ‘authorized uses’ of the EHR, as those terms apply to research and reporting that requires access to the EHR and use of screenshots,” she writes.

Furthermore, when researchers are able to access screenshots to share information for system improvement, vendors are given a high level of control regarding what system information is released. This potentially prevents unbiased information from being published, hindering the improvement process.

“As long as researchers must ask vendors for permission to do research or to publish screenshots, and as long as vendors can deny permission for any reason, including not liking the results, there is a serious danger that research will be designed and findings presented in ways that garner vendor permission,” she writes.

Kenyon points out that these clauses exist to protect the intellectual property of EHR vendors. The vendors are concerned that should information regarding the look and functionality of their software be released to the public, other vendors may steal these features. This would cause vendors to lose “competitive advantage,” Kenyon says, and would hurt the business of the EHR industry.

Kenyon says that many EHR users state that this fear of vendors is not entirely well-founded considering the ease with which competitors are able to gather information regarding a certain EHR.

“...it is not that hard to discover what different EHRs look like. For vendors hoping to improve their EHRs by ‘stealing’ from others, waiting for research with screenshots to be published would be an exceptionally inefficient way to do so,” she writes.

Furthermore, many physicians maintain that no price can be put on the safety of patients, Kenyon reports.

Kenyon maintains that under existing contracts, the provisions made to protect intellectual property are not functional for researchers. To increase patient safety while using EHRs, different standards are going to have to be implemented, Kenyon suggests.

“Stakeholder groups for patient and EHR safety, including parties to EHR contracts, should share interests in making health IT safety-related research and reporting as easy as possible,” Kenyon explains. “EHR vendor contracts should reflect as much consensus on these issues as is possible.”

She continues to provide suggestions for the construction of future EHR vendor contracts, stating that there should be no gag clauses, but rather clauses that encourage research and encourage reporting of adverse outcomes. By identifying these areas for improvement in EHR vendor contracts, research and adverse event reporting may potentially help increase patient safety.

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