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ONC EHR Oversight Rule Needs Better Testing Process, Pew Says

Pew Charitable Trusts has issued an analysis of the ONC EHR oversight final rule, stating that it still contains gaps for patient safety risk.

By Sara Heath

- Despite intentions to improve patient safety through better EHR oversight and testing, the recent ONC Health IT Certification Program still contains gaps for adverse patient safety events, according to Pew Charitable Trusts.


In a recent analysis, Pew explained that the Health IT Certification Program still leaves patients liable to adverse safety events because the ONC requirements only include limited testing.

“Unfortunately, even with this rule in place, gaps will persist in the ability of hospitals, doctors, and the developers of these systems to detect flaws that could put patients at risk,” wrote Pew’s Ben Moscovitch, who manages the organizations health IT initiative.

“That’s because the ONC requires only limited testing of EHRs to check for flaws before the products are installed, and no comprehensive system exists to collect information on safety problems related to these records.”

In order to better protect patient safety, ONC must implement requirements to prevent health IT pitfalls early on. ONC should require EHR vendors to test their products before putting them to market, Pew said, and ensure their safety after implementation at a healthcare organization. In doing so, ONC can mitigate any risk prior to agency testing.

Additionally, ONC should consult different industry stakeholders – EHR developers, hospitals, clinicians, government, and patient advocacy organizations – about common safety standards. According to Pew, Congress should pass legislation to make this a legal imperative.

Ultimately, these actions could help reduce adverse patient safety events because they would ideally eliminate issues prior to the technology reaching patient or provider use.

As it stands now, the ONC Health IT Certification Program works to improve technology transparency, ultimately helping providers to mitigate patient safety risk. When healthcare professionals know more about the technologies they purchase, the more likely they are to select safe and high-quality technology.

“More transparency and accountability in health IT is good for consumers, physicians, and hospitals,” said National Coordinator for Health IT Vindell Washington, MD, MHCM, following the finalization of the rule. “Today’s final rule strengthens the program by ensuring that certified health IT helps clinicians and individuals use and exchange electronic health information safely and reliably.”

The final rule also allows for increased oversight for ONC, establishing a process by which the agency can review health technologies, require amendments to the tools, or revoke certification should those amendments not be made.

The Health IT Certification Program is just one step ONC is making to improve health IT use. Earlier this week, the agency released its annual report to Congress, detailing the strides health IT adoption has made since 2008. Although EHR adoption has grown in recent years, the agency is looking toward better interoperability and data use.

“This progress, where an extraordinary amount of electronic health information and infrastructure now exist that the country lacked merely a decade ago, has set the stage for a transition in focus to the seamless and secure flow of this health information – also known as interoperability – to improve the health and care of individuals and communities,” the report stated.

ONC has established a three-pronged approach toward improving interoperability. First, the agency seeks to establish common, federally-recognized technology and data standards. Second, the agency will work to create a business case for better interoperability. Third, the agency intends to improve the interoperability culture in healthcare, specifically working to eliminate data blocking.

Ultimately, all of these actions from ONC are geared toward improving health IT use for the physician and experience for the patient. By implementing better testing to ensure IT safety and working to improve data use, the agency and industry stakeholders intend to achieve better health data and technology use to support value-based healthcare.

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