Pew: ONC's EHR direct review leaves patient safety gaps

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ONC’s increased oversight of EHRs embodied in new regulations doesn’t go far enough to protect patient safety, according to a new analysis from the Pew Charitable Trusts.

The new rule, released October 14, clarifies ONC’s ability to directly review certified EHR technology and hold EHR vendors accountable for non-conformities.

Both design errors and human factors have contributed to adverse patient safety events, sometimes seen as an unintended consequence of EHRs.

Pew warns that the new rule does not cover gaps in hospitals', doctors' and developers' ability to detect flaws that could put patients at risk because ONC requires only limited testing of EHRs to check for defects before products are installed and there is no comprehensive system to collect information on safety problems.

The analysis recommends two additional steps be taken to improve patient safety:

  • ONC should require vendors to better test EHRs for safety before bringing their products to market and after they are installed and customized to increased detection of flaws beforehand.
  • All stakeholders should come together to identify common safety problems and work together on solutions. Congress should pass legislation to establish this collaborative.

“These additional steps would help detect and prevent safety problems during the development and implementation of EHRs and reduce patient harm related to these products,” The analysis says.

Both design errors and human factors have contributed to adverse patient safety events, sometimes seen as an unintended consequence of EHRs.  

However, providers have been hampered in their ability to communicate safety issues attributable to EHRs for fear of repercussion from vendors, who by contract or otherwise seek to suppress such discussion. Even the EHR vendors’ code of conduct, updated earlier this year, doesn’t promote open discussion of patient safety issues except in certain circumstances.

The rule had received mixed reviews from stakeholders, with some applauding its attempts to improve patient safety and others concerned that ONC is over reaching its authority by delving into safety issues typically the purview of other agencies.