HHS OIG wants new compliance obligations from eClinicalWorks

The U.S. Department of Health and Human Services Office of Inspector General is seeking additional compliance obligations from eClinicalWorks relating to the safety of its electronic health record software.  

In a recent letter to eClinicalWorks compliance officer Michael D. Laycob, OIG expressed “significant concerns” regarding patient safety issues and the company’s current compliance with the obligations imposed under a corporate integrity agreement that was enacted following eCW’s 2017 False Claims Act settlement.  

The new obligations include:  

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  • Sending a Patient Safety Issue Advisory to each of its customers within 30 days.
  • Enhancing patient safety notifications.
  • Submitting monthly progress reports to OIG, the Office of the National Coordinator for Health IT and the Software Quality Oversight Organization.

eClinicalWorks did not immediately return requests for comment.  

WHY IT MATTERS  

eClinicalWorks in 2017 agreed to pay $155 million after the U.S. Department of Justice accused it of falsely obtaining meaningful use certification for its EHR software.

As part of that agreement eClinicalWorks entered into the CIA, the company is required to promptly notify its customers and users of patient safety issues and maintain a list on its customer portal of