Less than 6 months after paying $155 million to settle claims it falsely obtained certification for its EHR software, eClinicalWorks has been hit with a class-action lawsuit that claims deficiencies in the company’s software meant patients could not rely on the accuracy of their medical records.
The complaint (PDF), filed in the U.S. District Court in the Southern District of New York, was brought by Kristina Tot who oversees the estate of Stjepan Tot. The suit claims Tot, who died of cancer, was “unable to determine reliably when his first symptoms of cancer appeared” because his EHR “failed to accurately display his medical history on progress notes.”
Tot further alleged that because eClinicalWorks’ software did not meet the Office of the National Coordinator for Health IT’s certification requirements, “millions of patients have had their medical records compromised” and “can no longer rely on the accuracy and veracity” of their EHR. The suit noted that more than 850,000 healthcare providers use eClinicalWorks.
A cover sheet filed (PDF) with the complaint lists a monetary demand just shy of $1 billion.
The lawsuit points to specific shortcomings within the EHR software, including a failure to meet federal data portability requirements, accurately track user actions in an audit log and reliably record diagnostic image orders. Failure to meet these certification requirements meant patient information and progress notes were periodically displayed incorrectly, while inaccurate audit logs misled physicians over the course of a patient’s treatment.
The class-action suit claims eClinicalWorks breached its fiduciary duty by failing to maintain the integrity of medical records, categorizing the company's failure to meet federal certification requirements as "grossly negligent."
A spokesperson for the company did not immediately respond to a request for comment.
In May, eClinicalWorks paid $155 million to settle claims by federal prosecutors that the company had knowingly falsified Meaningful Use certification, triggering fraudulent incentive payments to providers. The case marked the first time the Department of Justice pursued an EHR vendor for failing to meet certification requirements, and some former federal IT officials hinted that eClincalWorks was not the only vendor that had taken liberties with ONC’s certification criteria.
When the settlement was announced, eClinicalWorks CEO Girish Navani said the agreement signaled the company had "addressed the issues raised, and have taken significant measures to promote compliance and transparency."
Despite that settlement, the company recently posted it's the best quarter of the year, adding 3,750 new providers and $130 million in revenue.