A leading vendor of electronic health record (EHR) systems has been sued for $999 million over allegations that its software’s patient data are not accurate and reliable.
The EHR vendor, eClinicalWorks, just coughed up $155 million in June to settle a False Claims lawsuit brought by the Department of Justice (DOJ) that also called the medical software faulty. The settlement did not constitute an admission of liability by the company.
The new lawsuit was filed in a federal district court in New York City last week by the estate administrator of StjepanTot, who died of stomach cancer in November 2016. One of Tot’s physicians had used eClinicalWorks to maintain his patient’s medical record. The suit alleges that before his death, Tot was unable to pinpoint when his first cancer symptoms appeared because “his medical record failed to accurately display his medical history on progress notes.”
The suit seeks class-action status for all patients — put in the millions — whose medical records reside in the eClinicalWorks EHR and which are similarly flawed, according to the plaintiff’s attorney.
eClinicalWorks CEO Girish Navani, MD, declined to comment on the case.
The lawsuit alleges that eClinicalWorks falsely claimed that its software satisfied the requirements of the federal government’s meaningful-use incentive program for EHRs. Besides not always accurately showing the medical history in progress notes, it periodically displayed incorrect patient data, and data for multiple patients at the same time, according to Tot’s estate.
In addition, his estate also alleges that the software audit logs did not accurately record user actions and sometimes misled users about the course of a patient’s treatment. Gordon Diefenbach, one of the plaintiff’s attorneys, told Medscape Medical News that a faulty audit log opens the door for people to falsify patient data without detection.
Diefenbach said that he discovered a major glitch in eClinicalWork’s software in the course of suing Tot’s physician for malpractice. Tot’s list of active problems — a standard feature of EHRs — consisted of the same 14 conditions for 6 years’ worth of visits. Diefenbach quoted the physician as saying that any new problem identified in a particular visit was “autopopulated” into all the past visits, making it impossible to tell when the problem first emerged.
“He blamed it on eClinicalWorks,” Diefenbach said.
2016 Revenue Was $440 Million
Diefenbach said he realized that Stjepan Tot’s experience with eClinicalWorks might be a widespread phenomenon when he came across the False Claims lawsuit that the company settled with the DOJ in June. In that case, the government said that the eClinicalWorks falsely obtained meaningful-use certification for its software by misrepresenting its capabilities. The DOJ faulted the software, among other things, for recording orders for diagnostic imaging in an unreliable fashion and failing to accurately capture user actions in the audit log. These violations of certification requirements meant that physicians who received incentive payments for meaningful use of the eClinicalWorks EHR were not entitled to them, according to federal prosecutors.
In its settlement, eClinicalWorks entered into a 5-year corporate integrity agreement with the Office of Inspector General (OIG) of the Department of Health and Human Services. Under that agreement, the company had to hire an outside firm to assess its quality-control systems and report the findings to the OIG twice a year. The company also must give updated versions of its software to customers free of charge.
The False Claims lawsuit was originally filed by a whistle-blowing software technician once employed by the New York City Division of Health Care Access and Improvement, which had done business with eClinicalWorks. The DOJ intervened in the case. Under the False Claims Act, a whistle-blower is entitled to share in any recovery, so the software technician received roughly $30 million of the settlement.
On its website, eClinicalWorks says that more than 130,000 physicians and nurse practitioners around the world use its cloud-based EHR in both ambulatory and inpatient settings. For clinicians who switch from another EHR system to eClinicalWork’s product, the monthly cost per provider is $449 per month, and $599 per month with the addition of practice-management functions.
The company’s EHR system stood out in a 2016 survey of Medscape readers. It was the third most widely used EHR at 7%, trailing systems by Cerner (10%) and Epic (28%). And it was the most widely used program among independent physician practices, at 12%. However, eClinicalWorks was farther down the list when independent clinicians graded it for ease of use, vendor support, and usefulness as a clinical tool, among other performance measures. In a field of 10 EHRs, eClinicalWorks ranked seventh on such measures, scoring 3.29 on a 5-point scale. Epic was number 1 at 3.47.
A privately held company founded in 1999, eClinicalWorks took in $440 million in revenue last year, according to its website. It employs 5000 people.
Follow Robert Lowes on Twitter @LowesRobert
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