The Health and Human Services (HHS) Office of Inspector General (OIG) fined electronic health record (EHR) vendor eClinicalWorks $132,500 for failing to report patient safety issues to the regulatory body as reportable events in a timely manner.
According to the OIG website, eClinicalWorks paid the fine July 18. The EHR vendor is required to report these patient safety issues to OIG as part of its corporate integrity agreement (CIA) with the agency.
eClinicalWorks entered into a CIA back in May 2017 as part of a settlement with the U.S. Department of Justice to resolve a False Claims lawsuit. According to the DOJ’s case, the company allegedly violated federal law by misrepresenting the capabilities of its software and for allegedly paying kickbacks to certain customers in exchange for promoting its product, according to the U.S. Department of Justice. As part of that settlement, eClinicalWorks also paid a $155 million settlement over the allegations.
The five-year CIA requires, among other things, that the company retain an Independent Software Quality Oversight Organization to assess eClinicalWorks’ software quality control systems and provide written semi-annual reports to OIG documenting its reviews and recommendations. The company must provide prompt notice to its customers of any safety related issues and maintain on its customer portal a comprehensive list of such issues and any steps users should take to mitigate potential patient safety risks.
Further, the agreement also requires eClinicalWorks to allow customers to obtain updated versions of their software free of charge and to give customers the option to transfer their data to another EHR software provider, without penalties or service charges. The vendor must also retain an Independent Review Organization to review its arrangements with healthcare providers to ensure compliance with the Anti-Kickback Statute.
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