On May 31, 2017, the U.S. Department of Justice announced that electronic health records (EHR) vendor eClinicalWorks (ECW), along with certain individual officers and employees, have agreed to pay a total of $155 million to settle a lawsuit under the False Claims Act (FCA). In its Complaint-in- Intervention, the government alleged ECW falsified compliance with certification requirements for EHR under the Meaningful Use program. The programming shortcuts ECW allegedly took in developing its software, along with inadequate post-market support and patches, could expose providers to increased risk of errors and jeopardize patient care. If you or your practice uses the eClinicalWorks software, you should be aware of ECW’s obligations and your rights under the Corporate Integrity Agreement (CIA).

ECW must provide an “Upgrade Option” to each existing customer and user of its EHR software as soon as practicable after the CIA’s May 30, 2017 effective date. The Upgrade Option must include the latest verison(s) of the EHR software being used by the customer. It must also include the most current updates to any supported drug database, including the customer’s preferred drug database from among those supported. These updates must be provided at no additional charge, including any fees for implementation, installation, or training associated with the Upgrade Option. In addition to these initial updates, ECW must provide ongoing upgrades, defect fixes, and patches to the EHR software for the duration of the term of the customer’s Software Agreement, as well as release notes and documentation, webinars and tools, and “other customary implementation support.” ECW must encourage customers to exercise the Upgrade Option and inform any customer that has not upgraded of known risks to patient safety associated with the EHR software version the customer is using.

Existing ECW customers will have one year from the date of the CIA within which ECW must, upon the customer’s request, timely transfer data free of any service charges or penalties, including any termination fee. ECW is required to provide data “in a commercially reasonable, structured format that allows for the customer’s data to be migrated to and useable by the customer’s subsequent EHR system and vendor, and provide timely good faith instructions on how this data is [sic] to be accessed by the customer or by the customer’s subsequent EHR vendor.”

ECW must provide notice of the foregoing to all of its existing customers within 60 days of the effective date of the CIA. If you or your practice uses eClinicalWorks software, keep an eye out for this notification and further information on how to exercise your options under the Corporate Integrity Agreement.

If you require assistance reviewing or negotiating your EHR agreement or have questions about the ECW settlement or health IT compliance generally, click here to contact a Nixon Law Group attorney.