Macon, Georgia – On June 4, 2025 U.S. District Judge Marc T. Treadwell DENIED a motion by eClinicalWorks, LLC to exclude expert testimony of Michael Arrigo in a lawsuit alleging violations of the False Claims Act, United States of America ex rel. Permenter, Wheeler, and Rodighiero v. eClinicalWorks, LLC, Case No. 5:18-CV-382, regarding Electronic Health Record certification standards, with focus on the privacy and security E.H.R. Certification Standards as set forth in 42 CFR 170.315:
§170.315 (d)(1) Authentication, access control, authorization
§ 170.315 (d)(2) Auditable Events and Tamper-Resistance
§ 170.315 (d)(3) Audit Reports
§ 170.315 (d)(4) Amendments
§ 170.315 (d)(5) Automatic Access Timeout
§ 170.315 (d)(6) Emergency Access
§ 170.315 (d)(7) End-user Device Encryption
§ 170.315 (d)(8) Integrity
§ 170.315 (d)(9)(ii) Trusted Connection when transporting ePHI
§ 170.315 (d)(11) Accounting of Disclosures
§ 170.315 (d)(12) Encrypt Authentication Credentials
Arrigo’s testimony centers on whether eClinicalWorks’ electronic health record (EHR) software met certification criteria established by the Office of the National Coordinator for Health Information Technology (ONC) under federal regulations.
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