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United States District Court for the Middle District of Georgia, Macon Division
December 6, 2022, Decided; December 6, 2022, Filed
CIVIL ACTION NO. 5:18-cv-382 (MTT)
In this action under the False Claims Act ("FCA"), 31 U.S.C. § 3729, Defendant eClinicalWorks moves to dismiss the relators' amended complaint on the grounds that the relators fail to state a claim. Doc. 69. The one count amended complaint alleges two theories, and each theory is based on discrete flaws in eClinicalWorks' software. Doc. 34. eClinicalWorks does not move to strike specific allegations of flaws; it moves to dismiss the amended complaint in its entirety. Thus, relators maintain that if any one [*2] flaw supports a plausible theory of recovery, eClinicalWorks' motion must be denied. For the reasons discussed below, eClinicalWorks' motion (Doc. 69) is DENIED.
A. eClinicalWorks and the Relators
eClinicalWorks is a healthcare technology company whose principal business is developing and licensing electronic healthcare records ("EHR") software to healthcare providers such as physician practices and hospitals. Doc. 34 ¶¶ 14, 16. According to eClinicalWorks, more than 130,000 healthcare providers use their software, making eClinicalWorks an industry leader. Id. ¶¶ 17-18. In 2017, eClinicalWorks settled an FCA claim alleging that eClinicalWorks' EHR software had numerous functional defects, including failing to reliably document and track medications administered to patients, failing to record and track patients' laboratory results, and failing to prevent editing of patient notes. Id. ¶ 19 (citing United States ex rel. Delaney v. eClinicalWorks, LLC, No. 2:15-cv-95, Doc. 1 ¶¶ 63-107 (D. Vt. May 1, 2015)). As part of the settlement of that FCA case, eClinicalWorks entered a Corporate Integrity Agreement ("CIA") with the Office of Inspector General of the U.S. Department of Health & Human Services ("HHS-OIG"). Id. ¶ 20.
The CIA went into effect on May 30, 2017 and remained in place [*3] five years. Docs. 34 ¶ 20; 17-1 at 2. As part of its obligations under the CIA, eClinicalWorks was required to provide "timely access to ... relevant software, media, and code" to an independent software quality oversight organization ("SQOO") approved by the HHS-OIG. Doc. 17-1 at 34. One of the SQOO's express obligations under the CIA was "to ensure that eClinicalWorks and its EHR software ... comply with applicable ONC Health IT Certification Program requirements." Id. at 32. In return for satisfying its obligations under the CIA, the HHS-OIG agreed not to seek eClinicalWorks' exclusion from participation in Medicare, Medicaid, or other federal healthcare programs.1 Doc. 34 ¶ 20.
Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.
2022 U.S. Dist. LEXIS 219919 *; 2022 WL 17478238
UNITED STATES OF AMERICA, ex rel. ALEX PERMENTER, ERIC RODIGHIERO, and CHRIS WHEELER, Plaintiffs, v. eCLINICALWORKS, LLC, Defendant.
Prior History: United States v. eClinicalWorks, LLC, 2022 U.S. Dist. LEXIS 54959, 2022 WL 906204 (M.D. Ga., Mar. 28, 2022)
eClinicalWorks, software, healthcare provider, user, allegations, flaws, technology, certification, vulnerabilities, health information, electronic, password, amended complaint, certify, regulations, compliance, algorithm, encrypt, hashing, certification requirements, patient, logs, healthcare, malicious, scienter, motion to dismiss, servers, stored, audit, false certificate