PERMENTER et al v. ECLINICAL WORKS LLC

IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF GEORGIA
MACON DIVISION
UNITED STATES OF AMERICA, ex rel. 	)
ALEX PERMENTER, 	)
ERIC RODIGHIERO, and 	)
CHRIS WHEELER, 	)
)
Plaintiffs, 	)
)
v. 	) 	CIVIL ACTION NO. 5:18-cv-382 (MTT)
)
eCLINICAL WORKS, LLC, 	)
)
Defendant. 	)
)
ORDER
On February 27, 2026, eCW moved the Court for judicial notice of the Assistant
Secretary for Technology Policy/Office of the National Coordinator for Health
Information Technology’s (“ONC”) recent rulemaking proposal entitled “Health Data,
Technology, and Interoperability: ASTP/ONC Deregulatory Actions to Unleash
Prosperity,” as published in the Federal Register at 90 Fed. Reg. 60,970, 60,988 on
December 29, 2025 (the “NPRM”). ECF 508. eCW subsequently moved the Court for
leave to supplement the expert report of Kyle Meadors to “incorporate[] ONC’s guidance
in the proposed rule, ONC’s subsequent comments about this rulemaking, and
comments submitted during the 60-day notice-and-comment period.” ECF 512 at 2–3.
For the reasons that follow, eCW’s motions (ECF 508; 512) are DENIED.1
1 The Relators also filed a motion in limine to exclude any reference to the NPRM at trial. ECF 564.
Because the Court concludes that the NPRM is irrelevant or, alternatively, should be excluded under Rule
403, the Relators’ motion in limine (ECF 564) is GRANTED.
Case 5:18-cv-00382-MTT Document 585 Filed 07/17/26 Page 1 of 6

-2-
I. DISCUSSION
eCW argues that the Court is required to take judicial notice of nine sentences in
the NPRM identified by eCW because 44 U.S.C. § 1507 provides that “[t]he contents of
the Federal Register shall be judicially noticed.” ECF 508 at 1–3. But as the Relators’
point out, the NPRM “is proposed prospective rulemaking document about what the
criteria should be going forward, considering this administration’s emphasis on
deregulation.” ECF 534 at 9. Accordingly, the Relators argue that the NPRM—published
on December 29, 2025—is irrelevant to the issue in this case: eCW’s alleged fraud in
obtaining and maintaining certification of Version 11 under ONC’s 2015 certification
standards. See Vallot v. Cent. Gulf Lines, Inc., 641 F.2d 347, 351 (5th Cir. Apr. 3,
1981)2 (“Although 44 U.S.C. § 1507 requires the contents of the Federal Register be
judicially noticed, [a party] cannot demand admission of . . . publications as evidence . .
. where they have no relevance.”).
eCW contends that the NPRM statements it identifies for judicial notice “clear the
very low bar for relevance and speak directly to whether (1) eCW’s software satisfied
the certification criteria (falsity); (2) eCW reasonably understood those criteria (scienter),
and (3) the government considered certification criteria compliance material to its MIPS
payments (materiality).” ECF 538 at 7. According to eCW, the NPRM
explains, in the government’s own words, that the criteria do not
require “assess[ing] discrete specific security capabilities at significant
depths” or “protect[ing] against known or unknown vulnerabilities”
such as vulnerabilities that would be detected with “penetration
testing” and “certified health IT cannot in isolation, or independently,
provide … necessary privacy and security capabilities … across all
relevant technologies of the enterprise-wide setting,” which exceeds
2 The Eleventh Circuit has adopted as binding precedent the decisions of the former Fifth Circuit rendered
prior to October 1, 1981. Bonner v. City of Prichard, 661 F.2d 1206, 1209 (11th Cir. 1981) (en banc).
Case 5:18-cv-00382-MTT Document 585 Filed 07/17/26 Page 2 of 6

-3-
the “Certification Program’s limited scope and policy purpose with
respect to health IT security.”
Id. at 4 (emphasis added). But the Court is not convinced the NPRM clarifies or
“explains” the existing certification criteria where the NPRM is proposing to change
those criteria.3 In fact, the NPRM “propose[s] to remove all the privacy and security
certification criteria in § 170.315(d) and the associated Privacy and Security Certification
Framework under § 170.550(h) as of the effective date of a subsequent final rule.” ECF
508-1 at 4.
eCW insists the NPRM is both clarifying and prospective. ECF 571 at 6-7.
Specifically, eCW maintains “ONC’s comments, [such as that] stakeholders have
‘incorrect expectations of certified health IT’ and ‘the costs and burden of these
Certification Program requirements far exceed their intended purpose and benefits’”
concern “‘the current Privacy and Security Certification Framework, which has been in
place for the past 10 years.’” ECF 538 at 6 (quoting ECF 508-1 at 5). But eCW
concedes the NPRM’s proposal to remove the security certification criteria is,
undoubtedly, prospective. ECF 571 at 6-7. eCW cites no authority supporting its view
that some statements in the NPRM—specifically those selected by eCW for judicial
notice—should have interpretive or clarifying effect while the proposed rule seeks to
3 Courts have long distinguished clarifications of existing laws from rules or regulations which change the
law. See Heimmermann v. First Union Mortg. Corp., 305 F.3d 1257, 1260 (11th Cir. 2002); Pope v.
Shalala, 998 F.2d 473, 483 (7th Cir. 1993), overruled on other grounds by Johnson v. Apfel, 189 F.3d 561
(7th Cir. 1999) (“A rule simply clarifying an unsettled or confusing area of the law . . . does not change the
law, but restates what the law according to the agency is and has always been: ‘It is no more retroactive
in its operation than is a judicial determination construing and applying a statute to a case in hand.’”)
(quoting Manhattan General Equip. Co. v. Commissioner, 297 U.S. 129, 135 (1936)). See also Farmers
Telephone Co. v. FCC, 184 F.3d 1241, 1250 (10th Cir. 1999) (“We agree with the FCC that the question
of retroactivity does not arise in the present case because its ruling is merely interpretive. If the rule in
question merely clarifies or explains existing law or regulations, it will be deemed interpretive.”) (citation
modified); Orr v. Hawk, 156 F.3d 651, 654 (6th Cir. 1998) (“So long as a change in a regulation does not
announce a new rule, but rather merely clarifies or codifies an existing policy, that regulation can apply
retroactively.”).
Case 5:18-cv-00382-MTT Document 585 Filed 07/17/26 Page 3 of 6

-4-
substantively change existing law. See Heimmermann, 305 F.3d at 1260 (determining
that an agency’s statement of policy was a clarification because the statement “itself
states that it is merely clarifying the [previous statement]; and nowhere in the
[statement] does [the agency] claim to be changing the law.”); Pope, 998 F.2d at 482-83
(concluding that new regulations were clarifications because “[t]he sole purpose of the
regulations was to clarify the law . . . , and they expressly provided that ‘these final rules
make no substantive change in our policy.’”). Without such authority, the Court declines
to adopt eCW’s position that specific statements from the prospective NPRM should be
construed to interpret the certification criteria existing during the time Version 11 was
certified. Accordingly, the Court concludes that eCW has failed to meet its burden of
establishing the relevance of the NPRM statements it seeks to have judicially noticed.
Even if eCW did establish marginal relevance, the NPRM’s minimal probative
value is “substantially outweighed by a danger of . . . unfair prejudice, confusing the
issues, misleading the jury, undue delay, wasting time, or needlessly presenting
cumulative evidence.” Fed. R. Evid. 403; see Tambourine Comercio Internacional SA v.
Solowsky, 312 F. App'x 263, 289 (11th Cir. 2009) (“[M]erely because a fact may be
subject to judicial notice, it is not insulated from other rules of evidence such as Rule
403”). Introducing the NPRM carries a high risk of confusing the issues. On falsity, the
jury will be tasked with determining whether eCW’s representations that its EHR
software complied with 45 C.F.R. § 170.315(d)(1) through (e)(2) were false when made.
If anything is to be drawn from eCW’s selected statements from the NPRM that
“stakeholders have expressed incorrect expectations of certified health IT and
developers” and “many stakeholders have overinterpreted the Certification Program’s
Case 5:18-cv-00382-MTT Document 585 Filed 07/17/26 Page 4 of 6

-5-
limited scope and policy” (ECF 508 at 2), it is that the current administration proposes a
change in the law—including eliminating the privacy and security certification criteria in
§ 170.315(d)—to foreclose interpretations of the certification criteria existing during the
relevant time period in this case. Despite eCW’s arguments to the contrary, these
statements have no bearing on the falsity of eCW’s attestations. On scienter, the NPRM
may lead the jury to believe eCW had the benefit of ONC’s statements at the time the
alleged fraud occurred, which it did not. On materiality, the prospective NPRM,
published eight years after Version 11 was certified and three years after eCW retired
its last certified Version 11 software (ECF 266-2 ¶¶ 132, 335; 300-9 ¶ 132, 335; 218-
152), tells the jury nothing about how and whether eCW’s alleged fraud was material to
the government during the relevant time period. See ECF 508-1. While the Court agrees
with eCW that some post-time period evidence could be probative of materiality, the
NPRM’s effort to substantively alter the existing regulatory program is not and only risks
confusing the jury about the certification rules.
The NPRM also carries a high risk of unfair prejudice. As a document emanating
from a federal agency, the NPRM is likely to receive undue weight from the jury. See
Johnson v. Ford Motor Co., 988 F.2d 573, 580 (5th Cir. 1993) (recognizing that the
“official nature” of government documents may cause a jury to give the evidence
inordinate weight) (internal citations omitted). Not only that, eCW’s cherry-picked NPRM
statements omit the context of the NPRM’s forward-looking deregulatory agenda. While
eCW wants to present the cherry-picked statements as guidance or at least “ONC’s own
statements about the meaning of the certification criteria at issue in this very case” (ECF
Case 5:18-cv-00382-MTT Document 585 Filed 07/17/26 Page 5 of 6

-6-
571 at 7), for the reasons explained above, that is wrong. They do not interpret the
existing law but rather explain the rationale for a proposed change in the law.
II. CONCLUSION
Because the Court concludes that the NPRM is irrelevant or, alternatively, should
be excluded under Rule 403, eCW’s motion for judicial notice (ECF 508) is DENIED and
the Relator’s motion to exclude any reference to the NPRM at trial (ECF 564) is
GRANTED. eCW’s motion for leave to supplement Mr. Meadors’ opinions to incorporate
the NPRM (ECF 512) is DENIED as moot.
SO ORDERED, this 17th day of July, 2026.
S/ Marc T. Treadwell
MARC T. TREADWELL, JUDGE
UNITED STATES DISTRICT COURT
Case 5:18-cv-00382-MTT Document 585 Filed 07/17/26 Page 6 of 6