hat forms the company, and (ii) the individual who is primarily responsible for directing or controlling the filing of the relevant document. See 31 CFR § 1010.380. FinCEN, the regulator tasked with the CTA’s implementation, estimates “that there will be approximately 32 million reporting companies in Year 1 of the reporting requirement and approximately 5 million new reporting companies each year thereafter.” See 87 Fed. Reg. 77,408 (Dec. 16, 2022) (available at: https://www.federalregister.gov/d/2022-27031). Some believe FinCEN’s figures significantly underestimate the number of reporting companies.See 31 CFR § 1010.380(b)(ii). 31 CFR § 1010.380(c)(2)(xix). 31 CFR § 1010.380(c)(2)(xxi). 87 Fed. Reg. 59,543 (Sept. 30, 2022). 31 CFR § 1010.380(c)(2)(xxii).See, e.g., 31 USC § 5336;31 CFR § 1010.380; 87 Fed. Reg. 59,498 (Sept. 30, 2022). 31 CFR § 1010.380(c)(2)(xxiii).See 31 CFR § 1010.380(d)(1)(i).See 31 CFR § 1010.380(d)(1)(ii).See 31 USC § 5336(c)(2)(B)(i)(I); 31 CFR § 1010.955(b)(1) (eff. Feb. 20, 2024); 88 Fed. Reg. 88,732 (Dec. 22, 2023).See also Fact Sheet: FinCEN, Beneficial Ownership Information Access and Safeguards Final Rule (Dec. 21, 2023), available here. See also 31 CFR § 1010.955(b)(1)(iii) (eff. Feb. 20, 2024).See 31 USC § 5336(c)(2)(B)(i)(II); 31 CFR § 1010.955(b)(2) (eff. Feb. 20, 2024); 88 Fed. Reg. 88,732 (Dec. 22, 2023).See 31 USC § 5336(h)(3)(A) (setting forth that “any person that violates… [the reporting obligations] (i) shall be liable to the United States for a civil penalty of not more than $500 for each day that the violation continues or has not been remedied; and (ii) may be fined not more than $10,000, imprisoned for not more than 2 years, or both”).[View source.]

The Office of Personnel Management (OPM) along with the Departments of Health and Human Services, Labor, and the Treasury (“the Departments”) announced on January 17, 2024, that they have reopened the public comment period for the “Federal Independent Dispute Resolution (IDR) Operations” proposed rules (“IDR Operations Proposed Rules”) (88 Fed. Reg. 75,744 (Nov. 3, 2023)) which relate to improving the Federal IDR process of the No Surprises Act. Specifically, the Departments seek comments regarding provisions in the IDR Operations Proposed Rules affected by changes in the administrative fee structure, which were finalized in a separate final rule titled “Federal Independent Dispute Resolution (IDR) Process Administrative Fee and Certified IDR Entity Fee Ranges” (“IDR Fees Final Rule”) on December 21, 2023 (88 Fed. Reg. 88,494 (Dec. 21, 2023)). The original comment period ended January 2, 2024. Interested parties now have until February 5, 2024, to submit comments.The No Surprises Act was enacted by H.R. 133, “Consolidated Appropriations Act, 2021” and went into effect January 1, 2022. Among other things, the law establishes an IDR process to determine the payment rate for certain services when a health plan and out-of-network provider cannot agree on a payment rate. The Departments have undertaken several rulemakings implementing the provisions of the No Surprises Act.Most recently, the Departments published the IDR Operations Proposed Rules on November 3, 2023, with comments originally due January 2, 2024, and the IDR Fees Final Rule on December 21, 2023. Some of the proposals in the IDR Operations Proposed Rules related to fees could be affected by the policies finalized in the IDR Fees Final Rule. In the IDR Operations Proposed Rules, the Departments made proposals regarding:Collecting the administrative fee directly f

lity Act (HIPAA). The application of a potential exception from consent for use of “identifiable private information” in the context of subject authorization of access to PHI for conduct of a clinical study may cause confusion for all parties—IRB, investigators, and patient subjects—at some institutions.SUMMARYIn this new rule, all parties involved in the sponsorship or conduct of FDA-regulated clinical investigations will be affected by the new option for IRBs to allow an exception to informed consent or a modification of informed consent requirements if five criteria are identified and met. Because the new rule is effective on January 22, 2024, sponsors will need to rapidly understand the new rule and initiate effective processes for the development of new internal policies, as well as procedures for training personnel, clinical sites, and investigators.1See FDA, Final Rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, 88 Fed. Reg. 88,228 (Dec. 21, 2023), https://www.federalregister.gov/documents/2023/12/21/2023-27935/institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical.2See FD&C Act §§ 505(i)(4) & 520(g)(3) (amended by 21st Century Cures Act, § 3024, Pub. L. 114–255, Dec. 13, 2016).3See FDA, Notice of Availability, Institutional Review Board Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects; Guidance for Sponsors, Investigators, and Institutional Review Boards, 82 Fed. Reg. 34,535 (July 15, 2017), https://www.federalregister.gov/documents/2017/07/25/2017-15539/institutional-review-board-waiver-or-alteration-of-informed-consent-for-clinical-investigations.4See FDA, Proposed Rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, 83 Fed. Reg. 57,378 (Nov. 15, 2018), https://www.federalregister.gov/documents/2018/11/15/2018-24822/institutional-review-board-waiver-or

ubject to CDD requirements, such as money services businesses and mortgage companies, will not receive access to BOI for some time.Additionally, some have raised concerns about the Access Rule’s ability to protect sensitive information. On December 15, 2022, Congressman Patrick McHenry, chairman of the House Financial Services Committee, issued a statement commenting that the proposal did not include enough protections to prevent unauthorized access and use of the sensitive information that would be collected by FinCEN.12 Few, if any, relevant changes were made to the final rule, and the Access Rule also does not address whether or how FinCEN intends to verify the BOI it collects nor how a financial institution should reconcile discrepancies between the BOI it collects from its customers and information reported by its customers to FinCEN. FIs will need to continue to engage with FinCEN and other policymakers on these issues.1See Beneficial Ownership Information Access and Safeguards, 88 Fed. Reg. 88,732 (Dec. 22, 2023) (to be codified at 31 C.F.R. pt. 1010), https://www.federalregister.gov/documents/2023/12/22/2023-27973/beneficial-ownership-information-access-and-safeguards.2See 31 U.S.C. § 5336.3 Beneficial Ownership Information Reporting Requirements, 87 Fed. Reg. 59,498 (Sept. 30, 2022) (to be codified at 31 C.F.R. pt. 1010), https://www.federalregister.gov/documents/2022/09/30/2022-21020/beneficial-ownership-information-reporting-requirements.4 31 U.S.C. § 5336(b), (c).5 Beneficial Ownership Information Access and Safeguards, and Use of FinCEN Identifiers for Entities, 87 Fed. Reg. 77,404 (Dec. 16, 2022), https://www.federalregister.gov/documents/2022/12/16/2022-27031/beneficial-ownership-information-access-and-safeguards-and-use-of-fincen-identifiers-for-entities.6 The CTA provides that BOI reports “shall be confidential and may not be disclosed by . . . (i) an officer or employee of the United States; (ii) an officer or employee of any State, local, or Tribal agency, or (iii) an officer or em

taxable years ending after the date on which final regulations are published in the Federal Register. As written, the proposed regulations do not include any transition rules, which means that the regulations could become effective in the middle of a tax year. Taxpayers are entitled to rely on the proposed regulations because the IRS will not take positions inconsistent with proposed regulations even if those regulations do not yet have the force of law.Interested parties can submit comments and requests for a public hearing through Jan. 16, 2024. Online submission of comments is encouraged, using this link: https://www.federalregister.gov/documents/2023/11/14/2023-24982/taxes-on-taxable-distributions-from-donor-advised-funds-under-section-4966. National Philanthropic Trust, 2023 Donor-Advised Fund Guide, (Nov. 14, 2023), available at https://www.nptrust.org/reports/daf-report/ Notice of Proposed Rulemaking on Taxes on Taxable Distributions From Donor Advised Funds Under Section 4966, 88 FR 77922, published Nov. 14, 2023. Prop. Treas. Reg. § 53.4966-3(b)(1). Prop. Treas. Reg. § 53.4966-3(c)(2). Prop. Treas. Reg. § 53.4966-4(b)-(d). Prop. Treas. Reg. § 53.4966-1(f). Prop. Treas. Reg. § 53.4966-1(h)(1). Prop. Treas. Reg. § 53.4966-1(h)(3). Prop. Treas. Reg. § 53.4966–5(a)(1). Prop. Treas. Reg. § 53.4966–5(a)(3).[View source.]

On August 9, 2023, President Biden issued an executive order entitled “Executive Order on Addressing United States Investments in Certain National Security Technologies and Products in Countries of Concern” (the “Order”) with the goal of reviewing U.S. investments in advanced technology industries in China to protect national security. This Order has been widely expected for months and serves as the first-ever outbound investment review mechanism in the United Staes. On August 14, 2023, the Department of Treasury, Office of Investment Security formally published an Advanced Notice of Proposed Rule 88 FR 54961 (the “Proposed Rule”) to implement the Order.Together the Order and the Proposed Rule put together an outline of what the eventual program’s scope could entail including: (1) a notification requirement; and (2) a prohibition requirement. The initial rules currently only apply to three sectors in China:(1) Certain artificial intelligence (“AI”) systems; (2) Semiconductors and microelectronics; and (3) Quantum information technologies and certain artificial intelligence (“AI”) systems.The Proposed Rule notes that the aim of the outbound investment program is not solely on restricting the investment of capital in Chinese companies. A White House senior administration official acknowledged “China doesn’t need our money. . . The thing they don’t have is the know-how. And the know-how [we] have seen is often very connected to specific types of investments.” Thus, the broader range of the Order is to restrict the “intangible benefits” that accompany U.S. investments, including “enhance

elp patients maintain access to high-quality, lawful health care.As rulemaking develops in this area, Regulated Entities offering reproductive care should consult with legal counsel to determine how state- and federal-level reproductive health laws may affect their businesses and to ensure that their PHI disclosures are compliant with applicable laws.Read Goodwin’s previous insights for more information on how the recent changes to abortion laws may affect fertility clinicsand technology companies. 88 Fed. Reg. 23,506. Executive Orders 14076. 88 Fed. Reg. 23,506. 88 Fed. Reg. at 23,527. U.S. Department of Health and Human Services, “HHS Proposes Measures to Bolster Patient-Provider Confidentiality Around Reproductive Health Care” (Apr. 12, 2023). 88 Fed. Reg. at 23,527. Proposed Rule 45 C.F.R. § 164.502(a)(5)(iii)(C); 88 Fed. Reg. at 23,531; Privacy Fact Sheet. Executive Orders 14076; 14079. Secretary of Health and Human Services, “Letter to Health Care Professionals” (Jul. 11, 2022). S88 Fed. Reg. at 23,509.[View source.]