Consumer Protection

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On February 25, 2025, President Donald J. Trump signed an executive order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the “2025 Order”) aiming to provide increased transparency regarding the pricing of health care services.  This executive order builds upon a prior executive order issued during President Trump’s first term in June 2019 (the “2019 Order”) that required hospitals to disclose to consumers pricing information for certain “shoppable” health care items and services and maintain this pricing information in accessible, consumer-friendly formats.  The 2019 Order also mandated the establishment of rules requiring health care providers, health insurance issuers and self-insured group health plans to facilitate consumer access to information concerning expected out-of-pocket costs for health care items and services prior to receiving care.Continue Reading Trump Administration Issues Executive Order Mandating Implementation and Enforcement of Health Care Pricing Transparency

On June 14, 2024, the SEC announced the settlement of administrative proceedings brought against a registered investment adviser for disseminating allegedly misleading performance information of a private fund that it advised.  The SEC alleged that from at least November 2021 through February 2023, the adviser advertised performance returns that were experienced by a single investor in a private fund as the private fund’s performance even though the investor’s performance was at times significantly higher than the fund’s performance.  According to the order, the performance disparity was due to certain successful IPO investments the fund had made that were credited to the investor’s capital account in greater proportion than other fund investors’ capital accounts because the other investors were unable to participate fully in the IPO investments due to investment restrictions under FINRA Rules 5130 and 5131.Continue Reading SEC Settles Enforcement Proceedings Against Adviser for Allegedly Misleading Performance Advertising

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Private equity investments in health care to be subject to increased oversight from federal and state regulators, including antitrust officials

Federal and state governmental regulation of health care transactions continues to increase rapidly.  At the federal level, there is increased focus on the role of private equity in health care and the perceived impact on access to care, quality of care and pricing.  At the same time, a growing number of states have passed and continue to propose legislation that increases state oversight of health care transactions.  As a result of this increase in regulatory scrutiny from federal and state regulators, parties interested in conducting health care transactions must consider various regulatory requirements and the factors regulators take into account when analyzing proposed health care transactions. Continue Reading Health Care Transactions Facing Increased Federal and State Regulatory Scrutiny

On May 13, 2024, the SEC and FinCEN jointly proposed a new rule under the Bank Secrecy Act (BSA) that would impose new customer identification program (CIP) requirements on registered investment advisers and exempt reporting advisers.Continue Reading SEC and FinCEN Propose Customer Identification Program Requirements for Investment Advisers

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On May 16, 2024, the SEC adopted amendments to Regulation S-P to enhance and modernize consumer privacy protections in light of technological developments in how individuals’ personal information is collected, shared and maintained. Regulation S-P applies to broker-dealers (including funding portals), investment companies, registered investment advisers and transfer agents (“covered institutions”) and currently requires (1) covered institutions (excluding transfer agents) to adopt written policies and procedures that address administrative, technical and physical safeguards for the protection of customer records and information (the “safeguards rule”), and (2) covered institutions (including transfer agents) to properly dispose of consumer report information (the “disposal rule”). The amendments are described below.Continue Reading SEC Adopts Regulation S-P Amendments to Enhance Protection of Customer Information

On April 26, 2024, the Federal Trade Commission (FTC) announced that it had finalized changes to the Health Breach Notification Rule (HBNR). These changes, which go into effect on June 25, 2024, are intended to modernize aspects of the HBNR such that the HBNR applies to entities not covered under the Health Insurance Portability and Accountability Act (HIPAA). The updated HBNR follows the FTC’s previously stated intention in a 2021 policy statement to broaden the interpretation of the HBNR to address the growing number of digital health applications, websites, and consumer-facing technology that were not subject to HIPAA. The scope of the finalized rule therefore aims to apply the HBNR to health care technology and digital health companies that obtain personal health records (PHR) and PHR identifiable health information.Continue Reading FTC Finalizes Broader Changes to the Health Breach Notification Rule

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On July 3, President Biden announced nominees Andrew Ferguson and Melissa Holyoak to the Federal Trade Commission, filling two Republican vacancies.

Ferguson has served as the Solicitor General of Virginia since February 2022, overseeing the state’s appellate litigation, including at the Supreme Court and federal courts of appeals. He served as counsel for Senators Lindsey Graham (R-SC), Chuck Grassley (R-IA), and most recently, Mitch McConnell (R-KY). Ferguson spent several years in private practice after clerking for Judge Karen Henderson on the U.S. Court of Appeals for the D.C. Circuit and for Justice Clarence Thomas on the US Supreme Court. Ferguson earned his undergraduate and law degrees from the University of Virginia.Continue Reading White House Announces Nominees for FTC

On April 13, the Federal Trade Commission (“FTC”) sent a Notice of Penalty Offenses to approximately 670 companies detailing conduct that the FTC claims violates the prohibition on unfair or deceptive trade practices set forth in Section 5 of the FTC Act.  The noticed offenses include failure to adequately substantiate claims made in marketing and advertising about products, particularly health benefit claims and claims of efficacy.  All product claims must be supported by competent and reliable evidence as of the time of the claim.  Claims of health or safety benefits, or that the product is effective in the cure, mitigation, or treatment of serious disease, must satisfy much higher evidentiary standards.Continue Reading FTC Issues New Notice of Penalty Offenses Concerning Substantiation of Product Claims