Newsletters

01.15.25

FDA Releases New Draft Guidance on Use of AI in Medical Product Development

On January 6, the Food and Drug Administration (FDA) issued two draft guidance documents relating to the use of artificial intelligence (AI) to support development and marketing of medical devices and drugs.


01.09.25

Massachusetts Expands Money Transmitter Law to Include Domestic Transactions

Massachusetts has passed a bill expanding its money transmitter law to include domestic money transmission. While Massachusetts historically has only regulated entities facilitating money transmission to foreign countries, effective September 2025, the law will now require any person facilitating ...


01.09.25

Bipartisan House Task Force Releases Report on AI

On December 17, the House Bipartisan Task Force on AI delivered its report to Speaker Mike Johnson (R-LA) and House Minority Leader Hakeem Jeffries (D-NY).


01.09.25

Departments Withdraw Contraceptives Rule Curtailing Religious and Moral Exemptions

With the clock ticking down on the Biden Administration, the Departments of Labor, Health and Human Services (HHS), and the Treasury (the Departments) announced the withdrawal of a proposed rule on December 24 that would have limited religious and moral exemptions to the requirement for health ...


01.09.25

IRS Proposes Rule for Calculation of the Tax Imposed on Drug Manufacturers Under IRA

On December 31, the Internal Revenue Service (IRS) issued a proposed rule for the calculation of the excise tax under the Medicare Drug Price Negotiation Program, as enacted under the Inflation Reduction Act (IRA).


01.09.25

Second Circuit to Hear Critical Interlocutory Appeal in Crypto Securities Enforcement Action

In a significant development for the digital asset industry, U.S. District Judge Katherine Polk Failla of the Southern District of New York certified for an interlocutory appeal her prior Order finding crypto assets fall within the purview of the SEC. This is an extremely rare procedure that allows ...


01.08.25

Supreme Court Allows Anomalous Antitrust Carveout for Bid Rigging by Dual Distributors

In November 2024, after the U.S. Supreme Court declined to review a decision throwing out an executive’s conviction for bid-rigging, companies in dual-distribution relationships in the Fourth Circuit now have an anomalous carve-out from criminal prosecution under Section 1 of the Sherman Act.


01.08.25

Texas Attorney General Paxton Sued a New York Abortion Provider. What Next?

Texas Attorney General Ken Paxton (the “AG”) recently filed a first-of-its-kind civil suit in Texas state court against a New York physician, Dr. Margaret Carpenter, for allegedly “providing abortion-inducing drugs to Texans through telehealth.”


01.07.25

Estoppel Applies if Prior Art Could Be Found; Patent Owner Must Prove Unreasonable Search

In Ironburg Inventions Ltd. v. Valve Corp.,[1]the U.S. Court of Appeals, Federal Circuit, held the proper test for inter partes review (IPR) estoppel is what a skilled searcher conducting a diligent search of prior art reasonably could have been expected to find where the petitioner was unaware of ...


01.06.25

Your IT Security Budget May Need to Increase: Proposed Updates to the HIPAA Security Rule

The Office of Civil Rights (OCR) recently issued a proposed rule that would substantially modify the Health Insurance Portability and Accountability Act (HIPAA ) security rule and require significant investment in informational technology (IT) security from providers and payors (the Proposed Rule). ...