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Legal Insights that help shape strategy and drive compliance.
Triage Health Law
This May, the food and drug law community gathered at an annual conference hosted by the Food and Drug Law Institute (“FDLI”) in Washington DC. The agenda featured speakers across the agency, including former Commissioner Makary, current Acting FDA Commissioner Kyle Diamantas, Grace Graham, Sara Brenner, FDA Chief Counsel Sean R. Keveney and leaders from...... Continue Reading
May 2026 | Blog
Publication
February 2026 | Americas
The 2025 U.S. government shutdown kicked in effective at 12:01am, October 1, 2025, and as of this posting, has been in place for over a week. The shutdown will continue indefinitely until Congress unifies and resolves the budget impasse. The U.S. Food and Drug Administration (“FDA”), tasked with protecting public health by ensuring the safety,...... Continue Reading
October 2025 | Blog
June 2025 | Americas
Summary On December 27, 2024, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS”) published its Notice of Proposed Rulemaking (“NPRM”) titled HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health Information. HHS seeks comments on proposed modifications to the Security Standards for the Protection of Electronic Protected Health...… Continue Reading
February 2025 | Blog
Privacy World
Summary On December 27, 2024, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS”) published its Notice of Proposed Rulemaking (“NPRM”) titled HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health Information. HHS seeks comments on proposed modifications to the Security Standards for the Protection of Electronic Protected Health... Continue Reading
In response to the shifting legal landscape around reproductive health care, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) finalized amendments to the HIPAA Privacy Rule to strengthen privacy protections for highly sensitive protected health information (PHI) related (or potentially related) to reproductive health care. OCR announced the final rule...… Continue Reading
October 2024 | Blog
April 2024 | Americas
This week, House Committee on Energy and Commerce Chair Cathy McMorris Rodgers (R-WA) and Senate Committee on Commerce, Science and Transportation Chair Maria Cantwell (D-WA) unveiled their bipartisan, bicameral discussion draft of the American Privacy Rights Act (APRA draft).[1] Chair Rodgers’ and Chair Cantwell’s announcement of the APRA draft surprised many congressional observers after comprehensive... Continue Reading
April 2024 | Blog
The US Department of Health and Human Services, Office for Civil Rights (OCR)and the Substance Abuse and Mental Health Services Administration issued a Final Rule modifying the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations under 42 C.F.R. Part 2 (Part 2), applicable to certain federally assisted SUD treatment programs (Part 2 Programs), and...… Continue Reading
frESH: Perspectives on Environmental, Safety & Health
On November 9, 2023, the FDA published notice of final guidance that delays FDA’s enforcement of some facilities’ registration and product listing compliance requirements under MOCRA to July 1, 2024. This enforcement delay applies to facilities that “engaged in manufacturing or processing of a cosmetic product” or products as of MOCRA’s enactment date (December 29,...… Continue Reading
November 2023 | Blog
Background President Biden signed into law the “Consolidated Appropriations Act, 2023” on December 29, 2022. The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”), which increased the authority of the United States Food and Drug Administration (FDA) to regulate cosmetics products and provide enhanced cosmetics protections for consumers. For insight, please see...… Continue Reading
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