On 21 May 2025, the European Parliament and Council reached a provisional agreement on a new Regulation which establishes an EU-level framework on compulsory licensing of patents for any crisis emergency-related products in the EU, including medicinal products. The draft
Health Care
“What You Need to Know About the National Vaccine Injury Compensation Program”–Available in English and Spanish
By Leah Durant
“What You Need to Know About the National Vaccine Injury Compensation Program” is a free resource from the U.S. Health Resources & Services Administration (HRSA) that contains lots of useful information for people who are coping with the effects of…
Wound Care in the Crosshairs: Reimbursements Risks Amid Skin Substitute Fraud Investigations
Effective wound care is critical for patients recovering from surgery or managing chronic or non-healing wounds. Advances in treatment have led to the development of skin substitutes—bioengineered or natural materials designed to promote healing by replacing or supporting damaged skin.…
Regulatory Roller Coaster: District Court Judge Vacates HIPAA Reproductive Health Privacy Rule
Who feels like they’ve been on a regulatory roller coaster lately?On June 18, 2025, in Purl v. U.S. Department of Health & Human Services, Judge Kacsmaryk of the U.S. District Court for the Northern District of Texas vacated key provisions of HHS’s HIPAA…
Medical: Limitation / Long stop period.
By Bill Madden
Hogan v Thornley [2025] NSWSC 640 (Link to Caselaw).
In this matter, the court ordered that pursuant to s 62A of the Limitation Act 1969 (NSW), the long-stop limitation period for the commencement of proceedings by the plaintiff be…
AstraZeneca demands confidential information from pharmacies
Within the last two weeks, AstraZeneca sent numerous letters to pharmacies requesting information regarding dispensing and purchasing FARXIGA® in 2024. These letters inform pharmacies that AstraZeneca has identified data discrepancies in billing and purchasing FARXIGA® for each flagged pharmacy.
AstraZeneca…
The Latest Refinements to DOJ’s White Collar Enforcement Policy
By Jeff Kaiser
Last month, the head of the Criminal Division of the U.S. Department of Justice (DOJ), Matthew R. Galeotti, issued a Memorandum outlining DOJ’s enforcement priorities and policies for prosecuting white-collar crime, identifying three core tenets to guide prosecutors: “(1) focus;…
EU Medical Device Software: New guidance on placing software medical devices on the EU market
The recently published MDCG 2025-4 guidance provides important clarifications on how Medical Device Software (MDSW) apps should be made available via online platforms and on the role of these online platforms. With digital distribution channels such as the App Store…
Healthcare & Life Sciences Private Equity Deal Tracker: Summit Partners Invests in RIS Rx
By Trey Andrews
Summit Partners has completed a growth investment in RIS Rx, according to a news release.
RIS Rx, founded in 2020 and based in Newport Beach, California, is a healthcare technology company that develops solutions designed to address revenue…
Federal Court Vacates 2024 Reproductive Health Privacy Rule
Late on Wednesday June 18, Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas issued an order vacating almost the entirety of HHS’s 2024amendments to the HIPAA Privacy Rule that created special protections for…