The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
340B Drug Pricing Program Compliance
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
Drug Pricing Initiatives During the Trump Presidency
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
News Briefs - U.S. to Accelerate Medicare Payments in Wake of Cyberattack - The U.S. government said it will accelerate Medicare and Medicaid payments to some hospitals hurt by a hack at insurer UnitedHealth's technology unit...more
A ransomware attack on Change Healthcare, a technology company owned by UnitedHealth that touches one of every three U.S. patient records, has resulted in hospitals and pharmacies across New York facing a cash crunch. The...more
On October 31, 2023, the New York State Department of Financial Services (DFS) released a notice withdrawing its proposed market conduct rules for pharmacy benefit managers (PBMs). The proposed rules, announced August 16,...more
Privacy Briefs: June 2023 - Long-term care pharmacy network PharMerica disclosed a breach involving more than 5.8 million patients, making it the largest breach reported to the HHS Office for Civil Rights (OCR) in the last...more
The Federal Trade Commission earlier this month undertook an enforcement action against online pharmacy and telehealth provider GoodRx, in the latest example of the agency seriously pursuing its role as the nation’s de facto...more
On February 7, 2023, the Department of Justice (DOJ) announced its annual False Claims Act (FCA) recoveries for fiscal year 2022. DOJ recovered $2.2 billion from a total of 351 settlements and judgments—the second-highest...more
STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Report on Patient Privacy 21, no. 6 (June 2021) - Scripps Health in San Diego experienced what it called “an information technology security incident” from ransomware that was detected May 1, forcing some of its operations...more
Report on Patient Privacy 18, no. 1 (January 2021) - The HHS Office for Civil Rights (OCR) settled its 13th enforcement action in its Right of Access Initiative, first announced in 2019 to support individuals’ rights to...more
The first ever VIRTUAL Managed Care Compliance Conference will have the great speakers and content you have come to expect from the in-person event. Each year, we look forward to hosting compliance professionals at our...more
Report on Patient Privacy Volume 19, Number 11. (November 2019) ? The biggest threat to protected health information comes from carelessness within your organization, according to a brief from the Clearwater...more
HHS’ Proposals are Designed to Promote Patient Care Coordination, Management, and Efficiencies, and Include Several Points of Interest for Pharmaceutical and Medical Device Manufacturers - In today’s Federal Register, the...more
Here’s the inside scoop on “Sheltered Harbor,” a “doomsday project” from US banks that they hope will “prevent a run on the financial system should one of them suffer a debilitating cyberattack.” The gargantuan voluntary...more
The FBI has issued new guidance specifically applicable to medical and dental facilities regarding the cybersecurity risk of File Transfer Protocol (“FTP”) servers operating in “anonymous” mode. FTPs are routinely used to...more
The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more
And we thought Brexit was something. Buckle up. It’s going to be a wild market ride... Whoa....more
As we all know by now, HIPAA required the Secretary of the U.S. Department of Health and Human Services (HHS) to adopt regulations protecting the privacy of "protected health information" (PHI). HHS responded to that...more