Jones Day’s Anti-Human Trafficking Initiative: Health Care Supply Chains and Forced Labor
On August 23, Johnson & Johnson (J&J) announced changes to its 340B Drug Pricing Program discount available to disproportionate share hospital (DSH) Covered Entities on purchases of two of J&J’s most popular drugs, STELARA...more
Last year, the American Hospital Association (AHA) sued the U.S. Department of Health and Human Services (HHS) in the U.S. District Court of the Northern District of Texas, requesting that HHS be barred from enforcing a new...more
On August 29, 2024, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) withdrew its appeal of the US District Court for the Northern District of Texas’s June 20, 2024, decision in American...more
On August 19, 2024, the US Department of Health and Human Services Office for Civil Rights (OCR) filed a notice of appeal of the US District Court for the Northern District of Texas’s June 20, 2024, decision in American...more
According to the American Hospital Association, cyber criminals are becoming more organized and sophisticated. For example, in addition to attacks on the troves of patient data held by healthcare systems, cybercriminals now...more
On July 19, Change Healthcare Ince. filed a breach report with HHS Office for Civil Rights (OCR) concerning its mammoth ransomware attack and breach. The organization’s breach report to OCR identifies just 500 individuals as...more
As we recently reported, in its Final Rule banning most worker non-competes, the Federal Trade Commission (“FTC”) previously warned of its intent to vigorously enforce its non-compete ban wherever possible, which may include...more
In an earlier report, we examined the recent decision of the U.S. District Court for the Eastern District of Pennsylvania in ATS Tree Services, Inc. v. FTC, in which the Court rejected the plaintiff’s request for the...more
The recent U.S. Supreme Court decision overturning the Chevron Doctrine, which curtailed the power of the federal agencies to interpret the laws they administer, could prove to be disruptive in the health care realm, said two...more
Since our last edition of the Mintz IRA Update, the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) and related maximum fair price (MFP) negotiation process for each of the 10 high-expenditure...more
The ability of OCR to enforce expansive portions of its controversial web tracking guidance has been severely limited. A federal district court ruled that the guidance exceeded the agency’s authority, and in particular...more
This week in New York, many leading health systems came together for the long-running Not-For-Profit Health Care Investors Conference, now sponsored by Barclays, HFMA and the American Hospital Association. The conference...more
The U.S. Food and Drug Administration (FDA) published a final rule amending its regulations to include in vitro diagnostic products (IVDs) as devices, even those manufactured in a laboratory, and issuing policy to phase out...more
Kaiser Permanente is notifying 13.4 million current and former members that their personal information may have been compromised when it was transmitted to tech giants Google, Microsoft Bing and X (formerly Twitter) when...more
On April 23, 2024, the Federal Trade Commission (“FTC”) issued its final rule regarding noncompete clauses, and which determined that such clauses are an unfair method of competition and therefore violate section 5 of the...more
The U.S. Food and Drug Administration's (FDA) recent announcement of a final rule extending regulatory oversight to laboratory developed tests (LDTs) has sparked controversy. As discussed in a previous Holland & Knight alert,...more
More than two months after the February 2024 Change Healthcare cyber-ransom attack, the healthcare industry continues to grapple with the fallout, creating significant challenges, disruptions, and outages to the healthcare...more
The U.S. Department of Health and Human Services, Office of Civil Rights (OCR) recently updated its controversial, year-old guidance document on the use of online tracking technologies by healthcare providers and other...more
Modern warfare is no longer restricted to physical battlefields and professional military. Countries like North Korea and Russia have few qualms about using cyberspace to reach well beyond their physical borders to target...more
News Briefs - Lawmaker Introduces Health Care Cybersecurity Improvement Act - Senator Mark Warner (D-VA) has introduced the Health Care Cybersecurity Improvement Act of 2024, which would allow for advance and accelerated...more
On March 18, 2024, the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) updated the guidance first issued in December 2022 regarding the use of online tracking technologies in the...more
When the U.S. Department of Health and Human Services, Office for Civil Rights (HHS OCR) issued its guidance on “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates” on Dec. 1, 2022 Original...more
Change Healthcare Cyberattack - On February 21, 2024, Change Healthcare—a healthcare technology company owned by UnitedHealth Group—issued a statement that it had been impacted by a ransomware attack. According to Change...more
The American Hospital Association (AHA) has warned that information technology (IT) help desks are being targeted in a social engineering scheme that uses the stolen identity of revenue cycle employees or employees in other...more
The American Hospital Association estimates that half of Americans suffer from chronic conditions like heart disease, diabetes, and cancer. Following a diagnosis, many experience concerns about the kind of care they will...more