Jones Day’s Anti-Human Trafficking Initiative: Health Care Supply Chains and Forced Labor
On November 12, 2024, the drug manufacturer Johnson & Johnson (J&J) filed a lawsuit against the Health Resources and Services Administration (HRSA) in the United States District Court for the District of Columbia. The lawsuit...more
Covered entities (CEs) and business associates (BAs) may receive a “discount” for having recognized security practices (RSPs) in place when the HHS Office for Civil Rights (OCR) calculates financial penalties for Security...more
In June 2023, the Federal Trade Commission (Commission) proposed major changes to its premerger notification rules that implement the Hart-Scot-Rodino Act and impact a large swath of merger and acquisition transactions each...more
On September 26, 2024, the Health Infrastructure Security and Accountability Act was introduced in the U.S. Senate. The bill would amend the Health Insurance Portability and Accountability Act (HIPAA) and direct the U.S....more
On April 29, 2024, the Food and Drug Administration (FDA) announced a final rule to consider laboratory-developed tests (LDTs) to be medical devices and thus under FDA oversight. LDTs are laboratory tests that are designed,...more
The HHS Office for Civil Rights (OCR) has abandoned its appeal of a federal judge’s ruling overturning OCR’s guidance prohibiting covered entities (CEs) and business associates (BAs) from using the web-tracking technologies...more
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