Policy & Compliance

Expert Analysis

• A Shifting Trend In FDA Form 483 Disclosure Obligations

  

  A New York federal court's Checkpoint Therapeutics decision extends a recent streak of dismissals of securities class actions alleging that pharmaceutical companies failed to disclose U.S. Food and Drug Administration Form 483 inspection reports, providing critical guidance for companies during the FDA approval process, say attorneys at Alston & Bird.

• The Future Of Lab-Test Regs After FDA Rescinds Rule

  

  The U.S. Food and Drug Administration recently rescinded its laboratory-developed tests rule in response to a Texas federal court decision this spring, reinforcing a separation of authority between the FDA and the Centers for Medicare & Medicaid Services, and calling into question the FDA's role in overseeing such tests without congressional action, say attorneys at Venable.

• Unpacking Ore. Law's Limits On PE Healthcare Investment

  

  A recent Oregon law imposes significant restrictions on nonphysicians owning or controlling medical practices, but newly enacted amendments provide some additional flexibility in certain ownership arrangements without scuttling the law's intent of addressing concerns about the rise of private equity investment in healthcare, say attorneys at Debevoise.

• Criminal Healthcare Fraud Takeaways From 4th Circ. Reversal

  

  After the Fourth Circuit reversed a doctor’s postconviction acquittal in U.S. v. Elfenbein last month, defense attorneys should consider three strategies when handling complex criminal healthcare matters, says Jonathan Porter at Husch Blackwell.

• AG Watch: Texas Embraces The MAHA Movement

  

  Attorneys at Kelley Drye examine Texas Attorney General Ken Paxton's actions related to the federal Make America Healthy Again movement, and how these actions hinge on representations or omissions by the target companies as opposed to specific analyses of the potential health risks.

• How States Are Regulating Health Insurers' AI Usage

  

  The absence of a federal artificial intelligence framework positions states as key regulators of health insurers’ AI use, making it important for payors and service providers to understand the range of state AI legislation being passed in California and elsewhere, and consider implementing an AI-focused compliance infrastructure, say attorneys at Ropes & Gray.

• HHS Plan To Cut Immigrant Benefits Spurs Provider Questions

  

  A recent notice from the U.S. Department of Health and Human Services identifying new federal public benefit programs for which nonqualified aliens are not eligible may have a major impact on entities that participate in these programs — but many questions remain unanswered, say attorneys at Foley.

• Noncompete Forecast Shows Tough Weather For Employers

  

  Several new state noncompete laws signal rough conditions for employers, particularly in the healthcare sector, so employers must account for employees' geographic circumstances as they cannot rely solely on choice-of-law clauses, say lawyers at McDermott.

• Previewing State Efforts To Regulate Mental Health Chatbots

  

  New York, Nevada and Utah have all recently enacted laws regulating the use of artificial intelligence to deliver mental health services, offering early insights into how other states may regulate this area, say attorneys at Goodwin.

• How DOJ's New Data Security Rules Leave HIPAA In The Dust

  

  The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.

• Texas Med Spas Must Prepare For 2 New State Laws

  

  Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.

• DOJ-HHS Collab Crystallizes Focus On Health Enforcement

  

  The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.

• How The Healthline Privacy Settlement Redefines Ad Tech Use

  

  The Healthline settlement is the first time California has drawn a clear line in the sand around how website tracking must function in practice, so if your site uses tracking technologies, especially around sensitive content like health or finance, regulators are inspecting your website's back end, not just its banner, say attorneys at Baker Donelson.