Expert Analysis

• New Colo. Teen Privacy Rules Signal National Regulatory Shift

  

  Recently released proposed rule amendments to the Colorado Privacy Act that would create some of the most robust protections for minors' online data in the U.S. reflect an ongoing trend of states taking steps to extend privacy protection for their residents, complicating the compliance burden for companies, say attorneys at Morgan Lewis.

• 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  The U.S. Food and Drug Administration recently rescinded its laboratory-developed tests rule in response to a Texas federal court decision this spring, reinforcing a separation of authority between the FDA and the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.

• 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.

• 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.

• 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.

• High Court Cert Spotlights Varying Tests For Federal Removal

  

  A recent decision by the U.S. Supreme Court to review Chevron v. Plaquemines Parish, a case involving the federal officer removal statute, highlights three other recent circuit court decisions raising federal removal questions, and serves as a reminder that defendants are the masters of removal actions, says Varun Aery at Hollingsworth.

• IRhythm IPR Denial Raises Key PTAB Discretion Questions

  

  By giving the passage of time a dispositive role in denying institution of five inter partes review petitions filed by iRhythm Technologies, the U.S. Patent and Trademark Office has upended the strategic considerations for filing and defending against IPRs, disclosing prior art during prosecution, and engaging in licensing negotiations, say attorneys at Dentons.

• Rising Enforcement Stakes For Pharma Telehealth Platforms

  

  Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.

• Handling Revenue Cycle Management Disputes In The AI Age

  

  As healthcare providers and revenue cycle management vendors face an increasing use of artificial intelligence in claims adjudication, it's important for providers and their general counsel to plan in advance for potential disagreements with vendors and investigate the root causes behind any underperformance that arises, say consultants at AlixPartners.

• Prepare For Increased FDA Inspections Of Foreign Facilities

  

  In light of the U.S. Food and Drug Administration's recently announced plans to expand use of unannounced inspections of foreign drug manufacturing factories, foreign firms should implement best practices in anticipation of an imminent increase in enforcement activity, say attorneys at McGuireWoods.

• How Medical Practices Can Improve Privacy Compliance

  

  In light of recent high-profile patient privacy violations, health practices — especially in California — should better position themselves to comply with medical privacy laws by shoring up strategies ranging from mapping electronic protected health information to building a better compliance culture, says Suzanne Natbony at Aliant Law.

• 5 Open Questions About FDA's AI-Assisted Review Plans

  

  The U.S. Food and Drug Administration recently touted the completion of a generative artificial intelligence program for scientific reviewers and plans for agencywide deployment to speed up reviews of premarket applications, but there is considerable uncertainty surrounding the tools' ability to protect trade secrets, avoid bias and more, say attorneys at King & Spalding.