OCR Kicks Off 2026 With Reminders About "System Hardening" For HIPAA Covered Entities

InvaGen Pharmaceuticals Inc., a Cipla Limited subsidiary, has entered into a strategic partnership with Qilu Pharmaceutical Co., Ltd. for the licensing and supply of QL2107, a biosimilar to Merck's KEYTRUDA® (pembrolizumab), in the United States. This collaboration represents the latest in a series of partnering transactions directed to pembrolizumab biosimilar candidates, with Qilu handling development and regulatory registration while Cipla USA manages commercialization.

The No Surprises Act's Independent Dispute Resolution process is undergoing a major technology transformation with a new centralized portal for open negotiations. This development introduces standardized procedures for billing disputes between healthcare providers and payers, but also raises critical questions about compliance, system capacity, and whether the portal adequately addresses persistent challenges in payment collection and claim eligibility determination.

Diagnosis coding practices in the Medicare Advantage (“MA”) risk adjustment space continue to be a top enforcement priority for the Department of Justice (“DOJ”).

Hospital and health system counsel face unprecedented challenges as AI transforms patient data into a critical asset, requiring navigation of complex de-identification strategies, state AI and privacy law compliance, and model ownership issues. This session provides in-house legal teams with a practical framework for managing AI-driven healthcare data transactions and governance structures they were never formally trained to handle.

Pharmacies frequently engage marketers, develop relationships with prescribers and offer services intended to attract and retain patients. While these efforts can support legitimate business growth, arrangements involving referral payments, copay waivers or free services may create significant regulatory and contractual exposure.

Organizations rushing to adopt AI often focus on eliminating all risks, inadvertently stalling beneficial implementations. This analysis explores how healthcare institutions can establish clear risk tolerance thresholds and implement multi-layered compliance frameworks that enable responsible AI adoption while maintaining appropriate safeguards and oversight mechanisms.

The US Department of Health and Human Services Office of Inspector General recently issued an unfavorable advisory opinion regarding physician consulting arrangements with compensation tied to product line sales, raising concerns about the medical device industry's approach to royalty payments.

Health tech adoption is outpacing governance frameworks and investor diligence playbooks. This analysis examines five critical considerations that separate durable, profitable AI-enabled healthcare models from expensive missteps, focusing on real ROI, platform consolidation, data governance, workflow integration, and documentation integrity.

The Fifth Circuit's en banc ruling on the No Surprises Act challenges federal agencies' methodology for calculating provider reimbursement rates, specifically addressing the controversial inclusion of "ghost rates" and exclusion of bonus payments in determining the qualifying payment amount. This landmark decision will reshape how insurers calculate reimbursement rates for out-of-network claims and significantly impact negotiations between healthcare providers and insurance companies.

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage.

Private placement life insurance (PPLI) has been characterized as a tax loophole for the ultra-wealthy, but is that characterization accurate? This analysis examines the mechanics, regulatory framework, and evolving accessibility of PPLI, challenging common misconceptions about how these insurance products actually work and who can benefit from them.

The Supreme Court has clarified how to determine whether LLP members have "significant influence" for tax purposes, establishing that qualifying influence must derive from legally enforceable rights traceable to the LLP agreement rather than informal power or strong performance. This landmark ruling provides a structured framework for assessing member status prospectively...

Commercial litigation partner Jacques Semmelman joins Dateline NBC's True Crime Weekly podcast to demystify the complex world of international extradition law. Drawing on his experience as a former Assistant US Attorney, Semmelman explains the legal standards, treaty requirements, and diplomatic considerations that govern how individuals are transferred between countries to face criminal charges or serve sentences.

HMRC is increasing scrutiny of earn-out arrangements, particularly where founders remain involved in the business after completion and deferred consideration depends on future performance of the target company.

In the latest episode of the TMA Chicago/Midwest Podcast, Katten Restructuring Partner Paul Musser interviews TMA CEO Christine Melendes about her diverse career path in association management, her early priorities since joining TMA in March, and her strategic vision for the organization's future. Their conversation explores the value of chapter involvement, the power of TMA's global network, and practical strategies for maximizing conference attendance and volunteer opportunities.

A California appellate court has ruled that plaintiffs must demonstrate actual harm beyond a mere statutory violation to establish standing under the state's Automated License Plate Recognition Act. The decision in Mata v. Digital Recognition Network addresses a critical question for ALPR operators and end-users: can individuals sue solely based on subjective privacy concerns without proving concrete damages?

TMA CEO Christine Melendes joins host Paul Musser to discuss her unconventional path to leadership, her strategic vision for the association through 2030, and how TMA is preparing members for industry transformation driven by artificial intelligence and technological change. The conversation explores practical networking strategies, the value of cross-disciplinary collaboration in restructuring, and why early volunteer engagement can drive more than half of a professional's business referrals.

Katten's Financial Markets and Funds Quick Take provides a comprehensive monthly overview of significant regulatory developments, policy changes, and legal updates affecting financial markets, funds, and digital assets. This edition examines groundbreaking SEC-NFA coordination, the SEC's proposed crypto framework, IRS regulatory fixes for life insurance exchanges, and major UK and EU transaction reporting overhauls.

Prediction markets have rapidly evolved from a niche financial sector into one of the fastest-growing areas of the derivatives industry, attracting institutional investors, exchanges, and heightened regulatory scrutiny. As the CFTC, courts, and industry participants work to define the regulatory framework for this emerging asset class, questions around market structure, customer protection, and risk management have moved to the forefront. Katten's Financial Markets and Regulation team provides cutting-edge

For those who own family-held and closely held businesses, the business is usually the largest single concentration of the family’s net worth. The choices made now about succession, governance, liquidity and growth will influence whether that wealth and legacy last.