Expert Analysis

• The Next Pressure Point In Digital Health: Informed Consent

  

  Two new federal digital health initiatives will usher in a new era where virtual care, software-enabled devices and home-based monitoring are integrated into care and reimbursement models, with the impact of shifting rules and opportunities felt most immediately in the context of informed consent, says Kimberly Chew at Husch Blackwell.

• 4 Trends Shaping Drug And Medical Device Law For 2026

  

  2025 saw some significant legal developments with potential impact for drug and device manufacturers, ranging from growing skepticism in science and regulatory entities to new regulation of artificial intelligence, say attorneys at Faegre Drinker.

• Unique Aspects Of Texas' Approach To AI Regulation

  

  The Texas Responsible AI Governance Act — which will soon be the sole comprehensive artificial intelligence law in the U.S. — pulls threads from EU and Colorado laws but introduces more targeted rules with fewer obligations on commercial entities, say attorneys at MVA Law.

• Shutdown Imperils Telehealth Access For Medicare Patients

  

  The federal government shutdown that commenced on Oct. 1 coincided with the expiration of certain telehealth flexibilities that had preserved expansive access to telehealth services for Medicare beneficiaries following COVID-19, creating significant legal and financial uncertainty for healthcare providers and patients, say attorneys at Robinson & Cole.

• How Courts May Interpret Data-Driven Healthcare Fraud Suits

  

  As the U.S. Department of Justice and other agencies increasingly turn to data mining as an enforcement tool, courts will have to determine how far data alone can take a fraud case, and sound theory, clinical expertise and institutional context will play an important role, say Jaime Jones at Sidley and Andrée-Anne Fournier and Atang Gilika at Analysis Group.

• Drug Ad Crackdown Demonstrates Admin's Aggressive Stance

  

  Recent actions by the U.S. Food and Drug Administration and U.S. Department of Health and Human Services targeting pharmaceutical companies' allegedly deceptive advertising practices signal an active — potentially even punitive — intent to regulate direct-to-consumer advertising out of existence, say attorneys at King & Spalding.

• Transmission Security Has A Critical Role In Healthcare

  

  In light of the U.S. Department of Health and Human Services' Office of Civil Rights' continuing enforcement initiative focusing on businesses' accurate and thorough security risk assessments under the Health Insurance Portability and Accountability Act, covered entities should not neglect the importance of transmission security, says John Howard at Clark Hill.

• When AI Denies, Insurance Bad Faith Claims May Follow

  

  Two recent rulings from Minnesota and Kentucky federal courts signal that past statements about claims-handling practices may leave insurers using artificial intelligence programs in claims administration vulnerable to suits alleging bad faith and unfair trade practices, say attorneys at Cozen O'Connor.

• DOJ's Novel Cybersecurity FCA Case Is A Warning To Medtech

  

  The U.S. Department of Justice's recent False Claims Act settlement with Illumina over alleged cybersecurity deficiencies suggests that enforcement agencies and whistleblowers are focusing attention toward cybersecurity in life sciences and medical tech, but also reveals key unanswered questions about the legal viability of such allegations, say attorneys at Morgan Lewis.

• Federal AI Action Plan Marks A Shift For Health And Bio Fields

  

  The Trump administration's recent artificial intelligence action plan significantly expands federal commitments across biomedical agencies, defining a pivotal moment for attorneys and others involved in research collaborations, managing regulatory compliance and AI-related intellectual property, says Mehrin Masud-Elias at Arnold & Porter.

• 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.