Expert Analysis

• New Clinical Trial Law Promotes Diversity And Modernization

  

  The Food and Drug Omnibus Reform Act, signed into law last month, will likely encourage more equitable subject recruitment and enrollment in clinical trials, and also could create a pathway toward clarifying ambiguities that have historically been left for regulated entities to piece together, say attorneys at Ropes & Gray.

• Evaluating The Legal Ethics Of A ChatGPT-Authored Motion

  

  Aimee Furness and Sam Mallick at Haynes Boone asked ChatGPT to draft a motion to dismiss, and then scrutinized the resulting work product in light of attorneys' ethical and professional responsibility obligations.

• 2022 Law And Policy Highlights In Digital Health Care

  

  This year, federal regulators made good on several commitments to create new opportunities for digital health innovators, and a number of promising cybersecurity bills are on the horizon, but not all virtual health care law and policy developments have been positive, say attorneys at Arnold & Porter.

• Next Compliance Steps For Health Cos. Using Tracking Tech

  

  In light of the U.S. Department of Health and Human Services Office for Civil Rights' expansive view of what constitutes protected health information, regulated entities seeking to provide websites and mobile apps for patients may need to choose between several imperfect compliance pathways if they wish to continue using tracking technologies, say attorneys at Ropes & Gray.

• Top Trends And Challenges For Health Care Financing In 2022

  

  Rising inflation, interest hikes, supply chain issues and public market disruption are just some of the factors that made 2022 a challenging year for financing health care deals, and all indications point to continued headwinds next year, say Stephanie McCann and Samantha Koplik at McDermott.

• 2022 Data Privacy Suits Tested New Liability Theories

  

  In the absence of a comprehensive federal data privacy law, plaintiffs lawyers are testing new theories of liability under state laws, and a look at recent lawsuits against online companies that have resulted in large settlements shows these attempts are more frequently being met with success, say attorneys at Quinn Emanuel.

• How EU's New Pharma Incentives May Affect US Cos.

  

  Geneviève Michaux and Georgios Symeonidis at King & Spalding examine Europe's recent revisions to its General Pharmaceutical Legislation and the Orphan and Paediatric Legislation, and consider the European Commission's related policy proposals, with an emphasis on pharmaceutical incentives and impacts for U.S. pharmaceutical developers and manufacturers that market products in Europe.

• HHS Bulletin Raises HIPAA Risks For Online Tracking Vendors

  

  A new bulletin from the U.S. Department of Health and Human Services clarifies how the Health Insurance Portability and Accountability Act applies to information collected by tracking technology on websites and mobile apps, creating new compliance considerations for online tracking vendors that may be unfamiliar with HIPAA, says Mason Fitch at Hintze Law.

• Compliance Considerations For Virtual Ketamine Clinics

  

  In the wake of investigations into several online prescribers of controlled substances, it is more important than ever that virtual clinics providing off-label ketamine treatment for mental and behavioral health issues consider five key aspects to staying compliant with medical practice and controlled substance regulations, say attorneys at Goodwin.

• State Regulation Compliance Tips For Telehealth Employers

  

  Nondisclosure, onboarding and reimbursement challenges are behind many remote work-related telehealth employment lawsuits, but with advance planning and knowledge of the state's requirements where practitioners are located, telehealth employers can avoid costly mistakes from the inception through the end of employment, say attorneys at Foley & Lardner.

• 9 Legal Ethics Considerations In Natural Disaster Preparation

  

  Since natural disasters like Hurricane Ian do not relieve lawyers of their ethical obligations to clients, law firms should focus their preparedness efforts on specific areas crucial to continuity of representation and ethics compliance, like business and communications contingency planning, record redundancy and more, says Mark Hinderks at Stinson.

• NY Data Breach Penalty Expands Regulatory Requirements

  

  The New York Department of Financial Services’ recent consent order with EyeMed is an aggressive reading of state regulation that arguably expands current requirements, which could increase the complexity of the risk assessment process and may serve as a precedent for other privacy and data security regulators, says Rick Borden at Frankfurt Kurnit.

• Cybersecurity Expectations Intensify For Medical Device Cos.

  

  A recent FBI industry notification and U.S. Food and Drug Administration draft guidance highlight urgent compliance considerations for medical device manufacturers, and contrasts with how federal regulators have previously treated health care players as victims in cybersecurity incidents, say attorneys at Morrison Foerster.