Expert Analysis

• 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.

• Risk Mitigation In Face Of Rising Legal Malpractice Claims

  

  As the recent rise in frequency and cost of legal malpractice claims is expected to continue amid global high inflation and economic uncertainty, law firms and insurers would be wise to evaluate key risk areas and consider six steps to minimize exposure, say Nicole Shapiro and Cory Stumpf at Atheria Law.

• Unpacking FDA's Final Clinical Decision Support Guidance

  

  The U.S. Food and Drug Administration's latest guidance on clinical decision support software introduces new concepts, questions and ambiguities, and may be challenging to implement in practice, say attorneys at Covington.

• How Cos. Can Adapt To Global AI Regulation Trends

  

  Companies can prepare for the future of artificial intelligence regulation by monitoring proposed and existing regulations both in the U.S. and abroad, tailoring their internal compliance architecture for AI-specific risks, and looking for opportunities to lead on governance issues, says Nicholas Diamond at Jackson Walker.

• 4 Strategies For Drafting Effective Consumer Breach Notices

  

  Businesses should consider key strategies when drafting consumer breach notification letters, such as knowing their audience and what is on their mind, and prioritizing user-friendliness and tone, say attorneys at Troutman Pepper.

• How Contractors Can Avoid Cybersecurity FCA Violations

  

  Recent U.S. Department of Justice settlements and remarks underscore heightened focus on cybersecurity liability under the False Claims Act, so government contractors should consider compliance measures such as conducting periodic risk assessments, being responsive to employee concerns, and more, say attorneys at WilmerHale.

• EU Regulation Highlights AI Issues For Digital Health Cos.

  

  As the regulation of artificial intelligence is high on the agenda for EU and U.K. policymakers and regulators, and likely imminent in the U.S., now is the time for providers in the digital health space to consider how compliance may need to change, and safeguard their position in the market, say Chris Eastham and Olivia Morgan at Fieldfisher.