Digital Health & Technology

Expert Analysis

• 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.

• 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.