Expert Analysis

• Emerging Trends In Electronic Health Record Enforcement

  

  As electronic health record systems become increasingly ubiquitous in health care, recent Anti-Kickback Statute and False Claims Act cases involving EHR systems provide a helpful list of issues that tech-savvy relators and government investigators might identify, say Ellen London at London & Stout and former Assistant U.S. Attorney Li Yu.

• FTC's GoodRx Action Highlights Risks For Digital Health Cos.

  

  The Federal Trade Commission's first-of-its-kind enforcement action against GoodRx for unlawfully sharing sensitive customer information is indicative of regulators' growing interest in the digital health space and heightens the importance of taking proactive compliance steps, say attorneys at Ropes & Gray.

• What DOJ's 2022 Recovery Stats Say About FCA Enforcement

  

  Despite showing a decline in False Claims Act recoveries in fiscal year 2022, the U.S. Department of Justice's recently released statistics should lead companies to expect a continued rise in government-initiated investigations, pandemic-related fraud enforcement and FCA cases involving new technology, say attorneys at Crowell & Moring.

• Medicare Developments Ahead For Remote Health Monitoring

  

  Stakeholders interested in remote monitoring services should keep an eye on an upcoming multijurisdictional contractor advisory committee meeting that may lead to a new local coverage determination affecting Medicare coverage for remote monitoring devices, say attorneys at McDermott.

• Calif. Privacy Law Holds Implications For Mental Health Apps

  

  California is leading the way in privacy regulation with its amended Confidentiality of Medical Information Act, which has important compliance repercussions for mental health app developers and could serve as a model for similar laws in other states, say Christine Moundas and Elana Bengualid at Ropes & Gray.

• 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.