Expert Analysis

• Navigating Risks In FDA's New Digital Health Tech Guidance

  

  The U.S. Food and Drug Administration’s recent guidance highlights several key benefits and risks regarding the use of digital health technologies to collect data in remote clinical trials, so practitioners will need to address the legal ramifications, including potential liability and data privacy concerns, says Janice Sperow at Sperow ADR.

• Anti-Kickback Safe Harbors May Be Less Safe After Medtronic

  

  A California federal court's recent order denying dismissal in U.S. v. Medtronic improperly acknowledges intent as a liability factor in a suit alleging violations of the Anti-Kickback Statute, which is likely to erode certainty in statutory AKS safe harbor protections, says Scott Landau at Abell Eskew.

• How Health Care Cos. Can Prepare For DOJ's Cyberfraud Push

  

  Enforcement of the U.S. Department of Justice’s new cyberfraud initiative will initially occur largely through civil investigations that broadly apply the False Claims Act, so health care organizations should ensure that their practices can withstand hacks, whistleblowers and government scrutiny, say Katie McDermott and Mark Krotoski at Morgan Lewis.

• How Investors Can Navigate A Vibrant Digital Health Market

  

  With investment activity surging across the digital health care industry, investors must balance their interest in transformative technologies with the inherent risks of platforms and models that have yet to be fully proven, says Brian Gordon at McDermott.

• What Cos. Can Learn From The 2021 FCA Recovery Statistics

  

  Attorneys at Winston unpack the recently released U.S. Department of Justice False Claims Act recovery statistics for fiscal year 2021, discuss how they compare to prior years and what companies in an expanding array of industries should expect next.

• Expect Aggressive Life Sciences Enforcement In 2022

  

  This year, life sciences companies should prepare for heightened activity from the U.S. Department of Justice and U.S. Food and Drug Administration, which will likely target illicit opioid distribution, clinical trial fraud and other key areas, say attorneys at Ropes & Gray.

• The Rising Demand For Commercial Litigators In 2022

  

  Amid broken supply chains, pandemic-induced bankruptcies and a rise in regulation by litigation, strong commercial litigators — strategists who are adept in trying a range of tortious and contractual disputes — are becoming a must-have for many law firms, making this year an opportune moment to make the career switch, say Michael Ascher and Kimberly Donlon at Major Lindsey.

• Health Care Policy Priorities To Watch In 2022

  

  The Build Back Better Act is at the forefront of Congress' lengthy health care agenda this year, but there are a number of other issues that health companies and their legal teams should watch closely, including the pandemic's continuing impact on telehealth licensure requirements, surprise-billing regulations and increasing scrutiny of market consolidation, say Miranda Franco and Robert Bradner at Holland & Knight.

• The State Of FDA Regulation Of Software As A Medical Device

  

  Though the U.S. Food and Drug Administration has accelerated activities related to software as a medical device, developers should carefully consider guidance gaps and challenges regarding transparency and change management in software that utilizes artificial intelligence and machine learning, says Nicholas Diamond at C&M International.

• What DOJ's Cyberfraud Initiative Means For Health Cos.

  

  Though the U.S. Department of Justice's new cyberfraud initiative does not single out the health care industry, health and life sciences companies may be subject to heightened scrutiny under the False Claims Act and should prepare accordingly, say attorneys at Ropes & Gray.

• How Medical Device Cos. Can Limit Enforcement, Legal Risks

  

  With recent cases highlighting the myriad consequences that compliance failures can bring to medical device manufacturers, it is imperative that companies take proactive steps to avoid U.S. Food and Drug Administration enforcement and pay particular attention to keeping warning letters out of evidence in product liability suits, say attorneys at Phillips Lytle and Compliance Team.

• How Growing Cyber Scrutiny Affects Corporate Compliance

  

  In the face of overlapping cybersecurity initiatives at the U.S. Departments of Justice and Health and Human Services, health care companies and government contractors should prepare for microscopic scrutiny by ensuring specific components are included in compliance programs and being mindful of reporting obligations under existing corporate integrity agreements, say attorneys at Verrill Dana.

• Choosing The Right IP Protections For Telehealth Innovations

  

  Telemedicine and digital health innovations are likely to stay after the COVID-19 pandemic ends, so inventing companies must decide on a comprehensive intellectual property strategy, considering the goals, risks and upfront requirements offered by both patent and trade secret protections, say Eric Sophir and Matthew Horton at Foley & Lardner.