Digital Health & Technology

Expert Analysis

• Life Sci Cos. Should Prep For Enforcement After COVID Pause

  

  With the U.S. Food and Drug Administration and other federal agencies beginning to turn their sights back to pre-COVID-19 agendas, now is the time for life sciences companies to proactively address certain key areas that are likely to draw enforcement action, including physician speaker programs and data integrity, say attorneys at Buchanan Ingersoll.

• 4 Considerations In Light Of Cyber Incident Notification Bill

  

  Following the recent introduction of a bipartisan bill that would require government contractors and critical infrastructure operators to report cyber intrusions to the federal government within 24 hours, companies should take several steps to assess their preparedness for identifying vulnerabilities and mitigating the risk of cyberattacks, say attorneys at Squire Patton.

• What COVID-19, Social Issues Mean For Pharma Case Juries

  

  Recent surveys of actual and potential jurors suggest that the turbulence of this time will likely affect the attitudes of juries in pharmaceutical and life science cases in at least five different ways, say Buffy Mims and Rachel Horton at DLA Piper, and Rick Fuentes at R&D Strategic Solutions.

• Health Cos. Must Prepare For Growing Ransomware Threat

  

  Health companies are a prime target for ransomware attacks due to their sensitive data and relative vulnerability, so they will need compliance and resilience to guard against the increasingly varied ways that hackers can attempt to extract funds, say Alaap Shah and Stuart Gerson at Epstein Becker.

• Medical Device Cases Show Increased Sunshine Act Scrutiny

  

  Recent U.S. Department of Justice and Centers for Medicare & Medicaid Services settlements with two medical device manufacturers signal ramped-up enforcement of the Sunshine Act, highlighting a departure from a historically gentler approach, say Jaime Jones and Brenna Jenny at Sidley.

• Compliance Considerations For Pharma Co. Testing Programs

  

  Diagnostic tests sponsored by pharmaceutical companies can provide real benefits to patients, but should be carefully structured to mitigate compliance risks related to possible fraud and patient privacy, say Eve Brunts and Alison Fethke at Ropes & Gray.

• Gov't Authorities Should Assist Ransomware Targets

  

  As more companies make the prudent decision to pay ransoms following cyberattacks — recently demonstrated by Colonial Pipeline's decision to make a multimillion-dollar payment — governments should use these opportunities to identify and punish perpetrators, rather than simply admonishing victims, say attorneys at Clifford Chance.

• Bracing For The Next Wave Of Health Care Enforcement

  

  Health companies should take proactive steps against a coming wave of federal enforcement, in light of massive new health funding, agencies' desire to protect COVID-19 relief funds, increased use of data analytics and a likely rise in qui tam suits, say attorneys at Foley & Lardner.

• Indoor Air Pollution Fix Will Require New Laws, New Tech

  

  The COVID-19 pandemic, an aging population and changing workplace dynamics all foretell more exposure to indoor air pollutants, so a multidisciplinary policy approach combining technology, insurance, funding and regulation will be needed to improve indoor air quality and health, says Ann Al-Bahish at Haynes and Boone.

• How Justices' AMG Ruling Affects Privacy And Cybersecurity

  

  The U.S. Supreme Court's recent ruling in AMG Capital Management v. Federal Trade Commission removes the regulator's ability to seek monetary damages that discouraged privacy and cybersecurity breaches, and as a result, companies should reassess their exposure in these areas, say attorneys at Orrick.

• COVID's Int'l Trade Impact Holds Health Co. Legal Implications

  

  Pandemic-prompted changes to international trade are highlighting novel legal issues related to the health care industry's reliance on an international supply chain, the proliferation of counterfeit supplies, and risks associated with offshoring administrative support, say Brett Johnson and Claudia Stedman at Snell & Wilmer.

• Mapping The Predicate Chain For Medical Device Approval

  

  Omar Robles at Emerging Health analyzes the potential magnitude of predicate chains created by the 510(k) pathway for medical device approval, in light of common criticism that the approval process can create chains of devices that reach the marketplace without recent clinical testing.

• Where Health Care Enforcement Is Headed Under Biden

  

  Early actions by President Joe Biden's administration signal a robust health care enforcement environment in which federal agencies will aggressively scrutinize pandemic-related and Medicare Advantage fraud, nursing homes, and medical technology, and False Claims Act activity will likely increase, say attorneys at Alston & Bird.