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When Your Life Sciences Are on the Line: Cybersecurity

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Morrison Foerster Investigations + White Collar Defense partner Nate Mendell, former Acting U.S. Attorney for the District of Massachusetts, hosted the fifth episode of When Your Life Sciences Are on the Line, where leading practitioners and thought leaders share the insights and advice needed to manage business and legal risk in the life sciences sector.

When Your Life Sciences Are on the Line: Cybersecurity

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Nathaniel (Nate) Mendell is a partner in Morrison Foerster’s Investigations + White Collar Defense and Privacy + Data Security practice groups and was the former Acting U.S. Attorney for the United States Attorney’s Office for the District of Massachusetts. He represents companies, financial institutions, boards, and executives through all phases of investigation and litigation involving allegations of corporate healthcare fraud, securities and other financial fraud, public corruption, criminal intellectual property theft, data breach or disclosure, and international money laundering. Nate leverages his two decades of service in the U.S. Department of Justice to offer clients an invaluable insider perspective on white collar defense, internal investigations, cyber breaches, and government enforcement actions.Prior to joining Morrison Foerster, Nate served as First Assistant U.S. Attorney and Senior Litigation Counsel advising the U.S. Attorney. As Acting U.S. Attorney, Nate led over 135 prosecutors and reported directly to the Attorney General. Before serving as First Assistant, Nate was Chief of the Narcotics and Money Laundering Unit, where he led more than a dozen prosecutors investigating and prosecuting money laundering cases across the United States, Colombia, Europe, and the Middle East. He also contributed to the creation of the District Court’s RISE Program and was an Assistant U.S. Attorney in the Southern District of Florida.Nate earned his B.A., cum laude, from Amherst College and earned his J.D. from Harvard Law School where he served as the Editor in Chief of the Harvard Latino Law Review.<h4>Representative Experience</h4><h5>Defense Experience</h5><ul><li>Representation of a multinational holding company in a DOJ investigation arising from the client’s investment into a telehealth company under investigation for the unlawful prescription of controlled substances involving potential violations of the Controlled Substances Act (CSA) and the False Claims Act (FCA).</li><li>Advising a pharmaceutical company seeking to mitigate Anti-Kickback Statute (AKS) risk in supporting commercially insured patients in the transition to a new biosimilar therapy. While providing support to commercially insured patients and carving out federally insured patients is not prohibited, such arrangements can draw government scrutiny if they are intended to induce or “pull through” federally insured patients to use medical services or products. We are helping formulate practical parameters for a program that will assist commercially insured patients, meet business goals, and comply with applicable laws and regulations. </li><li>Advising pharmaceutical company whose trade secrets and confidential information were used as the basis for a patent application filed by a competitor and former employees.</li><li>Advising a commercial bank on the acquisition of a medical records company under investigation by DOJ for alleged violations of the FCA.</li><li>Advising an investment management company on the acquisition of a medical device manufacturer under investigation by the DOJ for alleged violations of the FCA.</li><li>Provided training to an online market place regarding the legal framework of the AKS, recent enforcement trends, and compliance best practices.</li></ul><h5>Government Experience</h5><ul><li>Violations of the AKS against a variety of major pharmaceutical companies, which culminated in settlements involving nearly $1,000,000,000 in fines and restitution to resolve the improper use of “patient assistance programs” to subsidize patient co-pays.</li><li>Violations of the CSA against the founder and chief executive officer of a publicly‑traded pharmaceutical company related to the opioids epidemic.</li><li>FCA matters involving improper inducements, insurance pull-through schemes, and improper billing and coding practices.</li><li>Fraud and tax fraud charges against a professor suspected of stealing trade secrets and intellectual property from U.S. interests for a foreign government.</li><li>Conspiracy to obtain unauthorized access to computers and to commit wire fraud and securities fraud charges against a Russian businessman.</li><li>Charges of mail fraud, money laundering, bribery, conspiracy to commit mail and wire fraud, and racketeering conspiracy against coaches, administrators, and parents who fraudulently obtained test scores and college admissions for students related to the Varsity Blues scandal.</li><li>Six-week mail and wire fraud trial against an American businessman involved in a multi-million dollar Ponzi scheme.</li></ul>

Nathaniel R. Mendell

Partner

Kaylee Cox Bankston is a partner in Morrison Foerster’s Privacy + Data Security Group. She advises clients across all industries on complex cybersecurity, privacy, and data matters, including cybersecurity investigations and breach preparation, corporate governance and risk management, regulatory investigations, litigation and class action defense, and other emerging industry issues, such as the use and impacts of Artificial Intelligence (AI). Kaylee was recognized by The Legal 500 US for her work in Cyber law (including data privacy and data protection) in 2023.<ul><li>Cybersecurity Investigations and Incident Response Preparedness: Kaylee has extensive experience leading clients in investigations of sophisticated cyberattacks and security breaches conducted by high-profile threat actor groups, including ransomware, data extortion events, and business email compromises. She also counsels clients on incident response programs and preparedness, including developing and conducting cybersecurity simulations and “tabletop” exercises, preparing clients for security assessments, audits, and testing, and advising on post-assessment implementation and risk mitigation strategies. Kaylee also advises clients on cybersecurity information- and intelligence-sharing, data access requests, and related national security matters.</li><li>Regulatory Investigations and Litigation: Kaylee has substantial experience representing clients in privacy and security investigations and related regulatory actions. She has represented companies in cybersecurity and privacy matters before U.S. and international regulators, including the U.S. Federal Trade Commission (FTC), the U.S. Securities and Exchange Commission (SEC), the U.S. Department of Justice (DOJ), the U.S. Department of Health and Human Services, Office of Civil Rights (HHS OCR), New York Department of Financial Services (NYDFS), and state attorneys general, and in litigation matters in various U.S. federal and state courts.</li><li>Public Companies Counseling, Corporate Governance, and Compliance: Kaylee has advised numerous companies in connection with the new SEC Cybersecurity Disclosure Rules, including counseling on disclosure obligations for material cybersecurity incidents and developing annual SEC cybersecurity disclosures for publicly traded companies. Kaylee also counsels executives and boards of directors on cybersecurity and privacy corporate governance and risk management matters. She also regularly advises clients on the development of cybersecurity and privacy programs and compliance with other regulatory requirements and standards, such as the NYDFS Part 500 cybersecurity requirements, the FTC Safeguards Rule, the FTC Act, the California Consumer Privacy Act (CCPA) and state data privacy laws, the Illinois Biometric Information Privacy Act (BIPA), the Children’s Online Privacy Protection Act (COPPA), the Health Insurance Portability and Accountability Act (HIPAA), the Family Educational Rights and Privacy Act (FERPA), the Gramm-Leach-Bliley Act (GLBA), and the Payment Card Industry Data Security Standard (PCI DSS).</li><li>Corporate Transactions and Vendor Management: Kaylee counsels clients on vendor management programs, including developing security and privacy contracting frameworks and negotiating data protection agreements. Kaylee also advises clients on privacy and security diligence matters in connection with corporate transactions.</li></ul>Kaylee is an adjunct professor at Georgetown University Law Center, where she teaches a cybersecurity course. Kaylee is a Certified Information Privacy Professional (CIPP) through the International Association of Privacy Professionals. She previously served on the Center for a New American Security, Technology Policy Lab Working Group for Data Privacy and the Bar Association of the District of Columbia Board of Directors and National Security Steering Committee. She is also a member of Women in CyberSecurity (WiCyS).