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When Your Life Sciences Are on the Line: Privacy and Security Enforcement Trends

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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 second episode of When Your Life Sciences Are on the Line, where leading practitioners and thought leaders in the space share the insights and advice you need to manage business and legal risk in the life sciences sector.

When Your Life Sciences Are on the Line: Privacy and Security Enforcement Trends

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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

Melissa Crespo helps clients navigate a wide range of challenging privacy compliance and data security matters with a focus on the health information and the health care sector. She regularly helps clients develop and implement privacy compliance programs and advises companies on managing risk in connection with cutting-edge technologies and data initiatives.Melissa has particular experience in advising clients on compliance with the Health Insurance Portability and Accountability Act (HIPAA) and other laws governing the collection and use of medical and health information.Melissa regularly counsels clients responding to data breaches and security incidents. She has successfully defended clients in numerous regulatory inquiries regarding data security practices, including investigations by the Federal Trade Commission, the U.S. Department of Health and Human Services, state attorneys general, and foreign regulators following data security incidents.Melissa also advises multinational companies on the privacy and data security aspects of their M&A transactions and has experience drafting and negotiating tailored privacy and data security contract provisions.In 2019, 2020, and 2021, The Legal 500 US recognized Melissa as a “Rising Star” in the area of cyber law, data privacy, and data protection. In 2016, she was shortlisted for the “Future Leader – Gender Diversity” award at the inaugural Chambers USA Diversity Awards. Melissa was a 2015 recipient of the Burton Award for Legal Achievement, which honors excellence in legal writing.Melissa earned her J.D., cum laude, from Howard University School of Law.