Overview With extensive experience successfully responding to a full range of criminal and civil enforcement actions and prosecutions, companies and their executives trust Choate with sensitive high-stakes matters, including those initiated by DOJ, HHS-OIG, SEC, FINRA, DOL and other federal agencies and states’ attorneys general. In particular, we: Conduct internal investigations on behalf of organizations and special board committees Represent companies, institutions, and individuals in criminal and civil government investigations Defend clients in agency enforcement actions Implement compliance programs and negotiate Corporate Integrity Agreements (CIAs), Consent Judgments, and Corrective Action Plans Advise clients on disclosure obligations Additionally, clients rely on us for timely and practical compliance advice and benchmarking based on enforcement trends and best practices. Academic Research Security & Compliance Research security at U.S. universities and affiliated medical institutions has become a top government priority with increasing concerns about conflicts of interest, malign foreign influence, data security, theft of intellectual property, and integrity in science. Our research security and compliance services to educational institutions are nationally recognized by Legal 500 and include leading high-stakes internal reviews of research security practices for prestigious universities and academic medical centers and responding to funding agency inquiries and DOJ investigations on a wide range of research-related matters. Our team has helped numerous institutions favorably resolve identified issues, whether via self-disclosures, refunds, or settlement agreements. We closely follow revisions to federal regulations and guidance documents governing academic research, including research security requirements (e.g., NSPM-33) and provide thought leadership on these issues via speaking engagements at national conferences, podcasts, and nationally distributed webinars. Compliance & Due Diligence Our deep compliance experience brings a uniquely practical approach to addressing the tough issues our clients face. From skilled white collar defense attorneys who apply lessons learned from prior and ongoing cases to those with significant in-house experience, our team works collaboratively to ensure clients benefit from our collective knowledge, risk identification and strategic analysis skills, and knowledge of current industry trends. We counsel clients developing their compliance programs, offering scalable solutions based on the size and stage of their company, and as their compliance program matures, we perform program assessments to identify and advise on gaps and go-forward prioritization of risk management efforts. Our practice is built upon meaningful, enduring relationships with clients where we utilize significant understanding of their businesses to inform and shape our advice. With a focus on the life sciences and healthcare industries, we advise legal and compliance departments alike on activities that may implicate the False Claims Act, Anti-Kickback Statute, HIPAA, Food, Drug and Cosmetic Act, CAN-SPAM Act, TCPA, and similar state laws. Cybersecurity & Data Privacy Cybersecurity. Our team advises businesses and institutions responding to cybersecurity incidents, helping them recover, remediate, recoup, and mitigate further risk. This includes conducting internal investigations and cybersecurity reviews, preparing incident response plans, complying with federal and state data breach laws, interfacing with the FBI and other law enforcement agencies, and responding to follow-on class action or other litigation. We also retain and partner with sophisticated incident response and forensic investigation firms to assess the nature and extent of a cybersecurity incident. Data Privacy. We represent companies and investors in a wide range of privacy-related matters across industries. With a depth of experience in HIPAA and state privacy laws, including web-tracking technology, we routinely advise healthcare companies and their business associates on developing and enhancing their policies and procedures, and in responding to patient complaints, audits, and government investigations. Financial & Securities Fraud Choate has a preeminent practice in representing public companies, private entities, officers, and directors in complex litigation and government investigations regarding securities, complex financial transactions, and corporate governance. Dozens of corporate boards of directors and their committees rely on our team to handle highly sensitive matters. Clients trust us to handle a broad range of litigation, internal investigations, and criminal and civil investigations by the Department of Justice, SEC, FINRA and other state and federal government offices and agencies. Healthcare Fraud Our team has extensive experience representing pharmaceutical and medical device manufacturers, academic medical centers, hospitals, and alternative service providers facing allegations of healthcare fraud in government investigations and related litigation, including alleged violations of the False Claims Act, Anti-Kickback Statute, Stark laws, and the Food, Drug and Cosmetic Act. Significant cases handled by our group have involved issues including off-label promotion, kickbacks, the operation of patient services programs, interactions with independent charitable patient assistance programs, the withdrawal of products from the market, engagement with electronic health records vendors, compliance with National Coverage Decisions, and upcoding and Medicare billing anomalies. With many of our cases involving whistleblowers, we are experienced in conducting the internal investigations necessary to understand whether the allegations have merit. We are also experienced in litigating False Claims Act qui tam cases. Our market-leading talent enables us to provide an integrated response to allegations and to vigorously defend our clients in negotiations with government entities to resolve highly sensitive and brand–threatening matters as early and favorably as possible.