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Digital Health: Legal and Regulatory Trends in Artificial Intelligence and Data

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Join Biocom California and Morrison & Foerster for a discussion on the use of artificial intelligence (AI) in the life science and healthcare industries that's transforming everything from drug discovery to methods and devices for diagnosis and treatment, clinical trials, precision medicine, and telehealth. 

MoFo is a proud sponsor of Biocom California's October 19 virtual event, "Digital Health: Legal and Regulatory Trends in Artificial Intelligence and Data." Join <a target="_blank" title="https://www.biocom.org/" href="https://www.biocom.org/">Biocom California</a> and Morrison & Foerster for a fireside chat moderated by Partner and Co-Head, FDA Regulatory and Compliance Group, Stacy Amin alongside Travis Bond, CEO, Altoida and Keagan Lenihan, VP Operations, Altoida.The fireside chat will be followed by a panel discussion led by Morrison & Foerster attorneys Hogene Choi, Stacy Amin, and Melissa Crespo which will cover the use of artificial intelligence (AI) in the life science and healthcare industries that's transforming everything from drug discovery to methods and devices for diagnosis and treatment, clinical trials, precision medicine, and telehealth.Companies are leveraging the power of AI, machine learning, and data analytics across the value chain to speed up the R&D process and launch new products to market faster and more effectively than ever before. Our panel will discuss recent trends facing the industry including:<ul><li>The current FDA regulatory landscape</li><li>Strategic approaches to IP based on your business model</li><li>Privacy issues and the use of data</li><li>Best practices in due diligence for investments and acquisitions</li></ul><div>Watch the <a target="_blank" href="https://vimeo.com/641202049">full webinar</a>.</div><hr>

Digital Health: Legal and Regulatory Trends in Artificial Intelligence and Data

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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.

Melissa Crespo

Partner

Stacy Cline Amin leads the FDA + Healthcare Regulatory and Compliance practice within the firm’s Global Life Sciences + Healthcare Group and provides strategic regulatory and business advice to companies in the life sciences, healthcare, and technology industries. Stacy previously served as Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), and held senior positions within the White House Counsel’s Office and health committees in both the House and Senate. With her depth of experience across government agencies, she provides clients with an insider’s perspective on regulatory and compliance issues, enforcement actions, and litigation challenges.As chief counsel of the FDA, Stacy led an office of approximately 170 counselors and litigators and navigated difficult regulatory issues and litigation challenges across the agency’s entire portfolio. During her last year of service, Stacy played a critical role in nearly every aspect of FDA’s COVID-19 pandemic response effort, including record numbers of emergency use authorizations, guidances, and compliance actions. Most notably, she served as a key leader of the team responsible for issuing the first two COVID-19 vaccine authorizations.During her tenure, she served as a trusted strategist and advisor to several FDA Commissioners, including former Commissioner Scott Gottlieb, the FDA Center Directors and Deputy Commissioners, and the HHS Secretary. She worked closely with the leadership of the agency to resolve challenging legal and regulatory issues, including in the areas of human gene therapy and regenerative medicine, in vitro diagnostics, medical device safety and innovation, digital health, animal and plant biotech, food safety, compounding, opioids, and e-cigarettes. She advised on legal issues related to all aspects of the medical product life cycle and worked with Center leadership to resolve novel or challenging issues that arose during product review. She also oversaw the agency’s significant civil and criminal enforcement actions, in coordination with the Department of Justice, and advised on all of the agency’s novel or significant compliance activities.For more than a decade, Stacy’s work has often focused on the intersection of health, life sciences, and technology. At FDA, she advised on the creation and launch of the Digital Health Center of Excellence and oversaw the development of regulations and policy in all areas of digital health, including software as a medical device, artificial intelligence and machine learning, medical device interoperability, and cybersecurity. While serving in Congress, Stacy led multiple bipartisan investigations of digital health, health IT, and cybersecurity issues that resulted in an influential oversight report, a series of six bipartisan hearings, and significant provisions of the 21st Century Cures Act of 2016 and the Cybersecurity Act of 2015.Previously, Stacy served in the White House Counsel’s Office as Senior Associate Counsel to the President, where she advised on matters involving the FDA and Centers for Medicare and Medicaid Services, the Federal Trade Commission, and the Federal Communications Commission.Prior to joining the White House, Stacy served as the Chief Counsel of the Senate Health, Education, Labor and Pensions Committee and as a Counsel for the House Energy & Commerce Committee. She frequently advised on FDA, insurance market, and health IT matters and led significant oversight investigations. These efforts supported a number of legislative accomplishments, including passage of the Drug Quality and Security Act of 2013.Earlier in her career, Ms. Amin served as an associate at two leading Washington, D.C. law firms, where she advised multinational financial services industry clients and startup organizations.She graduated cum laude from Harvard Law School and summa cum laude from the George Washington University in philosophy and clerked for the Hon. John R. Gibson on the U.S. Court of Appeals for the Eighth Circuit.

Stacy Cline Amin

Life Sciences + Healthcare

Artificial Intelligence (AI)

Patent Strategy + Prosecution

FDA + Healthcare Regulatory and Compliance

Digital Health: Legal and Regulatory Trends in Artificial Intelligence and Data - 575423161

Digital Health: Legal and Regulatory Trends in Artificial Intelligence and Data

19 Oct 2021 9:00 AM - 11:00 AM PDT