Faculty Affiliated with Health Law & Policy
Lindsay Wiley, Associate Professor of Law Co-Convenor, Health Law and Food and Drug Law Faculty Practice Group Faculty Advisor, Health Law and Justice Society, Health Law and Policy Brief, and Health Law Regulatory and Compliance Competition Team
LAW-834-001 Public Health Law & Policy
LAW-640-001 Health Law
Lindsay F. Wiley is Associate Professor of Law, Co-Convenor of the Health Law and Food and Drug Law Faculty Practice Group, and Faculty Advisor to the student-run Health Law and Justice Society, Health Law and Policy Brief, and Health Law Regulatory and Compliance Competition Team. She joined the faculty of American University Washington College of Law in 2010. She teaches, writes, and speaks in the areas of health care law, public health law, global health law, and torts. Her research focuses on access to health care and healthy living conditions in the U.S. and globally. She is co-author (along with Lawrence O. Gostin) of Public Health Law: Power, Duty, Restraint (3rd. ed., forthcoming from U.C. Press in 2015).
Prior to joining the faculty at WCL, Professor Wiley was the Global Health Law Program Director at the O'Neill Institute for National and Global Health Law at Georgetown University. She also previously worked at the Center for Law and the Public's Health at the Johns Hopkins Bloomberg School of Public Health, the American Society for Law, Medicine, and Ethics, and Gordon, Feinblatt, Rothman LLC in Baltimore, MD.
Professor Wiley serves on the Board of Directors of the American Society for Law, Medicine, and Ethics and the National Conference of Lawyers and Scientists. She received her AB and JD from Harvard, where she served on the Harvard Law Review, and her MPH from Johns Hopkins.
Lewis A. Grossman is the Co-Convenor of the Health Law and Food and Drug Law Faculty Practice Group. He joined the faculty of the Washington College of Law in 1997. He became Professor of Law in 2003 and served as Associate Dean for Scholarship from 2008 to 2011. He teaches, writes, and speaks in the areas of food and drug law, health law, American legal history, and civil procedure.
Prior to joining the faculty of WCL, Professor Grossman was an associate at Covington & Burling LLP. Prior to that, he was clerk for Chief Judge Abner Mikva, U.S. Court of Appeals, D.C. Circuit. Professor Grossman is coauthor (with Peter Barton Hutt and Richard A. Merrill) of Food and Drug Law: Cases and Materials 4th ed. (Foundation Press 2014). He is at work on a book tentatively titled You Can Choose Your Medicine: Freedom of Therapeutic Choice in American Law and History. His scholarship has appeared in journals such as Yale Journal of Health Policy, Law & Ethics; Cornell Law Review; and Law and History Review.
Professor Grossman was a member of the National Academies' Institute of Medicine (IOM) Committee for Review of FDA's Role in Ensuring Safe Food (2009-10) and was a legal consultant for the IOM Committee on the Framework for Evaluating the Safety of Dietary Supplements (2002-04). He is on the Board of Directors of the Food and Drug Law Institute and is an active member of the American Society for Legal History. He earned his Ph.D. in History from Yale University, his J.D., magna cum laude, from Harvard Law School and his B.A., summa cum laude, from Yale University.
Asha Scielzo, Law and Government Health Law & Policy Fellow and Adjunct Associate Professor of Law
LAW 719B1-001 The False Claims Act in the Health Care Industry
LAW 719H2-001 Health Care Compliance and Governance
Asha Scielzo is the Law and Government Health Law & Policy Fellow and Adjunct Associate Professor of Law. In this leadership role, Professor Scielzo assists with development of the health law and policy curriculum, recruitment of adjunct professors, expansion of health law externships, career counseling, career panels and other programming. She advises the student-led Health Law & Policy Brief and Health Law & Policy Students Association. She founded and manages the annual WCL National Health Law Writing Competition and directs the annual Health Law & Policy Summer Institute.
Professor Scielzo brings over 15 years of large law firm practice experience to the law school. As a practitioner, she concentrated her practice on health care regulatory counseling, with significant expertise in fraud and abuse and reimbursement considerations and their impact on day-to-day operations, corporate compliance and governance, and transactions.
A leader in the health law academic community, Professor Scielzo has assisted several law schools with the development of health law curricula for their JD and LLM programs. She teaches a wide range of courses on the subject of health care fraud and abuse, compliance, governance, and mergers & acquisitions at various law schools, including AUWCL, Loyola University Chicago School of Law, and Georgetown University Law Center.
Professor Scielzo serves on the Board of Directors of the American Health Lawyers Association (AHLA), and has also served for many years as the Chair of the Planning Committee for the annual AHLA Fundamentals of Health Law Conference. She had the privilege of serving as the At-Large member of the AHLA Nominating Committee for the 2014-2015 year. She is a frequent speaker and author in the field of health law, and serves as a mentor to several law students and young lawyers.
Prior to attending law school, Professor Scielzo worked as a health care strategy analyst at the Advisory Board Company in Washington, D.C. With a background in science, Professor Scielzo co-authored several articles published in distinguished clinical journals such as the Journal of the American Medical Association and Critical Care Medicine.
Nick Bath started his career on the Hill in 2006 as Counsel and Investigator for the Democratic Policy Committee. From 2007 to 2008, he worked as Senior Counsel on Senator Edward M. Kennedy’s HELP Committee staff. In early 2009, he joined Senator Sheldon Whitehouse’s staff as Legislative Counsel for Health Care and staffed the Senator on the HELP Committee during the health reform debate. As Senior Health Policy Advisor to Chairman Harkin, Professor Bath handles issues related to the coverage title of the Affordable Care Act, including health insurance exchanges, insurance market reforms, and consumer protections, as well as health care quality, HIT, Medicare and Medicaid issues.
No health law classes currently associated with this professor.
Katie Bertram is a partner at Bertram & Amell, PLLC, with over 25 years of trial experience. Her practice focuses on medical malpractice, nursing home abuse and corporate fraud cases, including whistleblower/qui tam actions. Professor Bertram was partner at Regan Zambri Long & Bertram. She was previously the Director of Risk Management at Georgetown Hospital and is uniquely able to identify unsafe care and fraud. She received her BA from the University of Wisconsin-Madison and her JD from the Catholic University of America, Columbus School of Law.
Robert Dinerstein is professor of law, director of the clinical program (1988-96 and 2008-present), and director of the Disability Rights Law Clinic (2005-present) at AU's Washington College of Law, where he has taught since 1983. He was the law school's associate dean for academic affairs from 1997-2004. He specializes in the fields of clinical education and disability law, especially mental disabilities law (including issues of consent/choice, capacity and guardianship), the Americans with Disabilities Act, Civil Rights of Institutionalized Persons Act, legal representation of clients with mental disabilities, the interaction between disability and the criminal justice system, and disability and international human rights.
Professor Dinerstein was appointed by President Clinton in 1994 to serve on the President's Committee on Mental Retardation (on which he served until 2001). He has consulted for the World Health Organization regarding the revision of mental health laws in Ghana and Malawi, and was a signatory to the Montreal Declaration on Intellectual Disabilities, adopted in Montreal, Canada in October 2004. Prior to joining AU, Professor Dinerstein worked as an attorney in the U.S. Department of Justice's Civil Rights Division, Special Litigation Section, where he handled federal court cases on the rights of people institutionalized in mental hospitals, institutions for people with intellectual disabilities (mental retardation) and juvenile institutions, prisons, and jails. In addition to the Disability Rights Law Clinic, which he founded (and which handles special education, admission/commitment of people with intellectual disabilities, guardianship, ADA, and other cases), he teaches a seminar on law and disability and has taught interviewing and counseling, legal ethics, the supervised externship seminar, and the criminal justice clinic (which he directed from 1989-1995).
Professor Dinerstein is actively involved in organizations related to legal education nationally. He is a member of the Council of the American Bar Association Section on Legal Education and Admissions to the Bar, and previously was on the section’s Standards Review Committee. He has been a member of over 15 ABA-AALS joint site inspection teams, chairing two teams. Within the Association of American Law Schools, he has, among other things, chaired the section on clinical legal education, committee on clinical legal education, committee on sections and the annual meeting, and the planning committee for the 2006 clinical teachers’ conference (and has been a member of a number of other planning committees). He currently serves as chair-elect of the AALS section on law and mental disability as well as the secretary of the section on disability law. Previously, he served on the association’s Membership Review Committee.
Professor Dinerstein currently sits on the boards of directors of the Quality Trust for Individuals with Disabilities, Inc. (president), Equal Rights Center (treasurer), and Washington Legal Clinic for the Homeless, Inc. (treasurer), and in the past has served on the boards of the District of Columbia Bar Board of Governors (2002-05), Society of American Law Teachers, Mental Disability Rights International, Legal Counsel for the Elderly, and Maryland Disability Law Center, among other organizations. He has made numerous presentations on clinical legal education and disability law, among other topics, and has published a number of articles, chapters and other writing on these subjects. He is co-editor and co-author, with Profs. Stan Herr and Joan O=Sullivan, of A GUIDE TO CONSENT (AAMR, 1999); author of “Guardianship and Its Alternatives,” in ADULTS WITH DOWN SYNDROME (Siegfried M. Pueschel, ed., 2006); and co-author of the forthcoming LAWYERS AND CLIENTS: CRITICAL ISSUES IN INTERVIEWING AND COUNSELING (Thomson West, forthcoming 2009). He has an A.B. degree from Cornell University and a J.D. degree from Yale Law School.
Sean Flynn teaches courses on the intersection of intellectual property, trade law, and human rights and is the Associate Director of the Program on Information Justice and Intellectual Property (PIJIP). At PIJIP, Professor Flynn designs and manages a wide variety of research and advocacy projects that promote public interests in intellectual property and information law and coordinates PIJIP’s academic program, including events, student advising and curriculum development. Professor Flynn’s research examines legal frameworks promoting access to essential goods and services. He serves as counsel for advocacy organizations and state legislatures seeking to promote and defend regulations that promote access to essential medicines. (PIJIP).
Prior to joining WCL, Professor Flynn completed clerkships with Chief Justice Arthur Chaskalson on the South African Constitutional Court and Judge Raymond Fisher on the U.S. Court of Appeals for the Ninth Circuit. He also represented consumers and local governments as a senior associate with Spiegel & McDiarmid and as senior attorney for the Consumer Project on Technology, served on the policy team advising then Assistant Attorney General for Civil Rights Deval Patrick, and taught Constitutional Law at the University of Witwaterstrand, South Africa.
LAW-774-001 Bioethics and the Law
Heidi Gertner has been a drugs counselor in the Office of the Chief Counsel of the U.S. Food and Drug Administration (FDA) for the past ten years. Her areas of expertise are over- the-counter drug product regulation, drug safety, drug marketing and advertising, human subject protection, preemption, and combination products. Prior to joining FDA, Professor Gertner was a Bioethics Fellow in the Department of Clinical Bioethics of the U.S. National Institutes of Health from 1999 to 2001.
Before joining FDA, Professor Gertner was a Visiting Assistant Professor at Case Western Reserve University's Schools of Law and Medicine. She has published two law review articles, one of which was cited by the Massachusetts Supreme Court. She has also published articles in The Lancet, Archives of Internal Medicine, Obstetrics & Gynecology, The Journal of Clinical Ethics, and Cambridge Healthcare Ethics Quarterly, among others.
From 1997-1998, Professor Gertner was a Clinical Bioethics Fellow at the Cleveland Clinic Foundation. Professor Gertner has given lectures in Helsinki and London. She graduated cum laude from Binghamton University in 1994, and from Washington University School of Law in 1997 where she was a staff member of the Washington University Law Review Quarterly.
Derek Kung is Vice President and General Counsel of MedAssist, a company that assists hopsitals with simplifying the financial experience for their patients and the people of their organization. Derek Kung joins MedAssist as Senior VP and General Counsel with broad expertise in corporate affairs and healthcare regulatory matters. He has worked with various provider types across the healthcare industry spectrum, ranging from physician practices, laboratories, skilled nursing facilities and hospitals. Derek brings with him experience in mergers and acquisitions, structuring joint ventures, and other corporate transactional matters. Prior to joining MedAssist, he was with a Richmond, VA based law firm and former general counsel of a clinical laboratory. Derek holds a BA, Economics from Georgetown University in Washington, DC as well as a Juris Doctor from Emory University School of Law in Atlanta, GA.
Kristi Kung is a Counsel in Sheppard Mullin Richter & Hampton’s Health Care practice, located in the Washington, DC office. She represents health care industry clients in a range of regulatory, compliance, and transactional healthcare matters including: fraud and abuse counseling (Anti-Kickback Statute, Stark Law, and False Claims Act issues), internal compliance investigations, responses to government anti-fraud enforcement actions and investigations, responses to reimbursement audits, Medicare/Medicaid enrollment and reimbursement issues, health information privacy and security compliance, and licensing and accreditation of healthcare providers and suppliers. She also advises on the health regulatory requirements and risks related to mergers/acquisitions/sales, insolvency and restructuring, private equity investment and healthcare lending transactions.
Ms. Kung's portfolio includes the evolving area of telemedicine, mobile health and the use of big data, with an emphasis on federal and state regulatory compliance. Ms. Kung frequently advises telehealth companies and mobile health app developers on matters related to licensing, credentialing, reimbursement, corporate practice, privacy and security, fraud and abuse, and FDA oversight, among other legal and compliance obstacles. She also works with hospitals seeking to expand patient access and specialty coverage through the use of e-health technologies.
Ms. Kung holds a Bachelor of Science in Interdisciplinary Studies – Law and Health from Michigan State University as well as a Juris Doctor from Emory University School of Law in Atlanta.
No health law classes currently associated with this professor.
Daniela Kraiem is the Associate Director of the Women and the Law Program and a Practitioner-in-Residence at American University Washington College of Law. Daniela works with the students, faculty and staff of the Washington College of Law incorporate gender into all aspects of legal education. She plans academic conferences on various subjects in the area of feminist jurisprudence (including in recent years meetings addressing Comparative Family Law, IP/Gender, Human Trafficking, and Prosecuting Sexual and Gender-based Crimes Before International/ized Criminal Tribunals). She coordinates grant-funded projects, including the Gender Jurisprudence Database Project (with the War Crimes Research Office). She collaborates with student groups to plan events on current issues in gender and law, works with the Academic Dean’s office to support the Washington College of Law’s comprehensive gender and law curriculum, and advises the students enrolled in the Gender and Law specializations in Washington College of Law’s two LLM programs.
Prior to joining the Washington College of Law, she represented labor unions and workers as an Associate at the law firm of McCarthy, Johnson and Miller in San Francisco. She was also a Staff Attorney at the Child Care Law Center, where she specialized in early childhood education workforce development, supporting women-owned small businesses, and increasing the availability of high quality child care for all children.
Her current research interests include the political economy of long term care for the elderly and persons with disabilities, child care, and gender and legal education.
LAW-719-005 International Human Rights Law and Global Health
Cristina Leria is a lawyer with almost twenty years experience in legal empowerment and international development. Now
an independent consultant, Professor Leria has worked with the Pan-American Health Organization in a variety of capacities since 2008, including most recently as Advisor, Human Rights Law for Health Services. As a member of the PAHO human rights team, she focused on the provision of technical cooperation to PAHO member countries, concerning the application of human rights legal obligations in areas such as medicinal products and technologies, mental health, disability, aging and HIV/AIDs. She has also helped develop and implement capacity building on human rights approaches within PAHO and for national-level public health services.
Prior to her work at PAHO, Professor Leria was a lawyer at the Food and Agriculture Organization of the United Nations in Rome from 1993 to 2006, where she was extensively involved in FAO’s program of legal assistance to member countries on natural resource management issues. Professor Leria holds degrees from the American University’s Washington College of Law (LLM, 2009, with a focus on health law and government); London School of Economics (LLM, 1991) and Universidad Autonóma, Madrid, Spain (1990).
LAW-719A-001 Health Law: Legislative and Regulatory Process
Bill McConagha is a Health Policy Advisor to Chairman Tom Harkin on the Health, Education, Labor, and Pensions (HELP) Committee, U.S. Senate. He handles issues related to FDA and has worked on the Affordable Care Act, the Food Safety Modernization Act, and the FDA Safety and Innovation Act. Professor McConagha is on detail to the HELP Committee from FDA, where he has worked since 1995. From 1995-2007, he worked in FDA’s Office of the Chief Counsel (OCC), first on litigation and criminal enforcement matters and later as regulatory counsel for drugs. In 2000-2001, he served as OCC’s Acting Principal Deputy Chief Counsel. From 2007-2009, Professor McConagha was FDA’s Assistant Commissioner for Accountability and Integrity, during which time he helped develop FDA’s new scientific dispute resolution policies and enhance the transparency and consistency of FDA’s Advisory Committee Program. He has also been detailed to a number of other agency positions, serving as Senior Advisor to the Associate Commissioner for Regulatory Affairs in 2000 and as Director of Policy Communications in 2007.
Mr. Nahra is a partner with Wiley Rein LLP in Washington, D.C., where he specializes in privacy and information security litigation and counseling, along with a variety of health care and compliance issues. He is chair of the firm’s Privacy Practice and co-chair of its Health Care Practice. He assists companies in a wide range of industries in analyzing and implementing the requirements of privacy and security laws across the country and internationally. He provides advice on data breaches, enforcement actions, contract negotiations, business strategy, research and de-identification issues and privacy, data security and cybersecurity compliance. He advises companies in virtually all industries, ranging from Fortune 500 companies to start-ups. He also works with insurers and health care industry participants in developing compliance programs and defending against government investigations into their practices.
A long-time member of the Board of Directors of the International Association of Privacy Professionals, he is the editor of Privacy Advisor, the monthly newsletter of the International Association of Privacy Professionals. He is also a founding Board Member of the Privacy Bar Section of the IAPP. He is a Certified Information Privacy Professional and serves on the Advisory Board for the Health Law Reporter, the Privacy and Security Law Report and the Health Care Fraud Report. He served as the Co-Chair of the Confidentiality, Privacy and Security Workgroup, a panel of government and private sector privacy and security experts advising the American Health Information Community (AHIC) on privacy and security issues arising from health information technology. He has held leadership positions with various groups within the American Health Lawyers Association and the American Bar Association Health Law Section.
Rated by Chambers USA in the nation’s top-tier of privacy attorneys, sources remark that he is “the guy you need to call” (2014) and is in “‘the top echelon’ of data privacy lawyers” (2013). Clients report that he is “great to work with, incredibly knowledgeable and always available” (2016). He is also praised for his “pragmatic advice on complex issues” (2015), “almost encyclopedic knowledge of the law and its application” (2012), and his professional sensitivity to “both costs and delivering results on time” (2013). Clients have commended him as “a fantastic lawyer who keeps abreast of new developments in the field” who “avoids legal jargon and goes the extra mile for his clients” (2011). He is also lauded for his “practical knowledge of what other health care organizations are doing and how they are interpreting the law” (2010). Kirk has also been named an expert practitioner by the Guide to the Leading US Healthcare Lawyers, a leading health care lawyer by The Best Lawyers in America directory and one of the leading privacy “hired guns” by Computerworld.
Mr. Nahra received his law degree from Harvard Law School, Cum Laude, in 1987. He received his undergraduate degree from Georgetown University, magna cum laude and Phi Beta Kappa, in 1984.
Mr. Nahra is an active author and lecturer in the health care, compliance, privacy, information security and anti-fraud areas.
LAW-719-009 Pharmaceuticals and the Law
Michael J. Ruggiero is Senior Director, Government Policy and External Affairs for Astellas Pharma US, the North American affiliate of Tokyo-based Astellas Pharma, Inc. Professor Ruggiero leads the team responsible for advising the company on the business impact of federal policy; developing and implementing the company’s federal public policy and government relations strategy; and working with patient and physician groups, industry organizations, and other stakeholders to advance common public policy goals.
Prior to joining Astellas, Professor Ruggiero practiced law in Washington, D.C. at the law firms of Arnold & Porter LLP and King & Spalding LLP, where he counseled healthcare and other businesses on a range of matters including issues arising under Medicare, Medicaid, and other government healthcare programs; regulation of products by the Food and Drug Administration; healthcare legislative analysis and advocacy; compliance with U.S. and foreign privacy and data protection laws; and compliance with laws governing political activities.
Professor Ruggiero is a former Vice Chair of the American Health Lawyers Association Life Sciences Practice Group; serves as adjunct faculty at the American University Washington College of Law; and is Vice Chair, Operations and a member of the Board of Directors of the National Kidney Foundation Serving the National Capital Area. He earned a J.D. cum laude from the Georgetown University Law Center and received his B.A. in Economics from Syracuse University. Prior to attending law school, Professor Ruggiero worked for the American Apparel Manufacturers Association and the American Textile Manufacturers Institute.
LAW-719-005 International Human Rights Law and Global Health
Javier Vasquez advises PAHO’s Member States in collaboration with its Representation offices on international human rights issues and strategies to improve the right to the highest attainable standard of health and other related human rights; on the formulation/review of national public health laws, polices, practices; and to structure public health services consistent with international human rights treaties and standards. Serve as the WHO focal point for human rights initiatives in the Americas in collaboration with WHO Headquarters (Geneva). He has officially conducted activities of technical collaboration and officially visited up to date 28 countries of PAHO/WHO. Previously, as a staff attorney for the IACHR, Professor Vasquez personally handled the first decision issued by the Inter-American System regarding violations to the human rights and fundamental freedoms of a person with a mental disability known as “the case of Victor Congo” which interpreted the American Convention on Human Rights in a manner consistent with international/regional health standards and European Human Rights Jurisprudence in the field of psychiatry and disability rights.