Kristen B. Rosati

Kristen spends her time on matters related to clinical research, electronic health records, health information privacy and security, and consent issues. Much of her work is at the intersection of these areas, including data sharing in collaborative research, the creation of data warehouses and tissue banks for research, and “secondary” use of health information.  Kristen is the President-Elect Designate of the American Health Lawyers Associaiton, the nation's largest educational organization devoted to legal issues in the healthcare field with more than 10,000 members.   

EDUCATION AND BAR ADMISSIONS

• J.D., University of Michigan, 1990, cum laude
• B.A., University of Michigan, 1987, magna cum laude
• Admitted in Arizona, 1990

CLERKSHIPS

• Hon. Thomas Tang, U.S. Court of Appeals for the Ninth Circuit, 1992-94
• Hon. Earl Carroll, U.S. District Court, District of Arizona, 1990-92

REPRESENTATIVE MATTERS

• Assisting national health systems and hospitals in establishing electronic health record systems, including crafting data use and privacy policies, developing contracts with community physicians, advising on remote access issues, navigating the Stark and Anti-Kickback rules related to EHR roll-outs, and assisting with vendor contracting
• Helping hospitals across the country in negotiating clinical trial agreements, assuring clinical research compliance, and defending against government investigations related to clinical research
• Working with hospitals and nonprofit research institutions in establishing data warehouses and tissue banks for research, including advising on privacy and security, data ownership, access and use, and governance issues
• Assisting the Arizona Biomedical Research Commission with the Arizona Translational Resource Network (AzTransNet)—a project to build clinical and translational research capacity in Arizona, including facilitating the development of the Arizona Biospecimen Consortium
• As Chair of the Legal Committee for Arizona Health-e Connection, Arizona’s health information exchange (HIE) initiative, facilitating the development of statutory and regulatory changes to enable HIE in Arizona, and assisting in the development of model policies and agreements for HIE
• Chairing the Arizona Hospital and Healthcare Association’s statewide task forces on HIPAA compliance and clinical research compliance
• Conducting HIPAA preemption analyses for the hospital associations in Arizona, Washington, and Maine, and leading the development of HIPAA Privacy compliance packages for hospitals, health plans, and employers

PROFESSIONAL ACTIVITIES AND RECOGNITION

• Listed in Best Lawyers in America for Health Care        (2007-2012)
• Listed in Arizona's Finest Lawyers 2011
• President-Elect Designate, American Health Lawyers Association (AHLA). June 2011 to present
• Member, AHLA Board of Directors, 2006-present
• Member, AHLA Executive Committee, June 2010 to present
• Secretary, AHLA Board of Directors, June 2010 to June 2011
• Chair, AHLA Professional Resources Committee,            June 2010 to June 2011
• Chair, AHLA Quality Council, July 2008 to June 2010
• Chair and Vice-Chair of the AHLA Health Information and Technology Practice Group, 2001-06
• Member, Brookings Active Surveillance Implementation Council (BASIC) at the Brookings Institution,                     May 2010 to present
• Member, Privacy Panel for the “Mini-Sentinel Coordinating Center” at Harvard Pilgrim (under contract with FDA)  March 2010 to present
• Member, National Governor’s Association State Alliance for e-Health, Health Information Protection Task Force, 2007-2008
• Founding Executive Committee Member of the Arizona State University Center for Healthcare Innovation and Clinical Trials, January 2008 - Sept. 2009
• Member, Arizona State University Biomedical Informatics Department Advisory Board, 2006-present
• Adjunct Professor, Health Care Law, Arizona State University College of Law; frequent guest lecturer at College of Law
• Member, Sun Health Institutional Review Board, 2005-2008
• Secretary and member of the Board of Directors for the Florence Immigrant and Refugee Right Project, 1997-2002

REPRESENTATIVE PUBLICATIONS AND SPEECHES

• Co-editor and co-author, The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks (AHLA) (2005)
• Co-author, Developments in Electronic Health Records (Aspen 2007 Health Law and Compliance Update)
• Author, Human Genetic Sampling and the HIPAA Privacy Standards (Jurimetrics: The Journal of Law, Science, and Technology, Winter 2005)
• HIPAA’s Impact on Litigation (WestGroup Health Law Handbook, 2005)
• Privacy Policy – Issues, Questions and Answers, eHealth Initiative Webinar Series on the American Recovery and Reinvestment Act (Mar. 27, 2009)
• HIE Legislation in Arizona: One State's Efforts to Remove Barriers, Ensure Privacy and Security, and Implement Consumer Choice, National Health Information Security and Privacy Collaboration Conference (March 6, 2009)
• See CV for more details