Kristen Rosati

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Kristen is considered one of the nation’s leading HIPAA compliance attorneys.  She also has deep experience in data breaches, health information exchange, data sharing for research and clinical integration initiatives, clinical research compliance, clinical trials contracting, biobanking and genomic privacy, and all things “Big Data.”   Kristen is a sought-after national speaker on these issues and has been active in national healthcare policy.  She is past president (2013-2014) of the American Health Lawyers Association, the nation’s largest health care legal organization.

Representative Matters

  • Represented health systems in responding to data breaches and Office for Civil Rights investigations, including a number of large data breaches involving millions of patients.
  • Advised the Food and Drug Administration on its Sentinel Initiative, an effort to create a national electronic distributed network to monitor product safety.
  • Represented Dartmouth College in creating the High Value Health Care Collaborative with Mayo Clinic, Intermountain Health Care, and other major hospitals systems, to study how to provide great care at a lower cost.
  • Worked with the Arizona Biomedical Research Commission to build clinical and translational research capacity in Arizona, including developing a “virtual” tissue bank.
  • Assisted health systems and hospitals in establishing electronic health record (EHR) 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.
  • Worked 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.

Awards & Recognitions

  • Chambers USA: Health Care (Leader in Health Care, 2015, 2017; Recognized Practitioner, 2016)
  • The Best Lawyers in America©: Health Care (2007 – present)
  • Best Lawyers®: 2014 and 2017 Phoenix Health Care Law “Lawyer of the Year”
  • Southwest Super Lawyers: Health Care (2015 – present)
  • Martindale-Hubbell® AV Preeminent® rated (2011 – present)
  • Arizona’s Finest Lawyers (2011 – present)
  • American Registry Corporate Counsel “Top Lawyers” (2011 – present)
  • Phoenix Business Journal, Most Outstanding Women in Business (2017)
  • Az Business magazine: Arizona’s Top 100 Lawyers (2014 – present)
  • Az Business magazine: Az Business Leaders (2015 – present)
  • Az Business magazine: Arizona Health Care Leadership Award, Legal Advocate of the Year (2014)
  • Az Business magazine: 50 Most Influential Women in Arizona Business (2013)

(SEE CV FOR COMPREHENSIVE LIST OF AWARDS & RECOGNITIONS)

Publications & Speeches

  • Presenter, “Data Sharing and Research in Clinical Environments,” ASU Health Futures Council Spring meeting (May 2017)
  • Author, “Health Care Data Breaches: Practical Advice for Trying Times,” AHLA Journal of Health Law and Life Sciences (Feb. 2017)
  • Author, “Anatomy of a Health Care Data Breach,” Aspen Publishers’ Health Law and Compliance Update (2014)
  • Author, “Using Electronic Health Information for Pharmacovigilance: The Promise and the Pitfalls,” Journal of Health & Life Sciences Law, Vol. 2, No. 4 (Jul. 2009)
  • Presenter, “The Changing Legal Landscape of Biobanking,” Southern Arizona Biomedical Research Symposia (Tucson, AZ Mar. 15, 2017)
  • Presenter, “Data Sharing for Clinical Integration and other ‘Big Data’ Initiatives,” AHLA Academic Medical Centers and Teaching Hospitals Institute (Baltimore, MD, Mar. 9-10, 2017)
  • Presenter, “Into the Breach: Practical Actions to Respond and Minimize Risk,” AHLA Physician and Hospital Institute (Orlando, FL, Feb. 3, 2017)
  • Presenter, “Handling Big Data Breaches,” AHLA Annual Meeting (Washington DC, Jun. 30-Jul. 1, 2015)
  • Presenter, “Big Data and Privacy,” Association of American Medical Colleges Compliance Officers’ Forum (Washington, DC, Jun. 12, 2014)
  • (SEE CV FOR COMPREHENSIVE LIST OF PUBLICATIONS AND PRESENTATIONS)

Activities & Memberships

  • American Health Lawyers Association (AHLA), President (2013 – 2014)
  • AHLA Board of Directors (2006 – 2015)
  • Planning Committee, AHLA Academic Medical Centers and Teaching Hospitals Institute (2015 – present)
  • Planning Committee, AHLA Precision Medicine Institute (2016 – present)
  • Healthcare Leadership Council for the Greater Phoenix Economic Council (2013 – 2015)
  • (SEE CV FOR COMPREHENSIVE LIST OF PROFESSIONAL ACTIVITIES)

Clerkships

  • Hon. Earl H. Carroll, Judge, U.S. District Court for the District of Arizona, 1990 – 1992
  • Hon. Thomas Tang, Judge, U.S. Court of Appeals for the Ninth Circuit, 1992 – 1994

Education & Admissions

  • J.D., University of Michigan, 1990; cum laude
  • B.A., University of Michigan, 1987; with high honors
  • Admitted in Arizona, 1990