Kristen Rosati

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Kristen is considered one of the nation’s leading “Big Data” and 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, and biobanking and genomic privacy.   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 (AHLA), the nation’s largest health care legal organization.

Representative Matters

  • Represented academic medical centers in data sharing arrangements to support the development of artificial intelligence in health care.
  • Worked with hospitals and nonprofit research institutions in establishing data and tissue repositories for research—and deals involving those resources—including advising on privacy and security, data ownership, access and use, and governance issues.
  • 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, 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.
  • 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, navigating the Stark and anti-kickback rules related to EHR roll-outs, and assisting with vendor contracting.

Awards & Recognitions

  • Appointed as a member of the Arizona State University Health Futures Council, leaders from across the country convened to guide the university’s health-related research, education and clinical programs.
  • Best Lawyers®: 2014 and 2017 Phoenix Health Care Law “Lawyer of the Year”
  • Phoenix Business Journal, Most Outstanding Women in Business (2017)
  • Az Business magazine: Az Business Leaders (2015 – present)
  • Az Business magazine: Arizona’s Top 100 Lawyers (2014 – 2018)
  • 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)
  • Chambers USA: Health Care (Leader in Health Care, 2015, 2017 – present; Recognized Practitioner, 2016)
  • The Best Lawyers in America©: Health Care (2007 – present)
  • Southwest Super Lawyers: Health Care (2015 – present)
  • Martindale-Hubbell® AV Preeminent® rated (2011 – present)
  • Sustaining Lawyer, Arizona’s Finest Lawyers Foundation (2017 – present); Arizona’s Finest Lawyers (2011 – present)
  • American Registry Corporate Counsel “Top Lawyers” (2011 – present)

(SEE CV FOR COMPREHENSIVE LIST OF AWARDS & RECOGNITIONS)

Publications & Speeches

  • Presenter, “Navigating Privacy Challenges in Collaborative Care Access,” Health Care Compliance Association – Nashville Regional Compliance Conference (Nashville, TN, Nov. 15, 2019)
  • Regulatory and Ethical Challenges in “Big Data” Research, University of California Ethics, Compliance & Audit Symposium (Newport Beach, CA, Oct. 29, 2019). 
  • Privacy in the Use of Big Data for Research, The National Academies of Sciences—National Cancer Policy Forum, Workshop on Applying Big Data to Address the Social Determinants of Health in Oncology (Washington, D.C., Oct. 28, 2019) 
  • Speaker and Moderator, “Protection of Privacy” panel, National Academies of Sciences’ Workshop on Neuroscience Data in the Cloud (Washington D.C., Sept. 24, 2019)
  • Presenter, “The Year in Review” (a tour through major developments in health care over the last year), American Health Lawyers Association Annual Meeting (Boston, MA, Jun. 24, 2019)
  • Presenter, “A Trip Through the GDPR (European Union General Data Protection Regulation),” Arizona Health Information Management Association Annual Meeting (Jun. 14, 2019)
  • Moderator, “Data Science and Health Disparities – Obstacles and Opportunities,” Arizona State University Health Future Council Biannual Meeting (May 2019)
  • Presenter, “The Year in Review” (a tour through the major developments in health care law in 2018), Arizona Society of Healthcare Attorneys (Phoenix, AZ, Feb. 21, 2019)
  • Presenter, “The Year in Review” (a tour through the major developments in health care law in 2018), American Health Lawyers Association Physicians and Hospitals Law Institute (San Antonio, TX, February 4, 2019)
  • Presenter, “Protecting Genomic Information,” Arizona State University, Workshop on Patents and Data Sharing/Access for Molecular Diagnostics (Tempe, Arizona Dec. 6, 2018)
  • Presenter, “The General Data Protection Regulation (GDPR) and its Impact on US Healthcare Entities,” Health Care Compliance Association– Nashville Regional Compliance Conference (Nashville, TN, Nov. 16, 2018)
  • Presenter, “Sentinel System: Data Sharing for Public Health Activities and Data Use Agreements,” Sentinel System Annual Summit (Boston, MA, Nov. 6, 2018)
  • Presenter, “’Future Proofing’’ Your Activities: Keeping up with Regulatory Developments,” National Academies of Sciences, Engineering, and Medicine, Forum on Neuroscience and Nervous System Disorders, workshop Harnessing Mobile Technology to Predict, Diagnose, Monitor, and Develop Treatments for Nervous System Disorders (Washington, D.C., June 6, 2018)
  • Co-author (with Scott Bennett), “Legal Compliance in Using Biospecimens for Research,” Chapter 4, Health Law and Compliance Update, Wolters Kluwer (2018)
  • Co-author (with Melissa Soliz), “Data Sharing for Clinical Integration and other ‘Big Data’ Initiatives,” AHLA Fundamentals of Health Law (2018)
  • Co-presenter, “Navigating New Terrain: Recent Developments in Human Subjects Research Regulation,” Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions, AHLA (Jan. 25, 2018)
  • Co-presenter (with Scott Bennett), “Legal Ethics in Cybersecurity and Data Breaches,” Arizona Society of Healthcare Attorneys (Nov. 14, 2017)
  • Panelist, “Cybersecurity for Healthcare Organizations – and Their Counsel,” Sandra Day O’Connor College of Law CLE Seminar (Oct. 26, 2017)
  • Co-author (with Melissa Soliz), “Privacy Compliance in Clinical Research,” Bloomberg Law (Oct. 2017)
  • Co-author (with Melissa Soliz), “White Paper: Part 2 Challenges for HIOs,” presented at SHIEC Annual Conference (2017)
  • Author, “Patient Privacy and Clinical Laboratory Data,” Clinical Chemistry 63:8, (Jun. 2017)
  • Presenter, “Data Sharing in Research and Clinical Environments,” ASU Health Futures Council Spring meeting (May 2017)
  • Co-author (with Scott Bennett), “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)

(SEE CV FOR COMPREHENSIVE LIST OF PUBLICATIONS AND PRESENTATIONS)

Activities & Memberships

  • Member, Planning Committee, National Academies of Sciences’ Workshop on Neuroscience Data in the Cloud (May 2018 – present)
  • Member, Arizona State University Health Futures Council (November 2018 to present)
  • President, American Health Lawyers Association (AHLA) (2013 – 2014); Board of Directors, AHLA (2006 – 2015)
  • Member, AHLA Governance Council (June 2017 to September 2018)
  • Planning Committee, AHLA Academic Medical Centers and Teaching Hospitals Institute (2015 – present)
  • Planning Committee, AHLA Precision Medicine Institute (2016 – 2017)
  • Founding Member, Arizona Leadership Council, Take the Lead Women (October 2015 to 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