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 governance and strategy, data sharing for research and innovation, data breaches, state consumer data privacy, biobanking and genomic privacy and clinical research. Kristen is a sought-after national speaker on these issues and has been active in national healthcare policy. She is Past President (2013-2014) and Fellow (2021) of the American Health Law 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.
Advised many telemedicine companies and hospital systems on internal evaluation and response to use of web-tracking technologies for marketing; acted as privacy counsel in class action litigation.
Assisted data services companies serving the health care industry in data strategy, de-identification, compliance, and contracting.
Worked with hospitals and nonprofit research institutions in establishing data and biospecimen 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.

Awards & Recognitions

Top 25: Women Arizona Super Lawyers: 2024
Southwest Super Lawyers: Top 50 Arizona Super Lawyers (2024)
AzBusiness magazine: Who’s Who in Healthcare (2024)
AzBusiness magazine: AzBusiness Leaders, Healthcare Law (2015 – present)
PHOENIX Magazine: Top Lawyers (2022)
AzBusiness magazine: Arizona’s Top 100 Lawyers (2014 – 2018, 2022)
Chambers USA: Privacy & Data Security: Health Care, National (2020 – present)
Chambers USA: Health Care, Arizona (2015 – present)
The Best Lawyers in America©: Health Care (2007 – present)
The Best Lawyers in America©: Administrative/Regulatory Law (2020 – present)
The Best Lawyers in America©: 2014, 2017, 2021, and 2025 Phoenix Health Care Law “Lawyer of the Year”
Elected as an American Health Law Association Fellow (2021)
Phoenix Business Journal: Most Outstanding Women in Business (2017)
AzBusiness magazine: Arizona Health Care Leadership Award, Legal Advocate of the Year (2014)
AzBusiness magazine: 50 Most Influential Women in Arizona Business (2013)
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)

Publications & Speeches

Presenter, “AI Governance and the Evolving Regulatory Landscape,” Arizona Hospital and Healthcare Association Leadership Conference (Oct. 16, 2024)
Co-Commenter (with Erin Dunlap), “OCR’s Update on Online Tracking Guidance Still Tricky,” Healthcare Risk Management (June 1, 2024)
Co-Commenter (with Erin Dunlap), “Steps to Take in Response to OCR Guidance on Online Tracking,” Healthcare Risk Management (June 1, 2024)
Moderator, “Health AI Governance”, American Health Law Association, The Complexities of AI In Health Care (Chicago, IL, May 17, 2024)
Co-Presenter, “The Cutting Edge of Digital Health Privacy Law”, American Telemedicine Association 2024 NEXUS (Annual Meeting) (Phoenix, AZ, May 5, 2024)
Presenter, “The Legal Landscape for Data Sharing in the U.S.,” Brain Health Nexus Workshop, Washington, D.C. (Mar. 7-8, 2024)
Planning Committee Member, Moderator and Presenter, “Optimizing Public-Private Partnerships for Clinical Cancer Research: A Workshop,” National Academies of Sciences, Engineering, and Medicine (Oct. 17-18, 2023)
Co-Presenter, “Meta Pixel and Other Online Tracking Technologies—Investigation and Legal Response” Arizona Society of Healthcare Attorneys (July 19, 2023)
Co-Presenter, “Web Tracking Technologies Investigation and Response,” Arizona Hospital and Healthcare Association (Jun 8, 2023)
Co-Presenter, “Web-Tracking Technologies: Investigation and Legal Response,” Nashville Healthcare Privacy Network Meeting (April 13, 2023)
Presenter, “Arizona Health Law Annual Review” Arizona Society of Healthcare Attorneys Arizona Health Law Conference (Feb. 24, 2023)
Co-Presenter, “What’s the Big Deal? Tips on Transactions Involving ‘Big Data’ and Genomics,” Academic Medical Centers and Teaching Hospitals and Physicians and Hospitals Law Institutes (Orlando, FL, Jan.30-31, 2023)
Presenter, “AI Compliance Challenges,” CommonSpirit CRP National Summit (Las Vegas, NV Dec. 13, 2022)
Author, “Legal Compliance and Good Data Stewardship in Data Sharing Plans,” Harvard Data Science Review (Jul. 28, 2022)
Co-Presenter, “Health Law Year in Review,” AzSHA Health Law Conference (Feb. 25, 2022)
Co-Presenter, “Year in Review,” AHLA Physicians and Hospitals Law Institute Annual Meeting (Feb. 2, 2022)
Co-Presenter, “Year in Review,” AHLA Fraud and Compliance Forum 2021 (Sept. 21, 2021)
Co-author, “Designing a Trusted Framework for the application of AI in Health Care,” AHLA White Paper (Sept. 3, 2021)
Author, “Coping with Evolving Standards of Data De-identification,” 2021 Health Law Handbook, Thomson Reuters Health Law Series (Aug. 2021)
Co-Presenter, “Year in Review,” AHLA Annual Meeting (June 28, 2021)
Planning Committee Member, Moderator and Presenter, “Changing the Culture of Data Management and Sharing – a Workshop,” National Academies of Sciences, Engineering, and Medicine Virtual Workshop (April 28, 2021)
Presenter, “Legal Considerations – Patient Privacy and Data Security,” National Academies of Sciences, Engineering, and Medicine, National Cancer Policy Forum Workshop on Opportunities and Challenges for Using Digital Health Applications in Oncology (July 13, 2020)
Presenter, “De-identification Demystified: Legal Standards, Risks, and Mechanisms to Prevent Re-identification,” AHLA webinar (April 23, 2020)
Presenter, “Coping with Evolving Standards for De-Identification of Clinical Information,” National Cancer Institute, Workshop: De-identification of narrative clinical documents” (Washington, D.C., Feb.25, 2020)
Moderator and Presenter, “Doing Deals in the Genomic and Big Data Era,” AHLA Academic Medical Centers and Teaching Hospitals Institute (Arlington, VA, Jan.10, 2020)
Presenter, “Navigating Privacy Challenges in Collaborative Care Access,” Health Care Compliance Association – Nashville Regional Compliance Conference (Nashville, TN, Nov. 15, 2019)
Presenter, “Regulatory and Ethical Challenges in “Big Data” Research,” University of California Ethics, Compliance & Audit Symposium (Newport Beach, CA, Oct. 29, 2019)
Presenter, “Privacy in the Use of Big Data for Research,” National Academies of Sciences, Engineering, and Medicine, National Cancer Policy Forum workshop on Applying Big Data to Address the Social Determinants of Health in Oncology (Washington, D.C., Oct. 28, 2019)
Presenter and Moderator, “Protection of Privacy” panel, National Academies of Sciences, Engineering, and Medicine, Forum on Neuroscience and Nervous System Disorders, workshop on Neuroscience Data in the Cloud (Washington D.C., Sept. 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 Futures Council Biannual Meeting (May 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-presenter, “Navigating New Terrain: Recent Developments in Human Subjects Research Regulation,” AHLA Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions (Jan. 25, 2018)
Co-author, “Legal Compliance in Using Biospecimens for Research,” Chapter 4, Health Law and Compliance Update, Wolters Kluwer (2018)
Co-author, “Data Sharing for Clinical Integration and other ‘Big Data’ Initiatives,” AHLA Fundamentals of Health Law (2018)
Co-author, “Privacy Compliance in Clinical Research,” Bloomberg Law (Oct. 2017)
Co-author, “Health Care Data Breaches: Practical Advice for Trying Times,” AHLA Journal of Health Law and Life Sciences (Feb. 2017)

(SEE CV FOR COMPREHENSIVE LIST)

Activities & Memberships

Member, Planning Committee, “Optimizing Public-Private Partnerships for Clinical Cancer Research—a Workshop,” National Academies of Sciences, Engineering, and Medicine (Washington, D.C., October 17-18, 2023)
Member, Planning Committee, “Changing the Culture of Data Management and Sharing – a Workshop,” National Academies of Sciences, Engineering, and Medicine Virtual Workshop (April 28, 2021)
Member, Planning Committee, National Academies of Sciences, Engineering, and Medicine Workshop on Neuroscience Data in the Cloud (May 2019 – Sept. 2019)
Member, Arizona State University Health Futures Council (2018-2021)
American Health Law Association (AHLA) President (2013 – 2014); Fellow (2021); Board of Directors (2006 – 2015); Governance Council (June 2017 to September 2018)
Member, Program Planning Committee for AHLA Artificial Intelligence Convener Session (2020-2021)
Planning Committee, AHLA Academic Medical Centers and Teaching Hospitals Institute (2015 – 2020)
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)

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