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, 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 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.
  • 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.
  • Worked with the Arizona Biomedical Research Commission to build clinical and translational research capacity in Arizona, including developing a “virtual” biospecimen bank.

Awards & Recognitions

  • Elected as an American Health Law Association Fellow (2021)
  • Chambers USA: Privacy & Data Security: Health Care, National (2020 – present)
  • Chambers USA: Health Care, Arizona (2015 – present)
  • The Best Lawyers in America©: 2014, 2017 and 2021 Phoenix Health Care Law “Lawyer of the Year”
  • The Best Lawyers in America©: Health Care (2007 – present)
  • The Best Lawyers in America©: Administrative/Regulatory Law (2020 – present)
  • 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, 2022)
  • 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)
  • 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, “Health Law Year in Review,” AzSHA Health Law Conference (Feb. 25, 2022)
  • Presenter, “Year in Review,” AHLA Physicians and Hospitals Law Institute Annual Meeting (Feb. 2, 2022)
  • 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)
  • Commenter, “Arizona: Genetic testing law enters into effect,” OneTrust DataGuidance (Sept. 2021)
  • Contributor, “2021 Health Law Handbook,” Thomson Reuters Health Law Series (Aug. 2021)
  • 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)
  • Co-author (with Melissa Soliz and Erin Dunlap), “Proposed Changes to the HIPAA Privacy Rule: The Good, The Bad and The Ugly – An Operational Perspective,” Coppersmith Briefs (Jan. 25, 2021)
  • Co-author (with Melissa Soliz), “Just in Time Delay: ONC Extends Information Blocking Compliance Deadline to April 5, 2021,” Coppersmith Briefs (Oct. 29, 2020)
  • Presenter, “Legal Considerations – Patient Privacy and Data Security,” National Academies of Sciences, Engineering, and Medicine Virtual Workshop (July 13, 2020)
  • Co-author (with Viki Prescott), “OCR Guidance on Contracting COVID-19 Survivors about Blood Donation,” Coppersmith Briefs (July 7, 2020)
  • Co-author (with Amanda Coulter), “Update: New FDA Guidance on Clinical Trials During COVID-19 Pandemic,” Coppersmith Briefs (May 31, 2020)
  • Presenter, “De-identification Demystified: Legal Standards, Risks, and Mechanisms to Prevent Re-identification,” AHLA webinar (April 23, 2020)
  • Co-author (with Amanda Coulter), “OHRP and FDA Guidance on Clinical Trials during the COVID-19 Pandemic,” Coppersmith Briefs (April 22, 2020)
  • Author, “Suspension of HIPAA Enforcement for COVID-19 Community-Based Testing Sites,” Coppersmith Briefs (April 16, 2020)
  • Co-author (with Amanda Coulter), “COVID-19 and Clinical Trials: Considerations for Sites and Investigators,” Coppersmith Briefs (March 31, 2020)
  • Co-author (with Melissa Soliz and Erin Dunlap), “Communicating with First Responders about Patient COVID-19 Status,” Coppersmith Briefs (March 31, 2020)
  • Co-author (with Melissa Soliz and Erin Dunlap), “Communicating with Health Care Employees about Patient COVID-19 Status,” Coppersmith Briefs (March 30, 2020)
  • Co-author (with Melissa Soliz), “The CARES Act: Sweeping Changes to Substance Use Disorder Privacy Law (42 USC 290dd-2),” Coppersmith Briefs (March 30, 2020)
  • Co-author (with Amanda Coulter), “How the COVID-19 Pandemic Immediately Impacts Clinical Trials: Considerations for Sites and Investigators,” AHLA Health Law Weekly (Mar. 27, 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 (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-author (with Melissa Soliz), “Privacy Compliance in Clinical Research,” Bloomberg Law (Oct. 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)

(SEE CV FOR COMPREHENSIVE LIST OF PUBLICATIONS AND PRESENTATIONS)

Activities & Memberships

  • 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, Arizona State University Health Futures Council (which convenes leaders from across the country to guide the university’s health-related research, education and clinical programs) (November 2018 to present)
  • Member, Planning Committee, National Academies of Sciences, Engineering, and Medicine Workshop on Neuroscience Data in the Cloud (May 2018 – Sept. 2019)
  • 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)

(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

Kristen Rosati

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Kristen Rosati
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