Kristen B. Rosati - Coppersmith Brockelman PLC

Kristen B. Rosati

Listed in Best Lawyers since 2007

Kristen is considered one of the nation’s leading HIPAA compliance attorneys. She also has deep expertise with large data breaches, health information exchange, data sharing for research and clinical integration initiatives, electronic health record roll-outs, clinical research compliance and contracting, biobanking, 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 more than 4 million patients.
  • Advised the Food and Drug Administration on its Sentinel Initiative, an effort to create a national electronic distributed network to monitor medical 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.

  • Represented ONE MIND™ in creating a governance structure and information technology portal to support data sharing for improved diagnostics, more effective treatment, and cures for all types of mental illness and brain injury.

  • 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.    

  • Helped health systems and hospitals across the country in negotiating clinical trial agreements, assuring clinical research compliance, and defending against government investigations related to clinical research.

  • 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.

  • As chair of the Legal Committee for Arizona Health-e Connection and the Health Information Network of Arizona, Arizona's health exchange (HIE) initiative, facilitated the development of statutory and regulatory changes to enable HIE in Arizona, and developed policies and agreements for HIE.

Publications & Speeches

  • Anatomy of a Health Care Data Breach, Aspen Publishers' Health Law and Compliance Update (2014)
  • HIPAA: Once Again a Major Compliance Concern, Health Care Program Compliance Guide, Bloomberg BNA (April 2012 and June 2013)

  • Using Electronic Health Information for Pharmacovigilance: The Promise and the Pitfalls, Journal of Health & Life Sciences Law, Vol. 2, No. 4 (July 2009)

  • Handling Big Data Breaches, AHLA Annual Meeting (Washington DC, June 30-July 1, 2015)

  • Regulatory Compliance in Biobanking, International Society of Biomedical and Environmental Repositories Annual Meeting (Phoenix, AZ, May 6, 2015) (co-speaker Stephen Schmechel)

  • Big Data?  Big Breaches!, AHLA Academic Medical Centers and Teaching Hospitals Institute (Washignton, D.C., Jan. 22-23, 2015)

  • Big Data and Privacy, Association of American Medical Colleges Compliance Officers' Forum (Washington, DC, June 12, 2014)

  • Biospecimen Identifiability, Privacy and Broad Data Sharing, International Society of Biomedical and Environmental Repositories (Orlando, FL, May 24, 2014)

  • Anatomy of a Health Care Data Breach:  Reporting, Investigation and Enforcement, The University of Texas School of Law, 26th Annual Health Law Conference (Houston, TX April 10, 2014)

  • Privacy Protection in Biospecimen Banking, Public Responsibility in Medicine and Research (PRIM&R) (Boston, November 6, 2013)

  • Individual Control and Ownership of Biospecimens, Public Responsibility in Medicine and Research (PRIM&R) (Boston, November 6, 2013)

University of MichiganJ.D. 1990University of MichiganBA 1987
American Health Lawyers Association (AHLA)AHLAHealthcare Leadership Council for the Greater Phoenix Economic Council2014 Planning Committee, Annual Meeting of the International Society of Biomedical and Environmental BiorepositoriesBrookings Active Surveillance Implementation Council at the Brookings Institution (2010 to present)Privacy Panel for the "Mini-Sentinel Coordinating Center" at Harvard Pilgrim (under contract with FDA) (2010 to present)eHealth Initiative National Council on Data and Analytics (2011 to present)

Case History

Dartmouth College High Value Health Care Collaborative — Negotiated collaboration agreement on behalf of Dartmouth College, with Mayo Clnic, Cleveland Clinic, Intermountain Health Care, Denver Health and Dartmouth Hitchcock, to create the High Value Health Care Collaborative.  Under the agreement, the parties agreed to pool data and collaboratively study how they provide high quality health care in an efficient manner. 
FDA Sentinel Initiative — Provided legal advice to the FDA and its subcontractor, Harvard Pilgrim, on the privacy issues involved in creating a distributed data network to utilize hospital electronic health records and health plans claims databases, for post-marketing drug safety sruveillance.
One Mind for Research — Provide strategic advice about compliance with HIPAA and human subject research protection laws, to One Mind for Research.  One Mind is a "new-model non-profit organization that will take the lead role in the research, funding, marketing, and public awareness of mental illness and brain injury, by bringing together the governmental, corporate, scientific, and philanthropic communities in a concerted effort to drastically reduce the social and economic effects of mental illness and brain injury within ten years. With ONE MIND as the hub for open-source big data and research, compelling the scientific, health care, and pharmaceutical communities to collaborate completely for the common good, we can decrease the time from research to treatment/cure from 30 years to less than a decade."
Explorys, Inc. — Represent early stage data services company in data strategy and transactions with major health systems.   Explorys is an innovation spinoff from Cleveland Clinic. Explorys addresses the national imperative to leverage BIG DATA in healthcare for the improvement of medicine and delivery of care. Healthcare data can span across a disparate ecosystem of employed and affiliate providers, payers and plans, care settings, and electronic medical systems; Explorys ties that data together into unique valued action. Originally inspired by physicians and informatics leaders, Explorys combines the most powerful healthcare computing platform in the world with turnkey solutions for clinical integration, at-risk population management, cost of care measurement, and pay-for-performance solutions.

Office Location

2800 North Central Avenue, Suite 1200
Phoenix, AZ 85004-1008
United States

Lawyer of the Year Awards

2017 Lawyer of the Year in Health Care Law of the Phoenix Metro Area2014 Lawyer of the Year in Health Care Law of the Phoenix Metro Area
Kristen B. Rosati has earned a Lawyer of the Year award for 2017!Kristen B. Rosati has earned a Lawyer of the Year award for 2014!

Practice Areas

Health Care Law (Academic Medical Centers, Clinical Research, HIPAA)