Rosati, Kristen B

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Address: One East Washington Suite 1200, Phoenix, AZ 85004
Lawyer Firm: Polsinelli PC
Phone: 602-650-2000
Fax: 602-264-7033

Areas of Practice Health Care, Privacy and Data Security

"I am fascinated by our clients’ businesses. I am privileged to be a part of their strategic business decisions regarding how to structure data sharing and other collaborative efforts involving health information and research."

Kristen Rosati leads the "Big Data" initiative at Polsinelli. As hospitals and other providers migrate to electronic health records, the health care industry is finding ways to harness that wealth of data for research, quality improvement, clinical integration, public health, and drug safety. Kristen is there to guide her clients through these exciting and complex changes.

Kristen is president of the American Health Lawyers Association, the nation’s largest educational organization devoted to legal issues in the health care field with more than 12,000 members.

A practical and strategic thinker, Kristen has deep experience in:

Data sharing for research, quality improvement, and clinical integration initiativesClinical research compliance and clinical trials contractingHIPAA compliance, including data breaches and Office for Civil Rights investigationsElectronic health record roll-outs, including subsidizing physician purchase of EHRsHealth information exchange

Kristen has been listed in Best Lawyers in America for Health Care since 2007 and was recognized as its 2014 Phoenix Health Care Law "Lawyer of the Year." She was also chosen as one of the 50 Most Influential Women in Arizona Business in 2013 by Arizona Business Magazine.

Key Matters

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 and assisting in the creation of collaborative institutional review board resources.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.Represented health systems and hospitals in responding to data breaches and Office for Civil Rights investigations.Assisted health systems and hospitals in establishing electronic health record 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 assisting in the development of policies and agreements for HIE.


Polsinelli’s Kristen Rosati Elected President of American Health Lawyers AssociationJuly 8, 2013 President – Elect of the American Health Lawyers Association Joins Polsinelli ShughartFebruary 11, 2013

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