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, clinical research compliance and contracting, biobanking and genomic privacy, 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.
- 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, an effort to create a national electronic distributed network to monitor medical product safety and build a network for research.
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. Kristen advised the parties on various compliance issues in the collaboration, and assisted in building a governance structure to support a long-standing collaboration.
Worked with the Arizona Biomedical Research Commission to build clinical and translational research capacity in Arizona, including developing the Arizona Biospecimen Consortium's “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, governance issues, and commercialization of data and biospecimens.
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.
Selected Publications & Speeches
- Health Care Data Breaches: Practical Advice for Trying Times, American Health Lawyers Association, Journal of Health Law and Life Sciences (Feb. 2017)
- 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)
Into the Breach: Practical Actions to Respond and Minimize Risk, AHLA Physician and Hospital Institute (Orlando, FL, Feb. 3, 2017)
Big Data and Privacy, International Association of Privacy Professionals and the Arizona Hospital and Healthcare Association (Phoenix, Sept. 29, 2016)
HIPAA Breach Reporting, 2016 Essential Cybersecurity Law Conference, University of Texas (Austin, TX, August 19, 2016)
The Intersection of Public Health and Healthcare Law: Emerging Trends in Health Information and Data, Part I: Health Information, Data Sharing, and the Law: A Primer (AHLA and Centers for Disease Control Webinar, May 31, 2016)
In a Different Voice: Ways Women Can Create Innovative Legal Service Models and Differentiate Themselves in a Competitive Market, AHLA Women’s Leadership Institute (Nashville, TN, May 16, 2016)
Legal Restrictions in Distributing Cord Blood for Research, Arizona Biomedical Research Commission (Phoenix, April 7, 2016)
More Issues with the Tissues, AHLA Academic Medical Centers and Teaching Hospitals Institute (Washington, D.C, March 15, 2016)
New Models of Clinical and Research Collaborations, AHLA Academic Medical Centers and Teaching Hospitals Institute (Washington, D.C, March 16, 2016) (panel moderator)
Lawyer and Client Data Breaches, Arizona Association of Health Care Lawyers (Phoenix, November 17, 2015)
A Roadmap for Exchange of Mental Health Data, ConnectHealthcare (Fairfield, California, Nov. 5, 2015)
- 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)