CAROL S. ALLIS

**** ***** ****, *******, ******** 21076 • 443-***-**** • ad33y9@r.postjobfree.com

Accomplished technology and regulatory attorney with expertise in drafting and negotiating complex technology transactions in commercial and government sectors, data privacy and security, compliance, product development, and litigation management. Experienced leading legal support for SaaS, software licensing and sales, and channel partnerships.

PROFESSIONAL EXPERIENCE

Health Gorilla, Inc., (Remote) Jan. 2022 – Nov. 2023

CHIEF COMPLIANCE & PRIVACY OFFICER

Advised on legal and regulatory developments in data privacy, security, information blocking, and enterprise risk management. at hyper-growth health IT platform start-up. Responsible for developing an enterprise compliance program, government affairs, and spearheading achievement of QHIN designation in Federally-sponsored TEFCA nationwide health information exchange network and QHIO designation in California state data exchange network. Provided transactional support, advised product development on data governance, and drafted policies and procedures.

Medical Device Innovation Consortium (MDIC), Arlington, VA Jan. 2020 – Dec. 2021

ASSOCIATE GENERAL COUNSEL

In house counsel at FDA-sponsored public-private partnership devoted to medical device safety and efficacy. Led initiative to build real world evidence data cloud to host global health data. Advised on privacy and security, data governance, health IT issues, and Federal grant management. Drafted and negotiated multi-party complex research and commercial transactions with industry and academic healthcare partners in developing innovative research network.

U.S. Department of Health and Human Services, Office of the General Counsel 2010 - 2019

Washington D.C. and Baltimore, MD

ATTORNEY

Lead counsel supporting the Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS) on legal and policy issues related to interoperability, health IT developments and rulemaking. Advised HHS agencies on information blocking, the 21st Century Cures Act, HITECH and HIPAA. Drafted official TEFCA materials and the Common Agreement. Worked on HHS Federal HIT Strategic Plans and the HHS Interoperability Roadmap. Collaborated on developing the ONC/OCR HIPAA Security Risk Assessment Tool. Advised on the ONC Health IT Certification Program, USCDI, Interoperability Standards Advisory, E-health Exchange and State HIE grants. Supported HHS stakeholders on health IT safety, intellectual property, trade secrets and licensing issues. Collaborated and advised ONC on intra-agency data exchange agreements and co-operative agreements.

Provided health IT legal expertise working with the HHS Office of the Inspector General and the Department of Justice on civil fraud enforcement actions involving fraud and abuse related to incentive payments for the adoption of health IT. Collaborated in the drafting of initial model pleadings and corporate integrity agreements in seminal Health IT fraud and abuse prosecutions. Advised ONC on its on-going monitoring of corporate integrity agreements.

Thomson Reuters (now IBM Watson Health/Merative), Ann Arbor, MI 2005 – 2010

SENIOR COUNSEL, Healthcare and Science Division

Drafted and negotiated complex technology transactions involving clinical and management decision support software licensing, SaaS, and data analytics in global government and commercial healthcare markets. Supervised outside counsel on litigation, government protests and appeals. Advised product development on joint ventures and consumer privacy.

Served on the Thomson Reuters global privacy and security committee and disaster recovery team. Collaborated on enterprise risk management, and drafted and implemented privacy and security policies. Negotiated complex multi-party data exchange agreements and HIPAA business associate agreements. Led data breach incident responses.

Served as lead counsel on Medicare and Medicaid payment integrity projects. Participated in RFP processes and bids in government and commercial transactions including FOIA, FAR and DFAR-related compliance concerns. Managed General Services Administration (GSA) schedules and defended GSA and customer audits. Negotiated licensing, distribution, intellectual property rights and royalty agreements with third party software suppliers. Advised on data privacy and security, state and federal regulations, Sarbanes-Oxley compliance, pending legislation and data governance.

CAROL S. ALLIS Page 2

Hackley Health System/Spectrum Health, Muskegon, MI 2004 - 2005

DIRECTOR, CORPORATE COMPLIANCE

Developed compliance program and trained staff on data privacy and security at multi-facility health system.

Law Offices of Alex Berman, P.C., Farmington Hills, MI 2002 - 2004

ASSOCIATE

Disability and workers compensation litigation practice representing mentally and physically disabled individuals.

University of Michigan Health System (UMHS), Ann Arbor, MI 1997 - 2001

GOVERNMENT AFFAIRS AND COMPLIANCE

In-house government affairs representative at UMHS captive health plan, (M-Care). Lobbied, advised and trained management and staff on legislative and regulatory compliance and data privacy matters in healthcare insurance industry. Corporate liaison to government officials and legislators. UMHS’ representative at HMO trade organization legislative committee. Monitored and advised on pending legislation, chaired genetics subcommittee. Organized and supervised defense of NCQA audits, government audits and site visits. Collaborated on strategic planning, product development, contracting, editorial board activities, sales training, marketing materials and enterprise risk management.

Federal Public Defender, Grand Rapids, MI 1997

ATTORNEY

Federal criminal defense practice. Litigated cases involving the death penalty, murder, kidnapping and narcotics.

McInerney Law Offices, Grand Rapids, MI 1996 - 1997

ASSOCIATE

General civil and criminal litigation practice.

KITCH, DRUTCHAS, WAGNER & KENNEY, P.C., Detroit and Ann Arbor, MI 1992 - 1996

ASSOCIATE

Insurance defense litigation practice focused on product liability and defense of hospitals and physicians.

CLERKSHIPS

United States District Court for the Western District of Michigan, Grand Rapids, MI

State of Michigan Twentieth Judicial Circuit Court, Grand Haven, MI

EDUCATION

Juris Doctorate – Case Western Reserve University School of Law, Cleveland, OH

Bachelor of Arts – Political Science, University of Michigan, Ann Arbor, MI

ADMISSIONSState Bar of Michigan • United States Sixth Circuit Court of Appeals • United States District Court for the Western District of Michigan

AFFILIATIONS/MEMBERSHIPS

CARIN Alliance, CARIN Trust Framework Workgroup • American Health Lawyers Association • State Bar of Michigan Health Law Section • University of Michigan Alumni Association • University of Michigan Letterwinners M Club

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