As former in-house counsel at an academic and community hospital system, Kate provides solutions on a broad range of legal issues affecting health care clients including digital health and privacy regulations, clinical trial compliance, and transactions for for-profit and non-profit clients.
Kate draws on her in-house experience to provide holistic counsel to hospitals, physician groups, clinical laboratories, retail health clinics, pharmacies, and payors, as well as new market entrants and start-ups in the digital health space.
Kate has a depth of experience with regard to clinical and bench research, including contractual matters, FDA regulations and NIH rules, as well as the complex issues at the intersection of transformative models for conducting clinical trials.
Related to privacy compliance, Kate advises clients on implementing and updating HIPAA policies, crafting compliant solutions to data sharing, and responding to potential breaches under HIPAA and state data breach rules.
Kate additionally has extensive experience with physician contracting and licensing and scope of practice issues. Her practice also encompasses representing providers, payors, and investors in mergers and acquisitions and joint ventures. She additionally counsels nonprofit health organizations on entity formation, governance, and tax-exemption issues.
Prior to rejoining Mintz, Kate served as associate general counsel of Beth Israel Lahey Health, where she focused on clinical, bench, and translational research at a major academic medical center, as well as advising community hospitals on regulatory compliance, physician matters, and transactions. She began her career in private practice at Mintz, first as Summer Associate, and then as an Associate in the Health Law Practice. Directly after graduating from law school, Kate was a law fellow at the O’Neill Institute for National and Global Health Law at Georgetown University, where she focused on international health governance, pre-exposure prophylaxis for HIV/AIDS, and food and drug safety issues.
Experience
- Provided state and federal health care regulatory advice to telehealth pioneer Amwell.
- Served a secondment to a behavioral health administrator, providing guidance on HIPAA compliance and other matters.
- Counseled providers and telehealth companies regarding multi-state telemedicine practice, including prescribing through telemedicine, corporate practice of medicine, reimbursement and licensing issues.
- Drafted and negotiated clinical trial agreements for a pre-clinical pharmaceutical company.
- Counseled private equity sponsors on health care acquisitions, including fraud and abuse issues, licensure, change of ownership, and privacy matters.
- Provided state and federal health care regulatory advice to American Well, a pioneer in telehealth technology.
viewpoints
Health Law Diagnosed — Transactions Part 2: The Role of Health Regulatory Diligence and How to Prepare for a Sell-Side Transaction
March 24, 2022 | Podcast | By Tara E. Dwyer, Xavier Hardy, Bridgette Keller, Lauren Moldawer, Cassandra Paolillo, Kate Stewart
Health regulatory diligence has the ability to make or break a deal. Listen to hear about our team’s firsthand experience in the importance of conducting health regulatory diligence and best practices in preparing for a sell-side transaction.
Health Law Diagnosed — Transactions Part 1: Regulatory Trends in Recent Health Care Transactions
March 3, 2022 | Podcast | By Xavier Hardy, Bridgette Keller, Lauren Moldawer, Cassandra Paolillo, Kate Stewart
Co-Owner of Clinical Trial Company Pleads Guilty to Obstruction of Justice in Connection with Falsification of Clinical Trial Data
January 18, 2022 | Blog | By Jane Haviland, Joanne Hawana , Kate Stewart
Health Law Diagnosed — Mintz’s 2022 Health Law New Year’s Resolutions
January 12, 2022 | Podcast | By Bridgette Keller
Webinar Recording: Telehealth Regulation & Enforcement: 2021 Year in Review & 2022 Outlook
December 7, 2021 | Webinar | By Alexander Hecht, Ellen Janos, Karen Lovitch , Kate Stewart
Have You Updated Your HIPAA Security Risk Assessment Lately?
September 29, 2021 | Blog | By Kate Stewart
Sunshine Act Expands to Advance Practice Nurses and Physician Assistants
October 9, 2018 | Blog
Massachusetts Employers Take Note: Non-Compete Changes Are Coming
August 15, 2018 | Blog
Potential Changes to PAMA Reporting in Medicare Physician Fee Schedule Rule
July 30, 2018 | Blog | By Karen Lovitch
Privacy and Security Round-up – Colorado Data Breach Law, Guidance from OCR
June 20, 2018 | Blog
News & Press
The Best Lawyers in America 2025 Recognizes 184 Mintz Attorneys across 56 Practice Areas
August 15, 2024
187 Mintz attorneys have been recognized by Best Lawyers® in the 2025 edition of The Best Lawyers in America©. Notably, three Mintz attorneys received 2025 “Lawyer of the Year” awards, and 64 firm attorneys were included in the 2025 edition of Best Lawyers: Ones to Watch.
Misplaced Fears Leave Pregnant Subjects Out Of Drug Trials
April 23, 2024
Mintz is pleased to announce that 120 firm attorneys have been recognized as leaders by Best Lawyers® in the 2024 edition of The Best Lawyers in America©.
The deal will take public ProKidney, a leading clinical-stage cellular therapeutics company focused on chronic kidney disease, and is expected to provide up to $825 million in gross cash proceeds.
Briefings on HIPAA: Inside the 21st Century ONC Cures Act
November 1, 2021
Lawsuits Allege Death, Morbidity From Cyberattacks: Is This the Next Phase of Medical Malpractice?
October 7, 2021
Events & Speaking
Tracking Technologies in Health Care
Women Business Leaders of the U.S. Health Care Industry Foundation
Online Event
Is Your Organization Prepared for Today’s Clinical Research?
Academic Medical Centers and Teaching Hospitals Law Institute 2023
Renaissance Orlando at SeaWorld
The Evolving Health Care Privacy Landscape
Women Business Leaders of the U.S. Health Care Industry Foundation (WBL) Event
Online Event
Telehealth Regulation & Enforcement: 2021 Year in Review & 2022 Outlook
Mintz & ML Strategies
Online Event
Recognition & Awards
Best Lawyers in America: Ones to Watch - Health Care Law (2024, 2025)
Recognized by The Legal 500 United States for Healthcare: Service Providers (2024)
Involvement
- Co-Editor, Chapter Newsletter/Blog, Massachusetts-Rhode Island Chapter, Healthcare Financial Managers Association (2014–present)
- Former Board Member, Massachusetts-Rhode Island Chapter, Healthcare Financial Managers Association (2016–2020)
- Member, American Health Lawyer Associate
- Member, American Bar Association
- Member, American Telehealth Association