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
National Academies of Science, Engineering, and Medicine Issues Report on Inclusion of Pregnant and Lactating Persons in Clinical Research
May 8, 2024 | Blog | By Madison Castle, Kate Stewart
Last month, the National Academies of Science, Engineering, and Medicine (“NASEM”) issued a report discussing the inclusion of pregnant and lactating people in clinical research and the health impacts of inadequate data from research involving this subpopulation. Titled “Advancing Clinical Research with Pregnant and Lactating Persons: Overcoming Real and Perceived Liability Risks,” the report came as a response to Congress calling upon NASEM to examine the real and perceived prevalence of legal liability resulting from including these research subjects in clinical trials. Overall, the report concluded that legal liability for including pregnant and lactating persons in research is very limited, but that perceptions of potential liability and a lack of explicit guidance for including this population safely have created real barriers to their inclusion. In response, the report provides recommended actions for Congress, the Food and Drug Administration (“FDA”), the National Institutes of Health (“NIH”), and the Office of Human Research Protections (“OHRP”) to take to enhance the inclusion of this population in clinical trials, thereby enhancing data around the safety and efficacy of approved drug products for pregnant and lactating persons. Study sponsors and institutions conducting research should continue to monitor developments in this area, including guidance from FDA.
Fighting for Access to Lifesaving HIV Medicine
November 16, 2023 | Article
Supporting a Road to Recovery for Injured War Survivors
October 17, 2023 | Article
OCR and FTC Issue Joint Statement Warning Health Care Providers and App Developers About Use of Third Party Online Tracking Technologies
July 24, 2023 | Blog | By Kathryn Edgerton, Lara Compton, Kate Stewart
Covered entities, business associates, and any entities that collect health information about consumers online should carefully review the latest joint letter from the Office for Civil Rights (OCR) and the Federal Trade Commission (FTC). On July 20, 2023, the agencies sent a joint letter to approximately 130 hospital systems and telehealth providers warning them about “serious privacy and security risks related to the use of online tracking technologies” such ad Google Analytics and Meta/Facebook Pixel. That letter was subsequently shared publicly and should be reviewed by any entity subject to regulation by either agency.
OCR and FTC Issue Joint Statement Warning Health Care Providers and App Developers About Use of Third Party Online Tracking Technologies
July 21, 2023 | Blog | By Kathryn Edgerton, Lara Compton, Kate Stewart
Covered entities, business associates, and any entities that collect health information about consumers online should carefully review the latest joint letter from the Office for Civil Rights (OCR) and the Federal Trade Commission (FTC). On July 20, 2023, the agencies sent a joint letter to approximately 130 hospital systems and telehealth providers warning them about “serious privacy and security risks related to the use of online tracking technologies” such ad Google Analytics and Meta/Facebook Pixel. That letter was subsequently shared publicly and should be reviewed by any entity subject to regulation by either agency.
Effective July 1, Florida Will Prohibit Offshore Storage of Health Records and Require Additional Ownership Disclosures
June 20, 2023 | Blog | By Kate Stewart, Cassandra Paolillo
A new Florida law will require certain Florida-licensed providers to ensure that patient information is physically maintained only in the continental United States and its territories or in Canada. Florida SB 264, which goes into effect July 1, 2023, amends the Florida Electronic Health Records Exchange Act, adding a ban on offshoring health information that goes beyond the requirements under HIPAA and most other generally applicable health privacy and security laws. Florida licensees to which the new requirements apply will need to attest upon initial licensure and any renewals that they are in compliance with the new requirements. Applicable licensees will also be required to ensure that no individual or entity with a controlling interest in the licensee has an interest in an entity that has a business relationship with certain foreign countries.
OCR Proposes HIPAA Amendments to Protect Reproductive Health Care Information
April 13, 2023 | Blog | By Dianne Bourque, Kate Stewart, Pat Ouellette
In response to concerns about the confidentiality of protected health information (PHI) related to reproductive health care less than one year after Dobbs v. Jackson Women’s Health Organization decision, and the prospect of such PHI being weaponized by states and used against patients, the U.S. Department of Health & Human Services Office for Civil Rights (OCR) has proposed amendments to the HIPAA Privacy Rule to protect that information.
Mintz Health Law: What We Are Grateful For
January 11, 2023 | Podcast | By Bridgette Keller
Bridgette Keller speaks with the Mintz Health Law team about what they are grateful for as they look back on a year of client service, mentorship, and working together as a team.
Is Your Website Collecting PHI Under OCR's New Tracking Technologies Bulletin?
December 7, 2022 | Blog | By Dianne Bourque, Lara Compton, Kathryn Edgerton, Cassandra Paolillo, Kate Stewart
Covered Entities and Business Associates should promptly and carefully review their use of online tracking technologies on their websites and mobile apps following a bulletin (Bulletin) published by the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) last week. The Bulletin addresses multiple facets of compliance with HIPAA when using online third-party tracking technologies (Tracking Technologies). In doing so, OCR significantly expands its interpretation of the definition of Protected Health Information (PHI) to include, in some instances, identifiable information gathered by Tracking Technologies where a user visits a website and does not interact with the entity in any other way. In its Bulletin, OCR interprets the act of an individual visiting a website as evidence of a relationship or anticipated future relationship between the visitor and the entity.
What Would the American Data Privacy and Protection Act Mean for the Health Industry?
June 23, 2022 | Blog | By Kate Stewart, Pat Ouellette
All players in the health and wellness ecosystem should be following developments around the American Data Privacy and Protection Act (ADPPA). If enacted, the ADPPA would be a watershed in the regulation of the privacy and security of personal information, including health information. The ADPPA would have a particularly large impact on entities that currently collect, process, and transmit health information but are not subject to HIPAA.
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