Skip to main content

Kate Stewart

Of Counsel

[email protected]

+1.617.348.4868

Follow:
Share:

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.
Read less

viewpoints

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.

Read more

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.

Read more

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.

Read more

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.

Read more
On January 12, 2022, the co-owner of a clinical research site in Miami, Florida pleaded guilty to one count of obstruction of justice after she knowingly lied to a United States Food and Drug Administration (FDA) investigator during a 2017 regulatory inspection. Olga Torres co-owned the clinical research site, Unlimited Medical Research (UMR). During its years of operation, UMR was engaged as a clinical trial site by a number of pharmaceutical companies. The conduct that led to the obstruction of justice charge stemmed from a clinical trial conducted at UMR to evaluate the safety and efficacy of a pediatric asthma drug.
Read more

Webinar Recording: Telehealth Regulation & Enforcement: 2021 Year in Review & 2022 Outlook

December 7, 2021 | Webinar | By Alexander Hecht, Ellen Janos, Karen Lovitch, Kate Stewart

Over the past year, the demand for health care via telehealth has continued to skyrocket as a result of the COVID-19 pandemic and the public’s increased comfort with obtaining health care goods and services virtually. Join Ellen Janos, Karen Lovitch, Kate Stewart and Alex Hecht as they demystify the current status of laws and regulations, untangle the web of legislation before Congress related to the expansion of telehealth services, discuss recent enforcement activity, and look ahead to trends we see on the horizon.  
Read more

Have You Updated Your HIPAA Security Risk Assessment Lately?

September 29, 2021 | Blog | By Kate Stewart

Last week, the HHS Office for Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC) hosted a webinar on the HIPAA Security Risk Assessment Tool (SRA Tool).  The webinar provided a guided tour of the SRA Tool, answered frequently asked questions, and gave updates on upcoming enhancements to the SRA Tool.  Most importantly, the webinar serves as yet another reminder for entities subject to HIPAA of their obligation to perform a security risk assessment and to update that assessment on a periodic basis and in response to new business processes, operations, and threats.
Read more
Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid package passed last week. Beginning with data reported in 2022, the Sunshine Act will cover payments made to advanced practice nurses and physician assistants. The change will also impact state laws requiring the reporting of payments made to these provider types, which will be preempted by federal law.
Read more
Employers with workers in Massachusetts will have a lot to do between now and October 1, 2018, when reforms to Massachusetts non-compete laws go into effect.
Read more
Clinical laboratories and hospitals should note the potential changes to the Protecting Access to Medicare Act of 2014 (“PAMA”) reporting requirements tucked into the 1,400 page Physician Fee Schedule Proposed Rule (the “Proposed Rule”) released by CMS earlier this month.
Read more
Read less

News & Press

Press Release Thumbnail Mintz

Mintz advised Seven Starling, a virtual health provider specializing in mental health care during fertility, pregnancy, postpartum, and early parenthood, on its $8M Series A-Prime financing, led by Rethink Impact. 

Press Release Thumbnail Mintz

173 Mintz attorneys across 53 practice areas have been recognized by Best Lawyers® in the 2026 edition of The Best Lawyers in America©. Five Mintz attorneys received 2026 “Lawyer of the Year” awards, and 61 firm attorneys were included in the 2026 edition of Best Lawyers: Ones to Watch.

Press Release Thumbnail Mintz

Mintz has earned top rankings in the 2025 edition of Legal 500 United States and Canada guides. The firm is recognized in 20 practice categories, and 78 of its attorneys are individually ranked in the guide, with several receiving recognition in more than one category. Additionally, two attorneys are featured in the "Hall of Fame," seven attorneys are named "Leading Lawyers," and five attorneys are recognized as a "Next Generation Lawyers."

Press Release Thumbnail Mintz

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.

Press Release Thumbnail Mintz

Mintz has earned top rankings in the 2024 edition of Legal 500 United States guide. The firm is recognized in 14 practice categories, and 72 individual attorneys are also recognized in the guide, some in more than one category. Additionally, two attorneys are featured in the "Hall of Fame," three attorneys are named "Leading Lawyers," four attorneys are recognized as a "Next Generation Lawyers" and one attorney is recognized as a "Rising Star."

Press Release Thumbnail Mintz

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©.

Press Release Thumbnail Mintz

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.

News Thumbnail Mintz
Mintz Of Counsel Kate Stewart was quoted in an edition of HCPro’s “Briefings on HIPAA” regarding policy and procedure considerations for HIPAA compliance officers with the Office of the National Coordinator for Health Information Technology (ONC)’s 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program in effect.
News Thumbnail Mintz
Mintz Of Counsel Kate Stewart was quoted in an article published by SC Magazine on an increase in private party litigation after outages, ransomware, and data breaches in health care. Ms. Stewart commented on the emerging trend and shared policy and procedure considerations for providers to help defend against these potential lawsuits.
Press Release Thumbnail Mintz
Mintz is advising a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their acquisition of Curo Health Services, one of the nation’s leading hospice providers. The definitive agreement was announced on April 23, 2018. The deal is valued at approximately $1.4 billion.
Read less

podcasts

Health Law Diagnosed – Understanding the New Massachusetts Health Care Market Review Law

March 11, 2025 | Podcast | By Bridgette Keller, Deborah Daccord, Kate Stewart, Cassandra Paolillo

Host Bridgette Keller discusses the new Massachusetts Health Care Market Review Law and what this means for health care providers, investors, and other key stakeholders. She is joined by Member Deb Daccord, Of Counsel Cassie Paolillo, and Of Counsel Kate Stewart, who share their insights on the law’s far-reaching implications.

Read more

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.

Read more

Health Law Diagnosed: Transactions Part 2: 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.

Read more

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

2021 was a busy year for Mintz ’s Health Law team, as they helped clients navigate complex health care transactions.
Read more
In this episode of the Health Law Diagnosed podcast, members of the Mintz Health Law team discuss their health law–focused 2022 New Year’s resolutions and how they’re helping clients and colleagues navigate the continued challenges and opportunities of the current era.
Read more
Read less

Events & Speaking

Panelist
Jun
4
2025

2024-2025 MA Health Law Updates: What You Need to Know

Boston Bar Association Health Law Conference

16 Beacon Street, Boston, MA

Conference Reference Image
Speaker
May
9
2024

HIPAA Update for 2024

Organized by HCCA (Health Care Compliance Association)

Webinar

Speaker
Apr
4
2023

Tracking Technologies in Health Care

Women Business Leaders of the U.S. Health Care Industry Foundation

Online Event

Webinar Reference Image
Speaker
Jan
30
2023

Is Your Organization Prepared for Today’s Clinical Research?

Academic Medical Centers and Teaching Hospitals Law Institute 2023

Renaissance Orlando at SeaWorld

Conference Reference Image
Speaker
May
25
2022

The Evolving Health Care Privacy Landscape

Women Business Leaders of the U.S. Health Care Industry Foundation (WBL) Event

Online Event

Webinar Reference Image
Speaker
Speaker
Read less

Recognition & Awards

  • Best Lawyers in America: Ones to Watch - Health Care Law (2024 - 2026)

  • Recognized by The Legal 500 United States for Healthcare: Service Providers (2024)

Read less

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
Read less