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Kate F. Stewart

Of Counsel

[email protected]

+1.617.348.4868

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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.
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viewpoints

Late on Friday afternoon the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule (MCLFS) made by the Protecting Access to Medicare Act of 2014 (PAMA).
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On Thursday Mintz Levin attorney Daria Niewenhous will be moderating an American Health Lawyers Association webinar entitled “Behavioral Health and ACOs—Challenges and Opportunities.” 
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Back to School – HIPAA 101

August 27, 2015 | Blog

After a summer that saw major data breaches at the Office of Personnel Management and UCLA Health System, this fall is a great time to take your organization back to school on HIPAA compliance and data security.  Here are four items to add to your fall to-do list, no #2 pencils required.
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On July 7th, the House introduced much anticipated bipartisan telehealth legislation.
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Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that would have prevented prescribing via telemedicine. 
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ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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The HHS Office of the National Coordinator for Health Information Technology (“ONC”) recently released a new and improved version 2.0 of their Guide to Privacy and Security of Electronic Health Information.
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In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the prescribed biological product.
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ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.
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Mintz’s Health Care Enforcement Defense Practice has published its most recent Qui Tam Update, highlighting two qui tam cases unsealed in November and December of 2014 and giving an overview of the other 17 cases unsealed during the same time period.
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News & Press

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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©.

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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.

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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.
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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.
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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.
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Events & Speaking

Speaker
May
9
2024

HIPAA Update for 2024

Organized by HCCA (Health Care Compliance Association)

Webinar

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Apr
4
2023

Tracking Technologies in Health Care

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

Online Event

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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

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May
25
2022

The Evolving Health Care Privacy Landscape

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

Online Event

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Recognition & Awards

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

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

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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
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