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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

In a recent Antitrust Alert, our colleagues Dionne Lomax, Bruce Sokler, Robert Kidwell, and Shawn Skolky discuss the allegations in the consolidated class actions, In re Blue Cross Blue Shield Antitrust Litig., the court’s analysis, and its market implications.
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Mintz and ML Strategies will host the 3rd Annual Pharmacy & Pharmaceutical Industry Summit on May 8, 2018! This year's summit will take place in Boston and we are thrilled to announce that Massachusetts Governor Charlie Baker will be the keynote speaker. 
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Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of July 24, 2017. This week's preview focuses on the Better Care Reconciliation Act and Senate parliamentary rules. 
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Our colleagues at ML Strategies have provided a Health Care Weekly Preview. This week's preview describes the ongoing wrangling in the Senate over health care reform as well as highlighting the upcoming need to address FDA User Fees and the health care minibus.
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Last week, in a case being watched locally and nationally, the Massachusetts Supreme Judicial Court ("SJC") ruled that local government approval is not required for the operation of a private needle exchange program and that the Town of Barnstable cannot bar such a program from operating.
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As we gear up for a busy week in Washington, D.C., our colleagues at ML Strategies have provided a Health Care Weekly Preview. This week's preview describes upcoming hearing on safety net health programs and prescription drug costs along with the progress of the American Health Care Act.
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In addition to yesterday's post on the June session of Congress, our colleagues at ML Strategies have provided another weekly preview of Congressional activity for the week of June 5, 2017. The preview includes the upcoming schedule of the House and Senate, along with the looming issues of the American Health Care Act, the health care minibus, and tax reform.
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It was a busy April for the Office for Civil Rights (“OCR”) (see our prior post on a settlement from earlier in April). On April 20, OCR announced a Resolution Agreement with Center for Children’s Digestive Health, S.C. (“CCDH”) related to CCDH’s failure to enter into a business associate agreement with a paper medical records storage vendor. 
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Regular readers of our blog know that we’ve been following developments related to biosimilar products for some time (see our past coverage here).  On April 26, 2017, the U.S. Supreme Court heard oral argument in its first case involving the Biologics Price Competition and Innovation Act (“BPCIA”), Amgen v. Sandoz. 
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Today, our colleagues at ML Strategies provided another installment of their Health Care Weekly Preview. The preview highlights upcoming activity in the House and Senate and other hot topics on the Hill.
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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

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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

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Recognition & Awards

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