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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

On March 21st, the HHS Office for Civil Rights officially launched Phase 2 of the HIPAA Audit Program. Covered Entities and Business Associates need to be prepared for these audits and to be on the lookout for emails from OCR that will begin the audit process.
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On March 21st, the HHS Office for Civil Rights (“OCR”) officially launched Phase 2 of the HIPAA Audit Program. Covered Entities and Business Associates need to be prepared for these audits and be on the lookout for emails from OCR that will begin the audit process.
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As reported in yesterday's Boston Globe, compared to national averages, Massachusetts physicians are less likely to receive payments or items of value from pharmaceutical companies and less likely to be heavy prescribers of brand-name drugs.
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As we have repeatedly emphasized on this blog, HIPAA Covered Entities must ensure that they have compliant business associate agreements (“BAAs”) in place with all of their business associates and must ensure that they have performed a comprehensive risk assessment.
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In a chain of events that should be a wake-up call to any entity using and storing critical health information, Hollywood Presbyterian Medical Center (“HPMC”) has announced that it paid hackers $17,000 to end a malware attack on the hospital’s computer systems.
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As 2015 comes to a close and you look ahead to the New Year, we hope that you will consider joining us for an informative webinar on health care enforcement trends for 2016.
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As the year winds down, we look back with a mixture of nostalgia and queasiness on the major Health Insurance Portability and Accountability Act (HIPAA) events that defined 2015. 
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Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects (known as the “Common Rule”) could add a 30-day comment period extension to the things they were grateful for at this year’s Thanksgiving dinner.
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This Halloween, the scariest monsters might not be in your closet or under your bed. They may be overseas, orchestrating intrusions into your electronic medical record. Or they may be lurking in your own workforce, carrying around unencrypted laptops or skipping out on HIPAA training.
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Hospital lawyers, whether in-house or outside counsel, have oversight over many facets of the hospital’s operations. One department they may not be focused on, but should be, is the hospital’s laboratory.
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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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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

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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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