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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

Congress returns after Labor Day for a four-week sprint that will likely be centered on funding the government by way of a continuing resolution. Since Congress was last in session, the landscape on a number of health care issues remains unchanged.
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Last week, in Deborah Heart & Lung Center v. Virtua Health, Inc., the Third Circuit affirmed a lower court’s dismissal of a suit filed by a hospital alleging an illegal exclusive dealing arrangement by a competing hospital and physician group for referrals made by the defendants to a third hospital rather than to the plaintiff hospital.
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Capping off a busy month of HIPAA settlements, on August 4, the Office for Civil Rights (“OCR”) announced a $5.55 million settlement with Advocate Health Care Network (“Advocate”), the largest fully-integrated healthcare system in Illinois.
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Expanding on our recent blog post discussing CMS's final rule (the "Final Rule") implementing portions of the Protecting Access to Medicare Act of 2014 related to clinical laboratories, my colleague Karen Lovitch and I published an article in BNA’s Medicare Report entitled CMS Regulations Overhaul Medicare Clinical Laboratory Fee Schedule.
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On Monday, the Office for Civil Rights (OCR) released important new guidance on ransomware for hospitals and other healthcare providers and finally addressed the question of whether electronic protected health information (ePHI) that has been encrypted on a covered entity’s systems, but potentially not accessed by the hacker, has been breached for HIPAA purposes. 
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After waking to news that the UK had voted to leave the EU, our London-based colleague Susan Foster provided insight on what the Brexit will mean for UK data protection laws.
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Last Friday afternoon CMS released its eagerly anticipated final rule (the Final Rule) implementing the Protecting Access to Medicare Act of 2014 (PAMA), which, together with the Final Rule, will make sweeping changes to the rate-setting process under the Medicare Clinical Laboratory Fee Schedule (MCLFS).
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Covered Entities need to continue to check their inboxes for emails from the HHS Office for Civil Rights (“OCR”) requesting verification of contact information in connection with Phase 2 of the HIPAA Audit Program. OCR previously indicated that Covered Entities would begin to receive verification emails in May.
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Last week the Supreme Court heard oral argument in a False Claims Act (“FCA”) case in which the Court is considering the validity of the so-called implied false certification theory. This theory attaches FCA liability when a person submits a claim for payment notwithstanding a violation of an underlying law or regulation, but without a factually false claim form.
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The HHS Office for Civil Rights (“OCR”) officially launched  the long-awaited (and dreaded) Phase 2 of the HIPAA Audits Program on March 21st. Covered Entities and Business Associates need to be prepared for these audits and be on the lookout for emails (check your spam filter!) from OCR that will begin the audit process.
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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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