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Pat G. Ouellette

(he/him)

Associate

[email protected]

+1.617.348.4759

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Pat is an attorney who focuses his practice on representing health care organizations and is a Certified Information Privacy Professional–US (CIPP–US). He advises clients on a broad spectrum of health care regulatory, clinical trial, data privacy, PBM, health care technology, and transactional matters. He has experience drafting and negotiating health care services agreements and with technology transactions as well as counseling clients on state licensure rules, compliance with fraud and abuse laws, privacy and data protection issues, and the Interoperability and Information Blocking Rules under the 21st Century Cures Act.

Prior to joining Mintz, Pat was corporate counsel for a Massachusetts-based company that provides products and services to individuals with renal disease. In that role, he provided counsel on a broad range of regulatory and compliance matters and drafted and negotiated acute care and other health services agreements. Earlier, he was an assistant general counsel for information technology with the Massachusetts Executive Office of Health and Human Services, where he negotiated technology transaction agreements and assisted with privacy issues. He also previously worked as an attorney with a Massachusetts-based consulting company focused on health care cost containment.

Pat earned his JD with a concentration in Health & Biomedical Law, with distinction. In law school, he served as chief content editor of Suffolk Law’s Journal of Health & Biomedical Law.

While attending law school, Pat worked in the development office of a teaching hospital affiliated with a preeminent medical school. He also served as a legal intern in the hospital’s Office of the General Counsel and as a certified student attorney with the Massachusetts Executive Office of Health and Human Services.

Before law school, Pat worked as sports writer and an editor for B2B health care and technology publications.

Pat is an editor of and contributor to the firm's Health Care Viewpoints.

viewpoints

In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a much-anticipated framework to establish and manage “appropriate disincentives” for health care providers under the Information Blocking Rules. As described in more detail in the blog post, the proposed rule (Appropriate Disincentives Proposed Rule) includes proposed disincentives for (i) hospitals and critical access hospitals (CAHs) participating in the Medicare Promoting Interoperability Program; health care providers eligible for Merit-Based Incentive Payment System (MIPS) adjustments; and health care providers participating in the Medicare Shared Savings Program (MSSP).
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On October 30, 2023, the Biden Administration released and signed an Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Executive Order) that articulates White House priorities and policies related to the use and development of artificial intelligence (AI) across different sectors, including health care.
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The Office for Civil Rights (OCR) recently offered covered entities and business associates (Regulated Entities) not-so-subtle reminders in its October 2023 Cybersecurity Newsletter that effective sanction policies can encourage HIPAA compliance.​​​​​​​ Regulated Entities are required by HIPAA to implement sanction policies in which they impose “appropriate sanctions” against their respective workforce members who fail to comply with the Privacy Rule or Security Rule, the Regulated Entity’s privacy policies and procedures, and/or the Regulated Entity’s security policies and procedures, as applicable. These sanction policies are important administrative safeguards meant to ensure there are objective, documented consequences for HIPAA non-compliance among workforce members. The recent proliferation of social engineering attacks and increasingly sophisticated nature of external cybersecurity threats in health care underscore the importance of Regulated Entities consistently reviewing and applying sanction policies.
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Mintz IRA Update — Inaugural Edition

September 20, 2023 | Blog | By Theresa Carnegie, Tara E. Dwyer, Mitchell Clough, Xavier Hardy, Stephnie John, Bridgette Keller, Lauren Moldawer, Pat Ouellette, Hassan Shaikh

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Though there has been much speculation and commentary among industry stakeholders, the Office of Inspector General (OIG) and the Office of the National Coordinator for Health Information Technology (ONC) have not yet begun enforcing statutory penalties associated with violations of the Information Blocking Rules. On July 3, 2023, OIG and Department of Health and Human Services (HHS) took a significant step toward enforcement of these penalties when they published long-awaited civil monetary penalty (CMP) final rule (CMP Final Rule) for certain Information Blocking Actors in the Federal Register.
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Federal Trade Commission’s GoodRx Settlement: Not Just a $1.5 Million Penalty

March 8, 2023 | Blog | By Lara Compton, Pat Ouellette

The Federal Trade Commission (FTC) recently kicked off enforcement of its Health Breach Notification Rule (Breach Rule) by taking aim at GoodRx’s use of tracking technologies (e.g. pixels) and the sharing of consumer health data for advertising purposes. According to Samuel Levine, director of the FTC's Bureau of Consumer Protection, the FTC “is serving notice that it will use all of its legal authority to protect American consumers' sensitive data from misuse and illegal exploitation." Bottom line, HIPAA applicability may no longer be as significant of a factor when it comes to the risk presented by collecting, using, disclosing, and maintaining identifiable health information (IHI).
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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.
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News & Press

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Mintz is pleased to announce that 32 attorneys have been named Massachusetts Super Lawyers and 27 attorneys have been named Massachusetts Rising Stars for 2023.
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Mintz Associate Patrick Ouellette co-authored an article published by the American Health Law Association titled "Medicare Advantage and Medicare Part D 2022 Final Rule". 
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Mintz Associate Patrick Ouellette co-authored an article published by Compliance Today titled "'Low-Hanging Fruit' and Other Recent HIPAA Compliance Items".
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Mintz Associate Patrick Ouellette co-authored an article published by The Health Lawyer titled "Analyzing the First Eliminating Kickbacks in Recovery Act (EKRA) Enforcement Action and Its Application to Federal and State False Claims Statutes".
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Mintz Associate Patrick Ouellette authored an article published by Health Law Weekly titled "Comparing and Contrasting AKS and EKRA Safe Harbors: Clinical Lab Impact". 
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Mintz Associate Patrick Ouellette authored an article published by The Self-Insurer titled "The Practical Impact of Ariana M. v. Humana Health Plan of Tex., Inc. on ERISA Denials of Benefits". 
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Mintz Associate Patrick Ouellette authored an article published by Journal of Health & Biomedical Law titled "Class Arguing False Advertising of Health Supplement Meets Sixth Circuit's Moderate Rule 23 Standards".
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Events & Speaking

Recognition & Awards

  • Massachusetts Super Lawyers Rising Stars: Health Care (2023)

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Involvement

  • Member, International Association of Privacy Professionals
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