Skip to main content

Pat G. Ouellette

(he/him)

Associate

[email protected]

+1.617.348.4759

Share:

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

Health Care Viewpoints Thumbnail

As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has generated plenty of cross-industry interest, for good reason. In some ways similar to the risk-based approach taken by the European Union (EU) in the EU AI Act, the Act aims to regulate developers and deployers of AI Systems, which are defined by the Act as “any machine-based system that, for any explicit or implicit objective, infers from the inputs the system receives how to generate outputs, including content, decisions, predictions, or recommendations, that can influence physical or virtual environments.”

Read more
Health Care Viewpoints Thumbnail

On April 18, 2024, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) released a new Final Rule for its oft-criticized 340B Administrative Dispute Resolution (ADR) Program (2024 Final Rule).

Read more

Preventing discrimination and bias in connection with the use of artificial intelligence (AI) in health care is among the principal current focuses of U.S. Department of Health and Human Services (HHS) and was among the health care directives in the recent Biden Administration Executive Order on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Executive Order). Consistent with these priorities, on April 26, 2024, the HHS Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) released an unpublished version of a new final rule under Section 1557 of the Affordable Care Act (ACA) that aims to broadly address inequity across health care but also requires certain actions of entities covered under Section 1557 around their use of AI in clinical decision-making (Final Rule).

Read more

As promised in the U.S. Department of Health and Human Services (HHS) concept paper in December 2023, the agency published voluntary health care and public health cybersecurity performance goals (HPH CPGs) in January 2024 and then proposed in the HHS FY 2025 Budget to establish certain HPH CPG compliance incentives and penalties for hospitals.

Read more

New Mexico recently became the latest state to receive Centers for Medicare & Medicaid Services (CMS) approval to expand the state’s behavioral health service offerings through mobile crisis intervention teams. Under its new state plan amendment, among other items, New Mexico will make available mobile (i.e., outside of a hospital or other facility setting) crisis and mobile response and stabilization services for individuals at the location in which they are experiencing a crisis, 24 hours a day, 7 days a week, 365 days per year. Mobile crisis services include stabilization of the person in crisis, prevention of further deterioration, and provision of immediate treatment and intervention but may also include telephonic follow-up interventions, such as additional intervention and de-escalation services and coordination with other supports and community partners, for up to 72 hours after the initial mobile response. New Mexico also will offer children’s mobile response and stabilization services (MRSS), which are mobile crisis services but specific to child, youth, and families and include up to 56 days of stabilization services.

Read more

As the Mintz Health Law team welcomes the beginning of 2024, many of its members take a moment to reflect on the exciting growth of the Health Law Practice, opportunities to partner with clients on complex legal issues, and the celebration of numerous milestones.

Read more

With the goal of enhancing health care quality and outcomes for individuals with moderate to severe behavioral health conditions and substance use disorders (SUD), the Centers for Medicare & Medicaid Services (CMS) recently announced it will launch the state-based, voluntary Innovation in Behavioral Health (IBH) Model in fall of 2024.

CMS will circulate a Notice of Funding Opportunity (NOFO) in spring of 2024 and select up to eight states to participate in the IBH Model, which is expected to last for eight years. Selected states will align with their respective state Medicaid agencies (SMAs) on clinical policies for integrated care and work with Medicaid Managed Care Organizations (MCOs) or other partners for model development and implementation. 

Read more

As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the regulatory environment with modern health care delivery, cutting-edge technologies, and innovative data-sharing techniques. Some of this work has been done in the form of federal agency guidance in which health care organizations will be looking for additional updates and there are also a handful of pending U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) proposals that call for substantial changes to the HIPAA Privacy Rule.

Read more

The Department of Health and Human Services (HHS) was tasked with formalizing and coordinating efforts to regulate artificial intelligence (AI) in health care under the November 2023 Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI EO) and has already begun its regulation of AI within certain certified health IT.  HHS and Office of the National Coordinator for Health Information Technology (ONC) recently published the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.

Read more
Read less

News & Press

Press Release Thumbnail

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.

News Thumbnail
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". 
News Thumbnail
Mintz Associate Patrick Ouellette co-authored an article published by Compliance Today titled "'Low-Hanging Fruit' and Other Recent HIPAA Compliance Items".
News Thumbnail
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".
News Thumbnail
Mintz Associate Patrick Ouellette authored an article published by Health Law Weekly titled "Comparing and Contrasting AKS and EKRA Safe Harbors: Clinical Lab Impact". 
News Thumbnail
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". 
News Thumbnail
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".
Read less

Recognition & Awards

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

Read less

Involvement

  • Member, International Association of Privacy Professionals
Read less