Danielle E. Sapega

Member

Recent Publication:

State AG Pulse | State AGs Weigh In On GLP-1s

In the final episode of Season 5, Keturah Taylor talks with Cozen O’Connor colleagues Danielle Sapega and Rick Van Buren about the complex regulatory environment for GLP-1 drugs—including increasing state AG scrutiny—and they outline a road map to help legitimate market participants avoid pitfalls.

Danielle is a health care and life sciences attorney focused on transactions and regulatory compliance. She advises clients on sophisticated transactions in nuanced health care sectors, assisting with due diligence, pre- and post-transaction compliance, licensing, regulatory filings, risk mitigation, and operational transition issues. She also regularly counsels clients on technical federal and state health law matters, including fraud and abuse, privacy and data breach incidents, Medicare and Medicaid reimbursement-related issues and audits, corporate practice of medicine and fee-splitting prohibitions, and general corporate compliance. Danielle is considered go-to counsel for compliance, training, and advice on HIPAA.

Danielle also advises clients on FDA regulatory and compliance matters, focusing on the regulations governing the approval, compliance, and marketing of drugs and medical devices. She supports clients in navigating the evolving landscape of FDA policies and guidance, offering tailored insights to address the complexities of the development and commercialization of new products. She also provides strategic counsel to FDA-regulated entities in transactions. Her clients include pharmaceutical companies, startups, and manufacturers.

Before joining Cozen O’Connor, Danielle was associate counsel at Penn Medicine Lancaster General Health (LGH) where she negotiated hospital contracts and counseled hospital leadership on HIPAA, fraud and abuse laws, governance, policy management, medical credentialing, governmental survey preparation and accreditation, and regulatory filings. She also provided counsel to the LGH Research Institute, including negotiating clinical trial sponsorship agreements and assisting with maintaining the institute's AAHRPP accreditation. 

Danielle has many years of experience serving as a member of multiple Institutional Review Boards. In this role, she provided legal perspective on informed consent documents and clinical protocols, assisting with regulatory compliance, ethical standards, and risk mitigation. 

Danielle earned her bachelor’s degree in political science from the University of Michigan and her law degree from Temple University Beasley School of Law. Danielle also holds a master’s degree in health policy from Thomas Jefferson University College of Population Health, and has completed graduate coursework in drug and device regulatory affairs through UC Berkeley.

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Experience

News

Cozen O'Connor's Corporate Practice Selected as a 2024 Best Corporate Practice of the Year Finalist by The American Lawyer

September 05, 2024

Cozen O’Connor is pleased to announce that the firm’s Corporate Practice has been selected by The American Lawyer as a 2024 Best Corporate Practice of the Year finalist for 2024.

Cozen O’Connor Represents Albaron Partners in First Private Equity Exit in U.S. Podiatry

January 09, 2024

PHILADELPHIA, January 9, 2024 — Cozen O’Connor advised Albaron Partners, a middle-market private equity firm focused on founder-led health care companies, in its sale of Albaron Podiatry Holdings LLC d/b/a Beyond Podiatry, a leader in the management of podiatric medicine in the Midwest, to CUC Inc. The deal represents the first private equity exit in U.S. podiatry history.

Cozen O’Connor Promotes 15 Attorneys to Member

March 25, 2021

Cozen O'Connor promoted 15 attorneys to member: Donnie Apodaca, Brian Burack, Jason Cabrera, Kristina Cherevas, Jonathan Gale, Matthew Glavin, Yehudah Gordon, Max Kaplan, Jason Kreps, Anna Will Kentz, Daniel Levine, Peter Lim, Matthew Policastro Laura Reinhart, and Danielle Sapega.

Pro Bono Lawyers at Weber Gallagher, Cozen O'Connor and Other Firms Have Gotten Creative in COVID-19 Response

May 06, 2020

Greg Fliszar and Danielle Sapega were quoted in The Legal Intelligencer about their pro bono work with the Physician Support Line during the COVID-19 pandemic.

Publications

State AG Pulse | State AGs Weigh In On GLP-1s

June 30, 2025

In the final episode of Season 5, Keturah Taylor talks with Cozen O’Connor colleagues Danielle Sapega and Rick Van Buren about the complex regulatory environment for GLP-1 drugs—including increasing state AG scrutiny—and they outline a road map to help legitimate market participants avoid pitfalls.

The Health Law Handbook

December 06, 2024

Christopher Raphaely and Danielle Sapega authored a chapter of the sixteenth edition of The Health Law Handbook.

HIPAA “Right of Access” Enforcement Trend Continues [Health Law Informer Blog]

September 27, 2022

The Office of Civil Rights of the Department of Health and Human Services (“OCR”) announced the resolution of three more right of access cases, bringing the total to a whopping 41 since the start of its drive to increase compliance with this Health Insurance Portability and Accountability Act...

Office of Civil Rights Releases Patient Privacy Guidance in the Wake of Dobbs Decision [Health Law Informer Blog]

July 01, 2022

Patient privacy concerns are at an all-time high following the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization. Following their statements affirming that abortion constitutes basic and essential health to which every woman should be entitled issued by both Xavier Becerra,...

Compliance with the hospital price transparency law almost a year in: Where are we now? [Cosmos]

December 01, 2021

Christopher Raphaely and Danielle Sapega co-authored an article about the Centers for Medicare & Medicaid Services (CMS) hospital price transparency rule, which has been in effect since January 1, 2021.

HHS, Treasury and Labor Release First Set of Surprise Billing Rules [Health Law Informer Blog]

July 02, 2021

The United States Departments of Health and Human Services, Treasury and Labor released interim final rules (“Rules”) regarding the “No Surprises Act” (“Act”) yesterday. The Rules are effective beginning on January 1, 2022. They cover the requirements for the billing and payment of emergency and...

Northern District of California Grants Preliminary Injunction Against Most Favored Nation Rule [Health Law Informer Blog]

December 29, 2020

On December 28, 2020, the District Court for the Northern District of California granted a motion for a preliminary injunction enjoining the Centers for Medicare and Medicaid Services from implementing the Most Favored Nation Rule (the “Rule”, summarized in our December 23 post) until the notice...

District Court grants TRO on Most Favored Nation Rule [Health Law Informer Blog]

December 23, 2020

On December 23, 2020, The District Court for the District of Maryland granted a temporary restraining order temporarily ceasing the implementation of the Centers for Medicare and Medicaid Services’ (“CMS”) Most Favored Nations Rule (the “Rule”) for fourteen (14) days. The Rule, published on...

CMS Releases Final Stark Rules To Promote Value-Based Care [Health Law Informer Blog]

November 23, 2020

On Friday, November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released final regulations to remove certain barriers to the implementation of physician compensation arrangements under value-based payment arrangements posed by the “Stark” Physician Self-Referral law. The...

Pennsylvania Act 80: Central Service Technician and Surgical Technologist Regulation Act [Health Law Informer Blog]

November 06, 2020

On October 29, 2020, Governor Wolf signed House Bill 81 into law, creating new minimum education and certification requirements for central service technicians and surgical technicians working in the Commonwealth, and regulating the practice of surgical technology. The Act will take effect on...

Events & Seminars

Past Events

Health Care & Life Sciences 2025

December 05, 2024 - Philadelphia, PA

Health Law 2024

December 05, 2023 - Philadelphia, PA

Health Law 2022

December 08, 2021 - Webinar

Health Law 2021

December 07, 2020 - Webinar

Education

  • Temple University—James E. Beasley School of Law, J.D., 2011
  • Thomas Jefferson University College of Population Health, M.S., 2018
  • University of Michigan, B.A., 2007
  • New Jersey
  • Pennsylvania