In March 2024, the Department of Health and Human Services—through the Office of the National Coordinator for Health IT (ONC)—released a draft 2024-2030 Federal Health IT Strategic Plan for public comment. A collaborative effort between ONC and more than two dozen federal agencies, the plan outlines federal health information technology (health IT) goals and objectives, focusing on improving access to health data, delivering better and more equitable care, and modernizing the nation’s public health data infrastructure. More than just a roadmap of federal government priorities, the plan is also intended to catalyze the private sector.

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Kimberly Castellino Metzger

An experienced litigator, Kimberly Castellino Metzger plays an integral role on national counsel teams representing pharmaceutical manufacturers in courts across the country. She frequently collaborates as either national or local counsel, working closely with co-defendants and other attorneys to achieve favorable results for…

An experienced litigator, Kimberly Castellino Metzger plays an integral role on national counsel teams representing pharmaceutical manufacturers in courts across the country. She frequently collaborates as either national or local counsel, working closely with co-defendants and other attorneys to achieve favorable results for her clients. Kim has extensive experience with pretrial proceedings, including expert, fact witness and 30(b)(6) depositions, dispositive motion practice, Daubert/Rule 702 proceedings, and mediation. She enjoys the challenge of becoming a “non-scientist scientist” as she learns about the disease states, medicine, product science, and epidemiology underlying cases she prepares for trial.

As part of Kim’s healthcare-focused practice, she regularly counsels HIPAA-regulated entities (health care providers, health plans, and their business associates), as well as manufacturers of pharmaceuticals, medical devices, and cosmetics and personal care products, on complex data security and privacy issues, including HIPAA’s Privacy, Security, and Breach Notification Rules, the Cures Act, and GDPR compliance. Kim has earned several certifications through the International Association of Privacy Professionals (IAPP). Her qualifications include:

  • Certified Information Privacy Professional/U.S. Private Sector (CIPP/US).
  • Certified Information Privacy Professional/Europe (CIPP/E), and Certified Information Privacy Manager (CIPM) an industry-recognized combination for GDPR compliance.
  • Fellow of Information Privacy (FIP) in IAPP’s inaugural class in 2016.

Kim has worked with the HIPAA regulations for almost two decades and has extensive experience with and a deep understanding of these and other federal and state health information privacy laws. She works closely with large and small clients to establish and maintain HIPAA-compliant privacy programs – from the ground up, where needed – and counsels them on responding to security incidents and potential data breaches. Kim also proactively and responsively trains clients’ workforces, including the C-suite, on HIPAA privacy and security compliance in an effort to respond to and prevent breaches, and safeguard patient privacy.

Kim’s data security and privacy practice extends beyond healthcare. She regularly counsels clients across industries on compliance with the federal Telephone Consumer Protection Act (TCPA) and Controlling the Assault of Non-Solicited Pornography and Marketing Act (CAN-SPAM), and state consumer data privacy statutes such as the California CCPA/CPRA.

Kim’s practice also includes counseling pharmaceutical drug and medical device companies on various aspects of FDA regulatory compliance, including product classification, registration and listing, and product recalls. She has served on medical-legal-regulatory pre- and post-launch teams to evaluate product claims and warnings, and has worked closely with clients to evaluate product risk.

Kim is a lifelong Midwesterner and worked as a child welfare case manager and therapist before entering law school. She has had in-house experience as an associate director/general counsel for a large community mental health center in Northern Indiana. Kim is a passionate advocate for inclusion and belonging and LGBTQ+ organizations and individuals. She enjoys mentoring law students and early-career attorneys. Kim and her husband, Rick, have four children and a grandson.

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Megan Nigro

Megan Nigro’s practice focuses on the transactional and regulatory aspects of healthcare law.

Megan assists healthcare providers, including hospitals and health systems, home health agencies, and physician groups on mergers and acquisitions, joint ventures, restructuring, and other affiliations. Megan also advises on healthcare…

Megan Nigro’s practice focuses on the transactional and regulatory aspects of healthcare law.

Megan assists healthcare providers, including hospitals and health systems, home health agencies, and physician groups on mergers and acquisitions, joint ventures, restructuring, and other affiliations. Megan also advises on healthcare governance and compliance matters, physician contracting, financing transactions, and changes in healthcare law.

Megan’s experience advising on changes in the laws impacting the healthcare industry includes considering the possible impacts of a data privacy lawsuit on regulatory action and internal policy. Megan has written and presented about this topic, including how to evaluate the risks of using tracking technologies on hospital websites and mobile applications. Megan’s experience advising on healthcare compliance includes reviewing contracts with terms to protect patient information or to obtain patient consent.

Outside of healthcare, Megan assists nonprofit organizations, corporations, and schools with strategic transactions, restructuring, and governance, including a variety of tax-exempt bond transactions.  Megan has served as bond counsel, bondholder representative’s counsel and underwriter’s counsel in connection with governmental and conduit facility transactions.

Megan attended Seton Hall University School of Law where she was a member of the Health Law Forum, the Cybersecurity & Privacy Society, the First Generation Law Student Association, and the Denis F. McLaughlin Advanced Trial Advocacy Workshop. She served as President of the Health Law Forum and was an editor for the Seton Hall Law Review, which published her Comment, Getting to the Good Place: Implementing New Jersey’s Medical Aid in Dying for the Terminally Ill Act. Megan also participated in her law school’s Health Justice Clinic, where she prepared an appeal for a veteran’s discharge upgrade. She received the Center for Social Justice Award for Outstanding Contribution to the Health Justice Clinic and an Excellence in Health Law Award.  Megan has continued helping veterans through her pro bono work at the firm.

Prior to joining the firm, Megan was a Judicial Law Clerk to the Honorable Judge Mary Gibbons Whipple in the Superior Court of New Jersey, Appellate Division.

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