On April 22, 2024, the Department of Health and Human Services (HHS) announced a Final Rule titled HIPAA Privacy Rule to Support Reproductive Health Care Privacy. The Final Rule strengthens the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule by prohibiting disclosure of protected health information (PHI) related to lawful reproductive health care under certain circumstances. The Final Rule is designed to promote high-quality health care by fostering trust and communication between individuals and their health care providers.

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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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Kay Klele

Khaled “Kay” Klele is a dedicated and knowledgeable healthcare attorney. He represents numerous clients in the healthcare industry, including group practices, ambulatory surgery centers, urgent care centers, telemedicine providers, laboratories, medispas, infusion centers, healthcare service firms, home health agencies, imaging centers, addiction centers…

Khaled “Kay” Klele is a dedicated and knowledgeable healthcare attorney. He represents numerous clients in the healthcare industry, including group practices, ambulatory surgery centers, urgent care centers, telemedicine providers, laboratories, medispas, infusion centers, healthcare service firms, home health agencies, imaging centers, addiction centers, senior living facilities, management service organizations (MSOs), pharmacies, hospitals, and rural clinics, among others. Kay is well-versed in healthcare litigation, regulatory compliance matters, and transactional matters, providing comprehensive legal support to his clients. To better assist his clients, Kay keeps track of statutory and regulatory changes to both state and federal laws, and routinely writes and speaks on healthcare issues. His in-depth knowledge and experience in healthcare law make him a valuable asset to his clients.

As an experienced litigator, and with extensive knowledge of regulatory issues, Kay represents healthcare clients in a wide range of disputes including payor audits, healthcare reimbursement issues, including ERISA, and claims involving the federal False Claims Act and its state equivalents. He also represents his clients in contract disputes, partnership disputes, facility construction disputes, non-compete actions, as well as other general litigation matters. Additionally, Kay represents individual physicians and other healthcare professionals before their respective boards for investigations and disciplinary actions, as well as in other licensing matters.

Kay also counsels his clients on compliance and operational issues. He provides guidance, among other things, on a variety of licensure issues, the corporate practice of medicine, marketing plans, Stark and Anti-Kickback laws, state self-referral and anti-kickback laws, DEA and controlled substances and prescription issues, HIPAA, fair market value issues, fee-splitting laws, telemedicine, Medicare/Medicaid, federal and state transparency laws, and licensing and certification renewals and transfers.

He is frequently called upon by his clients, including MSOs, to analyze and create compliant business structures or arrangements. He advises MSOs on compliance issues throughout their operations from the MSO’s creation, scaling, and then the ultimate sale of all or part of the MSO.

In his transactional practice, Kay is actively involved in practice and facility mergers and acquisitions, practice consolidation, and private equity healthcare transactions. He assists in the sale and purchase of practices, in creating multi-specialty groups, and drafting provider agreements, independent contracts, and HIPAA Agreements.

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Photo of Alex Major Alex Major

Mr. Major is a partner and co-leader of the firm’s Government Contracts & Export Controls Practice Group. Mr. Major focuses his practice on federal procurement, cybersecurity liability and risk management, and litigation. A prolific author and thought leader in the area of cybersecurity…

Mr. Major is a partner and co-leader of the firm’s Government Contracts & Export Controls Practice Group. Mr. Major focuses his practice on federal procurement, cybersecurity liability and risk management, and litigation. A prolific author and thought leader in the area of cybersecurity, his professional experience involves a wide variety of litigation and counseling matters dealing with procurement laws and federal regulations and standards. His diverse experience includes complex litigation in federal court under the qui tam provisions of the False Claims Act and bid protest actions. He counsels all sizes of companies on issues relating to compliance with government regulations including, among other things, cybersecurity (NIST, FIPS, FedRAMP, and DFARS) requirements, multiple award schedule compliance, Section 508 issues, country of origin requirements under the Buy American and Trade Agreements Acts, cost accounting, and small business requirements. He also regularly conducts internal investigations to assist companies ensure that they are in full compliance with the law.

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