In a Notice of Proposed Rulemaking published December 2, 2022 (the Proposed Rule), the United States Department of Health and Human Services (HHS) proposed long-awaited changes to the regulations protecting the confidentiality of substance use disorder patient records under Part 2 of Title 42 of the Code of Federal Regulations (42 CFR Part 2, or Part 2). Specifically, the Proposed Rule would implement provisions of Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which required HHS to align Part 2 with certain provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and to make certain changes to the HIPAA Notice of Privacy Practices, the form given to patients and plan members that describes patient privacy rights, covered entity duties, and the covered entity’s uses and disclosures of protected health information (PHI).
Major Changes Proposed to Substance Use Disorder Confidentiality Law
Posted In Employee Benefits, Health and Welfare Plans
Scott WeinsteinScott A. Weinstein provides legal counsel on health care regulatory compliance, contracting and transactional due diligence, with a focus on health information privacy and security, Medicare and Medicaid's health information technology and quality reporting requirements, and clinical research regulations. Scott additionally provides legal counsel on federal and state privacy and data protection laws, with a focus on privacy audits and the development of internal and externally facing privacy policies for websites and mobile applications. Read Scott Weinstein's full bio.
Edward G. ZachariasEdward G. Zacharias is the managing partner of McDermott’s Boston office. Clients across the healthcare industry and beyond turn to him for practical, business-oriented counsel on their most significant privacy and cybersecurity compliance, healthcare regulatory and transactional matters. Ed’s clients include “Big Tech” companies, health information technology and digital health companies, healthcare providers, insurers, electronic health record platforms, pharmacies, drug and device manufacturers, life sciences companies and health services vendors. Read Edward Zacharias' full bio.
Abby HigginsAbby Higgins provides regulatory counseling on all aspects of state and federal healthcare laws impacting hospitals and healthcare systems, with a particular emphasis on digital health products and services. Abby has experience handling issues related to fraud and abuse, Stark Law, federal Anti-Kickback Statute (AKS), Food & Drug Administration regulations, cannabis laws and patient data protection. Read Abby Higgins's full bio.
Li WangLi Wang focuses her practice on transactional matters including mergers and acquisitions and private equity transactions in the healthcare industry as well as healthcare regulatory and compliance matters, including fraud and abuse, corporate practice of medicine and Medicare and Medicaid enrollment. Li also has significant experience advising on regulatory matters related to HIPAA, health information privacy and security, genetic privacy, data subject consent requirements and research compliance. Read Li Wang's full bio.
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