In a new post on the Covington Digital Health blog, our colleagues discuss recently issued proposed rule to implement statutory amendments enacted by Section 3221 of the 2020 Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”).  Specifically, the proposed rule would harmonize certain provisions of the Confidentiality of Substance Use Disorder Patient Records under 42 C.F.R. Part 2 (“Part 2”) with the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”).   The post highlight specific sections of the proposed rule that would modify Part 2 in accordance with the CARES Act.

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Photo of Anna D. Kraus Anna D. Kraus

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into…

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and HIPAA privacy and security. Anna is co-chair of the firm’s Health Care Industry practice group.

Anna regularly advises clients on Medicare reimbursement matters, particularly those arising under Part B and the Part D prescription drug benefit. She also has extensive experience with the Medicaid Drug Rebate program. She assists numerous pharmaceutical and device manufacturers, health care providers, pharmacy benefit managers, and other health care industry stakeholders to navigate the challenges and opportunities presented by the Affordable Care Act.

Anna is a trusted adviser on health information privacy, security and breach notification issues, including those arising under the Health Insurance Portability and Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. Her background in this area dates back to the issuance of the original HIPAA privacy regulations.

Anna’s clients depend on her to guide them through compliance with the Anti-Kickback statute, the Stark regulations, and other laws preventing fraud and abuse in the health care industry. Her deep knowledge of these laws has made her an important component of the firm’s representation of pharmaceutical companies and health care organizations under federal investigation or facing allegations under the False Claims Act. In addition, clients contemplating acquisitions in the health care sector rely on her to guide due diligence efforts.

Photo of Olivia Vega Olivia Vega

Olivia Vega advises global companies on a broad spectrum of privacy, healthcare, and technology matters, helping them navigate both established and emerging laws and regulations. Her practice includes helping clients comply with state privacy laws, such as the California Consumer Privacy Act and…

Olivia Vega advises global companies on a broad spectrum of privacy, healthcare, and technology matters, helping them navigate both established and emerging laws and regulations. Her practice includes helping clients comply with state privacy laws, such as the California Consumer Privacy Act and the Washington My Health My Data Act, as well as federal frameworks like HIPAA and the privacy standards established by the Federal Trade Commission.

As part of her practice, Olivia helps clients develop privacy notices and policies, negotiate privacy terms with third-party vendors, and design governance programs for new products and services. Olivia also represents clients in enforcement actions brought by the Federal Trade Commission, particularly in areas like data privacy, artificial intelligence, and marketing practices. In addition, she plays a key role in advancing clients’ advocacy efforts during regulatory rulemaking processes on issues related to data privacy, cybersecurity, and artificial intelligence.

Olivia maintains an active pro bono practice, including assisting small and nonprofit entities with data privacy topics.

Photo of Elizabeth Brim Elizabeth Brim

Elizabeth Brim is an associate in the firm’s Washington, DC office, where she is a member of the Data Privacy and Cybersecurity and Health Care Practice Groups and advises clients on a broad range of regulatory and compliance issues related to privacy and…

Elizabeth Brim is an associate in the firm’s Washington, DC office, where she is a member of the Data Privacy and Cybersecurity and Health Care Practice Groups and advises clients on a broad range of regulatory and compliance issues related to privacy and health care.

Elizabeth’s practice includes counseling clients on compliance with the complex web of health information privacy laws and regulations, such as HIPAA, the FTC’s Health Breach Notification Rule, and state medical and consumer health privacy laws as well as state consumer privacy and genetic privacy laws. She also advises clients on health care compliance issues, such as fraud and abuse, market access, and pricing and reimbursement activities.

Elizabeth routinely advises on regulatory compliance as part of transactions, clinical trial programs, collaborations and other activities that involve genetic data, and the development and operation of digital health products. As part of her practice, Elizabeth routinely counsels clients on drafting and negotiating privacy and health care terms with vendors and third parties and developing privacy notices and consent forms. In addition, Elizabeth maintains an active pro bono practice.

Elizabeth is an author of the American Health Law Association treatise, Pricing, Market Access, and Reimbursement Principles: Drugs, Biologicals and Medical Devices and the U.S. chapter of the Global Legal Insights treatise, Pricing & Reimbursement Laws and Regulations.