In response to increased cybersecurity threats and significant regulatory enforcement actions, on Dec. 27, 2024, the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking seeking to enhance cybersecurity protections under the Security Rule implemented pursuant to the Health Insurance Portability and Accountability Act of 1996. While the proposed rule is an important component of HHS’ ongoing effort to enhance cybersecurity requirements, many of the proposals raise new questions regarding HHS’ expectations. If adopted, the sweeping changes could have a major impact on the way covered entities and business associates conduct business, including with each other.

Read on for further details on the proposed rule and its implications for regulated entities.

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Photo of Kimberly J. Kannensohn Kimberly J. Kannensohn

Kimberly focuses her practice on the provision of corporate, regulatory and compliance counseling to healthcare and life sciences companies. The cornerstone of her practice is providing guidance to clients regarding HIPAA and the HITECH Act, the Medicare and Medicaid fraud and abuse laws…

Kimberly focuses her practice on the provision of corporate, regulatory and compliance counseling to healthcare and life sciences companies. The cornerstone of her practice is providing guidance to clients regarding HIPAA and the HITECH Act, the Medicare and Medicaid fraud and abuse laws, the Stark Law, Medicare coverage and reimbursement rules, and state healthcare laws and regulations.

Photo of Kristen McDermott Woodrum Kristen McDermott Woodrum

Kristen focuses on transactions and regulatory matters for healthcare industry clients as a partner in the national healthcare practice of McGuireWoods. Kristen anticipates potential issues and provides practical counsel to clients in structuring complex healthcare deals, including mergers, acquisitions, joint ventures, and other…

Kristen focuses on transactions and regulatory matters for healthcare industry clients as a partner in the national healthcare practice of McGuireWoods. Kristen anticipates potential issues and provides practical counsel to clients in structuring complex healthcare deals, including mergers, acquisitions, joint ventures, and other transactions and contracting arrangements. Clients across the industry rely on Kristen’s deep healthcare experience and business-focused approach.

Photo of William Clayton Landa William Clayton Landa

Clay’s practice focuses on assisting national hospital chains, nursing homes, community hospitals, ambulatory surgery centers, private physician practices, solo practitioners, pharmacies, mental healthcare provider, dental providers and laboratories with their corporate, transactional, and regulatory compliance matters.

Photo of Kristen H. Chang Kristen H. Chang

Kristen assists clients in traversing regulatory, compliance, corporate transactional, and reimbursement issues related to the healthcare industry. She counsels clients on the federal Anti-Kickback Statute, Stark Law, Medicare policy, state fraud and abuse laws, state corporate practice of medicine laws, state licensure laws…

Kristen assists clients in traversing regulatory, compliance, corporate transactional, and reimbursement issues related to the healthcare industry. She counsels clients on the federal Anti-Kickback Statute, Stark Law, Medicare policy, state fraud and abuse laws, state corporate practice of medicine laws, state licensure laws, HIPAA, fee-splitting prohibitions, and other regulatory matters.

Photo of Allyson M. Maur Allyson M. Maur

Allyson advises on regulatory issues affecting diagnostics developers, biopharma manufacturers, and clinical laboratories, including CLIA/CLEP and FDA regulatory advice, MLR and MRC review of marketing and promotional materials, clinical studies, global data privacy issues, ethics & compliance, commercial contracting, commercial litigation and more.

Allyson advises on regulatory issues affecting diagnostics developers, biopharma manufacturers, and clinical laboratories, including CLIA/CLEP and FDA regulatory advice, MLR and MRC review of marketing and promotional materials, clinical studies, global data privacy issues, ethics & compliance, commercial contracting, commercial litigation and more. Allyson’s healthcare regulatory work ranges from clinical bioethics and informed consent issues to counseling on compliance with U.S. federal fraud, waste, and abuse laws such as the Anti-Kickback Statute, Stark Law, Sunshine Act, and their state law equivalents, as well as HIPAA, state healthcare privacy laws, change of ownership and state licensing requirements for various healthcare and healthcare adjacent entities.

Photo of Taleena Nadkarni Taleena Nadkarni

Taleena focuses her practice on the healthcare industry, advising clients on transactional, regulatory, and compliance matters.