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Articles by Kyle Hafkey
Healthcare Regulatory Check-Up | October 2025 Recap | JD Supra
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for October 2025, which was relatively quiet due to the federal government shutdown.
HHS OCR Proposes Significant Modifications To HIPAA Security Rule
HIGHLIGHTS The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced on December 27, 2024, and published in the Federal Register on January 6, 2025, a Notice of Proposed Rulemaking (NPRM) proposing extensive modifications to the HIPAA Security Rule.
HHS OCR Proposes Significant Modifications to HIPAA Security Rule | JD Supra
§ 160.101 Statutory basis and purpose. The requirements of this subchapter implement sections 1171–1180 of the Social Security Act (the Act), sections 262 and 264 of Public Law 104–191, section 105 of Public Law 110–233, sections 13400– 13424 of Public Law 111–5, and section 1104 of Public Law 111–148. Please see full publication below for more information.
Final Action On HIPAA Security Rule Modifications Now Projected For July 2027
McDermott Will & Schulte are most popular: within Cannabis & Hemp, Environment and International Law topic(s) Overview The US Department of Health and Human Services’ Office for Civil Rights has extended its projected timeline for finalizing modifications to the HIPAA Security Rule.
FTC Amends Health Breach Notification Rule
On April 26, 2024, the Federal Trade Commission (FTC) issued a final rule to amend its Health Breach Notification Rule (HBN Rule). The HBN Rule works as a compliment and counterpart to the breach notification requirements established under the Health Insurance Portability and Accountability Act (HIPAA) for HIPAA-regulated entities.
Ftc Amends Health Breach Notification Rule to Regulate Health Apps and Expand Breach Notification Requirements | JD Supra
OVERVIEW On April 26, 2024, the Federal Trade Commission (FTC) issued a final rule to amend its Health Breach Notification Rule (HBN Rule). The HBN Rule works as a complement and counterpart to the breach notification requirements established under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for HIPAA-regulated entities.
HHS’s CARES Act Final Rule Better Aligns Part 2 Substance Use Disorder Patient Records Confidentiality Regulations with HIPAA | JD Supra
On February 8, 2024, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) jointly issued a final rule to amend the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations under 42 C.F.R. Part 2 (Part 2), applicable to certain federally assisted SUD treatment programs (Part 2 Programs), to implement Section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
Healthcare Regulatory Check-up Newsletter | October 2023 Recap | JD Supra
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the Anti-Kickback Statute (AKS).
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