News & Analysis as of

Notice of Proposed Rulemaking (NOPR) Comment Period Department of Health and Human Services (HHS)

Bradley Arant Boult Cummings LLP

Top 10 takeaways from the new HIPAA security rule NPRM

On Jan. 6, 2025, the U.S. Department of Health and Human Services (HHS) proposed new regulations to enhance cybersecurity protections for electronic protected health information (ePHI) under the Health Insurance Portability...more

Health Care Compliance Association (HCCA)

Awaiting New Leader, OCR Collects NPRM Feedback, Closes Breach, 14th Access Case

Report on Patient Privacy 21, no. 2 (February 2021) - Unless an extension is granted or the notice of proposed rulemaking (NPRM) is withdrawn, covered entities (CEs) and business associates (BAs) have until late March to...more

Akin Gump Strauss Hauer & Feld LLP

HHS Proposes to Rein In Its Use of Regulatory “Dark Matter”

- HHS is overhauling its process for developing interpretive guidance documents under a new Proposed Rule. - HHS proposes to no longer use “guidance documents” to establish broadly applicable legal obligations on the...more

Bradley Arant Boult Cummings LLP

HHS Proposes Revisions to Part 2 Regulations Governing Confidentiality of Substance Use Disorder Records - Healthcare Alert

On August 26, 2019, the Substance Abuse and Mental Health Services Administration, part of the U.S. Department of Health and Human Services (HHS), published its much-anticipated notice of proposed rulemaking to revise 42...more

McDermott Will & Emery

HHS Proposes to Revise Discount Safe Harbor Protection for Drug Rebates

On January 31, 2019, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (the Proposed Rule) as part of ongoing administration drug pricing reform efforts. The Proposed Rule would modify...more

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