On May 26, 2016, the Food and Drug Administration (FDA) approved Probuphine as part of a targeted initiative by the U.S. Department of Health and Human Services (HHS) and the FDA to reduce prescription opioid and heroin-related overdose, death and dependence.
Health and Human Services, Labor and Treasury Departments Release New Summary of Benefits and Coverage Templates and Accompanying Documents
The Departments of Health and Human Services (“HHS”), Labor (“DOL”), and Treasury (the “Departments”) have jointly released final changes to the Summary of Benefits and Coverage (“SBC”) template, the Uniform Glossary, and accompanying documents.
The Scope of FDA’s Proposed Revisions to the IND Regulations May Not Be Sufficient to Achieve Its Stated Goals
Last week, the U.S. Department of Health and Human Services (“HHS”) announced that FDA intends to update its regulations governing clinical studies of new drugs.
In a move that could affect all hospitals reimbursed by Medicare, the American Hospital Association (AHA) this week renewed strenuous objections to various aspects of ongoing hospital compliance reviews conducted by the Department of Health and Human Services (HHS) Office of Inspector General (OIG).
Covered Entities need to continue to check their inboxes for emails from the HHS Office for Civil Rights (“OCR”) requesting verification of contact information in connection with Phase 2 of the HIPAA Audit Program.
“A most curious and convoluted argument whose mother was undoubtedly necessity,” wrote Judge Rosemary M. Collyer in describing the argument made by the U.S. Department of Health and Human Services (HHS) to uphold the constitutionality of cost-sharing reduction payments to insurers under Section 1402 of the Affordable Care Act (ACA).
The United States Supreme Court (SCOTUS) on Monday remanded to the lower courts its docket of cases raising the question of whether the Department of Health and Human Services (HHS) sufficiently accommodated religiously affiliated non-profits in its exception from the contraceptives mandate.
An overview of stakeholder comments on the redefinition of “biospecimen” as a “human subject” and the consent requirements for secondary use of these biospecimens.
Daily struggles to protect personal data from hacking, phishing, theft and loss make it easy to forget that HIPAA is not just about privacy and security.