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.
Over the next few months, the Office for Civil Rights (OCR) will begin the second phase of its HIPAA audit program, as part of its continued efforts to assess compliance with the HIPAA Privacy, Security and Breach Notification Rules.
The Third Circuit granted on Tuesday the Federal Trade Commission’s (“FTC”) request for an injunction pending appeal of the proposed merger between Penn State Hershey Medical Center and Pinnacle Health System.
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.
On May 25, 2016, the European Union (“EU”) Council and Parliament politically agreed on the provisions that will go into the final version of the long-awaited EU medical device and in vitro diagnostic (“IVD”) regulations.
New Rules On Silica, Workplace Exams, and Eventually Diesel Particulate Matter Top MSHA’s New Agenda
With just seven months left in the Obama administration, MSHA published this week its Spring 2016 Semiannual Regulatory Agenda.
An organization interested in participating in the Medicare Shared Savings Program (MSSP) as an accountable care organization (ACO) must file a non-binding notice of intent (NOI) by 5:00 pm EDT Tuesday, May 31.
Added Sugars are in. Calories From Fat are out. And would the typical American eat the package of food in one sitting?
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).
Phase II of the HIPAA Audit Program has begun, with many covered entities and business associates receiving a “Audit Entity Contact Verification” message from the Department of Health and Human Services (HHS) and the Office of Civil Rights (OCR).