AG/FDA Blog

Dietary Guidelines 2020

By Marshall Matz, as published in Agri-Pulse The drafting of the 2020 Dietary Guidelines for Americans (DGA) has started….and it’s a good start. The U.S. Department of Agriculture (USDA) and U.S. Department of Health and Human Services (HHS)…

FDA Updates Some Recall Practices

FDA has released a draft guidance, “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff” (1/17/2018).  It essentially discloses FDA’s intent to accelerate the release of recall informa…

Trump Administration Personnel Update Through December 22: White House, USDA, Defense, Energy, HHS, Labor, State, EPA, Ambassadors

More announcements are being made each day.  We will update this list, as appropriate. PRESIDENT DONALD J. TRUMP WHITE HOUSE STAFF Chief of Staff – Reince Priebus – head of the RNC (Resigned July 27, 2017) Gen. John Kelly, former Secret…

FDA Inspector General Report on Progress of FSMA Inspections

On September 28, 2017, the Department of Health & Human Services’ Office of Inspector General (OIG) released its internal report on the agency’s domestic food facility inspections: Challenges Remain in FDA’s Inspections of Domestic Food Fac…

Medical Privacy Ramifications Of Hurricane Harvey – HHS Issues: Limited Waiver of HIPAA Privacy Rule Protections; and Bulletin Addressing HIPAA Rules in Emergency Situations

In response to the tragic fallout from Hurricane Harvey, an unprecedented storm that decimated the city of Houston and a large swath of the Gulf Coast of Texas and Louisiana, the U.S. Department of Health and Human Services (HHS) declared a public he…

OFW Law Launches New Health Industry Practice; Ladd Wiley Joins Firm as Principal and Chair of Practice

OFW Law is pleased to announce the creation of a new Health Industry Policy and Regulatory Practice.  The practice will be focused on government health program payment issues and FDA-related policy issues for clients in the health care delivery syst…

Trump’s New OCR Director and HIPAA Policy

As federal policy rapidly develops under the Trump Administration, much of it reversing or seeking to reverse the Obama legacy, the world of medical privacy (at least that which is on the books for now) remains static – after all, privacy always ha…

What Will A Trump Administration Mean For The Medical Privacy Landscape?

With President-Elect Donald Trump’s unlikely victory in Tuesday’s election, we begin to look ahead at what the Trump Administration will mean from a medical privacy perspective.  Neither the media, nor Trump himself, made privacy, much less medi…

Medical Privacy Update: OCR Issues Revised Audit Protocol For Phase II

As a foundation for moving forward with Phase II of its Audit Program of Covered Entities (CEs) and their Business Associates (BAs), HHS’s Office for Civil Rights (OCR) has quietly released its beefed-up Audit Protocol (Protocol). Significantly, th…

Medical Privacy Update: HHS Guidance on Permitted Uses and Disclosures of PHI for Treatment and Health Care Operations

Late last week, HHS’s Office for Civil Rights (OCR) and Office of the National Coordinator for Health IT (ONC) issued two Fact Sheets (or guidance documents) intended to assist regulated industry in Understanding Some of HIPAA’s Permitted Uses an…

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