AG/FDA Blog

OFW Founder Rick Frank Named Best Lawyers® Washington DC Health Care Lawyer of the Year

Five OFW Law Attorneys Named to 2017 Best Lawyers in America for FDA Law One of OFW Law’s Founding Principals, Richard L. Frank, was recognized as the Health Care Lawyer of the Year in the 2017 Washington, D.C., edition of The Best Lawyers in Amer… Read More
Read More

FDA Publishes Draft Guidance on Dissemination of Patient-Specific Data – But Doesn’t Say Much About HIPAA

Last week, FDA’s Center for Devices and Radiological Health (CDRH) announced the availability of a Draft Guidance on “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” to clarify that “manufacturers may share… Read More
Read More

FDA Finalizes Guidance Document about Medical Foods

FDA has updated and published its Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition (05/12/2016).  The guidance document is consistent with the agency’s good guidance practices regulation, 21 C.F.R. § 10.115. F… Read More
Read More

NYT: Mosquito vs. Mosquito in the Battle Over the Zika Virus

Please see Dr. Nina Fedoroff and former USDA Secretary John Block’s op-ed featured in the New York Times on April 6, 2016 – Mosquito vs. Mosquito in the Battle Over the Zika Virus. Read More
Read More

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… Read More
Read More

The Zika-Agriculture Connection

By Marshall Matz, as published in Agri-Pulse Q. Is there a connection between the Zika virus and global food security?A. Yes. Genetic engineering has an important role to play in meeting both challenges. The mosquito is the deadliest animal on eart… Read More
Read More

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… Read More
Read More

“The Guidance Is Coming” . . . For Real! OCR Issues Guidance On Individuals’ Right to Access

In our last blog on medical privacy, we noted that HHS’s Office for Civil Rights (OCR) promised that a number of HIPAA guidances were forthcoming in the next several months.  It appears that (at least so far) OCR is keeping its promise, issuing it… Read More
Read More

2015 Dietary Guidelines for Americans Released... And Some Thought Already Being Given to the 2020 Guidelines!

The Secretaries of Agriculture and Health and Human Services have released the 2015-2020 Dietary Guidelines for Americans (DGA) following what had been a captivating review of the Scientific Report of the Dietary Guidelines Advisory Committee, a proc… Read More
Read More

Medical Privacy Update and 2015 Retrospective

MEDICAL PRIVACY UPDATE: New PHI Disclosures Permitted for Firearm Background Checks Earlier today, HHS published a Final Rule modifying the HIPAA Privacy Rule (45 C.F.R. § 164.512) to allow certain Covered Entities to disclose limited PHI to the FBI… Read More
Read More

Follow Blog Via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.