AG/FDA Blog

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… Read More
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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… Read More
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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… Read More
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2016 – Gone But Not Forgotten

Happy 2017, everyone!  2016 has come and gone.  Looking at 2016 in my rear-view mirror, here are a few matters that caught my personal attention. As food and drug lawyers and corporate execs in regulated companies know (or definitely should know!),… Read More
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Food Rules Potential Targets for Elimination or Revision

Ever since the election we have been asked which Obama Administration regulations and executive actions are likely to be stricken by the new Trump Administration or the 115th Congress.  Will the focus be on the rules issued since mid May of this yea… Read More
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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… Read More
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Aspartame Potentially Subject to California Prop 65 Listing – Update

As previously reported, at an upcoming, November 15, 2016, public meeting of the Proposition 65 Carcinogen Identification Committee (CIC), aspartame will be discussed prior to the CIC sending advice to the Office of Environmental Health Hazard Assess… Read More
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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
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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
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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
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