AG/FDA Blog

FDA implements 21st Century Cures Act Requirements for Reusable Devices

Last week, the Food and Drug Administration (“FDA”) published a notice in the Federal Register implementing additional requirements for medical devices under the 21st Century Cures Act (“Cures Act”).   Section 3059 of the Cures Act requires… 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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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
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2015 In Retrospect

Happy New Year, readers!  Yet another year has come and gone.  I hope that 2015 was a good year for you, professionally and personally.  As I look back on 2015, here are a few developments that caught my attention. In January, the House Energy and… Read More
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