AG/FDA Blog

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FDA Publishes Draft Guidance on Dissemination of Patient-Specific Data – But Doesn’t Say Much About HIPAA

Last week, FDA’s Center for Devices and Radiological Health (CDRH) announced the availability of a Draft Guidance on “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” to clarify that “manufacturers may share… Read More
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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
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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
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“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
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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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Privacy Update: Refill Reminders Expressly Permitted In California – The State Finally Catches Up to the Feds

Although HIPAA-compliant sponsored “refill reminders” have always been legally permissible for a host of treatments under California’s Confidentiality of Medical Information Act (CMIA), Cal. Civ. Code §§ 56-56.37, the state finally came right… Read More
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Privacy Update: White House Drops Draft Consumer Privacy Bill . . . Splat!

The White House (via the Department of Commerce) has released a “discussion draft” of consumer privacy legislation intended to codify President Obama’s 2012 Consumer Data Privacy In A Networked World: A Framework For Protecting Privacy And Prom… Read More
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