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FDA Publishes Draft Guidance on Dissemination of Patient-Specific Data – But Doesn’t Say Much About HIPAA

Last week, FDA’s Center for Devices and Radiological Health (CDRH) announced the availability of a Draft Guidance on “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” to clarify that “manufacturers may share… Read More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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“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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FTC Reminds Us That HHS’s Office for Civil Rights Not Only One Watching Medical Privacy

Seasons greetings from the Federal Trade Commission (FTC). Yesterday, the FTC published its Agreement Containing Consent Order and attendant press release regarding its settlement with a medical billing company (PaymentsMD) and the company CEO for al… Read More
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HIPAA Comes of Age... Thanks to HITECH, D.D.S.

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part II) In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to shar… Read More
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HHS Releases HIPAA Security Rule Risk Assessment Tool

The Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR), Office of the National Coordinator for Health Information Technology (ONC), and Office of the General Counsel (OGC), have released their Security Risk Assessment (SRA… Read More
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HIPAA, the TCPA and Robodialing

Over the past several months, we have received several questions regarding how HIPAA interacts with the FCC’s implementation of rules under the Telephone Consumer Protection Act (TCPA).  Specific questions center around when authorization may be r… Read More
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