The National Law Forum

The Blog of the The National Law Review

Category Archives: Health Care Law

Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Pill Conference. A pill on a podium addresses lines of pills

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives.  In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing investigating drug pricing.  Meanwhile, the Energy and Commerce Committee (E&C) held a hearing regarding implementation of biosimilars.  While all the attention will …

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HHS Issues Final Rule on HIPAA and Firearm Background Check Reporting

gun

On January 6, as part of President Obama’s executive action to combat gun violence, HHS promulgated a final regulation modifying the HIPAA Privacy Rule to allow certain HIPAA covered entities to disclose limited information to the National Instant Criminal Background Check System (NICS). Background:  The NICS, maintained by the Federal Bureau of Investigation (FBI), is …

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Gun Control: HIPAA Final Rule Targets Background Checks and Mental Health Reporting

gun

President Obama has announced plans to tighten gun control regulations, including applying the background check requirement to dealers at gun shows and on websites.  Federal law already requires that those “engaged in the business” of selling guns must have a Federal Firearms License (FFL) and conduct background checks at the time of every purchase.  Some …

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Extension of 2015 Affordable Care Act Reporting Deadlines

Magnifying glass over Affordable Care Act policy and piggy bank

On December 28, 2015, the Internal Revenue Service issued Notice 2016-4 extending the deadline for information reporting requirements under the Patient Protection and Affordable Care Act (the “ACA”). The reporting requirements are intended to assist the IRS in application of ACA penalties and were two-fold: an initial disclosure to the employee and a final report to …

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Center for Devices and Radiological Health (CDRH) Schedules January 2016 Cybersecurity Workshop

cybercrime graphic

Center for Devices and Radiological Health, CDRH has scheduled a cybersecurity workshop entitled, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity,” on January 20-21, 2016 (see here for the Federal Register announcement). Background and Workshop Context As we discussed in a previous post, cybersecurity vulnerability is an increasing concern as medical devices are becoming more connected …

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