A Look Ahead to 2021

A Look Ahead to 2021

The new year has much in store for electronic health information exchange compliance!  Today’s post provides an overview of anticipated changes to the health information regulatory landscape in 2021, including increased interoperability efforts and telehealth expansion due to the coronavirus pandemic. It is not surprising that many of the topics discussed below are a direct result of the interoperability requirements created by the 21st Century Cures Act (“Cures Act”) enacted in December 2016.

read more
Our Stockings are Stuffed with Compliance Tools

Our Stockings are Stuffed with Compliance Tools

Seasons Greetings to all of our readers!  First, we want to wish you and yours a holiday season filled with health, happiness and hope!  We also want to thank you all for continuing to make Legal HIE such a popular and highly visited blog!  It puts a smile on our face seeing so many of you enjoying our posts and returning to our site often!  

As stockings are being hung by chimneys with care, we want to make sure you know that Legal HIE’s stockings are absolutely stuffed to the brim with tremendous tools, sample forms, polices and turn-key solutions that can help your organization stay on top of the most pressing compliance challenges, and ever-changing healthcare regulatory landscape. 2021 promises to be a year with many new and final regulations going into effect, and being released. The Legal HIE compliance library was created specifically for this purpose – to help busy and overwhelmed compliance officers and attorneys keep up with these changes by offering turn-key samples and solutions as a solid starting point.

read more
Big Changes to Big Breaches of Data and Notification Requirements Coming Soon!

Big Changes to Big Breaches of Data and Notification Requirements Coming Soon!

Yesterday, the period for public comment on the FTC’s Health Breach Notification Rule closed.  The FTC’s Health Breach Notification Rule requires vendors of PHRs and PHR-related entities to notify the FTC if they experience a breach of security involving unsecured health information. Another area of change to Breach Notification is arising out of the CARES Act which was was enacted into law on March 27, 2020 and is making significant changes 42 C.F.R. Part 2.  Among other changes that the CARES Act is introducing, it creates an entirely new obligation on Part 2 providers to notify SAMHSA of uses and disclosures of Part 2 data in any manner not authorized under Part 2!  To date, 42 CFR Part 2 did NOT include an independent obligation to report or notify any agency (i.e., SAMHSA or HHS) of any use or disclosure of Part 2 information which was in violation of 42 CFR  Part 2.

read more
Changes on the Horizon for Part 2 Confidentiality Regulations

Changes on the Horizon for Part 2 Confidentiality Regulations

As part of its comprehensive COVID-19 response, Congress quietly passed through changes to the federal drug and alcohol confidentiality framework known as “Part 2” under the CARES Act, enacted on March 27.   One of the more underreported components of the CARES Act, the changes do not completely overhaul the Part 2 regulations, however, they relax several restrictions that health care providers have struggled with, particularly in the electronic exchange and electronic health records (“EHR”) context (the “CARES Act Changes”).

read more

Archives