Perhaps lost amidst the waiting for the proposed ONC rule on information sharing and 21st Century Cures support was ONC releasing three very detailed guidance documents dealing with post-certification surveillance: Overview Post-Certification Assessment Disclosure of Material Information Surveillance You can find the three documents here identified as Program Policy Resource #18 dated October 5, 2018. The three documents work together and provide clarity and insight into the

A few weeks ago ONC announced a major change in their testing and certification process. They introduced “self-declaration” as a method for ONC-ATLs to accept test results for over half of the criteria in 2015 Edition, and ONC announced a scaling back on their focus on randomized surveillance. It has generated significant conversation, including notable criticism by some. My thoughts on what they got right, what they got wrong, and what people are overlooking. What They Got R

The ONC Enhanced Oversight and Accountability (which we will just refer to as EOA) Final Rule came out the same day the MIPS/APM Final Rule was released. Because of that, it was largely overlooked, but it is an extremely notable regulation as it signals a major change in the direction and role of the ONC in our modern health IT landscape. The rule introduces three new elements, two of which are rather minor, but the third, Direct Review, is a true game changer. Chart Lux did

This is a blog post in a series on our review of our Enhanced Oversight and Authority (EOA) Final Rule. Check out the others on our blog via the EOA tag. Summary The main focus on this Final Rule is the establishment of a regulatory framework to allow ONC to do a “direct review” or surveillance into the functionality of certified health IT. Previously, this was only the bailiwick of the ONC-ACBs, but ONC has now established themselves as an active participant in surveillance

This is a blog post in a series on our review of our Enhanced Oversight and Authority (EOA) Final Rule. Check out the others on our blog via the EOA tag. Summary ONC issued some specific requirements on surveillance and transparency of certified health IT systems in their 2014 Edition Final Rule. They expanded their scope of surveillance requirements with the 2015 Edition Final Rule where they required randomized, “in-the-field” surveillance as well as continuing reactive sur

This is a blog post in a series on our review of our Enhanced Oversight and Authority (EOA) Final Rule. Check out the others on our blog via the EOA tag. Summary Since the ONC Permanent Certification Final Rule, EHR testing was to be completed by labs accredited by NVLAP. However, the approval process was different for testing labs compared to the certification side. Certification bodies not only had to be accredited by ANSI, but they must subsequently be approved and authori

This is a blog post in a series on our review of our Enhanced Oversight and Authority (EOA) Final Rule. Check out the other on our blog via the EOA tag. Last month we decided to make some predictions on what we thought the EOA Final Rule would contain given its NPRM, comments received, and our experience with ONC. How did we do? Read on below. Direct Review Predictions Grade: A Predictions were generally right on. Most notably, ONC did not make significant changes from their

This is a blog post in a series on our review of our Enhanced Oversight and Authority (EOA) Final Rule. Check out the others on our blog via the EOA tag. First, it is the opinion of Chart Lux Consulting that this is the best constructed and composed final rule that ONC has released in the Meaningful Use era (and we have read them all). It is no small praise as overall ONC has done an excellent job with their rule making. While the 201X Edition Final Rules are more impressive

In March of this year, ONC released perhaps is most expansive and program-altering proposed rule since its initial certification ruling called Enhanced Oversight and Accountability. It is currently under OMB review leading to the assumption it will be out near/around October 1st. The proposed rule address three areas. Two are low impact, but it is the third, ONC Direct Review, which will be a game changer. ​ Proposal #1: Establishing ONC-ATLs Summary Currently testing la