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 because of the scope of material to cover, their sheer size and volume and not to mention the typical time rush to get them released alongside the CMS MU rules prevent them from going into the depths of the requirements.
Without a CMS companion bill to expedite its release and a more tightly focused scope, ONC made a concentrated effort to elaborate on why this rule was important, clearly explained their rationale by their choices, and provided detailed examples and scenarios applying their rule.
It is interesting to contrast this rule to the original 2011 Edition Final Rule. The 2011 Edition rule came in at 228 pages (using double spaced PDF format) while EOA is longer at 257 pages. Rather than being unnecessarily wordy, its length shows the pains ONC went to clearly communicate their intent and application.
This statement of being a well-crafted regulation is not just casual praise, but something to strongly consider in understanding its impact. A regulation this well done indicates it is a regulation which ONC is very invested in and truly committed to carrying out. While the recent 2015 Edition rule marked a pivot to move away from being criteria exclusive to Meaningful Use, the reality is the CMS Stage X rules have initiated the health IT direction and the subsequent ONC rulings have followed their lead.
With the EOA, we have ONC establishing its own direction as an organization committed to making health IT work as it has long been envisioned. They are no longer going to sit on the sidelines and hope the actors make the right choices, but they will be an active participant to ensure what needs to be done will in fact occur. Even if their direct review efforts are indeed rare as they have expressed, the mere threat of them adds a very real incentive for developers to do as much as they can to pro-actively prevent problems from occurring and develop health IT systems which meet the spirit of the rules and not just the letter of the regulation.
Perhaps the most important line from this rule comes in the beginning when ONC states: “While the PHSA provides authority for ONC to directly review certified health IT in a broad range of circumstances, at this time we have finalized a regulatory framework for the exercise of such review in a more limited set of circumstances.” (emphasis added by Chart Lux)
In this, ONC clearly states they believe they have justification to further expand their role in the health IT space in the future, if needed. While ONC may never move beyond the circumstances described in EOA, this does mark a milestone in their work and existence. Since their inception, they have played the role of teacher, promoter, director, researcher, and manager of health IT. They are now adding the hat of enforcer. It is a new day in health IT.