Wednesday, October 28, 2015

The ONC 2015 Certification Rule

Just as I summarized the CMS Meaningful Use Final Rule last week, this week I’ll summarize the 560 pages of the ONC 2015 Certification Final Rule.

Key points to understanding the rule include

1.  The 2015 Certification Rule is decoupled from Meaningful Use.    Thus, you’ll find functionality to support EHR Incentive Programs plus  several certification criteria for long-term/post-acute care, chronic care management, behavioral health,  and other programs such as merit-based incentive payments  (MIPS).

2.  The concept of the Complete EHR  was eliminated in the 2014 Edition Release 2 final rule.  Everything in the 2015 Certification rule is conditional based on the functionality that a module supports.   The CMS Meaningful Use rule requires certified technology to support each element of that rule, but customers are encouraged to select modules/vendors/applications however they wish.

3.  There are standards included in the 2015 Certification rule that are not ready for prime time, such as Data Segmentation for Privacy (DS4P).   However, there are no corresponding Meaningful Use attestation criteria for these standards, so vendors are unlikely to implement them.   I believe the 2015 Certification Rule should be limited to Meaningful Use certification without optionality in the interest of providing a clear path to the industry.   The ONC Standards Advisory could have enumerated the potential standards suggested for non-Meaningful Use related requirements.  Luckily, ONC has prepared a presentation which illustrates the sections of the 2015 Certification Rule that can be ignored by vendors seeking to limit their development effort to Meaningful Use support.

To begin understanding the rule, you should read this presentation, published last week by ONC

Slide 35 contains a final rule table.  The last column to the right enumerates certification criteria and accompanying standards outside of Meaningful Use.  The first column is always applicable for products getting certified and the second column is conditionally applicable depending on what criteria are in scope for certification.

If you want to read the actual 560 page rule, you can save a great deal time by just reading about 50 pages as follows

The standards required by the rule are described between 170.202 Transport standards  and  170.299 Incorporation by reference.

The certification requirements are described in section labeled Regulation Text.

There are really only three new substantive requirements applicable to Meaningful Use that are non-public health: implantable device list, patient generated health data capture, and the Application Program Interface functionalities.   Otherwise, all the other “new” criteria are public health specific to give more Meaningful Use flexibility.  As noted above, slide 35 in the presentation is key.  Some of the “revisions” are really minimal in comparison to 2014 edition despite being marked that way.

Assessing  the vendor burden of implementing the 2015 Certification rule is heavily dependent on the number of functions certified.    There are even optional choices for some criteria.  For example, in the View/Download/Transmit criteria there are two standards referenced for web content accessibility guidelines, Level A and Level AA.  The baseline requirement is Level A, which effectively makes Level AA “optional”.  However,  vendor implementation details will be represented on ONC's updated "open data" Certified Health Product List so if a developer wanted to differentiate themselves on web content accessibility they would be able to do so and such effort would be publicly accessible.

Overall there are more criteria to support public health for Meaningful Use than providers need to actually use to meet Meaningful Use, so there is flexibility for public health reporting.  Developers do not need to support all the public health certification criteria.

I hope this analysis helps you focus since the powerpoint plus reading about 50 pages is all you have to do to understand the 560 page rule.

My only editorial comment - in the future, I believe the private sector will innovate in ways that regulation cannot foresee.  There is a time for regulation to catalyze change and a time for regulation to be reduced to enable innovation.   I believe that we are entering a time for reduction of regulation.     My term limit in the Obama administration requires my service in the federal advisory committees to end in January 2016.   I will watch with great interest as the  Obama administration ends and a new administration works to find a balance between regulation and private sector innovation.

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