Big news today coming out of ONC as they released the healthcare interoperability proposed rule that came out of the 21st Century Cures Act. We knew that ONC had been working on important information blocking components of the 21st Century Cures Act, but the proposed rule included much more than just information blocking including new EHR certification requirements, rulemaking on API fees, patient export of EHR data, and much more.
We’re still unpacking everything that’s in the proposed rule and likely will for the next 2 months, but you can download the full proposed rule (all pages of it) and take a look at the 9 fact sheets ONC has provided with the proposed rule.
At first glance, it was interesting to see ONC decide to outline where information blocking was acceptable versus trying to define when information blocking was not ok. You can see the 7 exceptions to the information blocking provision which outlines when information blocking is exempted from the requirement to share information. No doubt, the lawyers will take some time unpacking these 7 exceptions.
The proposed rule also outlines the allowed API fees as a condition of certification. Looking at the Fact Sheet, the provisions are pretty general and seem to be up to a lot of interpretation using such terms as reasonable and allowing for fees for “value-added services.” I’ll be interested to see if they provide more specificity in the full rule. Plus, it specifically says that permitted API fees do not apply to API Data Providers because they’re not a certified Health IT product by ONC.
The other big portion of the proposed rule is around exporting of Electronic Health Information (EHI). This requires “All EHI produced and electronically managed by a developer’s health IT must be readily available to export” for both a single patient and all patients for a provider switching health IT systems. This is a big deal for both patients and providers who are switching systems. It’s also a challenging rule for health systems to implement. The rule requires that the export file must be in a computable format and that the documentation for interpreting the data must be publicly available.
What’s interesting is seeing how they’re approaching enforcement of this new rule. The majority of ONC’s enforcement is coming through the EHR certification requirements. This is made really clear in the Conditions and Maintenance of Certification Requirements Fact Sheet. Given Greenway Health’s recent $57 million settlement for not fully complying with EHR Certification requirements and eCW’s previous $155 million settlement, it’s clear that there’s some real teeth behind what’s being required. You don’t want to be caught in violation of your EHR certification requirements. Plus, that doesn’t include CMS’ enforcement actions through their own related rules.
No doubt there’s a lot more to discover in this rule. Take a look at the Fact Sheets and the full rule and let us know what you find. What stands out to you about this rule? What did we miss? What do you think of the provisions we covered above? Let us know in the comments and on social media with @healthcarescene.