As expected, HHS together with CMS and ONC have released the 21st Century Cures Act Final rule that most people have been calling the Information Blocking rule and/or the Interoperability Final rule. You can find the blog post announcing the final rule here and the Cures Act final rule landing page here. You can download all 1244 pages of the final rule here or on the Federal Register (Note: the ~98 pages from 1145-1243 is the meat of the rule. The rest is background, commentary, and context). ONC will be hosting an information webinar on Wed, March 11 at 3 PM ET if you’d like to sign up for that webinar as well or a recorded version will be made available on the Cures Act website.
Here’s a quick summary of the major efforts this act works on:
- Patient access to health information
- Third Party app access to health information (as requested by the patient) through APIs
- Effort to address “gag clauses” for sharing of usability and safety issues
- Health plans have to share patient data (if they do business with a government program)
- Health plan provider directory available through an API
No doubt it’s going to take weeks and months to fully understand what’s in the rule and what’s been changed. Although, it seems like most of what was in the interim rule has stuck around, but with some minor changes based on the ~2000 comments they received. HHS Secretary Seema Verma did say that they didn’t finalize the requirements around trusted exchange networks and participation in those. You can see the full analysis of changes here.
This Cures Act timeline is useful in understanding when all of this new regulation will need to be implemented:
No doubt this is just the start of the conversation. It will be interesting to see how EHR vendors in particular respond to this rule. I’m particularly interested in diving into the details of patients receiving free access to their data and the new rules about the reasonable fees vendors can charge for API access.
I’m also interested in looking at the 8 information blocking exceptions and how those will be applied. We’ll see how many people actually use this healthcare information blocking form that ONC has created and what they’ll do when the form is submitted.
At this point, there are more questions than answers, but at least a lot of the answers are now there in the final rule. Let us know what you think and what items in the final rule stand out to you.