SMART Health IT

App Store for Health | Health Data -- Innovation Interface | Computational Health Informatics Program @Bos_CHIP @mandl @JoshCMandel

[Josh Mandel, MD @JoshCMandel]

Here's how today's HTI-2 Final Rule stacks up against @SMARTHealthIT comments (thanks Gemini Experimental!)

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Here's a breakdown, organized by the topics you raised in your comments:

1. FHIR Bulk Data Enhancements

Export Performance Parity:

Status: NOT ADDRESSED in this final rule. This was one of the more ambitious proposals, and it seems ASTP/ONC has decided to defer it for later consideration. This topic falls under the broader category of proposals from HTI-2 that were not addressed in this particular rule.

Assessment: Feedback not heeded in this final rule; likely deferred.

Server Support for Patient Group Creation:

Status: NOT ADDRESSED in this final rule. Similar to export performance parity, this was likely deferred. ASTP/ONC has acknowledged the early work in the Argonaut Project but has not yet taken action to incorporate it into the regulations.

Assessment: Feedback not heeded in this final rule; likely deferred.

Server Support for _since and _type:

Status: NOT ADDRESSED in this final rule. This proposal, while valuable, was likely deemed less urgent than other priorities addressed in this partial final rule.

Assessment: Feedback not heeded in this final rule; likely deferred.

2. EHI Export

Status: NOT ADDRESSED in this final rule. Your recommendations for enhancing EHI Export, including download functionality in patient portals, third-party app access, and handling of non-computable formats, were not part of this partial final rule. These are significant proposals that likely require more consideration and potentially a separate rulemaking process.

Assessment: Feedback not heeded in this final rule; likely deferred.

3. Image Links in API Responses

Status: NOT ADDRESSED in this final rule. The specifics of image access via API were not covered in this partial final rule. Your concerns about the shareability and programmatic accessibility of "imaging links" remain unaddressed for now.

Assessment: Feedback not heeded in this final rule; likely deferred.

4. Subscriptions for US Core Data

Status: NOT ADDRESSED in this final rule. The proposal to require subscription capabilities for US Core data was not included in this partial final rule. Your recommendations regarding a phased approach, alignment with Argonaut's work, and specific technical details were not acted upon at this time.

Assessment: Feedback not heeded in this final rule; likely deferred.

5. Dynamic Registration outside of Trust Frameworks

Status: NOT ADDRESSED in this final rule. The proposal to adopt dynamic registration, along with your recommendation to support self-signed certificates, was deferred.

Assessment: Feedback not heeded in this final rule; likely deferred.

6. CDS Hooks

Status: NOT ADDRESSED in this final rule. The inclusion of CDS Hooks 2.0 in the certification requirements was not part of this partial final rule.

Assessment: Feedback not heeded in this final rule; likely deferred.

Overall Assessment

This final rule primarily focused on establishing the regulatory framework for TEFCA and making some limited updates to the ONC Health IT Certification Program. It did not address the majority of the substantive proposals in your comments, which were largely related to:

Enhancements to FHIR Bulk Data Access

Improvements to EHI Export

Specific API requirements for image access

Implementation of subscriptions for US Core data

Details of dynamic registration

Adoption of CDS Hooks

It's important to reiterate that the absence of these topics in this final rule does not necessarily mean they have been rejected. ASTP/ONC has explicitly stated that the remaining proposals from HTI-2 are still under consideration for future rulemaking. It's likely that your comments will be taken into account as they develop those future rules.

It may be worthwhile to follow up with ASTP/ONC during future comment periods or through other engagement channels to reiterate your recommendations and track their progress.

[Ken Mandl @mandl]

@JoshCMandel @SMARTHealthIT https://t.co/wxZNwbtjam

[Ken Mandl @mandl]

Come join us tomorrow, Thursday at 4pm to hear the wonderful @chrissyfarr

[Ken Mandl @mandl]

.@ONC_HealthIT Cures Rule Act Rule supports patient-controlled export of all their electronic health information. We prototyped an app/API/FHIR approach to make it turnkey. It's based on an Argonaut IG. @AMIAinformatics @JoshCMandel @gotdan @SMARTHealthIT https://t.co/EPkGHwyYZI

[Ken Mandl @mandl]

Journeys from innovation to interoperability, showcased by SMART on FHIR, Bulk FHIR Access, & SMART Health Cards. Could AI integration be the key driver in accelerating our digital health ecosystem?

@SMARTHealthIT @NatureMedicine

https://t.co/wjsITCOPtt

[Josh Mandel, MD @JoshCMandel]

Just out: https://t.co/uxQHq0f3aw

Health AI integration requires workflow & data access. @SMARTHealthIT experience: it takes products, pragmatics, open standards... and regulations.

Better alignment & precision on "jobs to be done" => (much) faster timeframes!

@mandl @gotdan

[Ken Mandl @mandl]

Impressively, the Health Information Exchange in our network rapidly launched its own, high performing @SMARTHealthIT @HL7 Bulk FHIR API on top of its data – a testament to standardized access to large-scale EHR data, showcasing the potential of modern technology for healthcare.

[Brendan Keeler @healthapiguy]

@mandl @HealthPrivacy @SMARTHealthIT @HL7 @ONC_HealthIT @aneeshchopra @JoshCMandel @gotdan @anilsadbhav @prpayne5 Ah this is cool

[Ken Mandl @mandl]

New regulatory science on push button population data export from EHRs.

How well does it work?

We measure @SMARTHealthIT @HL7 Bulk #FHIR Access API performance @ 5 delivery sites.

It’s required under 21st Century Cures Act and by @ONC_HealthIT reg.

https://t.co/XIe9gTT8OU

[Ken Mandl @mandl]

Ted Shortliffe’s monumental achievements as informatics leader and ⁦@theNAMedicine member⁩ recognized with the Walsh McDermott Award. ⁦@AMIAinformatics⁩

[Susannah Fox @SusannahFox]

COVER REVEAL: I am thrilled to share the cover for my book, REBEL HEALTH, which will be published in Feb. 2024 by @mitpress: https://t.co/UykAQvvb5r
#RebelHealth is a celebration and a call to action, a protest and a party -- this design captures it!

[Ken Mandl @mandl]

Back from the 2023 @BostonChildrens Computational Health Informatics Program @bos_chip faculty retreat. Still absorbing the fantastic discussion and scientific debates. And spectacular keynotes by @stephen_wolfram @raykurzweil @rickmalley

[Ken Mandl @mandl]

The personally controlled health record #PCHR taking shape once again! @Apple

[Ken Mandl @mandl]

Perhaps a good step for ensuring meaningful and not just minimal compliance with the 21st Century Cures Act Rule. Another contribution to the @SMARTHealthIT on #FHIR apps economy.

https://t.co/IM590AK7yp

[seanno @seanno]

Another SMART Health Card/Link post, a deep dive into the code behind the viewer I've been working on for @MyCommonHealth. Audience is folks working with SHC/SHL/IPS/SHIC/etc. Not a page turner unless you're deep in those weeds. ;)
https://t.co/JykQDVcnVk

[Health Affairs @Health_Affairs]

In their new Forefront article @mandl @gotdan + @JoshCMandel of @Bos_CHIP @SMARTHealthIT + @Health_IT argue that a proposed rule allowing orgs to opt out of interoperability obligations risks impeding our strides towards an interconnected health landscape. https://t.co/MjGaX7Hg0p

[Aneesh Chopra @aneeshchopra]

@mandl @JoshCMandel @gotdan @SMARTHealthIT Agree. Am hopeful this will be corrected in the final rule!

[Ken Mandl @mandl]

Is a regulatory clash brewing? TEFCA provisions in ONC HTI-1 rule could weaken FHIR-based interop. We propose TEFCA align fully with the FHIR ecosystem, allowing no exceptions to 21st Century Cures Act API reqs. @JoshCMandel @gotdan @SMARTHealthIT

https://t.co/meyNIQPVed

[SMART Health IT @SMARTHealthIT]

Applications are due August 29th for the @AMIAinformatics / @HL7 FHIR Apps Competition.

Submit your app online to compete!

Enable EHR-launch demo by listing the app in the SMART App Gallery.

#AMIA2023 #SMARTonFHIR

https://t.co/AXi5JLG6HR
https://t.co/E7WcyTYWCO

[Ken Mandl @mandl]

Come join us this coming Tuesday, June 27th at 4pm
Register here: https://t.co/rliEomxEPj
@bos_chip @hoifungpoon