§170.205 Content exchange standards and implementation specifications for exchanging electronic health information. The Secretary adopts the following content exchange standards and associated implementation specifications:
(d) Electronic submission to public health agencies for surveillance or reporting.
(1) Standard. HL7 2.3.1(incorporated by reference in §170.299).
(2) Standard. HL7 2.5.1(incorporated by reference in §170.299).
Implementation specifications. Public Health Information Network HL7 Version 2.5 Message Structure Specification for National Condition Reporting Final Version 1.0 and Errata and Clarifications National Notification Message Structural Specification (incorporated by reference in §170.299).
§170.302 General certification criteria for Complete EHRs or EHR Modules. The Secretary adopts the following general certification criteria for Complete EHRs or EHR Modules. Complete EHRs or EHR Modules must include the capability to perform the following functions electronically, unless designated as optional, and in accordance with all applicable standards and implementation specifications adopted in this part:
(l) Public health surveillance. Electronically record, modify, retrieve, and submit syndrome-based public health surveillance information in accordance with the standard (and applicable implementation specifications) specified in §170.205(d)(1) or §170.205(d)(2).One of the teams that was looking to implement this internally discovered a number of issues with this selection. In reviewing the PHIN specification, we found this [emphasis mine]:
This document specifies the structure and methodology for the use of the Health Level 7 (HL7) Version 2.5 Unsolicited Result Message (ORU^R01) to support electronic interchange of any de-identified Nationally Notifiable Condition message from public health entities to the CDC. The message structure is the same for the individual Case Notification, the Summary Notification, the Environmental Investigation Notification, and the notification of Laboratory report results to meet national reporting requirements to CDC.
On followup with experts from a state public health agency, we heard that this was wrong on several counts:
- This specification describes a framework for public health reporting from states to the CDC, not for reporting to state public health.
- It's an old version (Version 2.0 is out).
- It describes a framework for communication but doesn't describe what goes into the message. One observer reported: "It specifies what the picture frame should look like, but not what the picture should be that goes in it."
So what is an implementor to do while we wait for CDC and the rest to find the right solution, and for ONC to announce that there really is a problem and that it will be fixed?
Well, here's my advice:
1. Use HL7 Version 2.3.1, because there is no implementation guide specified, and you can do something reasonable with it.
2. Use the message formats defined in HITSP C39 Encounter Message Component, which is designed (in 2006 I might add) for the purpose of "sending patient encounter data (excluding laboratory, radiology) from a Biosurveillance Message Sender to a Biosurveillance Message Receiver.", but change the version from 2.5 to 2.3.1
This should be compliant with §170.205 (d)(2) (it will be an HL7 Version 2.3.1 message) and §170.302 (l) (by compliance with §170.205 (d)(2)).
Now, what should CDC and ONC do?
- Fess up. Everyone makes mistakes. Please correct this one swiftly, and with as much transparency as you possibly can. We don't need heads to roll. Meaningful Use has amazingly crazy schedules that we are all trying to meet. Make it possible for us to meet them by giving us the information we need, when you know it, not after you've had a change to make it all better. Cause by then, it will already be too late.
- Give us a schedule for when you think the correction will be made.
- Consider seriously using the HITPS C39 specification which was purpose designed for this specifc use case for the replacement. I'll point out that the HITSP C39 guide had the input of experts from the CDC and Federal Advisory Committees conveigned on this topic, and State Public Health agencies.