At last week's Meaningful Use Workgroup meeting, Leslie Kelly Hall and I reviewed the HIT Standards Committee recommendations for patient generated healthcare data from online applications and devices.
We offered guiding principles for Meaningful Use Stage 3 in general. Meaningful Use should avoid "certification only" items since requiring engineering in products to support untested workflows with immature standards is unlikely to accelerate progress. We should only apply standards/certification to those processes where they are needed and useful.
For patient generated data sent from interfaced applications, CCDA is recommended as a container for types of templates that are well understood (e.g. problems, meds, allergies). CCDA over existing (Direct, Exchange) and other modes of transport are reasonable ways to get data in and out of EHRs, PHRs, and patient facing applications.
CCDA should not be required as the architecture that integrated applications must use. The outcome goal is for the entire care team (patient/families/providers) to be able to contribute to a shared medical record and that can be achieved without CCDA in a fully integrated application. We need to allow for innovation and flexibility in this area and not unduly constrain options for individuals to connect with their care teams in the ways they prefer.
For patient device generated data, we need to support innovation, as the marketplace is still rapidly evolving.
Continua implementation guides (and their underlying IEEE 11073 standards) are directionally appropriate, but ONC needs to align certification with FDA guidance and other regulatory or sub-regulatory policy without constraining the marketplace.
Due to the immaturity of the market, we need to be flexible regarding incorporation of device data and other remote data sources. Thus, we do not believe a specific standard should be mandated at this time, just an attestation requirement that some approach has been used successfully.
We are fully supportive of efforts to integrate patient generated healthcare data from applications and devices into provider workflows. By using the CCDA and encouraging market-based innovative device integration, we believe burden and benefit can be balanced.
John, thank you for the wonderful review. I wanted share a story. Yesterday I had the pleasure to meet with Gunnison Health, a small critical access system in rural Colorado. We were discussing patient engagement approaches and the needed HIT. The director spoke up and stated that there were many different EHRs, even in their small community, and as a result they will be going forward with a standards based approach. He went on to say that they will be using DIRECT for all of their provider to provider communication, and hope to use DIRECT with patients. He commented that they were going to nail down the CCDA for their community to further interchangeability. One of the providers then spoke up and said, "we think this (next phase of interoperability) is sort of "HL8"." WOW!
ReplyDeleteI was so impressed with them, and it hit home to me the importance of our work in standards. Thank you John for your leadership.
I too am very hopeful that the work we are doing will help all of us when we are patients to be co-producers of our health and well being.