Standards for Patient Generated Healthcare Data

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.