Quis custodiet ipsos custodes?

Quis custodiet ipsos custodes? (Who will guard the guardians?)
-- Juvenal

I was reading the reports from the Healthcare Policy Committee meeting held last Friday. One of the recommendations from the certification/adoption workgroup was that:

"ONC should develop an accreditation process and select an organization to
accredit certifying organizations"

I agree wholeheartedly with this notion. I think it will address many of the concerns that have been expressed about CCHIT, both in the media, and in reports from the HIT Policy Committee. One point of clarification I'd like to see made is that ONC not "develop an accreditation process", but rather that they develop a set of requirements for a certification process, and to leave the development of the process to the organization selected. Let's not reinvent the wheel again. One organization that has plenty of experience certifying certifiers is the American National Standards Institute.

On the flip side, the committee also recommended that:

"If necessary, ONC should commission (not just harmonize) the development of
standards."

On this recommendation, I am rather more hesitant -- because of the lack of oversight. The Federal government has been commissioning healthcare standards development for a number of years. There are many challenges in these activities:

1. They are often based on US specific requirements. US-based requirements are certainly important, but healthcare is a global activity. When US standards are developed in a way that doesn't account for global requirements, we are left with standards that are used in just one of many jurisdictions.
2. Many of these standards activities will occur within HL7. I've heard a number of challenges over the last few years in HL7 from non-US members about the amount of time HL7 spends on US realm specific implementation guides. If ONC wants to start developing US-based standards and guides, it should consider funding a US-realm affiliate in HL7 to support this process.
3. Federal initiatives in the development of healthcare standards are not coordinated across the federal agencies. There are numerous projects sponsored by the FDA, CDC and VA which have overlaps.
4. The selection of contractors to develop standards almost certainly preselects the standards organizations where these actitivities will occur, and often the approaches used. This may be appropriate when the activities is specific to one SDO, but this will not always be the case.
5. Contracts to develop consensus based standards need to work within reasonable timelines. Most recently I've been involved with a project that is looking to go from start to finish in just a few short months. This is neither practical, nor an acceptable way to develop a consensus based standard. Good work takes time.

There are three suggestions for ONC that I would make in regard to this recommendation:

1. Track the healthcare standards activities commissioned by Federal agencies.
2. Make a call for standards development before funding new work
3. Commission standards development activities as a "last resort" after a harmonization process identified gaps in standards, and calls for development through existing channels fails.

Tracking Standards Activities
I can count at least a double handful of standards activities that have been developed in HL7 or elsewhere over the past two years that have been either commissioned by or supported by Federal government agencies. Some of these include:

• CDA Implementation Guide for Patient Assessments (ASPE)
• eMeasures (Indirectly by CMS)
• Implementation Guide for CDA Release 2 – Level 3 Healthcare Associated Infection Reports (CDC)
• Implementation Guide for CDA Release 2 – Level 3: Public Health Case Reporting (CDC/NCPHI)
• EHR Vital Records Functional Profile (CDC)
• Composite Privacy Consent Directive (SAMSHA)
• Individual Case Safety Report (FDA)
• HL7 Version 2.5.1 Immunization Implementation Guide (CDC)
• Hardened Rules for Clinical Decision Support (AHRQ)

This is an incomplete list by the way. It is based on my own knowledge of these activities, and some cursory review of the HL7 Project planning resources. I know there are more projects going on, but there is no one resource that I can use to access that information. ONC should be responsible for tracking these projects and making that information publicly available.

The information should include all contracts and projects that involve the development of standards, implementation guides, value sets, minimum data sets, clinical decision support rules and similar specifications that have Federal involvement. One use of this resource would be to help coordinate Federal activities in healthcare standards. There should also be a way to readily identify these projects before contracts are awarded similar to what is presently offered on the grants.gov website.

Call for Standards Development
I'd like to see ONC use the process ANSI/HITSP already in place for:

1. Requesting information about standards that might be used to fulfill harmonization requests
2. Request development of standards to meet gaps found during the harmonization process

We've successfully used those processes in ANSI/HITSP to obtain information about standards activities relevant to harmonization requests and to foster the development of new work. These processes have been very effective in pushing forward activities within OASIS, HL7, IHE and elsewhere to develop standards meeting requirements for the EHR- Emergency Responder and Consultations and Transfers of Care harmonization requests (formerly known as Use Cases).

I would recommend that ONC lead with a request for standards development first to the relevant standards development organizations. We've seen that they can effectively produce necessary standards without additional federal spending. It's only when those activities aren't effective that commissioning of standards should be considered. The benefit to this approach is that it doesn't necessarily preselect the SDO, and opens the process to participation by multiple organizations. It also doesn't precondition the development down one or another pathway, which leads to more innovation in the exchange of healthcare information.