From the HL7 TSC Chair... at the WGM by Charlie McCay

The Orlando Working Group Meeting was the first WGM for Lynn Laasko, the new Technical Steering Committee Project Manager. Lynn has allowed the TSC to take on more substantial planning work and is helping to make all the activity within the working group more visible.

An new Enterprise Architecture Implementation Project (AE-IP) (login wiki password wikiwiki) was setup by the TSC during the working group meeting to manage the rollout of the new HL7 Enterprise Architecture work being undertaken by the Architecture Board (login wiki password wikiwiki). The successful adoption of the Enterprise Architecture is a major objective for HL7 and a good deal of thought and effort was put into getting this project off to a good start.

Work on making HL7 projects more visible has progressed over the last three months, with the searchable project list being available from the HL7.org home page  and also as an excel spreadsheet for those who want to do their own analysis.

There is also ongoing work to ensure that workgroup activity documents (minutes and agendas) are easier to find, and that committees have Mission and Charter documents that reflect their activity, and have three year plans available so everyone can share common expectations as to what the committees will produce.

A new set of activities led by John Quinn, the HL7 CTO, will ensure that we have a set of market-facing descriptions of the HL7 product set, and a process in place to maintain these descriptions. This should dramatically reduce the difficulty that newcomers have finding what offerings from HL7 are relevant to them. This work will compliment the activities of the HL7 marketing committee and market positioning work being led by Chuck Jaffe the HL7 CEO.

There is a final “visibility” initiative to make the working of the TSC and CTO more transparent. This includes publishing the roles and responsibilities for the CTO, TSC chair, and TSC project manager, and a work plan for the year, and the period until the next WGM. As part of this effort the TSC and CTO activities will be managed in clearly defined projects.

Both the TSC and the board spent time discussing how to deliver more effectively to National Initiatives, including in particular the new US administrations intended large investment in healthcare IT. This is an area where there will continue to be active planning, to ensure that HL7 can deliver the standards that are needed, and is seen to be able to do that.

This will clearly involve working with other standards organisations both internationally and in the US, and the CEO and CTO have been proactive in establishing the MoU agreements other collaborations that will help ensure that HL7 can provide its members with a gateway into a coherent set of standards that meet the needs of its members. The TSC work to make projects, products, and workgroups more visible is also being extended so that work across organisations can be coordinated and reused.

On a separate note, the Implementation Technology Working Group is continuing to look at the schemas produced to support implementation of the XML ITS, and seeking ways to improve these, as well as considering how to take the “New ITS” proposals forwards. As the body of implementation experience grows there is a better understanding of the challenges and compromises that can be made. The new HL7 Enterprise Architecture work (login wiki password wikiwiki) introduces different levels of conformance, and this may help to address some of the concerns expressed during balloting on the New ITS proposals.

Melvin Reynolds

I: Device communications highlights, some of which arose from informal discussions:

1. We made significant headway on MDC ontology maintenance and conformance, and IHTSDO coordination.

2.  The issue of the potentially confusing differentiation between personal health devices and medical devices was aired and will have to be revisited.
   The fact that healthcare providers and drug companies have joined, and driven, Continua has to a large extent created this confusion in a consortium originally dedicated to growing a consumer business. The crossover usage links back to the increasing urgency to address (1).

3. For the first time two use cases for HL7 v3 messages for medical device data began to emerge; the first for use in the UK CfH context, the second in Spain for medical engineering surveillance of clinically deployed devices.
   Previously, there have been disparate uses of HL7 CDA and the harmonised use of HL7 v2 as profiled in IHE PCD.

4. Lack of time forced postponement of the important issue of device representation in HL7 Clinical Statements/Templates and 13606 Archetypes into the next meeting agenda - where we will spend at least half of one day on this topic - perhaps allied to the existing MFER and emerging HL7 GAS and IDC CDA work.

5. There was continued support for formalisation of the position of UCUM (mostly to address maintenance and governance issues) - which is central to much device data reporting.

6. Lastly, it was clear that the use of the HL7 Common Product Model driven by the FDA lacks consensus both within the FDA and amongst other regulators. The Devices joint groups represented in the HL7 joint session with RCRIM advised explicit agreement in GHTF before attempting to impose a drug-centric, US-purpose model on the international drug and device sectors.

See papers at http://www.hl7.org/Special/committees/healthcaredevices/index.cfm for more detail of these meetings.

II: The HL7 Affiliates Council met Before the JIC JWG (WG9) on Sunday; some highlights included:

1. Chuck Jaffe (HL7 CEO) noted the increasing Profiler-Enforcer Organisations (e.g. NHS CfH) and that HL7 will look for income from them.

2. John Quinn (HL7 CTO) noted 3 types of tooling: balloting and publishing, CDA implementation guidance/templating, v3 implementation/guidance tooling. All major users seem to apply v3 in different ways depending on infrastructure and architecture choices.

3. A question was asked about IHE specifications that are, functionally, standards (e.g. XDS). The stance of HL7 staff seemed antipathetic towards IHE, though in conversations it was difficult to ascertain the reason for this.

III: The JIC JWG (WG9)

1. It was notable that the meeting (again after explicit questioning) approved without dissent the proposal (to JIC) on the table that the work item on Identification of Medicinal Products (IDMP) should be recognised as a joint (JIC) item - though the issue of leadership was not discussed (perhaps an omission on my part as Co-Chair?).

2. The addition by the Convenor of ISO WG7 (Devices) of an item proposing 11073 (MDC) co-ordination with IHTSDO (SNOMED CT) was received with enthusiasm by a number of persons present - including the HL7 CEO who is closely linked with Continua.
   Unfortunately there was no IHTSDO representative at these meetings but Dr Norton was able to organise a joint exploratory session (CEN/ISO/IHTSDO with IEEE and HL7 participation by phone/Webex) for the IHTSDO meetings at the beginning of April in Helsingors (DK).

See the agenda (and forthcoming draft minutes) posted at www.global-e-health-standards.org for more details.

IV: The Joint Initiative Council (JIC)

1. Considerable time was spent on joint publication format issues - the HL7 editors (most notably Mead Walker) of the ISO WG6 ICSR items have done excellent work - which should enhance each of the CEN, ISO and HL7 html document structures - and readability.

2. The new JIC project template was approved, though the added value above that of an ISO Form 4 or and HL7 proposal is not yet clear.

3. In the absence of the TC251 Chair I abstained on behalf of CEN from a vote agreeing the CDISC/ HL7/ISO BRIDG-model project - though noted that I was unaware of any objections or problems.

4. The most contentious discussion was around the approval of the CEN proposal that the IDMP project (see above) be approved. Though agreed in principle, this was predicated on the agreement amongst the regulators (chiefly FDA and EMEA) that they had shared requirements and views about the technical output.