MSIA: Software standards and eHealth
Software standards in general and eHealth software standards in particular provide a methodology and governance framework to encapsulate community agreed best practice in a readily accessible and stable specification.
The wide stakeholder engagement, public comment processes and concentrated expert input are a proven and trusted path to high quality documents. Standards provide stability for industry and building blocks towards interoperability that are vendor neutral. International standards aim to provide capabilities that can be built once and deployed across international boundaries.
eHealth standards in Australia are governed by Standards Australia and managed by the IT-014 Technical Committee.
There are sub-committees of IT-014 for specific domains including Health Concept Representation (IT-014-02), Electronic Health Record Interoperability (IT-014-09), Information Security (IT-014-04), Telehealth (IT-014-12) and Messaging and Communication, including clinical documents (IT-014-06).
IT-014-06 in turn has Working Groups (WG) responsible for Patient Administrative Messaging (IT-014-06-03), Prescription Messaging (IT-014-06-04), Diagnostic Messaging (IT-014-06-05) and Collaborative Care Communications (IT-014-06-06).
The Medical Software Industry Association (MSIA) has members who attend all IT-014 committee meetings on a regular basis. Recent developments at IT-014 have included:
- Formation of a Conformity Assessment Task Force looking at how standards should specify conformance requirements and how conformance requirements and test cases should be documented.
- Formation of a Clinical Decision Support sub-committee (IT-014-13) with the inaugural meeting taking place on June 12, 2012.
- A large and complex work program of approximately 72 projects to provide standards support for the PCEHR project and National Health Identifiers in existing and new standards.
- Major current work items include topic areas such as: (i) a new CDA based ETP standard; (ii) standardising the CDA documents specified for the PCEHR (shared health summary, event summary, referral, discharge summary and specialist letter) and extending their applicability for point-to-point exchange; (iii) Profiling the HL7 V2 referral standard to carry the same content as the CDA Referral document; (iv) Updating the diagnostics implementation handbook and standard to incorporate National Healthcare identifiers and terminology; and (iv) Updating the patient and provider identification standards and patient administrative messages to include support for National Health and other identifiers.
The Department of Health and Ageing (DoHA) provides significant financial support for IT-014 administrative functions but the members of the IT-014-subcommittees and working groups are all unpaid technical experts.
In the Australian context, the majority of eHeath international standards work occurs at HL7 International and at the International Organisation for Standardisation (ISO) eHealth Committee (ISO/TC215). Related bodies are the European Economic Community (EEC) eHealth standards Committee (TC251) as well as other Standards groups with eHealth work programs such as the Object Management Group (OMG), CDISC, IEC and IEEE.
Increasingly there are cross standards organisations and joint standards development between these groups. Examples include HSSP (collaboration between HL7 International and OMG) and the various joint working groups such as JWG7, which is a collaboration between ISO/TC215 and IEC.
Internationally, Australia is well represented at HL7, with six co-chairs of influential HL7 International committees, as well as input to the board advisory panel and has a strong team representing Australia’s interests at ISO/TC215. Both of these teams receive DoHA support for costs (administered by Standards Australia) but volunteer their time to attend working meetings and weekly or fortnightly teleconferences.
For the eHealth software industry, a significant development at ISO/TC215 over the last few years has been the move to develop a prescriptive approach to eHealth software system safety in a standards framework. Initial attempts promoted by the healthcare devices groups proved too inflexible and were not accepted by TC215.
However, two new work items have recently been proposed to develop both a catalogue of international standards that may be useful for developing safe eHealth software and a renewed attempt to standardise concepts and behaviour that are requirements of safe eHealth software.
Many regulatory bodies are watching these developments carefully. Achieving a balance between cost effective, practical standards and the ability to support a prescribed level of safety and certainty will be difficult – doing so in a manner that is acceptable to a broad spectrum of the international eHealth community will add an additional level of challenge.
The formation of IT-014-13 as an Australian Standards focus for Clinical Decision Support (CDS) is a welcome development. In recent years there has been general agreement that standards for this rapidly developing area are necessary to underpin safe, reproducible, traceable clinical outcomes, but there was no local body tasked with their production.
The imminent delivery of the national PCEHR for the first time provides the potential for a rich source of data to facilitate clinical decision support systems. The IT-014-13 sub-committee will act as a local mirror committee to the HL7 International Clinical Decision support committee and is co-chaired by representatives from two MSIA member companies.
The sub-committee’s work plan will include localisation and support for the HL7/OMG Service Oriented Architecture (SOA) Clinical Decision Support Service as well as standardisation of data inputs to CDS systems – the HL7 Virtual Medical Record (VMR).
At the last HL7 International meeting, frustration with the complexities of HL7 v3 implementation led to a proposal by local HL7 Standards guru and MSIA member, Grahame Grieve, for the next step – Fast Health Interoperability Resources (FHIR).
This proposal is being loosely referred to as HL7 V4! It connects the strong data modelling of the HL7 V3 Reference Information Model (RIM) to the easy to implement world of RESTful service oriented architecture.
FHIR has been endorsed by many of the HL7 v3 stalwarts though there are many details still to be finalised. Work on FHIR has attracted an enthusiastic, highly motivated community of people and is being progressed at a pace that is likely to see some mature outcomes in unprecedented short timeframes.
Whilst the standards support for the PCEHR has been a prominent focus for the federal government over the last two years, there have been many other areas of progress in eHealth standards development. Australian expertise is playing a significant role in international standards initiatives and this is being reflected in local standards developments across a broad spectrum.
A major limiting factor at present is availability of expert volunteer time. NEHTA has made a number of significant resource contributions to major specifications that are now being passed to Standards Australia to develop and progress through the standards development process. However, the current capacity is being challenged by large sets of documents comprising many thousands of pages, produced over many years which are now inputs to new standards and are to be processed by small numbers of volunteers in relatively short timeframes.
A few years ago IT-014 received an award as the most productive committee within Standards Australia. Refinements of process and resources are being undertaken to address the current challenges so that the same efficiencies can be reached to achieve the required outcomes in quantity whilst maintaining quality.
The prospect of a cutting edge, richer eHealth standards landscape is tantalisingly close. However, it will require the eHealth community in general, the eHealth software industry and MSIA members in particular, to provide significant support in order to build effectively on the foundations provided by NEHTA and DoHA.
Dr Vincent McCauley MB BS, Ph.D
MSIA National eHealth Implementation Coordinator
Dr Vincent McCauley is an acknowledged national and international expert in eHealth standards. He leads MSIA’s team assisting its membership of more than 120 leading eHealth software vendors and the wider vendor community in creating a richly interconnected, semantically interoperable eHealth environment.
Posted in Australian eHealth