Draft standard to ensure software is fit for purpose

This article first appeared in the November 2012 edition of Pulse+IT Magazine.
Australia is one of 10 countries involved in an international effort to draft a new standard to ensure healthcare software is safe and 'fit for purpose'. There will shortly be a call by Standards Australia for comment on the first public draft.

There are many accredited eHealth standards development organisations (SDOs), and in Australia the vast majority of eHealth standards are developed by the Standards Australia IT-014 Committee, with support from local chapters of international SDOs such as HL7 Australia and IHE Australia.

The Pharmacy Guild of Australia (PGA) became accredited as an SDO last year but will not be developing standards in the areas covered by Standards Australia. The National eHealth Transition Authority (NEHTA) is not an SDO, although its specifications are sometimes loosely referred to as “standards”.

Many of the NEHTA-developed specifications, such as the Clinical Document Architecture (CDA) content used with the PCEHR, are in the process of becoming Australian Standards following their submission to Standards Australia as draft documents to commence the rigorous standards process. A previous article in Pulse+IT detailed the structures and responsibilities of the Standards Australia committees.

Internationally, HL7 International is arguably the best known SDO in the eHealth area and is responsible for the widely deployed HL7 V2 messaging standard and CDA, among many others. Integrating the Healthcare Enterprise (IHE) International has been very successful in developing integration profiles that combine standards from other SDOs, especially HL7 and DICOM, into useful specifications to solve real-world common problems.

More recently IHE has become an SDO in its own right. The peak international SDO is the International Standards Organisation (ISO) and its technical committee, TC215, is responsible for eHealth standards. Most OECD countries participate in ISO and the other eHealth SDOs often submit their key standards to ISO to make them more widely available. Thus HL7 International has submitted its Reference Information Model (RIM) and IHE International its Cross Enterprise Document sharing (XDS) profile – which is the underlying infrastructure of the PCEHR – for publication as ISO standards.

However, there is a confusing “alphanumeric soup” of other standards development bodies that are active in the eHealth space and the number is increasing rather than decreasing. These include the European Community’s CEN TC251 (not to be confused with ISO TC215!); the Object Management Group (OMG), better known for its XML standards; the Clinical Data Interchange Standards Consortium, which is developing electronic standards for health research; the International Health Terminology Standards Development Organisation (IHTSDO), responsible for SNOMED; the Regenstrief Institute, responsible for LOINC (diagnostics terminology); and IEC 62A, MITRE, IEEE, DICOM and GS1.

IEC 62A was responsible for much of the standards for medical devices along with their embedded software but has recently extended its scope to cover all health software. A joint working group, JWG7, has been established between ISO TC215 and IEC 62A to coordinate development of work on safety of health networks and health software.

The MITRE corporation has been very active in developing general IT standards, in particular a “light” web service technology – hData – similar in function to SOAP but easier to implement for internal networks where security requirements are lower.

MITRE has been working jointly with HL7 International in developing hData implementations of HL7 Service standards and hData is the core communication component of HL7's latest rapid development technology FHIR, the brainchild of our own Grahame Grieve.

IEEE concentrates on electrical standards and, via ISO TC215, is responsible for many sensor standards (ECG, finger oximetry etc) and standards such as those for electrical interference with medical equipment. DICOM works principally in the area of imaging, particularly diagnostic imaging. DICOM standards are used for digital x-ray acquisition, storage and retrieval systems.

GS1 works in the area of product identification and barcoding and has a specific subgroup working with medical identification systems for products, medications, equipment and personnel.

To attempt to coordinate some of this standards development work and foster cooperation, a number of joint groups and cross publication agreements have been established. One of the first of these was the Health Services Specification Program (HSSP), which is a joint program between HL7 International and OMG. It leverages the health domain knowledge and content expertise of HL7 with the IT implementation expertise of OMG.

Draft standard specifications are developed in HL7 as implementation-independent service specifications. These are passed to OMG, which gathers member companies to produce platform-specific implementations that undergo rigorous assessment for conformance and utility. The final platform-specific specifications are published as OMG standards.

Issues encountered, lessons learned and ideas for further refinement are handed back to HL7 to be incorporated into a final platform independent service specification published as an HL7 standard.

The Joint Initiative Council (JIC), consisting of HL7, ISO TC215, GS1, IHE, CEN TC251, IHTSDO and CDISC, is a grouping of SDOs whose aim is to enable common and timely health informatics standards and which was constituted to undertake projects that cross SDO boundaries. It conducts joint work that spans member organisations.

IHE, HL7 and IEEE have special arrangements with ISOTC215 that allow standards they have published to be fast-tracked for publication as ISO standards, making them available to most of the developed world.

Keeping track of who is doing what and where each of the draft standards are in their development cycle is often challenging. We are extremely fortunate to have Richard Dixon-Hughes as the head of the Australian delegation to ISO TC215, the chair of HL7 Australia and a member of the HL7 International Advisory Board.

His expertise in the area of eHealth standards development coordination has recently been recognised by his appointment to the chair of the JIC. This is a significant responsibility and achievement which has been a possible by his personal dedication, coupled with the support of the team of volunteers who, like Richard, provide their time for free in attending HL7 and ISO TC215 meetings with expenses supported by the Department of Health and Ageing (DoHA).

A potentially “game changing” standard for health software vendors is currently in the early stages of development by JWG7. With the catchy title of “IEC/ISO 82304-1 Health Software – Part 1: General requirements for product safety”, this standard has been developed from the same source as the standards used for regulating medical devices. When complete, it could form the basis for regulation of health software and hence is vital to get correct.

Australia has been accepted as one of 10 countries involved in actively drafting this standard, which gives us an excellent opportunity to ensure that it is “fit for purpose”. There will shortly be a call by Standards Australia for comment on the first public draft. I would encourage everyone active in eHealth and concerned with the impact of health software on patient safety (isn’t that everyone?) to look at this draft and get involved.

The author and Dr Patricia Williams are the nominated Australian experts for this work and Richard Dixon-Hughes will be coordinating the Australian team response. Their combination of clinical, security and engineering eHealth backgrounds respectively is a great start in getting this work onto an appropriate track, but wide sector involvement will be needed to bring this work to a conclusion appropriate for the Australian eHealth community.

Author Details

Dr Vincent McCauley MB BS, Ph.D
MSIA National eHealth Implementation Coordinator
This email address is being protected from spambots. You need JavaScript enabled to view it.

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

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