On the 30th January 2007 The Australian published a long article entitled “ Doing the numbers on e-health” by Karen Dearne which was described as the “world according to Dr Ian Reinecke” CEO of the National E-Health Transition Authority (NEHTA).
It seems to me that a sensible way to approach the article is to endeavour to distil what was being said or implied and to offer commentary on that basis. As the comments were made by the NEHTA CEO it seems fair to assume he is accurately reflecting the views and understanding of the NEHTA Board and it is my plan to address the apparent policy directions and choices being made by that Board, based on the position reflected in the comments documented in the Australian.
First it was obvious throughout the interview that NEHTA has no sense of urgency about advancing the e-health agenda. We are told that the business case for the National Shared Electronic Health Record (SEHR) may be ready for Council of Australian Governments (COAG) in 2007 (or if not 2007, hopefully 2008) although it was not clear, even if ready, whether it could actually make it onto COAG's agenda. Elsewhere we are told that (presumably) after approval has been given it will take three years (at least) to develop before it can be progressively implemented (over how long is not specified). What this says is that implementation may start in 2011 at the earliest and then proceed at presumably an equally relaxed pace.
Given Australia has been working on a variety of Shared EHR proposals since a House of Representatives Report in 1997 it is just flabbergasting that it can take a decade to get to the stage of developing a business case for e-Health which is yet to be completed or released. (The UK, the US and Canada did this years ago.) Worse it seems they are then prepared to wait another un-specified number of years to actually begin to deliver benefits in terms of patient safety and the quality of care – to say nothing of health sector efficiency. We know from studies overseas the opportunity costs of not implementing Health IT are billions of dollars in benefits forgone per annum (Canada thinks about six billion per annum in their country, which is similar in size to Australia) but it seems clear the NEHTA Board is content to just ignore such costs and proceed at the current leisurely pace. NEHTA itself, in documents published almost a year ago, has shown it understands this opportunity cost – so where is the action?
The lack of urgency with which NEHTA is proceeding becomes even clearer when it is recognised that responsibility for development of the SEHR was passed to NEHTA from the Commonwealth Health Department in April 2005. What progress has been made since then has not been obvious to this observer. Very little - is likely to be the answer given the interview comment like “A lot of that detail will start to move into the public domain, and (the SEHR) will be the subject of intensive work over the next 12 months”.
Second we are told by Dr Reinecke that “My understanding is that the access card will operate quite separately from the healthcare identifier. At this point there's really no place where the projects intersect.”
Just how can this be right?. The Access Card is going to allocate an identifier for use in the access of Health Services - how then can it be that this doesn't intersect with the identifier NEHTA plans to allocate for use in the Health Sector? If this proceeds all it means is that essentially every user of the Health Sector will have two identifiers on their health records – one from Minister Ian Campbell and one from NEHTA. I wonder does the Board understand just how bizarre and potentially wasteful this is?
Worse than that, the NEHTA identifier is likely to be the less robust of the two and yet it is the one that is intended to assure reliable linkage of health records rather than the much more carefully verified Access Card identifier!
Even more difficult to follow is that NEHTA thinks it can provide a health identifier for $15 million a year over three years ($45 million) and the Access Card project is costed at over $1.1 billion over about four years. Someone surely has their costings badly wrong?
Third we are told that it is NEHTA's preference to change the law so they can mine the most reliable of the Medicare client databases for names and addresses to populate their identity database.
I wonder what Professor Alan Fels of the Access Card Privacy Task Force and Ms Karen Curtis of the Commonwealth Privacy Commission would think of this proposal to covertly, and without consent, mine a Medicare database for details provided by citizens in good faith. My suspicion is that they would be gravely concerned. The Board should certainly make sure they are consulted (if it hasn’t) before any more money is spent.
Last we learn that NEHTA is confident the Standards it needs will be ready and that great progress is being made. This is true to the extent that we see the emergence of pragmatism and a sense of urgency in the US and also work in the UK to simplify implementation of HL7 V3.0. While progress is being made at a good pace on the Healthcare Services Specification Project Overview (a collaboration between HL7 and OMG) this work is unlikely to be ready for “prime-time” anytime soon.
It should be remembered that when NEHTA was conceived its job was to *quickly* choose amongst the available (and evaluated) standards - now it is trying to write the standards, which will probably take a decade to agree upon and even longer to generate the evidence that says they actually work. The much lower risk profile for using proven currently working standards versus scrapping them for their obvious defects (they will have these, by definition, of course) and going for long term high risk standards development has never been discussed, nor acknowledged. It is a fundamental shift in NEHTA's program, and seems to almost have happened by accident. Yet it is a profound shift. For this to happen without anyone worrying about it, seems to show an apparent loss of control on the part of the Board in its oversight of NEHTA’s direction.
Without rehearsing again all the other matters I have raised over the last month or two it seems to me that the NEHTA Board has not demonstrated (after two years) it is up to the task of providing National E-Health Leadership and delivering the required oversight to NEHTA. If NEHTA’s CEO reflects the Board’s priorities and views accurately, and I am sure he does, it is my opinion that, on the public evidence to hand, the Board is strategically inept, ill-informed, technically out of its depth, out of touch with the e-health community and stakeholders and their requirements and simply inadequate to the task.
It would be of value to the whole E-Health domain in Australia if the NEHTA Board was to produce a paper documenting their understanding of the issues raised herein and their proposed strategic action plan to address them.
I would also suggest a lot of the problems we now see are related to the loss of the Australian Health Information Council (AHIC) and its role in providing technical and strategic governance of NEHTA. AHIC is apparently to be re-constituted in the next few months (after a two year hiatus) but unless it is properly constituted, resourced and empowered this may be more of a hindrance than a help. We will see.
What I was hoping to hear, and didn’t, was that work on a National E-Health Strategy was well underway and that calls from a large number of stakeholders for improved pragmatism, responsiveness, transparency and consultation from NEHTA’s stakeholders and customers were being taken seriously and actioned. I would also have liked to hear that NEHTA was going to push for rapid progress in implementation of the Health IT applications and approaches that are known to work in saving lives and improving efficiency while pursing its long term R&D agenda. No such luck it seems!
The E-Health Domain is one area where a Commonwealth takeover and Commonwealth leadership is to be welcomed!
David.
Sunday, February 04, 2007
Saturday, February 03, 2007
A Weekend Treat!
Just a short note to let everyone who has a moment on the weekend that the Robert Wood Johnson Foundation has posted a fabulous presentation on their web site entitled “Can Health IT Enhance the Pace and Power of Research? The Case for Rapid Learning Systems” dated Jan 23, 2007. The URL is:
http://www.rwjf.org/newsroom/activitydetail.jsp?id=10195&type=3
Those involved in the roughly one hour presentation are described as follows:
“Carolyn Clancy, director of the Agency for Healthcare Research and Quality joins national technology experts, including David Eddy and Lynn Etheredge, to showcase ways in which EHRs are making rapid advances in diabetes and cancer care, how rapid-learning capabilities will help accelerate personalized health care, and how, through rapid learning, doctors will do a much better job of advising patients. Also featured are John R. Lumpkin, M.D., M.P.H., RWJF senior vice president and director of the Health Care group and Joel Kupersmith, M.D., Chief Research & Development Officer, Veterans Health Administration. (HHS Secretary Michael O. Leavitt, originally scheduled, is unable to attend.)”
This is a very serious cast and this presentation is by far the best way to gain an initial appreciation of the key contents of the Health Affairs special issue on Rapid Learning Health IT and its implications.
I would highly commend this to all readers of my blog.
David.
http://www.rwjf.org/newsroom/activitydetail.jsp?id=10195&type=3
Those involved in the roughly one hour presentation are described as follows:
“Carolyn Clancy, director of the Agency for Healthcare Research and Quality joins national technology experts, including David Eddy and Lynn Etheredge, to showcase ways in which EHRs are making rapid advances in diabetes and cancer care, how rapid-learning capabilities will help accelerate personalized health care, and how, through rapid learning, doctors will do a much better job of advising patients. Also featured are John R. Lumpkin, M.D., M.P.H., RWJF senior vice president and director of the Health Care group and Joel Kupersmith, M.D., Chief Research & Development Officer, Veterans Health Administration. (HHS Secretary Michael O. Leavitt, originally scheduled, is unable to attend.)”
This is a very serious cast and this presentation is by far the best way to gain an initial appreciation of the key contents of the Health Affairs special issue on Rapid Learning Health IT and its implications.
I would highly commend this to all readers of my blog.
David.
Thursday, February 01, 2007
Guest Article II - Supporting Diversity in Views.
Today's guest article is from a frequent commenter who asked for a little more space to present his views. Others are welcome to also ask for space!
Short Biography of Our Guest.
Dr.Ian Colclough has over 30 years experience in medical informatics in a career spanning medical practice, hospital administration and strategic and tactical sales and marketing in the corporate sector in Australia, South Africa and the United Kingdom. He has been involved in the research, development and design of hospital administration and departmental clinical systems, medical practice systems, the computerised medical record, patient profile systems and occupational health and safety systems.
That 'sensible' Roadmap
Tom Bowden touches on some very important points when presenting what he describes as “a sensible ‘roadmap’ for secure health messaging in Australia”.[1]
His arguments have merit and bear careful consideration. Is it a sensible roadmap? If yes – why has no-one come up with it earlier? If no – we need to know why it is not sensible. This is the sort of question NEHTA has been established to answer.
In posing his question - “However Can We Get to A Connected Health Sector from where we are today? ” - Tom echoes a presentation given by Ian Reinecke at the Health-e-Nation Conference in 2005: “e-Health – Getting There from Here”. Ian said that the new company (NEHTA) “will provide the critical standards and infrastructure required to support connectivity and interoperability of electronic health information systems across Australia”. How far have we travelled along that road?
The Pathology Sector
Many will argue strongly with Tom's view that “Australia's track-record in health sector automation (e-health) is among the worst in the developed world” [1]! Few, however will differ with his claim that the way to speed up implementation of much-needed health sector reforms is to put in place a universal communications framework. This is predicated on the proviso that the framework is independent of any one messaging vendor and accessible by all.
He asks “why Australia's health system (is) so substantially lacking in connecting its primary care sectors by comparison with Holland, New Zealand, and some of the Scandinavian countries” [1].In seeking the answer he points to the Pathology sector as offering the most expedient way forward.
Pathology laboratories are high-volume transaction-based entities totally dependent on sophisticated computer software systems to manage their large complex enterprises. In the 1970’s they were at the forefront of health care computing and over the last three decades they have continued to invest heavily in deploying ICT to deliver efficiencies and drive down costs.
Significant rationalisation of this sector occurred throughout the 1990’s. This led to the emergence of a small number of very large pathology providers such as Sonic, Healthscope and Symbion. Also, around 1992-1993 a small group of Australian laboratories collaborated to develop a way to deliver pathology reports by e-mail using standard print-file formats. This led to development of the Pathology Information Transfer (PIT) messaging format as an expedient way to solve the immediate problem at hand.
Pathology Information Transfer
PIT has served the pathology sector well to-date. It has however not been adopted elsewhere outside of Australia. Other countries have adopted either HL7 or some other alternative, such as EDIFACT which is used widely in Scandinavian countries. This has left Australia hostage to its own solution; one which developed locally through necessity and which, through its widespread adoption, ultimately became a de-facto standard throughout Australia.
Within this context Tom makes the point that the PIT message is “unable to be usefully incorporated within an electronic medical record” [1] (EMR) as it can only be displayed in its entirety and stored as an object. This means that, unlike an HL7 message, the PIT message cannot be broken down into separate data elements which can each be incorporated into the EMR. Hence PIT messages do not easily allow for follow-up recalls, the monitoring and display of trends using graphs and bar chats, and large scale epidemiological and other population-based research studies.
Clearly the widespread use of PIT as a de-facto Australian standard has ‘severely hampered adoption of internationally supported messaging standards within the Australian health sector”
[1].
The vendor community would agree that the best opportunity to initiate the adoption of widespread electronic communications throughout the Primary and Secondary care sectors is to drive into place as quickly as possible the deployment of automated secure messaging (based on internationally accepted standards) between pathology centres (and radiology) and their medical practice clients.
The argument for the immediate adoption and standardisation of HL7-based messaging is well founded and should receive widespread support.
HL7 Messaging Standards
In passing, it is important to note that the National E-Health Transition Authority (NEHTA) has stated that pathology providers “have indicated support for the open, web service standards (which) NEHTA has proposed and that they (the pathology providers) understand the benefits they would bring in a contestable market.” [2] That having been said however NEHTA has also noted that pathology providers “perceive a business imperative to address the issues arising from the current market situation” … and more importantly … “they are considering creating a message environment that will still form barriers to cross-sector connectivity and interoperability[2].”!
Regardless of whether they have a vested interest in maintaining the status quo or not the pathology service providers need to accept that PIT's days are over. They should move on without further delay. How might this be achieved? Should it be left to market forces alone to address, or to the State and Federal Governments, or to NEHTA? Or should the vendor community together with their clients, the pathology providers, drive the changeover? Ideally, Government should provide appropriate support to the vendor community to enable them to 'assist' their clients to make the change.
There is a further point about PIT which needs to be borne in mind. Part of its attraction could be that the reporting pathologist is legally liable for the content and accuracy of the pathology report. By sending information in the PIT format the pathologist has taken all legally necessary and reasonable steps to ensure the results in the report cannot be altered. (Just like an Acrobat .PDF file.) At the medical practice end the report is simply attached to the patient record as a document.
When dispatching HL7 format results, the reporting pathologist needs to be satisfied that the atomic data that will populate the patient clinical record, at the medical practice, is similarly protected. This requires some additional software complexity at the medical practice end to ensure that these results cannot be altered. The associated complexities of cross-mapping the incoming results definitions to those of the clinical desktop system also need to be addressed.
Nevertheless, HL7 V2.3.1 is the method of choice for transmitting pathology messages. There are sufficient numbers of organisations and people well versed in HL7 in Australia today to drive HL7 standards based solutions into place. The changeover to HL7 will be a formidable exercise given that the majority of pathology results being delivered today use the proprietary, non-standards-based, PIT message format. To bring this change about will require astute enlightened leadership underpinned by some very sophisticated strategies and a finely-honed understanding of all parties that will be impacted by the change and the obstacles and issues that will be encountered. The key to the solution lies in the strategies required to effect the change and the political will to bring it about. Careful analysis of the problem reveals that it can be resolved reasonably quickly.
Tom is not alone in expressing the thoughts of many in the vendor community when he says, “the really sad thing is that Australia has already spent huge amounts of effort and money developing many of the standards, support services, systems and capabilities needed to do the job” …. and … “that the basic tools to enable there to be a connected health sector do exist; they are just not being used properly. [1]”
He observes that “the National e-Health Transition Agency (NEHTA) is using very little of the immense amount of work that was already underway prior to its formation” …. and that …. “based upon the present rate of progress it is likely to be some years before we see any implementable results. [1]”
Standards can be so contentious
The standards argument is divisive and very complex. Yet, all would agree that work on developing standards and resolving the many conflicts and issues involved is very important. The unresolved issues however should not be permitted to impede the development of interoperability between software vendors. Nor should they be permitted to impede the step-by-step resolution of problems encountered in building an integrated, shared, longitudinal Electronic Health Record (EHR) for widespread use across all health sectors. [3]
On this subject David More presents a well reasoned view in his recent blog on Archetypes and Standards 4. He points to the "considerable successes achieved in the Health Sector with messaging technologies including EDIFACT and HL7 V2.x.". He also notes that "to-date - in the messaging arena - HL7 V3.0 and EN13606 are still in the process of development and tools and implementations are by no means common.[4]"
In terms of the ‘clinical data’ to be transmitted, it is clear from his discussion that much of the work based around standardising ways of storing and retrieving the atomic elements of information required to populate the EHR over a patient's lifetime is still in its infancy and evolving slowly.
It should be apparent that NEHTA has a major R&D role to play in the years ahead. That being the case the marketplace cannot and should not be made to wait until NEHTA has completed its deliberations on the many complex and elusive issues which it is trying to solve. Rather, the Government's and Health Departments should embrace David's call for a dual approach. One which supports "appropriate and promising R&D" ……. "blended with dramatically more energetic investment and deployment of systems which are already known to work and for which evidence as to their value is quite unarguable" [4].
Engaging 'the' stakeholders
NEHTA was established to drive forward critical e-health initiatives. Its governance is under a Board of Directors made up of CEOs from the Health Departments of the Federal, State and Territory jurisdictions across Australia.
The jurisdictions provide NEHTA's funding. As a consequence they are stakeholders and also NEHTA's only shareholders. However, they are not the only stakeholders to be impacted by NEHTA's work; far from it. The IT vendor community, medical, pharmacy and allied health care practices, hospitals, nursing homes, aged care and community health centres, and others, have a major vested interest as stakeholders in NEHTA's outcomes.
NEHTA's governing stakeholders are predominantly driven by imperatives arising from the highly politically sensitive public hospital (tertiary) sector. Yet, in many ways NEHTA has more to offer the Primary and Secondary care sectors than the Tertiary hospital sector. Hence, the absence of Primary and Secondary care sector stakeholder representation and influence at the highest level of NEHTA's governance is disconcerting; more so, should the immediate e-health needs of the Primary and Secondary care sectors become bogged down by the complex web of e-health and ICT related issues and politics so prevalent in the Tertiary care sector.
Fundamentally, the Primary and Secondary care sectors (organisationally, functionally and politically) are quite distinct from the Tertiary (hospital) sector; even more so when it comes to categorising health-ICT vendors into the particular health sector niche which each predominantly services.
A strong case can be made for allocating significant resources to focussing on addressing some of the more immediate e-health needs of the Primary and Secondary sectors separately from the needs of the Tertiary sector. The urgency of this is further reinforced by Ian Reinecke's comment that "we need to be carefully aligned with the powerful players internationally"[5]. Reflecting on this leads one to enquire as to which powerful international players NEHTA may have in mind. Could they be Cerner, Philips, GE Healthcare, and Siemens?
Whoever it may be it seems to indicate that NEHTA has blatantly failed to appreciate that the Primary and Secondary care sectors are not the domain of the powerful international players. Rather, they are serviced, professionally and competently, by a cohort of small, highly skilled, agile, homebred software vendors. Some have made very impressive inroads internationally. Some are at the cutting edge of standards-based implementation projects that test the operability of HL7 V3 and OpenEHR technology as an investment in advancing towards the EHR. They work in a market sector in which the powerful international players have shown little or no interest!
In February 2006, NEHTA discussed the consequences of a “proliferation of incompatible systems and technologies” and it noted that “harnessing the capabilities of software vendors and service providers in the health sector to provide this connectivity will be a key to success” [2]. In light of this the time has come to clearly distinguish between what activities should be classified as R&D and what should be classified as ‘implementable today’.
It is time to reconsider what benefits could flow from drawing upon and utilizing a lot more of that 'pre-existing effort and the skills and expertise' so readily available in the vendor community.
HL7Messaging – What is NEHTA’s view?
In order to achieve widespread standardisation of messages there needs to be a process in place to achieve consistency when implementing standards.
Few would disagree that Australia should “define one standard for each purpose and rigorously enforce it ……… to prevent proliferation of non-standard formats.” [1] The general consensus among industry experts seems to be that Australia should implement HL7 V2.3.1 (AS 4700.2) as the minimum health industry standard.
A strong case can be made for populating medical practice records with discrete results without further delay as opposed to continuing with the PIT format. As this can be achieved using HL7 V2.3.1 and transmitted under control of the HL7 messaging protocol it is clear that HL7 V2.3.1 provides a nationally consistent base from which to move forward building upon what is readily available today.
NEHTA’s view on messaging standards is unclear at this time although it would be enormously beneficial to everyone if it could be clarified quickly.
Australian Health Messaging Laboratory
Tom comments that the Australian Healthcare Messaging Laboratory (AHML) has an important role to play in helping to secure the consistent deployment of HL7 messaging standards by software vendors.
AHML, as part of the Collaborative Centre for eHealth (CCeH) based at the University of Ballarat, is unique in Australia. Having been accredited by the National Association of Testing Authorities (NATA) it has positioned itself to act as an on-line test-bed laboratory for the technical evaluation and certification of electronic messages in healthcare applications being deployed by vendors in more than 30 countries. It is therefore well placed to test for conformance and monitor compliance against Australian and International Standards.
State jurisdictions and the Federal Government have a vested interest in securing AHML's future as the central reference point for HL7 messaging standards[6]. It should not be too problematic to find the funding required for this to happen without undue delay.
This will likely necessitate AHML having to be constituted formally as a Reference Laboratory. Under this arrangement AHML's funding should be derived from a mix of Government support and self-generated revenue. Its staff and management should be focused entirely on the testing, certification and compliance of messages against standards. The Reference Laboratory will need to be seen to operate transparently and impartially, totally devoid of any potential for the development of conflicts which could arise should its management and staff elect to undertake consulting assignments where they may be compromised by competing against vendors whose messaging software is subject to AHML testing.
HL7 V2.3.1 is widely implemented, tried and proven. It offers substantial benefits over PIT and even more importantly, it provides a way for the entire e-health community in Australia to move forward. It is therefore time for a seriously concerted effort to be made to move the pathology sector away from PIT towards the adoption of HL7 V2.3.1 or above. This seems to be a very good way to go for the next few years and it can be done today; delivering enormous benefits with minimal pain by using standards which have a good track record of runs on the board worldwide. An important element in driving the uptake of standards is to implement strategies which will create a dynamic contestable market environment.
Is there a better way?
There has to be a better way to move the e-health agenda forward. Tom lists three strategic options for the way ahead, opting for some form of collaborative partnership in which “small, specialised service organisations are given government backing and modest financial incentives[1]” to achieve sector integration.
In broad principle the concept of a ‘collaborative environment’ has the most likelihood of succeeding. It should be appreciated however that the optimal selection and order of enrollment of ‘participants’ is not a straightforward exercise. It is absolutely imperative that the setting up of a ‘collaborative structure’ (consortium) is done thoroughly and properly at the outset in order to contain risk and ensure the consortium’s longevity and success.
Collaborative consortia are quite complex to construct, more so in the health sector than in most other industries. Building a successful Health-E-ConsortiumTM requires a unique business model and organisational structure. The partners must work in harmony together, where often they are in competition with each other. They must be committed, highly motivated, well led and well rewarded, and they must be prepared to work in an environment which promotes a culture that is based on trust, a concern for each other's profitability, and a mutual commitment to customer satisfaction.
References.
[1.] Bowden T, A Connected Health Sector – However Can We Get There From Here? (16 January 2007) Guest Blogger Article www.aushealthit.blogspot.com
[2.] NEHTA, Towards a Secure Messaging Environment – An E-Health Transition Strategy Version 1.0 – 2/02/2006 For Comment, page 6.
[3.] Colclough I, Comment attached to Implementation Really Matters (8 January 2007) Blogger Article www.aushealthit.blogspot.com
[4.] More D, Archetypes, Standards and All That Jazz - Part 2 (28 January 2007) Blogger Article www.aushealthit.blogspot.com
[5.] Dearne K, Doing the numbers on e-health - the world according to Dr Ian Reinecke, The Australian (30 January 2007) IT Business, page 3.
[6.] Australian Health Messaging Laboratory, Available Test Profiles, accessed 30 January 2007, http://www.ahml.com.au
© Copyright 1 February 2007
Dr Ian Colclough - Integrated Marketing and e-Health Strategies
ihsipl@smartchat.net.au, 0412 059 392
Note: These views are those of our guest commentary provider and should be read as such. This forum is to provide a space for comment and debate and I hope this contribution helps. Thanks Ian.
David.
Short Biography of Our Guest.
Dr.Ian Colclough has over 30 years experience in medical informatics in a career spanning medical practice, hospital administration and strategic and tactical sales and marketing in the corporate sector in Australia, South Africa and the United Kingdom. He has been involved in the research, development and design of hospital administration and departmental clinical systems, medical practice systems, the computerised medical record, patient profile systems and occupational health and safety systems.
Secure Health Messaging - Where to tomorrow?
An independent commentary on “A Connected Health Sector”.
An independent commentary on “A Connected Health Sector”.
That 'sensible' Roadmap
Tom Bowden touches on some very important points when presenting what he describes as “a sensible ‘roadmap’ for secure health messaging in Australia”.[1]
His arguments have merit and bear careful consideration. Is it a sensible roadmap? If yes – why has no-one come up with it earlier? If no – we need to know why it is not sensible. This is the sort of question NEHTA has been established to answer.
In posing his question - “However Can We Get to A Connected Health Sector from where we are today? ” - Tom echoes a presentation given by Ian Reinecke at the Health-e-Nation Conference in 2005: “e-Health – Getting There from Here”. Ian said that the new company (NEHTA) “will provide the critical standards and infrastructure required to support connectivity and interoperability of electronic health information systems across Australia”. How far have we travelled along that road?
The Pathology Sector
Many will argue strongly with Tom's view that “Australia's track-record in health sector automation (e-health) is among the worst in the developed world” [1]! Few, however will differ with his claim that the way to speed up implementation of much-needed health sector reforms is to put in place a universal communications framework. This is predicated on the proviso that the framework is independent of any one messaging vendor and accessible by all.
He asks “why Australia's health system (is) so substantially lacking in connecting its primary care sectors by comparison with Holland, New Zealand, and some of the Scandinavian countries” [1].In seeking the answer he points to the Pathology sector as offering the most expedient way forward.
Pathology laboratories are high-volume transaction-based entities totally dependent on sophisticated computer software systems to manage their large complex enterprises. In the 1970’s they were at the forefront of health care computing and over the last three decades they have continued to invest heavily in deploying ICT to deliver efficiencies and drive down costs.
Significant rationalisation of this sector occurred throughout the 1990’s. This led to the emergence of a small number of very large pathology providers such as Sonic, Healthscope and Symbion. Also, around 1992-1993 a small group of Australian laboratories collaborated to develop a way to deliver pathology reports by e-mail using standard print-file formats. This led to development of the Pathology Information Transfer (PIT) messaging format as an expedient way to solve the immediate problem at hand.
Pathology Information Transfer
PIT has served the pathology sector well to-date. It has however not been adopted elsewhere outside of Australia. Other countries have adopted either HL7 or some other alternative, such as EDIFACT which is used widely in Scandinavian countries. This has left Australia hostage to its own solution; one which developed locally through necessity and which, through its widespread adoption, ultimately became a de-facto standard throughout Australia.
Within this context Tom makes the point that the PIT message is “unable to be usefully incorporated within an electronic medical record” [1] (EMR) as it can only be displayed in its entirety and stored as an object. This means that, unlike an HL7 message, the PIT message cannot be broken down into separate data elements which can each be incorporated into the EMR. Hence PIT messages do not easily allow for follow-up recalls, the monitoring and display of trends using graphs and bar chats, and large scale epidemiological and other population-based research studies.
Clearly the widespread use of PIT as a de-facto Australian standard has ‘severely hampered adoption of internationally supported messaging standards within the Australian health sector”
[1].
The vendor community would agree that the best opportunity to initiate the adoption of widespread electronic communications throughout the Primary and Secondary care sectors is to drive into place as quickly as possible the deployment of automated secure messaging (based on internationally accepted standards) between pathology centres (and radiology) and their medical practice clients.
The argument for the immediate adoption and standardisation of HL7-based messaging is well founded and should receive widespread support.
HL7 Messaging Standards
In passing, it is important to note that the National E-Health Transition Authority (NEHTA) has stated that pathology providers “have indicated support for the open, web service standards (which) NEHTA has proposed and that they (the pathology providers) understand the benefits they would bring in a contestable market.” [2] That having been said however NEHTA has also noted that pathology providers “perceive a business imperative to address the issues arising from the current market situation” … and more importantly … “they are considering creating a message environment that will still form barriers to cross-sector connectivity and interoperability[2].”!
Regardless of whether they have a vested interest in maintaining the status quo or not the pathology service providers need to accept that PIT's days are over. They should move on without further delay. How might this be achieved? Should it be left to market forces alone to address, or to the State and Federal Governments, or to NEHTA? Or should the vendor community together with their clients, the pathology providers, drive the changeover? Ideally, Government should provide appropriate support to the vendor community to enable them to 'assist' their clients to make the change.
There is a further point about PIT which needs to be borne in mind. Part of its attraction could be that the reporting pathologist is legally liable for the content and accuracy of the pathology report. By sending information in the PIT format the pathologist has taken all legally necessary and reasonable steps to ensure the results in the report cannot be altered. (Just like an Acrobat .PDF file.) At the medical practice end the report is simply attached to the patient record as a document.
When dispatching HL7 format results, the reporting pathologist needs to be satisfied that the atomic data that will populate the patient clinical record, at the medical practice, is similarly protected. This requires some additional software complexity at the medical practice end to ensure that these results cannot be altered. The associated complexities of cross-mapping the incoming results definitions to those of the clinical desktop system also need to be addressed.
Nevertheless, HL7 V2.3.1 is the method of choice for transmitting pathology messages. There are sufficient numbers of organisations and people well versed in HL7 in Australia today to drive HL7 standards based solutions into place. The changeover to HL7 will be a formidable exercise given that the majority of pathology results being delivered today use the proprietary, non-standards-based, PIT message format. To bring this change about will require astute enlightened leadership underpinned by some very sophisticated strategies and a finely-honed understanding of all parties that will be impacted by the change and the obstacles and issues that will be encountered. The key to the solution lies in the strategies required to effect the change and the political will to bring it about. Careful analysis of the problem reveals that it can be resolved reasonably quickly.
Tom is not alone in expressing the thoughts of many in the vendor community when he says, “the really sad thing is that Australia has already spent huge amounts of effort and money developing many of the standards, support services, systems and capabilities needed to do the job” …. and … “that the basic tools to enable there to be a connected health sector do exist; they are just not being used properly. [1]”
He observes that “the National e-Health Transition Agency (NEHTA) is using very little of the immense amount of work that was already underway prior to its formation” …. and that …. “based upon the present rate of progress it is likely to be some years before we see any implementable results. [1]”
Standards can be so contentious
The standards argument is divisive and very complex. Yet, all would agree that work on developing standards and resolving the many conflicts and issues involved is very important. The unresolved issues however should not be permitted to impede the development of interoperability between software vendors. Nor should they be permitted to impede the step-by-step resolution of problems encountered in building an integrated, shared, longitudinal Electronic Health Record (EHR) for widespread use across all health sectors. [3]
On this subject David More presents a well reasoned view in his recent blog on Archetypes and Standards 4. He points to the "considerable successes achieved in the Health Sector with messaging technologies including EDIFACT and HL7 V2.x.". He also notes that "to-date - in the messaging arena - HL7 V3.0 and EN13606 are still in the process of development and tools and implementations are by no means common.[4]"
In terms of the ‘clinical data’ to be transmitted, it is clear from his discussion that much of the work based around standardising ways of storing and retrieving the atomic elements of information required to populate the EHR over a patient's lifetime is still in its infancy and evolving slowly.
It should be apparent that NEHTA has a major R&D role to play in the years ahead. That being the case the marketplace cannot and should not be made to wait until NEHTA has completed its deliberations on the many complex and elusive issues which it is trying to solve. Rather, the Government's and Health Departments should embrace David's call for a dual approach. One which supports "appropriate and promising R&D" ……. "blended with dramatically more energetic investment and deployment of systems which are already known to work and for which evidence as to their value is quite unarguable" [4].
Engaging 'the' stakeholders
NEHTA was established to drive forward critical e-health initiatives. Its governance is under a Board of Directors made up of CEOs from the Health Departments of the Federal, State and Territory jurisdictions across Australia.
The jurisdictions provide NEHTA's funding. As a consequence they are stakeholders and also NEHTA's only shareholders. However, they are not the only stakeholders to be impacted by NEHTA's work; far from it. The IT vendor community, medical, pharmacy and allied health care practices, hospitals, nursing homes, aged care and community health centres, and others, have a major vested interest as stakeholders in NEHTA's outcomes.
NEHTA's governing stakeholders are predominantly driven by imperatives arising from the highly politically sensitive public hospital (tertiary) sector. Yet, in many ways NEHTA has more to offer the Primary and Secondary care sectors than the Tertiary hospital sector. Hence, the absence of Primary and Secondary care sector stakeholder representation and influence at the highest level of NEHTA's governance is disconcerting; more so, should the immediate e-health needs of the Primary and Secondary care sectors become bogged down by the complex web of e-health and ICT related issues and politics so prevalent in the Tertiary care sector.
Fundamentally, the Primary and Secondary care sectors (organisationally, functionally and politically) are quite distinct from the Tertiary (hospital) sector; even more so when it comes to categorising health-ICT vendors into the particular health sector niche which each predominantly services.
A strong case can be made for allocating significant resources to focussing on addressing some of the more immediate e-health needs of the Primary and Secondary sectors separately from the needs of the Tertiary sector. The urgency of this is further reinforced by Ian Reinecke's comment that "we need to be carefully aligned with the powerful players internationally"[5]. Reflecting on this leads one to enquire as to which powerful international players NEHTA may have in mind. Could they be Cerner, Philips, GE Healthcare, and Siemens?
Whoever it may be it seems to indicate that NEHTA has blatantly failed to appreciate that the Primary and Secondary care sectors are not the domain of the powerful international players. Rather, they are serviced, professionally and competently, by a cohort of small, highly skilled, agile, homebred software vendors. Some have made very impressive inroads internationally. Some are at the cutting edge of standards-based implementation projects that test the operability of HL7 V3 and OpenEHR technology as an investment in advancing towards the EHR. They work in a market sector in which the powerful international players have shown little or no interest!
In February 2006, NEHTA discussed the consequences of a “proliferation of incompatible systems and technologies” and it noted that “harnessing the capabilities of software vendors and service providers in the health sector to provide this connectivity will be a key to success” [2]. In light of this the time has come to clearly distinguish between what activities should be classified as R&D and what should be classified as ‘implementable today’.
It is time to reconsider what benefits could flow from drawing upon and utilizing a lot more of that 'pre-existing effort and the skills and expertise' so readily available in the vendor community.
HL7Messaging – What is NEHTA’s view?
In order to achieve widespread standardisation of messages there needs to be a process in place to achieve consistency when implementing standards.
Few would disagree that Australia should “define one standard for each purpose and rigorously enforce it ……… to prevent proliferation of non-standard formats.” [1] The general consensus among industry experts seems to be that Australia should implement HL7 V2.3.1 (AS 4700.2) as the minimum health industry standard.
A strong case can be made for populating medical practice records with discrete results without further delay as opposed to continuing with the PIT format. As this can be achieved using HL7 V2.3.1 and transmitted under control of the HL7 messaging protocol it is clear that HL7 V2.3.1 provides a nationally consistent base from which to move forward building upon what is readily available today.
NEHTA’s view on messaging standards is unclear at this time although it would be enormously beneficial to everyone if it could be clarified quickly.
Australian Health Messaging Laboratory
Tom comments that the Australian Healthcare Messaging Laboratory (AHML) has an important role to play in helping to secure the consistent deployment of HL7 messaging standards by software vendors.
AHML, as part of the Collaborative Centre for eHealth (CCeH) based at the University of Ballarat, is unique in Australia. Having been accredited by the National Association of Testing Authorities (NATA) it has positioned itself to act as an on-line test-bed laboratory for the technical evaluation and certification of electronic messages in healthcare applications being deployed by vendors in more than 30 countries. It is therefore well placed to test for conformance and monitor compliance against Australian and International Standards.
State jurisdictions and the Federal Government have a vested interest in securing AHML's future as the central reference point for HL7 messaging standards[6]. It should not be too problematic to find the funding required for this to happen without undue delay.
This will likely necessitate AHML having to be constituted formally as a Reference Laboratory. Under this arrangement AHML's funding should be derived from a mix of Government support and self-generated revenue. Its staff and management should be focused entirely on the testing, certification and compliance of messages against standards. The Reference Laboratory will need to be seen to operate transparently and impartially, totally devoid of any potential for the development of conflicts which could arise should its management and staff elect to undertake consulting assignments where they may be compromised by competing against vendors whose messaging software is subject to AHML testing.
HL7 V2.3.1 is widely implemented, tried and proven. It offers substantial benefits over PIT and even more importantly, it provides a way for the entire e-health community in Australia to move forward. It is therefore time for a seriously concerted effort to be made to move the pathology sector away from PIT towards the adoption of HL7 V2.3.1 or above. This seems to be a very good way to go for the next few years and it can be done today; delivering enormous benefits with minimal pain by using standards which have a good track record of runs on the board worldwide. An important element in driving the uptake of standards is to implement strategies which will create a dynamic contestable market environment.
Is there a better way?
There has to be a better way to move the e-health agenda forward. Tom lists three strategic options for the way ahead, opting for some form of collaborative partnership in which “small, specialised service organisations are given government backing and modest financial incentives[1]” to achieve sector integration.
In broad principle the concept of a ‘collaborative environment’ has the most likelihood of succeeding. It should be appreciated however that the optimal selection and order of enrollment of ‘participants’ is not a straightforward exercise. It is absolutely imperative that the setting up of a ‘collaborative structure’ (consortium) is done thoroughly and properly at the outset in order to contain risk and ensure the consortium’s longevity and success.
Collaborative consortia are quite complex to construct, more so in the health sector than in most other industries. Building a successful Health-E-ConsortiumTM requires a unique business model and organisational structure. The partners must work in harmony together, where often they are in competition with each other. They must be committed, highly motivated, well led and well rewarded, and they must be prepared to work in an environment which promotes a culture that is based on trust, a concern for each other's profitability, and a mutual commitment to customer satisfaction.
References.
[1.] Bowden T, A Connected Health Sector – However Can We Get There From Here? (16 January 2007) Guest Blogger Article www.aushealthit.blogspot.com
[2.] NEHTA, Towards a Secure Messaging Environment – An E-Health Transition Strategy Version 1.0 – 2/02/2006 For Comment, page 6.
[3.] Colclough I, Comment attached to Implementation Really Matters (8 January 2007) Blogger Article www.aushealthit.blogspot.com
[4.] More D, Archetypes, Standards and All That Jazz - Part 2 (28 January 2007) Blogger Article www.aushealthit.blogspot.com
[5.] Dearne K, Doing the numbers on e-health - the world according to Dr Ian Reinecke, The Australian (30 January 2007) IT Business, page 3.
[6.] Australian Health Messaging Laboratory, Available Test Profiles, accessed 30 January 2007, http://www.ahml.com.au
© Copyright 1 February 2007
Dr Ian Colclough - Integrated Marketing and e-Health Strategies
ihsipl@smartchat.net.au, 0412 059 392
Note: These views are those of our guest commentary provider and should be read as such. This forum is to provide a space for comment and debate and I hope this contribution helps. Thanks Ian.
David.
Tuesday, January 30, 2007
Have you Noticed Your Control of Your Personal Private Information is Vanishing?
In this article I am going to suggest that the race to maximise Government intrusion in citizens lives is presently being comprehensively won by the UK (with its multi-biometric compulsory national ID Card). Even worse, in the last day or so we learn from e-Health Insider that the UK Government wants to move to link many of its databases to simplify administration and reduce errors – to ensure not a single move you make goes unrecorded!.
The US is presently managing to come second in my view with the vagaries of the US Health Insurance Portability and Accountability Act (HIPAA) permitting large amounts of identified health information to move between service providers and payers with essentially no control on the part of the individual, almost daily leaks of identified information on the web or from mislaid lap-top computers and recently discovered privacy invasions such as warrantless wiretaps and covert house searches on the basis of perceived protection of “National Security”.
Sadly, however, we also now have our own Governments working out how best it can catch up and minimise the number of barriers that exist to a complete individually detailed dossier being built on all of us.
In previous articles I have made the point that it seems to me that unless citizens are certain private health and, possibly more important, genetic information can be safely confided to healthcare providers, with essentially no risk of disclosure, virtually all efforts in the e-health domain will be put at risk. Simply put citizens will not confide in organisations and individuals they do not feel they can trust.
The lack of trust that exists in the community has been made clear by two recent events.
On January 21, 2007 the Australian Privacy Foundation announced the 2006 Orwells which are awarded for the worst privacy intrusions of the year. The awards went to the following – as reported in their press release:
“The ‘Orwells’ as they are known around the world after the author of ‘1984’, have been awarded for privacy intrusions including:
• electronic health records without consent, leading BBA judge Dr Roger Magnusson to warn that “[this] could threaten public trust in what could be an immensely valuable tool for improving both individual and population health"
• negligent disclosure of international financial transactions to US authorities
• the ‘access card’ – in reality a national identity card
• a business that uses GPS units to track junk mail deliverers
• ‘reverse search’ phone directories, outflanking their supposed prohibition
• insensitive collection of sexual health data in a university research study
• federal legislation that turns thousands of private sector employees into government snoops
• call centre nurses interrogating employees about sick leave
Commenting on the overall awards, BBA judge Laura Sigal said “The more our information is available to the prying eyes of government and corporate interests, the less freedom we enjoy."
It is of note that violations in the Health Sector featured so prominently and that the first listed (HealtheLink) was noted as having just the risk I have identified in earlier blog articles.
The second event has been the release of an initial batch of comments regarding the exposure draft of the Human Services (Enhanced Service Delivery) Bill 2007 just a few days ago. The Office of Access Card received over 120 submissions responding to the draft bill.
It is interesting that the Access Card was nominated for the People’s Choice Award Orwell.
Big Brother Award judge Dean Wilson felt this well-deserved for the: “relentless campaign of disinformation and doublespeak surrounding the Access Card project.”
On the basis of the submissions made so far it would seem the campaign has not satisfied the concerns of virtually all interest groups, except those with something to sell to Government.
Among those who offered many criticisms were all the ‘usual suspects’ who have had long standing concerns about the whole project (The Privacy Foundation, EFA etc) but also some much less aligned entities such as the AMA, the Privacy Taskforce set up by the Access Card program and even the Office of the Commonwealth Privacy Commissioner (OCPC).
Among the major concerns raised were (besides the near universal condemnation of having a truncated consultation period over the Christmas / New Year period):
1. The drafting of the Bill has left a lot of important, highly privacy sensitive issues, up to the discretion of the bureaucrats without providing firm legislative direction as to how things are to be done.
2. The Bill says the citizen owns the physical Access Card but the Data held is owned by the Commonwealth. It is totally unclear just how anyone is assisted by that.
3. The fact that Medicare payments require use of the Access Card meant that for all practical purposes virtually everyone would need a card and that it really is a de-facto National ID Card.
4. The lack of strength in the wording of the draft Bill that the card was not to be an ID Card. As it stands it says “It is not an object of this Act that access cards be used as national identity cards”, rather than something like “It is an object of this Act to ensure that the Access Card is not used as and does not become a national identity card.”
5. The apparently expanding (and unannounced until now) amount of information to be displayed on the front of the card (title, Date of Birth, Place of Birth etc) which is turning it more and more into an ID Card.
6. The lack of appeal mechanisms from Government decisions in a number of areas.
7. The apparent inability of citizens to block access to address information to protect themselves from harassment, stalking, attack and so on.
8. The apparent liability of a clinician who asks whether they can have your Access Card to access your (voluntary) health information to huge fines and gaol.
9. An apparent lack of clarity on the retention policy regarding identity documents which are provided to achieve registration. Not deleting them would create an unprecedented database on most of Australia’s citizens which has not existed previously.
10. Apparent conflict between the Draft Bill and current practice as to what age an Access Card can be issued to an individual.
11. Total failure to appreciate delivery of services that are to be reimbursed but which need to be provided anonymously (e.g STD services, HIV Testing etc) for the protection of the individuals privacy and to ensure treatment is sought.
There are obviously many more details that could be discussed but from this list it is clear to me that the proposed legislation is deeply flawed and needs to be re-thought based on a much narrower expectation of what the card is to do (i.e. provide access to services) and not what it may morph into unless more clearly defined (i.e. a National ID Card).
All these issues are, of course, separate from the concerns of those who fear all this numbering and identifying the Australian citizenry is simply an unwarranted and dangerous intrusion into individual’s rights to personal privacy and autonomy. We in Australia are ever so lucky to have both the Access Card Project and NEHTA busily working away to allocate us all a range of apparently un-co-ordinated identifiers! Frankly it is a farce.
It seems to me the concerns of entities such as the OCPC, the AMA and the Access Card Privacy Task Force should be taken exceptionally seriously and if they are not fully addressed by alterations to the proposed Bill the public should be more than a little concerned.
Without being apocalyptic about it there is a real sense that some core Australian freedoms are under threat with this present draft. There is also a real risk that the vulnerable and the infirm will fall through the cracks and suffer disproportionately if all their possible problems are not fully and sensitively addressed.
David.
The US is presently managing to come second in my view with the vagaries of the US Health Insurance Portability and Accountability Act (HIPAA) permitting large amounts of identified health information to move between service providers and payers with essentially no control on the part of the individual, almost daily leaks of identified information on the web or from mislaid lap-top computers and recently discovered privacy invasions such as warrantless wiretaps and covert house searches on the basis of perceived protection of “National Security”.
Sadly, however, we also now have our own Governments working out how best it can catch up and minimise the number of barriers that exist to a complete individually detailed dossier being built on all of us.
In previous articles I have made the point that it seems to me that unless citizens are certain private health and, possibly more important, genetic information can be safely confided to healthcare providers, with essentially no risk of disclosure, virtually all efforts in the e-health domain will be put at risk. Simply put citizens will not confide in organisations and individuals they do not feel they can trust.
The lack of trust that exists in the community has been made clear by two recent events.
On January 21, 2007 the Australian Privacy Foundation announced the 2006 Orwells which are awarded for the worst privacy intrusions of the year. The awards went to the following – as reported in their press release:
“The ‘Orwells’ as they are known around the world after the author of ‘1984’, have been awarded for privacy intrusions including:
• electronic health records without consent, leading BBA judge Dr Roger Magnusson to warn that “[this] could threaten public trust in what could be an immensely valuable tool for improving both individual and population health"
• negligent disclosure of international financial transactions to US authorities
• the ‘access card’ – in reality a national identity card
• a business that uses GPS units to track junk mail deliverers
• ‘reverse search’ phone directories, outflanking their supposed prohibition
• insensitive collection of sexual health data in a university research study
• federal legislation that turns thousands of private sector employees into government snoops
• call centre nurses interrogating employees about sick leave
Commenting on the overall awards, BBA judge Laura Sigal said “The more our information is available to the prying eyes of government and corporate interests, the less freedom we enjoy."
It is of note that violations in the Health Sector featured so prominently and that the first listed (HealtheLink) was noted as having just the risk I have identified in earlier blog articles.
The second event has been the release of an initial batch of comments regarding the exposure draft of the Human Services (Enhanced Service Delivery) Bill 2007 just a few days ago. The Office of Access Card received over 120 submissions responding to the draft bill.
It is interesting that the Access Card was nominated for the People’s Choice Award Orwell.
Big Brother Award judge Dean Wilson felt this well-deserved for the: “relentless campaign of disinformation and doublespeak surrounding the Access Card project.”
On the basis of the submissions made so far it would seem the campaign has not satisfied the concerns of virtually all interest groups, except those with something to sell to Government.
Among those who offered many criticisms were all the ‘usual suspects’ who have had long standing concerns about the whole project (The Privacy Foundation, EFA etc) but also some much less aligned entities such as the AMA, the Privacy Taskforce set up by the Access Card program and even the Office of the Commonwealth Privacy Commissioner (OCPC).
Among the major concerns raised were (besides the near universal condemnation of having a truncated consultation period over the Christmas / New Year period):
1. The drafting of the Bill has left a lot of important, highly privacy sensitive issues, up to the discretion of the bureaucrats without providing firm legislative direction as to how things are to be done.
2. The Bill says the citizen owns the physical Access Card but the Data held is owned by the Commonwealth. It is totally unclear just how anyone is assisted by that.
3. The fact that Medicare payments require use of the Access Card meant that for all practical purposes virtually everyone would need a card and that it really is a de-facto National ID Card.
4. The lack of strength in the wording of the draft Bill that the card was not to be an ID Card. As it stands it says “It is not an object of this Act that access cards be used as national identity cards”, rather than something like “It is an object of this Act to ensure that the Access Card is not used as and does not become a national identity card.”
5. The apparently expanding (and unannounced until now) amount of information to be displayed on the front of the card (title, Date of Birth, Place of Birth etc) which is turning it more and more into an ID Card.
6. The lack of appeal mechanisms from Government decisions in a number of areas.
7. The apparent inability of citizens to block access to address information to protect themselves from harassment, stalking, attack and so on.
8. The apparent liability of a clinician who asks whether they can have your Access Card to access your (voluntary) health information to huge fines and gaol.
9. An apparent lack of clarity on the retention policy regarding identity documents which are provided to achieve registration. Not deleting them would create an unprecedented database on most of Australia’s citizens which has not existed previously.
10. Apparent conflict between the Draft Bill and current practice as to what age an Access Card can be issued to an individual.
11. Total failure to appreciate delivery of services that are to be reimbursed but which need to be provided anonymously (e.g STD services, HIV Testing etc) for the protection of the individuals privacy and to ensure treatment is sought.
There are obviously many more details that could be discussed but from this list it is clear to me that the proposed legislation is deeply flawed and needs to be re-thought based on a much narrower expectation of what the card is to do (i.e. provide access to services) and not what it may morph into unless more clearly defined (i.e. a National ID Card).
All these issues are, of course, separate from the concerns of those who fear all this numbering and identifying the Australian citizenry is simply an unwarranted and dangerous intrusion into individual’s rights to personal privacy and autonomy. We in Australia are ever so lucky to have both the Access Card Project and NEHTA busily working away to allocate us all a range of apparently un-co-ordinated identifiers! Frankly it is a farce.
It seems to me the concerns of entities such as the OCPC, the AMA and the Access Card Privacy Task Force should be taken exceptionally seriously and if they are not fully addressed by alterations to the proposed Bill the public should be more than a little concerned.
Without being apocalyptic about it there is a real sense that some core Australian freedoms are under threat with this present draft. There is also a real risk that the vulnerable and the infirm will fall through the cracks and suffer disproportionately if all their possible problems are not fully and sensitively addressed.
David.
Sunday, January 28, 2007
Archetypes, Standards and All That Jazz – Part 2.
Well it has been an interesting week since I published my short article on archetypes. Sadly the conversation has gone on in a number of places (for quite sensible reasons) but it is hard to form an overview – much less try to distil what I have learnt and heard from all the discussion.
Before reading further I suggest those interested visit the openEHR site and review the “aus health it” thread, starting at the 21 January, 2007 entry. It can be found at:
http://www.openehr.org/advice/openehr-clinical/maillist.html
Initially, for some reason my e-mail is deferred and then rejected at the site (since I am not a registered member) so following some of the conversation can be a little difficult.
The following points summarise my conclusions on all this and the more general Health environment. They are based on private e-mails, the list above and the blog content and comments.
For some reason the topic is quite a 'hot button'. Despite that, all I am really saying is that I believe there are sufficient uncertainties regarding the successful deployment of archetypes to mean more work is required before ISO ballots and standardisation are undertaken. I must say I did not expect the idea to be quite so controversial (the article received four times the usual number of page views in less than two days).
1. Despite concerns regarding interoperability and so on, there is no doubt that there exist a number of commercial providers who offer very usable hospital and ambulatory care systems. In the hospital arena one only needs to think of EPIC, Cerner, McKesson, MiSys, IBA Health and a range of others. In the ambulatory care environment the Certification Commission for Healthcare Information Technology (CCHIT) (www.cchit.org) has certified a range of Ambulatory Systems (over 30 at last count) ensuring quite rich functionality is also available in that sector. This, when combined with experience in Australia, the UK and Scandinavia, makes it quite clear some reasonable level of ambulatory practice automation is more than feasible.
Incrementally more difficult certification criteria, year on year, as applied in the US, will ensure both functionality and interoperability improve over time for both ambulatory and hospital systems. The very recent announcements from Healthcare Information Technology Standards Panel (HITSP) (www.ansi.org/hitsp), as well as the January 2007 IHE Connectathon, only confirms a quite rapid march towards both improving functionality as well as practical, standards based interoperability.
The problem is not that these systems do not work to improve both safety and efficiency but that as yet they are not widely implemented. This bears repeating, the problem is not system capability but the level of deployment.
2. There have been very considerable successes achieved in the Health Sector with messaging technologies including EDIFACT and HL7 V2.x. To date – in the messaging arena - HL7 V3.0 and EN13606 are still in the process of development and tools and implementations are by no means common.
I do not believe standardisation is appropriate for these and other development technologies at this time and feel the Draft Standard for Trial Use (DSTU) approach is preferable by far, until such time as proven, demonstrable, properly scaled, implementations are available.
Use of a DSTU style of progress provides developers and implementers with clear directional guidance and allows progress to be made while preserving flexibility ;more so if the outcomes are less than ideal for modifications to be made.
This being said I do appreciate a “chicken or egg” argument, especially a point made regarding the failure of commercial use and investment until something becomes a Standard. However I believe the OMG / W3C / DSTU approach requiring implementation before finalisation is still to be preferred
3. The transfer (or communication) of a partial or complete Electronic Health Record (EHR) from one system to another system of a different origin, while preserving both the information and the meaning and context of the patient data is a non-trivial task. Even so, it is still an important and very useful objective. The effort to enable communications of patient information between just two providers in the GP2GP program in UK makes it abundantly clear that this is a non-trivial task. Further, as noted above, more general standards in this area are still under development.
4. At another level again there are a number of attempts to develop approaches which will ultimately lead to a standardised way of storing and retrieving longitudinal EHR information which may have been captured over a patient's lifetime. Clearly, for this to be made to work it is crucial to create a methodology that associates clinical observations and activity with its meaning unambiguously, and to be able to reliably document clinical encounters using a consistent approach that does not change over the life of the record.
It is also intended that different implementations of the standardised approach should be able to reliably and safely understand, interpret, process and fully utilise a clinical record from another system – providing so called 'semantic interoperation' if done correctly. Both the openEHR project(www.openehr.org) and HL7 V3.0 (www.hl7.org) aim to achieve this (with minor variations as to scope).
Both approaches have adopted what is called 'two layer' modelling where a basic reference data model is supported by a descriptive mechanism (called an archetype or template) which defines the information content and how it is represented. The outcome of this approach is that as many archetypes as are needed (to represent and describe the information required in a clinical record) can be developed separate from the basic data model which defines the EHR's overall framework. A requirement for this approach to work is that as well as knowing the basic data model, each system must utilise a common set of archetypes or templates to attach the clinical meaning and values to the data.
It is worth noting that the open MRS (Medical Record System) (www.openMRS.org) also implements a two layer concept based model. This system has been used successfully to create purpose-built systems for managing limited clinical domains (such as HIV in Africa). To date I am not aware of any significant production systems based on the other architectures (although I am assured they are coming soon!).
5. It is now becoming clear that the efforts of ONCHIT in the US are bearing considerable fruit (see http://www.dhhs.gov/healthit/), as I believe are those of the UK's Connecting for Health Program (see http://www.connectingforhealth.nhs.uk/)to say nothing of a range of private sector initiatives (Kaiser Permanente Health Connect for example and the ONCHIT trials of prototypes for the US National Health Information Network). This work is really starting to get there, looks to be picking up pace, and is likely, overtime, to simply and pragmatically move forward gathering major benefits while exploiting the proven (and not the experimental) already available Standards. I know where I will be looking for the evidence of real impacts on people's lives and indeed where much of it can be found (see last paragraph).
Sadly, the strategy free zone we call NEHTA is slipping further behind, as best as can be determined, due to a the lack of committed government support and the usual problems associated with herding the fractious States into any coherence.
Where this leaves me is with a quite clear view that very useful Health IT systems are available today and that a dual approach of supporting appropriate and promising R&D needs to be blended with dramatically more energetic investment and deployment of systems which are already known to work and for which the evidence as to their value is quite unarguable.
My priority is, with so much benefit possible and so many lives able to be saved by simply “getting on with it” I think it is vital there is as much more energy focussed on dissemination of what works today than there is on the development of the hoped for 2009 model for Health IT.
This view is very much confirmed by the Health Affairs Online Theme Issue On Rapid Learning Through Health IT referred to in my blog article of the 27th January 2007. The gap between what we are doing today and the good that is possible is huge and must be addressed at a gallop not a dawdle.
David.
Before reading further I suggest those interested visit the openEHR site and review the “aus health it” thread, starting at the 21 January, 2007 entry. It can be found at:
http://www.openehr.org/advice/openehr-clinical/maillist.html
Initially, for some reason my e-mail is deferred and then rejected at the site (since I am not a registered member) so following some of the conversation can be a little difficult.
The following points summarise my conclusions on all this and the more general Health environment. They are based on private e-mails, the list above and the blog content and comments.
For some reason the topic is quite a 'hot button'. Despite that, all I am really saying is that I believe there are sufficient uncertainties regarding the successful deployment of archetypes to mean more work is required before ISO ballots and standardisation are undertaken. I must say I did not expect the idea to be quite so controversial (the article received four times the usual number of page views in less than two days).
1. Despite concerns regarding interoperability and so on, there is no doubt that there exist a number of commercial providers who offer very usable hospital and ambulatory care systems. In the hospital arena one only needs to think of EPIC, Cerner, McKesson, MiSys, IBA Health and a range of others. In the ambulatory care environment the Certification Commission for Healthcare Information Technology (CCHIT) (www.cchit.org) has certified a range of Ambulatory Systems (over 30 at last count) ensuring quite rich functionality is also available in that sector. This, when combined with experience in Australia, the UK and Scandinavia, makes it quite clear some reasonable level of ambulatory practice automation is more than feasible.
Incrementally more difficult certification criteria, year on year, as applied in the US, will ensure both functionality and interoperability improve over time for both ambulatory and hospital systems. The very recent announcements from Healthcare Information Technology Standards Panel (HITSP) (www.ansi.org/hitsp), as well as the January 2007 IHE Connectathon, only confirms a quite rapid march towards both improving functionality as well as practical, standards based interoperability.
The problem is not that these systems do not work to improve both safety and efficiency but that as yet they are not widely implemented. This bears repeating, the problem is not system capability but the level of deployment.
2. There have been very considerable successes achieved in the Health Sector with messaging technologies including EDIFACT and HL7 V2.x. To date – in the messaging arena - HL7 V3.0 and EN13606 are still in the process of development and tools and implementations are by no means common.
I do not believe standardisation is appropriate for these and other development technologies at this time and feel the Draft Standard for Trial Use (DSTU) approach is preferable by far, until such time as proven, demonstrable, properly scaled, implementations are available.
Use of a DSTU style of progress provides developers and implementers with clear directional guidance and allows progress to be made while preserving flexibility ;more so if the outcomes are less than ideal for modifications to be made.
This being said I do appreciate a “chicken or egg” argument, especially a point made regarding the failure of commercial use and investment until something becomes a Standard. However I believe the OMG / W3C / DSTU approach requiring implementation before finalisation is still to be preferred
3. The transfer (or communication) of a partial or complete Electronic Health Record (EHR) from one system to another system of a different origin, while preserving both the information and the meaning and context of the patient data is a non-trivial task. Even so, it is still an important and very useful objective. The effort to enable communications of patient information between just two providers in the GP2GP program in UK makes it abundantly clear that this is a non-trivial task. Further, as noted above, more general standards in this area are still under development.
4. At another level again there are a number of attempts to develop approaches which will ultimately lead to a standardised way of storing and retrieving longitudinal EHR information which may have been captured over a patient's lifetime. Clearly, for this to be made to work it is crucial to create a methodology that associates clinical observations and activity with its meaning unambiguously, and to be able to reliably document clinical encounters using a consistent approach that does not change over the life of the record.
It is also intended that different implementations of the standardised approach should be able to reliably and safely understand, interpret, process and fully utilise a clinical record from another system – providing so called 'semantic interoperation' if done correctly. Both the openEHR project(www.openehr.org) and HL7 V3.0 (www.hl7.org) aim to achieve this (with minor variations as to scope).
Both approaches have adopted what is called 'two layer' modelling where a basic reference data model is supported by a descriptive mechanism (called an archetype or template) which defines the information content and how it is represented. The outcome of this approach is that as many archetypes as are needed (to represent and describe the information required in a clinical record) can be developed separate from the basic data model which defines the EHR's overall framework. A requirement for this approach to work is that as well as knowing the basic data model, each system must utilise a common set of archetypes or templates to attach the clinical meaning and values to the data.
It is worth noting that the open MRS (Medical Record System) (www.openMRS.org) also implements a two layer concept based model. This system has been used successfully to create purpose-built systems for managing limited clinical domains (such as HIV in Africa). To date I am not aware of any significant production systems based on the other architectures (although I am assured they are coming soon!).
5. It is now becoming clear that the efforts of ONCHIT in the US are bearing considerable fruit (see http://www.dhhs.gov/healthit/), as I believe are those of the UK's Connecting for Health Program (see http://www.connectingforhealth.nhs.uk/)to say nothing of a range of private sector initiatives (Kaiser Permanente Health Connect for example and the ONCHIT trials of prototypes for the US National Health Information Network). This work is really starting to get there, looks to be picking up pace, and is likely, overtime, to simply and pragmatically move forward gathering major benefits while exploiting the proven (and not the experimental) already available Standards. I know where I will be looking for the evidence of real impacts on people's lives and indeed where much of it can be found (see last paragraph).
Sadly, the strategy free zone we call NEHTA is slipping further behind, as best as can be determined, due to a the lack of committed government support and the usual problems associated with herding the fractious States into any coherence.
Where this leaves me is with a quite clear view that very useful Health IT systems are available today and that a dual approach of supporting appropriate and promising R&D needs to be blended with dramatically more energetic investment and deployment of systems which are already known to work and for which the evidence as to their value is quite unarguable.
My priority is, with so much benefit possible and so many lives able to be saved by simply “getting on with it” I think it is vital there is as much more energy focussed on dissemination of what works today than there is on the development of the hoped for 2009 model for Health IT.
This view is very much confirmed by the Health Affairs Online Theme Issue On Rapid Learning Through Health IT referred to in my blog article of the 27th January 2007. The gap between what we are doing today and the good that is possible is huge and must be addressed at a gallop not a dawdle.
David.
Saturday, January 27, 2007
A Must Read Contribution from Health Affairs
As a service to those who are not on the Health Affairs mailing list I pass on the following alert.
For the next week or so the articles will be accessible from the URL below. Enjoy and learn!
Health Affairs Online Theme Issue On Rapid Learning Through Health IT
Today Health Affairs has published online a set of papers that discuss using electronic data to advance knowledge. Data gathered in electronic health records on the experience of millions of patients have the potential to dramatically accelerate clinical research and provide the nation with timely, urgently needed knowledge about the value of new medical technologies, researchers report. You can access the set of papers at:
http://content.healthaffairs.org/cgi/content/full/hlthaff.26.2.w107/DC2
Highlights include:
Lynn Etheredge on what a rapid-learning system would look like and how we might get there.
David Eddy on how mathematical modeling can assist in medical decision making.
Sean Tunis et al. on the federal government’s unique position to generate information.
Joel Kupersmith et al. on the VHA’s electronic health records system.
Paul Wallace on integrated health IT at Kaiser Permanente.
Walter Stewart et al. on tools to help physicians bridge the gap between the knowledge they posses and the knowledge they do not.
Plus Perspectives from a wide range of system stakeholders.
This is important material that adds powerfully to the business case for the expanded implementation of Health IT both here and in the USA.
David.
For the next week or so the articles will be accessible from the URL below. Enjoy and learn!
Health Affairs Online Theme Issue On Rapid Learning Through Health IT
Today Health Affairs has published online a set of papers that discuss using electronic data to advance knowledge. Data gathered in electronic health records on the experience of millions of patients have the potential to dramatically accelerate clinical research and provide the nation with timely, urgently needed knowledge about the value of new medical technologies, researchers report. You can access the set of papers at:
http://content.healthaffairs.org/cgi/content/full/hlthaff.26.2.w107/DC2
Highlights include:
Lynn Etheredge on what a rapid-learning system would look like and how we might get there.
David Eddy on how mathematical modeling can assist in medical decision making.
Sean Tunis et al. on the federal government’s unique position to generate information.
Joel Kupersmith et al. on the VHA’s electronic health records system.
Paul Wallace on integrated health IT at Kaiser Permanente.
Walter Stewart et al. on tools to help physicians bridge the gap between the knowledge they posses and the knowledge they do not.
Plus Perspectives from a wide range of system stakeholders.
This is important material that adds powerfully to the business case for the expanded implementation of Health IT both here and in the USA.
David.
Wednesday, January 24, 2007
Evidence Based Health IT – What a Good Idea!
In what was almost a throw away line commenting on the recent discussion regarding archetypes
"My view is that the practice of health informatics needs, desperately, to become evidence-based, otherwise we will continue to see hundreds of millions or billions of dollars being poured into the deployment of health information systems based on what is in the sales brochure, or based on tender responses, which tend to be just more elaborate versions of the sales brochures."
Now, while I may disagree that the only current driver of Health IT deployments are sales brochures I find the broad sentiment most compelling. Tim is right in suggesting that the decisions regarding adoption and use of Health IT should be on much the same basis as we seek to consider and manage other Health interventions (drugs, treatment protocols, medical devices and so on).
This led me to consider what such Evidence Based Health Care IT may look like. What follows are my initial thoughts on how the idea could be actualised.
First it would be necessary to decide on the type of evidence that was being sought and in what domain the decisions would be assessed. The health sector has many years experience in the design and execution of clinical trials and there does not seem to me to be any intrinsic reason why such an approach would not be useful.
One can easily envisage trials comparing manual methods of practice with computer supported approaches as well as trials comparing computer systems with varying levels of sophistication in terms of user interfaces, functionality and decision support capability.
An issue which would need to be carefully considered is how, in a trial situation, the quality of the system is distinguished from the skill of the user and possibly patient related factors. We need to recognise that Health IT is much more an enabler of service delivery rather than a provider of services per se and this fact would need to be reflected in the trial design.
Second it would seem reasonable to use the typical types of trial endpoints for evaluation of clinically relevant systems – perhaps modified and controlled in different ways as appropriate. The use of endpoints, such as clinical outcomes, also has the advantage of taking a holistic view of an intervention and not seeing a Health IT intervention purely as a technical exercise – but also as something that involves the patient and the clinician as well as the technology.
Of course it is possible that in some situations there will be the need to consider intermediate outcomes rather than direct impact on morbidity or mortality when considering, for example, differing decision support systems aimed at improving specific clinician behaviours.
Third there is obviously a place for technical trials of different technical approaches to clinical problems evaluated on both technical as well as clinical criteria. In the same vein one would also want, in some circumstances, to ensure parameters such as cost, impact on workflow or efficiency and so on were evaluated as a component of an overall assessment.
Fourth as experience grows one would see, hopefully the emergence of multi centre trials of particular generic interventions and development of appropriate strategies for the conduct of systematic reviews of important interventions. Later expertise would also be encouraged to develop in cost benefit assessments of the different interventions using criteria rather more closely modelled on the Pharmaceutical Benefits Review Committee than what is done by the Therapeutics Good Administration where the focus is more on safety rather then efficacy and clinical outcomes.
Fifth it is important to consider how best the human side of Health IT deployment and use can be researched and practical trials conducted to come up with the best ways to manage system selection, clinician resistance to change, workflow alterations and so on.
Sixth one could consider the establishment of a Cochrane Collaboration like clearing house to make widely available the outcomes of both sponsored research, systematic reviews and so on – as well as Health IT guidelines to assist organisations move forward with an evidence based Health IT Agenda
Last it might make some sense to have at least some research that looks back on failures and disasters (something much beloved of IT project managers) to come up with evidence based guidelines on what tends not to work in the process of selection and deployment of apparently well considered Health IT interventions and systems.
I recognise that it could be said that what is being suggested is little more than what is classically referred to as Health Technology Assessment (HTA). I would suggest the focus on the deployments of, and the evaluation and trial of Health IT against clinical objectives using an experimental model moves a good deal beyond traditional HTA.
Overall, I can see there could be a case built for establishing an academic centre for the development, evaluation and implementation of Evidence Based Health IT.
What do others think? A good idea?
David.
Sunday, January 21, 2007
Archetypically Stupid!
Recently (December 1, 2006) the Health Informatics Technical Committee of the International Standards Organisation (ISO) released a draft Standard entitled Health informatics — Electronic health record communication — Part 2: Part 2: Archetype interchange specification. The closing date for comments is in March, 2007.
The draft document is on its way through the various ISO and CEN processes towards being approved as one of the five parts of the TC 215 Standard on Electronic Record Communication. (pr13606).
Overall the Standard – if approved - aims to define how extracts of patient records can be safely and reliably moved between two EHR systems which are compliant with the Standard once approved.
Key to the success of the approach being adopted is the use of an information construct called an Archetype which defines how clinical content within the record is to be laid out and interpreted.
Without going into too much detail an example of how the Archetype is intended to be used can be better understood as follows.
Assume we wish to place a patient’s blood pressure into an Electronic Health Record (EHR).
In the context of a defined and identified individual patient, an identified healthcare provider (the observer) and the date and time of the observation, it is possible to use an Archetype which has the concept name of ‘blood pressure’. This permits recording of the systolic and diastolic blood pressure values along with associated information (e.g. is this blood pressure part of an assessment for postural hypotension where body position is important or is this blood pressure measured with a described cuff size, etc). Given the detail that may be needed to handle electronic measurements, continuous or 24 hour measurements and so on, the possible complexity becomes obvious if a single archetype is required to handle the concept of ‘blood pressure’. (I guess the response from proponents of Archetypes would most likely be that this would be handled by higher level assemblages of Archetypes, but clearly the downside of this approach is the ultimate number of Archetypes needed).
All the actual data entered is intended to be stored, along with the patient and Archetype identifying information, in an EHR system that can access, when requested, the Archetype ‘framework’ into which the recorded values have been placed. This allows the re-creation of the ‘whole’ of the observation, as needed, in any compliant system. An individual patient record can of course be made up of many data elements (described and constrained by many different Archetypes) to build up a fuller and more complex EHR record.
The benefit claimed for this approach is that any computer system which can locate and ‘interpret’ the correct Archetype can accurately re-present and re-use the EHR information (i.e. provide semantic interoperability between EHR systems). The importance of finding the correct Archetype to utilise becomes obvious here as using a different version of an Archetype, or the wrong Archetype, could be very problematic. This has a range of obvious consequences around the need for effective naming and version control conventions.
Why am I bothering to comment on this somewhat obscure standards balloting event?
The answer is that I simply do not believe use of Archetypes is ready for ‘prime-time’, especially as a global standard, until a vast amount more work is done.
My specific concerns are as follows:
1. The draft standard admits it is unclear how many Archetypes are needed for a successful general purpose EHR and the amount of work needed to create them.
To quote:
Archetype Repositories
“The range of archetypes required within a shared EHR community will depend upon its range of clinical activities. The total set needed on a national basis is presently unknown, but there might eventually be several thousand archetypes globally. The ideal sources of knowledge for developing such archetype definitions will be clinical guidelines, care pathways, scientific publications and other embodiments of best practice. However, “de facto” sources of agreed clinical data structures might also include:
• the data schemata (models) of existing clinical systems;
• the lay-out of computer screen forms used by these systems for data entry and for the display of analyses performed;
• data-entry templates, pop-up lists and look-up tables used by these systems;
• shared-care data sets, messages and reports used locally and nationally;
• the structure of forms used for the documentation of clinical consultations or summaries within paper records;
• health information used in secondary data collections;
• the pre-coordinated terms in terminology systems.
Despite this list of de facto ways in which clinical data structures are currently represented, these formats are very rarely interoperable. The use of standardised archetypes provides an interoperable way of representing and sharing these specifications, in support of consistent (good quality) health care record-keeping and the semantic interoperability of shared EHRs.
In the longer term, it is anticipated that the involvement of national health services, academic organisations and professional bodies in the development of archetypes will enable this approach to contribute to the pursuit of quality evidence-based clinical practice. In the future regional or national public domain libraries of archetype definitions might be accessed via the Internet, and downloaded for local use within EHR systems.”
What is clear here is that not only do we not know how many are needed, but that no-one knows, and more importantly the needed Archetypes do not exist anywhere on the planet!
If one considers the number of diagnostic tests, types of observations and so on that exist I believe “several thousand” is just hopeful guesswork. Of course who is going to develop and pay for all the work required is a separate question.
2. The writers of the quotation above seem to me to be conceiving Archetypes at a level (clinical guidelines and the like) above where Archetype development and definition is needed (i.e. at the level of individual observations and investigations). Only once these basics are developed and stable can construction of the more advanced information constructs and uses begin.
3. It is also obvious that without a global reference source for Archetypes (as well as global governance mechanisms and the required technical, development and managerial infrastructure) the stated goal of sharable, interoperable EHR extracts is little more than a pipe dream. This reference source does not exist and is unlikely to anytime soon. The prospect of local divergent Archetype repositories dotted all around the world, resulting in all sorts of interoperation difficulties, is too horrible to contemplate.
4. There is no reference implementation of a system deploying even a slightly comprehensive set of Archetypes to prove the conceptual and performance capability of Archetype based systems. There seems to me to be little doubt that scalability of Archetype services could be a significant issue.
5. There seems to be some evangelical thrust on the part of Standards Australia (and possibly NEHTA) to spread the use of Archetypes globally (as a special pestilential and mind befuddling treat for the rest of the world) when the local investment in their development and deployment has been minimal, to say the least. If they really think Archetypes are such a great idea putting ‘the money where their mouths are’ would be a good idea!
6. The literature supporting the contemporary use of Archetypes in the draft standard comprises a total of four citations predominantly by only two people.
7. The HL7 Template Special Interest Group is still working (as of October 2006) to resolve how CEN Archetypes and HL7 Templates can be harmonised in ways that make them interoperable whilst recognising that many of the conceptual and operational problems with Archetypes exist just as significantly in the HL7 Template proposals.
8. It seems to me there are much more basic and important things to be standardised before attacking a problem of this complexity which has not been applied or asked for by the real world. Getting basic clinical information available at local points of care reliably and improving care-coordination with the simplest of care records would be a very good start rather than developing this misguided, over-engineered and over-complex standard which I doubt will be seriously considered by more than 50 people and which I suspect will never be actually implemented as intended by its creators. To posit adoption of this Standard without describing the governance, provisioning and funding of the necessary Archetype sever infrastructure is naïve in the extreme.
To be creating 150+ page specification documents on the basis of what seems to be a conceptually ‘good idea’ and to then, without proven reference implementations, launch such documents on an unsuspecting world is downright dangerous.It is likely to hamper more useful and important e-Health developments globally, as an overly complex mess is sorted out – if that is possible.
It is really time for the proponents of Archetypes to ‘put up or shut up’. This is way to serious to just allow this proposed standard to wander though the approval processes without some very hard questions being asked.
Until reference implementations exist and are working and harmonisation with other standards (HL7 etc) is finalised and demonstrable all involved really need a ‘cold shower’ as our politicians are so keen on saying.
David.
The draft document is on its way through the various ISO and CEN processes towards being approved as one of the five parts of the TC 215 Standard on Electronic Record Communication. (pr13606).
Overall the Standard – if approved - aims to define how extracts of patient records can be safely and reliably moved between two EHR systems which are compliant with the Standard once approved.
Key to the success of the approach being adopted is the use of an information construct called an Archetype which defines how clinical content within the record is to be laid out and interpreted.
Without going into too much detail an example of how the Archetype is intended to be used can be better understood as follows.
Assume we wish to place a patient’s blood pressure into an Electronic Health Record (EHR).
In the context of a defined and identified individual patient, an identified healthcare provider (the observer) and the date and time of the observation, it is possible to use an Archetype which has the concept name of ‘blood pressure’. This permits recording of the systolic and diastolic blood pressure values along with associated information (e.g. is this blood pressure part of an assessment for postural hypotension where body position is important or is this blood pressure measured with a described cuff size, etc). Given the detail that may be needed to handle electronic measurements, continuous or 24 hour measurements and so on, the possible complexity becomes obvious if a single archetype is required to handle the concept of ‘blood pressure’. (I guess the response from proponents of Archetypes would most likely be that this would be handled by higher level assemblages of Archetypes, but clearly the downside of this approach is the ultimate number of Archetypes needed).
All the actual data entered is intended to be stored, along with the patient and Archetype identifying information, in an EHR system that can access, when requested, the Archetype ‘framework’ into which the recorded values have been placed. This allows the re-creation of the ‘whole’ of the observation, as needed, in any compliant system. An individual patient record can of course be made up of many data elements (described and constrained by many different Archetypes) to build up a fuller and more complex EHR record.
The benefit claimed for this approach is that any computer system which can locate and ‘interpret’ the correct Archetype can accurately re-present and re-use the EHR information (i.e. provide semantic interoperability between EHR systems). The importance of finding the correct Archetype to utilise becomes obvious here as using a different version of an Archetype, or the wrong Archetype, could be very problematic. This has a range of obvious consequences around the need for effective naming and version control conventions.
Why am I bothering to comment on this somewhat obscure standards balloting event?
The answer is that I simply do not believe use of Archetypes is ready for ‘prime-time’, especially as a global standard, until a vast amount more work is done.
My specific concerns are as follows:
1. The draft standard admits it is unclear how many Archetypes are needed for a successful general purpose EHR and the amount of work needed to create them.
To quote:
Archetype Repositories
“The range of archetypes required within a shared EHR community will depend upon its range of clinical activities. The total set needed on a national basis is presently unknown, but there might eventually be several thousand archetypes globally. The ideal sources of knowledge for developing such archetype definitions will be clinical guidelines, care pathways, scientific publications and other embodiments of best practice. However, “de facto” sources of agreed clinical data structures might also include:
• the data schemata (models) of existing clinical systems;
• the lay-out of computer screen forms used by these systems for data entry and for the display of analyses performed;
• data-entry templates, pop-up lists and look-up tables used by these systems;
• shared-care data sets, messages and reports used locally and nationally;
• the structure of forms used for the documentation of clinical consultations or summaries within paper records;
• health information used in secondary data collections;
• the pre-coordinated terms in terminology systems.
Despite this list of de facto ways in which clinical data structures are currently represented, these formats are very rarely interoperable. The use of standardised archetypes provides an interoperable way of representing and sharing these specifications, in support of consistent (good quality) health care record-keeping and the semantic interoperability of shared EHRs.
In the longer term, it is anticipated that the involvement of national health services, academic organisations and professional bodies in the development of archetypes will enable this approach to contribute to the pursuit of quality evidence-based clinical practice. In the future regional or national public domain libraries of archetype definitions might be accessed via the Internet, and downloaded for local use within EHR systems.”
What is clear here is that not only do we not know how many are needed, but that no-one knows, and more importantly the needed Archetypes do not exist anywhere on the planet!
If one considers the number of diagnostic tests, types of observations and so on that exist I believe “several thousand” is just hopeful guesswork. Of course who is going to develop and pay for all the work required is a separate question.
2. The writers of the quotation above seem to me to be conceiving Archetypes at a level (clinical guidelines and the like) above where Archetype development and definition is needed (i.e. at the level of individual observations and investigations). Only once these basics are developed and stable can construction of the more advanced information constructs and uses begin.
3. It is also obvious that without a global reference source for Archetypes (as well as global governance mechanisms and the required technical, development and managerial infrastructure) the stated goal of sharable, interoperable EHR extracts is little more than a pipe dream. This reference source does not exist and is unlikely to anytime soon. The prospect of local divergent Archetype repositories dotted all around the world, resulting in all sorts of interoperation difficulties, is too horrible to contemplate.
4. There is no reference implementation of a system deploying even a slightly comprehensive set of Archetypes to prove the conceptual and performance capability of Archetype based systems. There seems to me to be little doubt that scalability of Archetype services could be a significant issue.
5. There seems to be some evangelical thrust on the part of Standards Australia (and possibly NEHTA) to spread the use of Archetypes globally (as a special pestilential and mind befuddling treat for the rest of the world) when the local investment in their development and deployment has been minimal, to say the least. If they really think Archetypes are such a great idea putting ‘the money where their mouths are’ would be a good idea!
6. The literature supporting the contemporary use of Archetypes in the draft standard comprises a total of four citations predominantly by only two people.
7. The HL7 Template Special Interest Group is still working (as of October 2006) to resolve how CEN Archetypes and HL7 Templates can be harmonised in ways that make them interoperable whilst recognising that many of the conceptual and operational problems with Archetypes exist just as significantly in the HL7 Template proposals.
8. It seems to me there are much more basic and important things to be standardised before attacking a problem of this complexity which has not been applied or asked for by the real world. Getting basic clinical information available at local points of care reliably and improving care-coordination with the simplest of care records would be a very good start rather than developing this misguided, over-engineered and over-complex standard which I doubt will be seriously considered by more than 50 people and which I suspect will never be actually implemented as intended by its creators. To posit adoption of this Standard without describing the governance, provisioning and funding of the necessary Archetype sever infrastructure is naïve in the extreme.
To be creating 150+ page specification documents on the basis of what seems to be a conceptually ‘good idea’ and to then, without proven reference implementations, launch such documents on an unsuspecting world is downright dangerous.It is likely to hamper more useful and important e-Health developments globally, as an overly complex mess is sorted out – if that is possible.
It is really time for the proponents of Archetypes to ‘put up or shut up’. This is way to serious to just allow this proposed standard to wander though the approval processes without some very hard questions being asked.
Until reference implementations exist and are working and harmonisation with other standards (HL7 etc) is finalised and demonstrable all involved really need a ‘cold shower’ as our politicians are so keen on saying.
David.
Subscribe to:
Posts (Atom)