Quote Of The Year

Timeless Quotes - Sadly The Late Paul Shetler - "Its not Your Health Record it's a Government Record Of Your Health Information"

or

H. L. Mencken - "For every complex problem there is an answer that is clear, simple, and wrong."

Thursday, April 12, 2007

Why The Government will Never Fund a Shared EHR – And Probably Shouldn’t.

As regular readers of the blog will know development of a National Shared Electronic Health Record (SEHR) has been some form of Holy Grail for the e-Health bureaucracy and for many government e-health strategists and planners. Indeed it is no secret that NEHTA is developing such a project. From their web site we read:

Shared Electronic Health Record

NEHTA is working to develop specifications and requirements for a national approach to shared electronic health records. These records will enable authorised healthcare professionals to access an individual's healthcare history, directly sourced from clinical information such as test results, prescriptions and clinician notes. The shared electronic health record will also be able to be accessed by individuals who have received healthcare services.

Specifically, NEHTA will focus on developing:

• Operating concepts for a national approach to establishing and maintaining shared electronic health records;

• Policies, requirements, architecture and standards for a national approach to shared electronic health records; and

• A business case to substantiate and validate the proposed approach.

For the health system within Australia to reap the full benefits from the IT, governments and healthcare providers need to make the case for undertaking further investment including the development of a national system of shared electronic health records. The case for the required level of investment depends on the credible quantification of the costs and benefits of providing such.”

I understand that NEHTA plans to have developed the SEHR business case ready for submission to the Council of Australian Government (COAG) sometime in 2008. I would be prepared to wager a whole days wages they will not get approval to proceed to implementation, but will concede there may be some funding provided to have NEHTA (or someone else) go ahead to develop some more detailed plans and costings.
Before considering the possibility of SEHR Project success and funding we need to identify what is being proposed. From the most recent NEHTA presentations we see the following:



So from when funding is approved to proceed with the total project – probably in 2008 / 9 at the earliest - we will have the following happening. First two years of set up, certification, planning and procurement of a SEHR provider – to 2011 – and then over the next five years a rollout of an interoperable healthcare provider desktop. Starting in 2013 it is also planned that remote e-consultation will begin.

Can I say that the whole plan has a total air of un-reality and fantastic (in the real sense) wishful thinking about it. Among the realities that need to be faced are the following:

Firstly the present Federal Government has had over a decade to consider a major investment of this sort on Health IT and has not done so – what has suddenly changed that a 2008 proposal would suddenly meet acceptance? The answer is not much. If Government changes at the end of the year then all bets would clearly be off ( and planning would start again most likely ) and if it does not I suspect the 2011 election would see change – and a long and detailed review would be inevitable. Timing thus seems less than optimal at best.

Secondly large scale top down complex IT projects – in mixed health sector funding environments – are likely to be very problematic. The only examples of success in such a strategy are Kaiser Permanente (and a couple of similar managed care entities in the US) and the UK NHS. Both of these projects have proved to be both quite expensive and very difficult to manage. The other successes at a national scale have been in countries like Denmark and the Netherland where a messaging based bottom up relatively simple, standards based and incremental strategy has been successful. The co-operative disseminated model adopted by Infoway in Canada also seems to be progressing reasonably well and is possibly the closest match to the Australian situation.

Thirdly no Government in their right mind would invest in a SEHR project of the type presently proposed without some very substantial pilot and trial implementations at considerable scale. At the very least an implementation of the scale of a smaller state (say South or Western Australia) would be required to provide a credible ‘proof of concept’. This pilot / trial would take at least two years to be planned, implemented and evaluated. Given the abysmal failure of the various HealthConnect pilots – and the consistent withholding from public review of any detailed evaluation reports – success in this pilot endeavour could hardly be guaranteed. To not conduct a rigorous pilot / trial would, of course, be the height of folly and exceptionally high risk. It is not clear where this is planned to be undertaken on the NEHTA timetable shown above.

Fourthly there is a major project risk which is in-escapable in projects of this type. That is the inevitable political interference that is seen with large public projects and the difficulty of preserving direction and focus over many years required to deliver satisfactory outcomes. It is hard to think of any major Federal Government computer systems which have met both financial and planed time-lines. An additional risk, which should not be minimised, is the technical and system integration risk. As anyone with experience of the Health IT field will confirm very often interoperable simply isn’t (despite the use of recognised Standards) and much work is needed to make it so!

Fifthly at present the scale of costs of such a project – extending over at least four to five years – is essentially unknowable until the pilot implementations are complete. Any business case prepared before such information is available is likely to be more wishful thinking than fact. Associated with this issue is the lack of clarity as to what would be invested in and who would be investing in what and who would be paying for what. It seems improbable that such a major infrastructural upgrade will be willingly paid for by the users – i.e. GPs, Specialists, Hospitals and Diagnostic Providers – without some major cost recovery mechanisms being in place that obviates their financial risk.

Sixthly there will be a problems with having Hospitals and GPs / Specialists / Diagnostics in the private sector (they have most of the information that is to be shared.) being co-ordinated and managed in terms of information flows, implementation timetables and investment levels by NEHTA / Government.

Seven, any Shared EHR will inevitably face the privacy, confidentiality and consent issues associated with projects of this type, where the is always lingering public doubt as to just who can access the shared records and what control the patient has over such sharing. A program to convince a sceptical public of the benefits of a project of this sort will be neither brief or cheap.

Eight, right now there is a total lack of a credible business case that actually explains what will be paid for and who will pay. It is all very well to assert that there will be vast benefits from clinical decision support and e-consultation but until all the assumptions regarding the technology(ies) and capabilities to be deployed, what information is shared and what remains on local systems, who will be the users of these new systems, how the transition will be funded and managed and how the required knowledge bases are acquired and maintained credibility is severely stained at best.

Nine, while a simple PowerPoint slide can illustrate the concept of a SEHR the length of time and the level of work required to have even the smallest amount of health information sharable across a national entity (e.g. the UK) shows this is an undertaking of very considerable complexity, which is underestimated at considerable peril. Remember the basic idea has been around in Australia since 2000 / 1 and real progress towards a working outcome has not been impressive to date.
Last it needs to be appreciated that the development of a transition plan to take Australia from a wide variety of partially linked disparate client systems to a reasonable number of certified high quality client systems with rich functionality all supplying appropriate standardised, reliable information to some central SEHR securely and privately will of itself be major and as yet unaddressed and unfunded task.

What should be done instead?

With adjustments to suit our local Commonwealth / State divide it seems to me a national strategy based on locally based health information sharing initiatives on a background of proven Standards and compliance certification has the highest probability of success – especially when combined with an appropriate benefits re-distribution strategy to ensure those who are meeting the costs are rewarded for their efforts.

We could learn from ONCHIT in the US and let three or four contracts to build demonstration systems based on established standards and take the best features of each to develop a scalable bottom up approach that could then be rolled out at relatively low risk. These would be project managed commercially and their outcomes fully evaluated in public.

I am also strongly persuaded of the truth of the argument that real benefits are predominantly derived from advanced (Level IV) system and that the key to real benefits lie in standardised basic information sharing between advanced client systems. Secondary data sharing also needs to be part of the mix to ensure public health and post marketing surveillance of medication side effects (as well as bioterrorism) are effectively addressed. A top down strategy is almost certain to fail in the Australian environment and we would be better to go down a path that involves the determination of client functionality required, development of appropriate certification processes and standards and have the private sector develop and support appropriate systems. There could also possibly with an initially government funded Open Source alternative that could be developed, supported and provided at low (but reasonable) cost and maintained as an exemplar of what is required. This strategy could provide an incentive for commercial system developers to ‘out develop’ the basic system to demonstrate the additional value provided by their offering.

The total funding of any national SEHR at the COAG meeting in 2008, based on the current plans, seems to me to be ‘courageous’ in the extreme. Cooler heads need to prevail and a strategy suitable for Australia in 2008 to 2018 and beyond needs to be developed free from the unsuitable large scale SEHR proposal that seems to currently be dominating NEHTA thinking.

David.

Tuesday, April 10, 2007

NEHTA and ACSQH e-Health conference 20 March 2007

With Professor Liaw’s permission, I am posting some just written notes he developed following his participation in the meeting. They provide a useful summary of the views and concerns of some of the key actors in the e-health domain in Australia at present.

------------

Report:

NEHTA and ACSQH e-Health conference 20 March 2007

By
Professor Teng Liaw
President, Australian College of Health Informatics

From the participant list, this was a clinician and consumer focused conference with representatives from a whole range of disciplines and professions. It was facilitated by Julie McCrossin who was quite consumer-centric and focused on achieving some results. She managed to get some discussion on how best to describe interoperability.

Ian Reinecke described NEHTA’s workplan (see NEHTA website). He pointed out that eHealth was moving too slowly and emphasized a need for a national approach. He saw NEHTA (Autralia) as a “fast follower” as opposed to an “early adopter”. He suggested that there is a rising tide in eHealth, driven by the clinical process and the clinical and consumer communities, which will lift all boats in the process.

Christine Jorm described the Australian Council on Safety and Quality in Healthcare (ACSQH) workplan (projects, education, open disclosure, accreditation) and the need to achieve KPIs within 4 years. She likened QI to the process of testing change; we all have 2 jobs – one to do our work and the other to improve it. She stressed the belief barriers to eHealth.

Julie McCrossin posed the question: Is the Privacy Law the problem?

Peter Sprivulis presented the benefits realization study into the (potential) benefits of national eHealth reform, using a systems dynamics approach and quality dimensions. The model appears to be well developed and potentially useful. However, the data underpinning the predictions appear to be US-centric and not based on Australian information systems or the Australian healthcare system. The other assumption that appears to be controversial is the web-based SEHR, which is still relatively untried and untested. My feeling is that this model will need the data from a few controlled implementations over the next few years to really test its validity.

Richard Eccles reported on the various Commonwealth activities with the PIP, BFH subsidies, NEHTA, supporting clinical practice and new ways of doing business e,g, the electronic signature. The Commonwealth’s next steps are to support and promote the NEHTA work, ePrescribing, standards development and the shared EHR. He stressed that the Commonwealth’s role is to build the national infrastructure and a supportive environment for eHealth. The role of the consumer is key and the health professional is encouraged to offer the patient access to the eHealth system. The industry is also encouraged to build standards-based eHealth systems. This presentation highlighted the theory-specification-implementation gap e.g. should the government build a standards-based reference implementation or should it prepare specifications and leave it to the industry a la the many versions of HL7.

Julie McCrossin facilitated a discussion on the relative merits of Google as a source of evidence and information. The optimum information source is a balance of breadth and depth of information. The other point to consider is what the pros and cons of a NEHTA-built SEHR or a Google-managed SEHR?

The Change Management Panel emphasized that Commonwealth funded incentives are important to the change management process, to encourage participation in eHealth initiatives. An example is the incentive to enter data into information systems. A health service reported that they have combined the library and health record department as a strategy to eliminate “silos”. A universal reporting system was mooted. The NSW HealthELink reported on its opt-out system (with a 30-days cooling off period) and that they are about to link 100 GPs. The NT HealthConnect project is still implementing the eDischarge summary. A long term view is important – for example, the current apparent success of the UK NHS has been the result of sustained efforts, some effective and some not, over the last 20 years.

The Consumers Health Forum did a skit to highlight that any health program, eHealth included, is all about communication. Not sure if it is aimed at the lack of open communication by NEHTA with their consumer and clinician stakeholders.

In the Next Steps Panel, I stressed (1) the implementation gap and the need for a well funded national implementation plan with support from the highest political levels; (2) the health component of the eHealth agenda – the need for well-trained and supported clinicians to implement the eHealth program; and (3) the need for built in evaluation to ensure that the eHealth programs actually improve health and health care.

In the “Reflection on the day”, the following points were highlighted:

• It is important to put technology in its place in health care
• The advantage of being a “fast follower”
• The need to apply best practice consistently
• CDSS is an important component of the eHealth agenda
• Change management is important
• The consumer is a key driver of eHealth adoption
• eHealth must enhance the consumers’ trust in their doctor
• Better information is essential
• We must discourage “work arounds”, even with regulation if indicated
• The health sector is very tribal

In summary, while the conference did not discuss anything new, it was an important effort to engage the consumer and clinical stakeholder groups. The most important outcome will be how some of the relevant issues raised will be followed up by the NEHTA and ACSQH specifically and the participants’ organisations generally.

Teng Liaw

----------

I hope this summary will provide readers with a useful summary of current thinking at the NEHTA and ACSQH centre. I would be very interested in any comments those interested may have.

David.

Monday, April 09, 2007

Useful Health IT Links from the Last Week

In the last week I have come across a few reports and news items which are worth passing on. These include:

First is the site established by HealthCareIT News to cover activities in the National Health Information Network (NHIN) Arena.

The site can be found at:

http://www.nhinwatch.com/index.cms

The site has an impressive range of coverage on the whole area and a lot of current news and resources. Among the areas covered are

• Federal Initiatives
• Privacy and Security
• The Business Case
• NHIN Architecture
• RHIOs
• Voice and Data Networks
• Events

The site requires one time registration for access to a wide range of resources and interesting news including an RSS Feed.

The site describes itself as follows:

About NHINWatch.com

Brought to you by the editors of Healthcare IT News, NHINWatch.com is the most comprehensive Web site covering the creation of a Nationwide Health Information Network in the United States.

During his tenure as the first National Health Information Technology Coordinator, David J. Brailer, MD, made the development of a NHIN the centerpiece of his plans to bring American healthcare into the 21st century. Based on feedback received from the industry, Dr. Brailer described the network as an Internet-based data exchange that would allow medical providers to share health data to improve care.

But in 2006, Dr. Brailer resigned from his post with many decision about the NHIN yet to be made. Will it require a national database of patient records? Will every patient need a national identifier, or will a federated system of identity management based on existing demographic data and record locator services suffice? How will privacy be protected?

Every day, the editorial team from the industry's leading and most trusted news source, Healthcare IT News, scours the wires for the latest developments. If there's a story on the NHIN, you'll find it here.

To stay abreast of NHIN developments, please take a moment to register. As a registered user, you'll be able to browse the growing collection of news, resources and events here at NHINWatch.com. You can also subscribe to NHINWatch.com newsletters to have the latest news delivered directly to your inbox, and configure the NHINWatch.com site to present stories that best match your topical interests.”

The second item is a really good news story from e-Health Insider.

http://www.e-health-insider.com/news/item.cfm?ID=2590

PACS roll-out milestone hit in London and the South

03 Apr 2007

All NHS hospital trusts across London and the South of England have now received systems to enable them to capture and store digital diagnostic images as part of the health service IT modernisation programme.

NHS Connecting for Health, the agency responsible for NHS IT, yesterday confirmed to E-Health insider that 56 digital picture archiving and communications systems (PACS) have now been installed in the past two years, covering all hospital trusts in the capital and South of England.

Prior to the NHS IT programme 18 trusts in the two regions had already put in PACS systems, taking the total number of installations to 74.

…..

The full article can be read at the site. This is really good news and the reactions of the users of these system reported by e-Health Insider offer considerable hope for other aspects of the Connecting for Health Program in the UK.

The third item is a tale of unintended consequences.

http://www.washingtonpost.com/wp-dyn/content/article/2007/04/04/AR2007040401935.html

CAD Mammograms Often Find Harmless Spots

By JEFF DONN

The Associated Press

Wednesday, April 4, 2007; 10:56 PM

BOSTON -- A good mammogram reader may do just as well at spotting cancers without expensive new computer systems often used for a second opinion, a new study suggests. Computerized mammography, now used for about a third of the nation's mammograms, too often finds harmless spots that lead to false scares, researchers found. That conflicts with earlier studies showing benefit from the systems.”
…..

It seems clear that while the technology to analyse mammograms is more sensitive than the simple careful visual inspection of the mammogram it also results in many more women needing invasive biopsies and so on – meaning much more worry and anxiety for many women and little, if any benefit. As the article puts it, summarising the New England Journal of Medicine report:

“The researchers in this five-year study _ backed by the federal government and the American Cancer Society _ analyzed mammograms from medical centers in Washington state, Colorado and New Hampshire. Seven of 43 centers used CAD. The mammograms came from 222,135 women and included 2,351 with a cancer diagnosis within a year of their tests.

The researchers found that with computerized mammography, a third more women were called back for suspicious findings and 20 percent more got biopsies than with ordinary mammograms. That might be a good thing, if enough cancers turned up to justify the minor surgeries and anxiety surrounding them.

Yet the computerized method showed no clear capability to turn up more cancer cases than unaided readings: Four cancers were found for every 1,000 mammograms, whatever screening method was used. That means that CAD would give 156 more unneeded callbacks and 14 more biopsies for every additional cancer it finds. And though these extra cancers tend to be early ones that are easier to treat, many would never be threatening anyway.”
…..

The lesson here is that adoption of any technology without understanding the full impact it has on patient outcomes is always risky and that trials of technology need to assess the full impact on patient care – not just an improved number of cases located.

The last report this week is of very considerable concern:

http://www.modernhealthcare.com/apps/pbcs.dll/article?AID=/20070406/FREE/70405006/1029/FREE

Quality chasm still exists: study

By: Joseph Conn / HITS staff writer

Story posted: April 6, 2007 - 6:00 am EDT

The more things change, well, you know the rest, even without reading the Fourth Annual Patient Safety in American Hospitals Study released this week by hospital report-card compiler HealthGrades.

"I think the bottom line is the quality chasm still exists between the top and bottom hospitals on the 13 quality indicators we compare," said Samantha Collier, the physician senior vice president of medical affairs and chief medical officer of the Golden, Colo.-based research company. "I think there is a significant gap, almost a 40% lower incident rate of these types of errors that we measured in the best performing hospitals to the lowest performing."

…..

The observation of a 40% difference in error rates makes it absolutely clear some hospitals are not trying hard enough. The impact of this being addressed:

“If all hospitals performed at the level of the top 15% in the study, which HealthGrades deems to be "Distinguished Hospitals for Patient Safety," there would have been 206,286 fewer patient safety incidents to Medicare patients, 34,393 fewer deaths and an estimated $1.74 billion would have been saved, according to Collier.”

…..

It would be good if statistics of the sort produced by HealthGrades were available in Australia so the debate on how to fix our hospitals could begin.

The full report can be read here:

http://www.healthgrades.com/media/dms/pdf/PatientSafetyInAmericanHospitalsStudy2007.pdf

A sobering read, as is the very good summary article I have quoted from.

David.

Tuesday, April 03, 2007

The 2007 AusHealthIT Blog “Looney Health IT Awards”

In the Spirit of April Fool's Day for 2007 the AusHealthIT blog felt it would be useful to award the “Blog Looney Health IT Awards” or BLHITAs – pronounced Blights (as in “Blight on the Landscape”)

Please hand over the envelopes, and to a drum roll, we announce the following awards:

The Grand Blight for 2007 goes to the Commonwealth Department of Health and Ageing (DoHA) – for managing to totally lose control of the National E-Health Agenda and for failing to ensure Australia has a National E-Health Strategy that the overall health system understands and supports.

The State Blight Award was shared in 2007 between NSW and South Australia. NSW earned its award for failing to recognise the importance of ensuring proper privacy standards in an e-Health Implementation (HealtheLink). South Australia achieved its award for its 'back to front' approach to system procurement where it plans to issue a tender for a Care Planning System before having even an interim evaluation of a Pilot Project.

The Stealth Blight Award for excessive discretion and information retention in the e-Health Domain is shared between DoHA and NEHTA. They both appear obsessed with unnecessary confidentiality / secrecy. DoHA wins the award for re-constituting the Australian Health Information Council without letting the public know. Even after two meetings those interested in these matters do not know who its members are, what they are doing and what their terms of reference are. NEHTA wins for its continuing use of stealth committees and consultants to provide it with advice rather than using the more traditional consultative processes when issues are of significant public interest and deserve transparent handling. DoHA also get a second dishonourable mention for its failure to report on the evaluation outcomes of the Eastern Goldfields Broadband Trial in Western Australia. A lot of public money went into that trial – and what do we hear of the outcomes – zip!

The “Can't See the Wood for the Trees” Blight is awarded to NEHTA for planning to allocate citizens a health identifier based on numbers allocated by Medicare Australia (which is part of the Department of Human Services) instead of using the identifier provided by the Access Card Division of the same department which is doing much the same thing. Worse, NEHTA claims the two projects don't intersect even though the major role of the Access Card is to replace the Medicare Card.

The “Creative Denial of Reality” Blight is awarded to DoHA for continuing to pretend there is any life in – or plans to seriously invest in – HealthConnect. SA Health are runner up for never explaining – when asked on the blog in public - how the security controls on their OACIS systems provide the level of security granularity and control most South Australians would expect.

The “Exaggeration of Importance of Influence” Blight is awarded to NEHTA for seemingly imagining it has the same level of influence (and is delivering as effectively) on the global E-Health stage as The US ONCHIT, The UK Connecting for Health Program and Canada's Health Infoway. The decision for HL7 last week – following the US, UK, Canada, Holland and Denmark makes it perfectly we are peripheral at best – and the delay in decision making confirms us as a ‘slow follower’ not a ‘fast follower’ as some have misguidedly claimed.

The “Tolerance in the Face of Extreme Provocation” Blight (or maybe it is an Anti-Blight) is awarded to the members of all the IT-14 Committees of Standards Australia for continuing to contribute despite a considerable level of side-lining, rail-roading and provocation by all sorts of external forces.

The “Failure to Grasp The Place of Health IT in the Health Sector” Blight goes to the proponents of Shared EHRs for attempting to progress projects of this type without continuing an in-depth public consultation with the total Australian Health Sector especially around the issues of privacy, consent, decision support and the location of functionality. This dooms them to failure I believe.

The “Silliest E-Health Presentation of the Year” Blight goes to NEHTA for suggesting there is $50+ Billion in benefits in health IT available without laying out what will be invested in to harvest these benefits and who will pay. Without a clear presentation of all the assumptions underlying these “models” it is just fantasy. It all may be true the case for major investment in Health IT is true (indeed I believe it is) – but how can anyone know without all the information? To publish half complete material like this just damages the credibility of those who work in the field in the eyes of the economic 'hard heads', who will not invest unless the full case is presented and is compelling.

The “Most Prolonged Gestation of an e-Health Concept” Blight is awarded to the proponents of the concept of archetypes for failing to explain, despite repeated requests from those who are somewhat sceptical, just how archetypes will be sustainably managed through their various versions, multiple iterations and inevitably large numbers over time. Just how the required infrastructure will be developed, funded, governed and supported into the future must be explained before archetype based systems can evolve beyond being a R & D projects and implementation of very limited scope – albeit very interesting ones.

The “Life is Cheap” Blight for failure to appreciate the need to urgently move on deployment of proven technology is awarded to all those who see progress in this area as a job rather than a passion and feel unnecessary deaths and suffering is not their problem. This Blight is shared with the Western Australian Health Department which also appears to have a very relaxed time-line in proceeding with updating the (presently quite limited) Health IT in that State.

All in all a sad list. I hope it might be better next April. All the points raised here can and should be addressed by those responsible and none are ‘rocket science’. I wonder what progress we might see.

For the sake of balance I am currently developing a list of awards for Health IT Stars (HITS). HITS will be awarded for exceptional contributions and efforts in a positive direction in e-Health. Nominations are welcome either as a comment or by e-mail. Please let me know about anything you know that seems to be useful, valuable and making a difference. I hope we can find a reasonable list.

David.

NEHTA – What is the Status of All These Specifications?

In a very recent press release from NEHTA there is the following:

http://www.nehta.gov.au/index.php?option=com_content&task=view&id=182&Itemid=144

NEHTA sets direction for electronic messaging in health

NEHTA confirms Health Level 7 as the national standard for the electronic messaging of health information across Australia.”

This set me to wonder, just where does NEHTA derive its authority to reach such conclusions? It is neither a government entity nor is it actually funded to make any product procurements which would seem to be the point at which what NEHTA wants and what the market has to offer intersect.

NEHTA's position would appear to be stated in the following terms (From the National E-Health Standards Development A Management Framework Version 1.0 – 15/03/2006):

3.3 Compliance

NEHTA's role includes the development of specifications for inclusion in Government and potentially other health sector procurement processes. These specifications will be technical in nature, normative, and incorporated into commercial contracts.

On their own, standards or technical specifications have no legal status and are free to be followed or not by manufacturers, consumers or the public. However, if a Standard or specification is referenced in legislation, or written into a commercial contract, it becomes enforceable by virtue of that legislation or contract. When this happens, Standards become mandatory and their reasonableness, quality and impact can be subject to the scrutiny of the courts. Accordingly, standards development organisations make every attempt to ensure that the principles and processes used to develop standards are based on good practice.

In respect of “specifications” such as those produced by NEHTA, the WTO Agreement on Government Procurement states that:

“Technical specifications prescribed by procuring entities shall, where appropriate:

(a) be in terms of performance rather than design or descriptive characteristics; and

(b) be based on international standards, where such exist; otherwise, on national technical regulations, recognized national standards, or building codes.”

Further to this the Council of Australian Governments (COAG) recently committed to: “promoting compliance with nationally-agreed standards in future government procurements related to electronic health systems and in areas of healthcare receiving government funding.”

While not being a lawyer, this seems pretty clear to me. The key points are:

1. Standards and specifications only become enforceable if they are either legislated or become part of a commercial contract.

2. If they become part of legislation or a commercial contract they are testable by the courts for their “reasonableness, quality and impact”.

3. To be valid they must be developed by appropriate processes.

4. They should be performance based (i.e. lead to an outcome if adopted – e.g. a level of fire resistance of material which if used will save life or property or with e-health, for example, be demonstrably workable and able to be implemented)

5. Be based on international standards unless there are compelling gaps in what is available internationally which need to be filled.

Most important, it seems to me, is the quality and depth of the development processes.

Standards Australia summarises the process needs very succinctly.

http://www.standards.org.au/cat.asp?catid=6

Cardinal Principles of Australian Standardisation

Open
Any affected or interested representative organisation has the opportunity to participate.

Balanced
The committee shall be balanced and not dominated by any single interest category or organisation.

Due Process
All valid objections shall have an attempt made towards achieving resolutions.

Consensus
More than a majority but not necessarily unanimity.”

Standards Australia also succinctly summarises the legal status of their work as they see it:

http://www.standards.org.au/cat.asp?catid=7

The legal status of Australian Standards®

Standards Australia is an independent organisation and our Standards are not legal documents. However, because of their convenience and the willingness of all parties to adopt them, many of the documents are called up in Federal or State legislation, with the result that they then become mandatory. Currently about 2400 of our Standards are mandatory, however most are used voluntarily by people who value their expertise and commonsense. They are practical and don't set impossible goals. They are based on sound industrial and scientific experience. And, because they are regularly revised, they keep pace with new technologies.”

It is interesting that much of the spirit of this is captured in the NEHTA Standards Development Framework document. However, I think there are many who think NEHTA's compliance with the requirements for openness, balance, due process and consensus is yet to be seen.

Equally the comments from Standards Australia on the need for practicality and the use of experience seem highly appropriate – and these have yet to really be taken to heart by NEHTA.

It is also interesting that after operating for over two years NEHTA finally perceived that it needed a formal documented relationship with Standards Australia on February 9 this year. See

http://www.nehta.gov.au/index.php?option=com_content&task=view&id=178&Itemid=144

I also find it fascinating that as of February 2, 2007 NEHTA can say – in the description of the document entitled “Supporting National E-Health Standards Implementation v1.0” the following.

“The consistent implementation of health informatics standards is critical to achieving an information technology enabled health sector within Australia. The structure of the health system in Australia is diverse and dynamic, which does not readily support standards implementation. To achieve the e-health goals for Australia it is necessary to address the current challenges associated with standards implementation.

The purpose of this document is to provide guidance to those in the health sector responsible for improving care delivery through information technology by identifying some of the challenges to health informatics standards implementation; defining adoption, uptake and implementation; and clarifying the strategies and activities that will assist in resolving the challenges. A framework to support successful standards implementation is also described.

This document completes the development of NEHTA's National E-Health Standards Plan.”

What is being said here, as I read it is:

1. This is all very hard (or, we think we need help, but who can help us?)

2. Someone – i.e. you out there - have to address the challenges it poses (or, we can only tell you what to do but you have to do it and make it work)

3. Here is a document to tell you how – with such memorable quotes as “The onset of e-health breeds confusion due to fear, uncertainty and doubt.[5]” – Page 6. (or, is it any wonder we are confused?)

4. We have done all we can – so over to you (or, we hope we’ve helped, good luck in your future endeavours).

Surely something as basic as a Standards Plan needs to be a living, developing, learning document – not a fait accompli.

That many in the Health IT industry are only reading NEHTA's documents “when there is nothing more useful to do” seems a valid approach to be adopting until the NEHTA processes move to a more appropriate level of consensus creation, communication and consultation.

It seems to me NEHTA has to do a much better job of explaining to the Health IT community the value and usefulness of their efforts for them to have much real impact and that pretending (with the words quoted in the compliance area above) they have legal enforceability on their side is probably little more than a rather pathetic bluff.

NEHTA does not have legislated authority and their specifications and recommendations are not the product of a recognisable standards creation process as they are traditionally undertaken.

For NEHTA to ever be really relevant a lot needs to change – and soon.

David.

Sunday, April 01, 2007

Interesting Newly Found e-Health Related Sites

A colleague has provided the following suggested site for all those interested in the use of Systems Methodologies to come to grips with the complexities of Health Service Delivery in the real world.

National Institutes for Health: Systems Methodologies for Solving Real-World Problems: Applications in Public Health Presented by: Patty Mabry, Ph.D., Bobby Milstein, Ph.D., M.P.H., John Sterman, Ph.D. and Ken McLeroy, Ph.D., Washington, March 2007

The Videocast is Described as follows:

“The first in a series of four educational seminars featuring leaders in various areas of systems science. The purposes are to raise awareness of particularly promising methodologies; and improve our collective understanding about how and when they may be used effectively by behavioural and social scientists (including researchers, policy analysts, planners/evaluators, grant reviewers, journal editors and government officials).

This first symposium provides an introduction to, and overview of, the rest of the series. The core principles of system-oriented inquiry will be described, while briefly surveying a variety of methodological traditions and emerging directions in the field. John Sterman (Director, System Dynamics Group at MIT) will share his view of the field followed by Ken McLeroy (Associate Dean at Texas A&M and Department Editor for AJPH), who will explore further implications and assess the prospects for incorporating systems methodologies more fully into routine public health work.

This is important material from some of the global experts in the field!

It is a large download – some 780 Megabytes – so be warned!

If interested in the area go to:

http://videocast.nih.gov/Summary.asp?file=13712

The following also seems to be very useful.

Learning from Mistakes

No news is said to be good news. For Scot Silverstein, M.D., however, lack of information is a symptom of a major industry problem. In 1998, Silverstein launched a Web site devoted to shining light on healthcare IT failures. Hospital leaders, IT vendors and the media have swept the topic under the rug, he says. “IT failure is a serious problem, but people are reluctant to study it,” says Silverstein, the director of the Philadelphia-based Institute for Healthcare Informatics at Drexel University College of Information Science and Technology. “We like to talk about success, not failure.”

According to Silverstein, the healthcare industry is plagued by projects that do not live up their potential—or in some cases, are scrapped altogether. His observations are drawn from several years of experience working at large health systems, where clinical documentation projects involving IT stalled due to mismanagement. In 1998, Silverstein launched the site, hoping to gather case studies from others in the field.

………

The site is: www.ischool.Drexel.edu/faculty/ssilverstein/medinfo.htm

—Gary Baldwin

The full article can be found at:

http://www.healthleadersmedia.com/magazine/view_magazine_feature.cfm?content_id=87842&category_id=155

Additionally – also important is this:

Proof of Impact: New Study Sheds Light on Economics of Health IT Investment

by Colleen Egan, iHealthBeat Editor

March 30, 2007

While many in the health care industry say that investment in IT leads to better quality and performance, there is a dearth of solid evidence to support that claim. A new report from PricewaterhouseCoopers aims to "retire the question of whether IT has a positive impact on hospital business performance."

The report, titled "The Economics of IT and Hospital Performance," used "econometric" techniques to study the relationship between IT adoption and organizational performance at nearly 2,000 U.S. hospitals over a five-year period. Researchers -- who used sources such as the Solucient ProviderView database and the American Hospital Association's Annual Survey Database -- collected three types of data:

• Hospital services and facilities utilization;
• Health IT investment; and
• Hospital operating costs.

……

The full article can be found at:

http://www.ihealthbeat.org/index.cfm?Action=dspItem&itemid=132349

Lastly:

Six tips for surefire EHR implementation success

Electronic Health Records Briefing, Mar. 27, 2007

Joel N. Diamond, MD, implemented an inpatient EHR, including 100 percent adoption of computerized physician order entry at the University of Pittsburgh Medical Center St. Margaret Memorial Hospital. This was one of the first successful community hospital installations in the United States.

Before launching CPOE in September 2004, Diamond went on a one-year campaign among St. Margaret’s 300 private physicians to promote acceptance of CPOE and identify those who resisted it. Because of this, the hospital launched the system two weeks ahead of schedule and now enjoys full participation by the medical staff. During the January 24 HealthLeaders Media (a division of HCPro, Inc.) Webcast “Bringing the Digital Hospital to Life: Expert advice and real-world lessons,” Diamond offered the following six tips for successful implementation:

……

Again the full article can be found at:

http://www.healthleadersmedia.com/view_content.cfm?content_id=88249

Enjoy!

David.

Thursday, March 29, 2007

What is NEHTA up to with Shared Electronic Health Records, HL7 and so on?

Last week we had the following announcement from NEHTA.

http://www.nehta.gov.au/index.php?option=com_content&task=view&id=182&Itemid=144

NEHTA sets direction for electronic messaging in health

NEHTA confirms Health Level 7 as the national standard for the electronic messaging of health information across Australia.

Across the Australian healthcare sector there are many different types of computer software and systems that are involved in the exchange of information. Currently, these systems use various exchange formats to send and receive information. To ensure that all systems across Australia have the ability to reliably and safely communicate with each other, a standard exchange format is required. The National E-Health Transition Authority (NEHTA) has determined that this standard will be based on the HL7 family of standards.”

NEHTA's roadmap for deployment and adoption is outlined later in the press release:

“To assist the health IT sector to migrate to this standard, NEHTA has identified the following approach:

a. Where HL7 version 2.x standards are already extensively used and yielding benefits, for example pathology and patient administration, these standards should continue to be supported. Where HL7 standards are not in use, they should be factored into system upgrades where practicable.

b. NEHTA will now focus on developing Web services specifications based on work undertaken by the HL7 Services Specification Project (HSSP), and content specifications based on the HL7 Clinical Document Architecture – Release 2 (CDA R2) for areas such as referral, discharge, prescribing, dispensing and pathology.

c. This work will then form the basis by which industry will migrate to HL7 version 3.”

This is really quite a large ‘change’ or dare I say ‘leap’ for NEHTA – so large in fact that a search of NEHTA’s “National E-Health Standards Catalogue - Supporting Standards Implementation - Version 2.0 - 19/01/2007” (8 weeks ago) does not have a single reference to HL7!

This is actually quite surprising given that HL7 V2.x was recommended by DH4 for continued use by the Australian Health Sector over 12 months ago and indeed it is widely deployed and Standardised nationally.

What is of major concern is not that NEHTA can show flexibility, but that they can show so much flexibility in moving from their previously announced path to this current path so quickly. Quite frankly, to put it bluntly this is not how Standards Development Organisations – even amateur ones – should behave. Were I a Health IT developer who had invested time and money in responding to NEHTA's previous Generic SOA approaches I would surely be suggesting that I would like my money back (with interest)!

This kind of strategic instability reflects a serious lack of real industry consultation over the last three years. There should be some accountability moment or action associated with this switch.

It is also difficult to understand why in NEHTA’s document entitled “Guidelines for Implementing Interoperable Web Services Version 1.0 – 28 March 2007” there does not seem to be any mention of either HL7 or HSSP. A comment as to where this new direction for interoperability with HL7 and HSSP fitted with this implementation guideline would have been useful and informative to everyone!

Indeed the delay in coming to a view of the place of HL7, given the expertise and advice available to NEHTA, is really unconscionable and has been a major barrier to e-health progress. One could have expected strategic clarity in the area much before this.

One must also wonder with the decision to deploy content based on CDA R2 just where all the NEHTA Clinical Data Specification work fits and how much of this will need to be altered or reviewed to conform with the HL7 Reference Information Model? It would also be interesting to know how all this fits with the long delayed but imminent Shared EHR announcements.

A final point - does anyone else think making a decision like the HL7 decision warrant a process of open public discussion and not simply an ex-cathedra announcement. Some of us don't worship at that sort of church!

Talk of the right hand not knowing what the left hand is up to.

David.

Tuesday, March 27, 2007

An Even Better Use for the Future Fund Money.

It seems that the Labor Party recognises that there are some pieces of technical infrastructure that require an element of Government funding to bring into existence, but that once implemented there will be ongoing benefit for the nation.

The essence of their internet broadband announcement is as follows:

“Federal Labor will revolutionise Australia’s internet infrastructure by creating a new National Broadband Network.

It will connect 98 per cent of Australians to high speed broadband internet services – at speeds over 40 times faster than most current speeds.

With the rollout of a new ‘Fibre To The Node’ (FTTN) network, Federal Labor will increase speed to a minimum of 12 megabits per second – so fast that household entertainment, business communication and family services will happen in real time.

The remaining two per cent of Australians in regional and rural Australia not covered by the FTTN network will have improved broadband services.

New services and benefits of the network – particularly in rural and regional areas – include:

• Slashed telephone bills for small business;

• Enhanced business services such as teleconferencing, video conferencing and virtual private networks;

• Enhanced capacity for services like e-education and e-health; and

• High definition, multi-channel and inter-active TV services.

It is estimated that the new National Broadband Network will deliver national economic benefits including:

• Up to $30 billion in additional economic activity every year;

• Making Australian small businesses more competitive;

• Creating new markets for businesses and new jobs for Australians; and

• Extending media diversity.

A Rudd Labor Government will:

• Partner with the private sector to deliver the national broadband network over five years;

• Undertake a competitive assessment of proposals from the private sector to build the network;

• Ensure competition in the sector through an open access network that provides equivalence of access charges and scope for access seekers to differentiate their product offerings;

• Put in place regulatory reforms to ensure certainty for investment; and

• Make a public equity investment of up to $4.7 billion.

This commitment will be financed from existing government investment in communications, including the $2 billion Communications Fund and through the Future Fund’s 17 per cent share in Telstra, which will earn dividends and be sold down to a normal market level after November 2008.”

It seems to me this is just the first step. No point in having train lines (i.e. the broadband network) if you don’t have trains (e.g. e-health) to take advantage of it!

Given that there is a clear business case for increased spending in the Health IT domain – with net benefits estimated at up to $A5.0 Billion per annum or more (based on studies undertaken in the US, UK and Canada) what could be a better use of a little more of the Future Fund than to kick start e-health with an investment designed to deliver a real return once implemented?

A sensible approach would to be develop a National E-Health Strategy, Business Case and Implementation Plan as a first step and to then establish an highly accountable implementation organisation – maybe modelled on the UK or Canadian models or a mixture of the two – with a focus on making sure the lessons learnt from both are properly absorbed. (While I plan a separate article on this area in the future the need for local involvement, ownership and choice in the context or appropriate standardisation and central direction setting now seem obvious for any national initiative.)

The Future Fund has as its objective a return of 7.5% + inflation over the long term I understand. It would seem this return could be achieved with expert project management and the deployment of Health IT is a way that is known to have beneficial impacts (i.e. use of advanced clinical workstations, in depth automation of investigative services and supply chains, improved secure messaging and the use of systems wherever possible with advanced clinical decision support). Measurement and well as realization of the return on investment I recognise will be a considerable challenge but should not be impossible. There is no doubt the econometric tools exist to undertake such work exist.

The main issue that will almost certainly emerge will be how the benefits achieved will be cashed out for return to the Future Fund – given the tendency of the Health Sector to aim to expand services when efficiencies are obtained rather than take the cash benefit.

I believe the scale of the return on investment in this sector is likely to mean that both some service expansion as well as cashing out of benefits will be possible – to everyone’s pleasure.

Health IT is an ideal candidate for a major planned capital investment and will both make a profit and do good things for the users of, and workers in, the Health Sector.

Let’s give it very careful thought.

David.

Monday, March 26, 2007

It's Nice to See The System Working!

This arrived today via Her Majesty's Post in response to my open letter of a week or so back.



Next step is to see what the Department's officers make of the suggestions and comments to be found here!

I wait with bated breath.

David.

Sunday, March 25, 2007

Imminent Fiasco Alert – SA HealthConnect running off the Rails.

I suspect there must be something in the water that reaches South Australia that has made those involved in the SA HealthConnect Care Planning Trial(s), and following Project, loose the plot. A few days ago I wandered onto the project web site to see how things were progressing with the one year trial. What I found has left me totally amazed.

For background on this project go to my post of late last year.

http://aushealthit.blogspot.com/2006/12/children-of-healthconnect-how-are-they.html

The Table of Project Activities says it all! What is described in the table is an absolute and incompetent disgrace which is even worse than some of the bungled HealthConnect trials of years gone by. It is chaotic and absurd in the way it is being organised and the table of activities shows those involved have no idea what they are doing. Just consider the following past and future sequences carefully.

--------------------------------------------------------------------------------------

February 2006 - Functional specification drafted

July 2006 - Care Planning Trial commenced

October 2006 - Commenced consultations with NEHTA re standards and data specifications and local groups, e.g. Health Provider Index (ongoing)

November 2006 - Care Planning Trial Go Live

February 2007 - Consumer Reference Group and Stakeholder Reference Group formed

Mar/April 2007 - Tender documents released to market

March 2007 - Communications plan developed

May 2007 - Tender responses due

May 2007 - Interim findings of the Care Planning and Communication Trial due

November 2007 - Care Planning and Communication Trial concludes

Late 2007 - State-wide implementation begins

-----------------------------------------------------------------------------------------

When considering the program – what does one see?

First, essentially out of the blue, HealthConnect SA caused a requirements specification for Care Planning (which has not been disclosed) to be drafted. On the basis of this specification it seems a trial of some commercial software has been commenced. The trial went live, it is claimed, in November 2006. It is quite clear the selection process was neither thorough nor open given the time it took, the apparent absence of a tender and the non-publication of full evaluation criteria.

What is claimed (on the project web site) is that the Ozdocsonline was selected by the following process:

“Consultations undertaken with key stakeholders identified that, in order for the care planning and communication system to be effective, it must:

  1. improve health outcomes
  2. be simple
  3. protect patient privacy
  4. provide patient access and control
  5. facilitate communication and collaboration between the health care team
  6. be accessible at the point of care.

Based on these criteria, and following an assessment of existing care planning systems, the Ozdocsonline system was selected for the trial. “

Hardly the level of detailed requirements needed to determine the appropriate system for a twelve month trial.

But – whoops! – it seems someone noticed that the trial now underway (despite its use of both state and federal funds) is hardly the type of non-standard, non-integrated system or approach NEHTA (or anyone else who had a clue) would choose to sponsor without solid evaluation as to alternatives.

So what happens?

In February 2007, presumably after a little 'jawboning' from NEHTA or DoHA, suddenly we see the actual formation of some management and consultative committees and the beginning of consumer and stakeholder consultation. Bit late since the trial has already been underway for four of its twelve months.

Presumably the Communications Strategy mentioned for March 2007 is to provide ‘spin control’ for the impending mess!

One also has to wonder how much pressure was exerted to spend committed funds with such haste concurrent with the establishment of such a large team (16 people in total in the group as of March 2007).

What happens next should be fascinating! A tender for a longer term solution is to be issued in March 2007 – but this is being done in the absence of any input from an interim evaluation of the first half of the trial – let alone a completed evaluation of the 12 month effort!

The responses to the tender specifications (whose requirements are presumably based on gut feeling of what might work rather than evidence of what is actually working) and the evaluation report of the tender are to be completed at the same time.

There is nothing like planning for success! This is an excellent example of the saying ‘If you fail to plan, you plan to fail. ’According to the timetable the tender will get evaluated, a solution will be selected, consultations will be held and State-wide implementation will begin by late in 2007!

Oh, and also – in November 2007 the trial closes down and all the data vanishes, unless the unsuitable incumbent as far as NEHTA's standards (and common sense) are concerned gets retained on a permanent basis or practitioners start paying to retain their own information.

Even more amazing is the following from the Project Site

“The South Australian Care Planning Project will also need to undertake work to:

  • Ensure the care planning system conforms, where possible, with the National e-Health Transition Authority's (NeHTA) standards for care plans.
  • Ensure that the Health Provider Registry, developed and maintained by SA Divisions of General Practice Inc (SADI), includes allied health providers.
  • Ensure the care planning system has decision support capability.”

Firstly – It is important to note that, as far as I know, there are no such things as NEHTA Standards for Care Plans (they certainly do not exist anywhere in the NEHTA Standards Catalogue), if indeed there are any recognized Australian Standards in the domain at all sanctioned by Standards Australia or the like. Second NEHTA is developing a National Health Provider Identifier which presumably will obsolete the local SADI effort – so just what is being planned here? Thirdly the vagueness of “Ensure the care planning system has decision support capability” is both vague and meaningless – especially given that addition of any really useful decision support to any care planning system is a major and complex undertaking which does not seem to be contemplated in this one-liner and certainly not in the time-frames proposed above.

While not wishing to be unreasonably critical (I am really keen there be ongoing development in the e-health space a quickly as possible) , it just seems to me this whole project is the wrong way to be going and is very far from what should be funded to further develop e-health. There is a real risk, I believe, that a serious waste of money and effort is occurring. I will happily publish here on the blog any reasoned explanation from the proponents of all this that can show I have got it wrong and that this is a well managed, strategically sensible, standards aligned, coherently planned, transparent and properly executed pilot and project.

Am I the only one who can see how silly and bizarre all this is, how poorly thought through it is, how it is lacking in any reasonable process, and how its chances of and substantive long term success are miniscule at the best?

David.

Thursday, March 22, 2007

HL7 to Assist Australian E-Health Development

The following was released by HL7 today.

==================

22 March 2007

MEDIA RELEASE

NEHTA confirms Health Level 7 as the national standards for the electronic messaging of health information across Australia.

Across the Australian healthcare sector there are many different types of computer software and systems that are involved in the exchange of information. Currently, these systems use various exchange formats to send and receive information. To ensure that all systems across Australia have the ability to reliably and safely communicate with each other, a standard exchange format is required. The National E-Health Transition Authority (NEHTA) has determined that this standard will be based on the HL7 family of standards.

"This decision provides a clear national direction. Those who develop these systems now have certainty about what the Australian customers of their systems will require," said Dr Ian Reinecke, Chief Executive of NEHTA. "Without all systems in the healthcare sector using common standards such as this, the promise of electronic health communication can't be fulfilled on a national scale."

"The endorsement of the HL7 standards by NEHTA is good news for the Australian e-health community and an acknowledgement of the value and maturity of HL7 standards in a global context. We look forward to working with NEHTA to develop the support required for industry to implement this national direction," said the Chairman of HL7 Australia and Board Member of HL7 globally, Mr Klaus Veil.

To assist the health IT sector to migrate to this standard, NEHTA has identified the following approach:

1. Where HL7 version 2.x standards are already extensively used and yielding benefits, for example pathology and patient administration, these standards should continue to be supported. Where HL7 standards are not in use, they should be factored into system upgrades where practicable.

2. NEHTA will now focus on developing Web services specifications based on work undertaken by the HL7 Services Specification Project (HSSP), and content specifications based on the HL7 Clinical Document Architecture – Release 2 (CDA R2) for areas such as referral, discharge, prescribing, dispensing and pathology.

3. This work will then form the basis by which industry will migrate to HL7 version 3 .

This approach ensures that migration occurs in a consistent manner, and in conformance with NEHTA's requirements.

"NEHTA will work closely with HL7 Australia and Standards Australia in this development work," said Dr Reinecke. "In addition, NEHTA is closely liaising with its international counterparts - such as the UK's National Health Service and Canada's Health Infoway - to ensure that the specifications developed in Australia are consistent with international efforts."

This direction is consistent with the endorsement of HL7 standards for use in Australia by the National Health Information Group in 2004. In the international community, the largest adopter of HL7 v3 standards is the Connecting for Health program run by the UK's National Health Service; the UK, US and Canada have also adopted HL7 CDA specifications.

A report providing further details on this decision will be released shortly by NEHTA. Further information about HL7 standards can be found at www.hl7.org.au.

====================

It must be said it has taken rather too long to get some basic clarity and to permit further e-health development to be undertaken with some confidence.

The decision is, however, most welcome. Whether it is the right one only time will tell.

David.

Wednesday, March 21, 2007

What a Difference a Presentation Makes!

Seems the Health E-Nation Conference that was organised by CHIK Services on 21 March, 2007 has had an interesting outcome.

It seems NEHTA has recognised, in its presentation, that there are Standards in place and in use that can’t be ignored and that the approach of the ‘jackboot’ as opposed to real consultation can lead to embarrassment! All of us in the health sector could have told them that three years ago!

At last – after three years – maybe we will see some sanity emerge. The steps announced to continue with use of HL7 V2.x are a useful first step.

Much, much more pragmatism, commonsense and flexibility is required – as is a real understanding of the Health Sector’s needs – but this step offers a minute glimmer of hope.

Well done – and how about some serious next steps!

I wonder will it be followed up with a range of other sensible moves - most especially the development of a National e-Health Development approach?

This blog is not short on suggestions on areas that could be fruitfully reviewed.

David.

Tuesday, March 20, 2007

Software Quality Assurance – What do we Need and must Demand?

A number of elements have come together over the last few weeks to have me thinking about the expectations we should have of the software and systems we deploy to aid the delivery of clinical care.

First there was a very lively discussion that emerged on the GP_TALK e-mail list which discussed the various issues that surround the handing of clinical results arriving into Patient Management Systems. The discussion was triggered by a question on just what the legal responsibilities were to monitor the incoming areas for arriving results from pathologists, radiologists etc and who was legally liable if an important result went astray and just what the dividing line, if any, was between the test orderer, the result provider and the result receiver / reviewer.

The interest in this topic is considerable because of previous legal liability decisions which make it clear it is the court's view that when a clinician orders an investigation which has the possibility to reveal 'clinically significant' information the practitioner has a considerable legal onus upon them to ensure they have systems in place to ensure that they will, within a reasonable period of time, note and act on the results as they are received.

Second there have been a number of concerns expressed by a range of authorities considering what expectations should be held for the functionality, reliability, usability and clinical safety of software designed to be used by clinicians. This is seen as encompassing areas such as scope, currency, accuracy and reliability of clinical decision support, the aspects of the system design that facilitate safe and consistent use of the software as well as the overall functionality offered.

Third the CEO of HealthLink (Mr Tom Bowden) recently wrote a discussion paper highlighting the problems that can arise if there is not 'end to end' accountability for the entire investigation ordering cycle – covering ordering, processing, resulting and review. This paper clearly recognises the need for substantive co-operation between clinical messaging providers and developers of clinician systems to ensure highly effective integration and the practical removal of any risk of important information 'falling between the cracks'.

This paper – in its current version – can be found at the following URL

http://www.healthlink.net/healthlink_documents/brochure/Electronic%20messaging%20safety%20Issues%20-%20HealthLink%20viewpoint.pdf

Fourth, as best I can tell, NEHTA has articulated no policies or plans in the area of clinical software quality and safety to date, and has not been sponsoring any publicly announced programs in the area.

Fifth, if discussions in GP e-mail forums are to believed, there are some real issues regarding to responsiveness of providers of GP software to both functional gaps and ‘bugs’.

Lastly, to date, while there has been medical software industry contribution work to support the health information Standards development process, there have been limited real outcomes in terms of data portability and interoperation between GP applications. We lack any Australian Standards for patient data portability, for medical software quality and for the quality of functionality and decision support provided.

None of these issues are exactly new, but their emergence does serve to highlight that there are considerable risks associated with having an e-health environment which is fragmented in terms of how quality and safety issues are addressed.

What is needed is really quite clear – a clear division of labour as to who is responsible for which part of the information chain and accountability on the part of all to deliver as fail-safe and reliable solutions as is humanly possible.

It seems to me there needs to be some form of national round table convened which brings together the patient management system developers, the messaging providers, result providers, expert clinicians and health informaticians to develop a framework under which responsibility for each part of the chain can be identified and those involved can then work to develop approaches and solutions which will solve the problem and obviate the risk of computerisation of General Practice being seen as a cause of patient harm.

Ideally all this could be handled in the form of a range of Industry Codes of Practice perhaps combined with appropriate Standards in the relevant areas. There is also a place for entities like the Australian Health Messaging Laboratory (AHML) to provide certification of conformance to agreed Standards to ensure safe inter-operation can be essentially guaranteed. Additionally the round table could consider the role of standardised approaches to interoperation between the various systems involved. Certification of GP systems may also need to be considered if progress in this area does not follow reasonably soon.

It is important for all involved to be very clear that we are only one Coroner's Case or Supreme Court decision away from compulsory application of solutions that may be neither ideal or in-expensive, so delay would be unwise. Recognition of the problem on the part of Medical Defence organisations is also likely to result in pressure to ensure safe and reliable systems are available and used.

It is also clear that well designed practice management systems can greatly assist in ensuring all important results are received (or followed up if not) and actioned appropriately once received. The issue is not if GP computing is needed or not – it clearly is. The issue is to be sure what is functional, safe and reliable and fully meets the needs of its users. I am not yet convinced the ‘market’ has sorted these issues out adequately and the patience of the GP community of users should not be too elastic.

Hopefully the area of the quality and safety of GP computing will be one that will be incorporated in the National E-Health Strategy, which I believe the new Australian Health Information Council should be developing. They should not see taking their time on this issue as an option!

David.

Sunday, March 18, 2007

An Open Letter to Minister Tony Abbott.

The following is a letter I e-mailed to Minister Tony Abbott a little over a week ago. In the covering note I pointed out I would like a response and that I planned to publish the letter on this site after a week or two.

-----------

An Open Letter to Minister Tony Abbott.

11th March 2007

The Hon Tony Abbott MP
Leader of the House; Minister for Health and Ageing.
PO Box 6022
House of Representatives
Parliament House
Canberra ACT 2600

Dear Mr Abbott,

The Australian health system is not as safe, as efficient or as cost effective as it could and should be.

A major, but not the only reason for this is that the health sector is not using proven Information and Communication Technology effectively in order to get the benefits which have been received by virtually all other sectors of the Australian economy.

I believe this is a major policy failure of the present Government and will have electoral consequences unless addressed promptly with a coherent, inclusive and properly funded National Health IT Strategy in conjunction with an appropriate Business Plan and Implementation Strategy. Neither NEHTA nor the newly re-formed Australian Health Information Council appear to be cognisant of and focussed upon the excess costs and suffering inaction is causing. Action is required promptly.

There will be electoral consequences due to the public perceptions of wastage of many dollars on the current strategy, the lack of transparency in the evaluation and reporting of what has been achieved to date, the recognition we are slipping well behind other countries (e.g. the UK, Canada and the Netherlands) and the unacceptable number of otherwise avoidable deaths and injuries due to unsafe and inadequate systems.

The net benefits of successful implementation of such a plan would conservatively be at least five percent of national health expenditure ($4 Billion per annum), if overseas research from the US, the UK and Canada are any guide.

I have developed an internet web-log containing over 140 articles on this topic over the last 12 months and I have exposed my thinking to public criticism and review. I have found that the 200 plus expert readers are typically very supportive of my suggestions in the Health IT domain.

I would be pleased to have your officials browse my web-log for a well considered and developed set of ideas and approaches on what is needed to recruit the benefits and to move Australia forward in this very important area.

The web-log can be viewed at http://www.aushealthit.blogspot.com/ .

Yours truly,

- Signed -

(Dr) David More MB, PhD, FACHI.

----------

As of the time of posting no response has been received from the minister

David.

Thursday, March 15, 2007

The Shared EHR – Can it Be Done Simply and Make a Difference?

In this short article I want to raise, and attempt to solve at a high level, some of the problems associated with the currently proposed Shared Electronic Health Record (SEHR).

The reason to document this is that in its latest presentations NEHTA is still saying it wants to put a business case for implementation of a National SEHR to the Council of Australian Government by the end of 2008.

What I mean by a SEHR is an arrangement (in its most simple form) where by a variety of feeder systems found in general practice, specialist offices, hospitals and services such as labs, pharmacies and radiology create summary records as they process patients which are then uploaded to a central repository. These summaries are envisaged to accumulate over the life of the patient to form a valuable longitudinal electronic patient record.

The central repository is then accessible to authorised users to assist with the care of the individual patient at some time later.

With minor tweaking around the edges the NEHTA proposal seems to be a re-run of the late 2004 HealthConnect project which was a month or two after that date placed into development limbo. The most evolved public version of the HealthConnect proposal was the Version 1.9 of its proposed Business Architecture (BA).

There do exist some slightly later NEHTA documents providing a “Concept of Operations” for a NEHTA SEHR but these are not publicly available.

It must be reasonably obvious to all that creation of a nation SEHR is not a uncomplicated exercise – indeed, since proposed in late 2001 – very considerable work has been done, pilots of components have been undertaken but any really extensible or expandable success simply has not been demonstrated. Those with a historical bent can follow all this is excruciating detail at the following URL:

http://www.health.gov.au/internet/hconnect/publishing.nsf/Content/home

This site was last updated 17 Feb, 2006.

I will state a prejudice here and state I think the SEHR of the BA Version 1.9 and NEHTA’s present plans are probably too complex, when fully analysed, to be made reality. That said I believe there is the possibility of doing something very clinically useful if those responsible stand back and work out clearly where information should be stored and processed within the health system.

What I suggest is that a practical approach to the SEHR should be a very simple base record – held voluntarily in a central repository - that contains the information that may change the way an individual is treated in the first day or so of an encounter with an emergency facility, hospital or new doctor. If that can be made to work, then, and only then, should consideration be given to doing more in a shared EHR sense.

There are a number of templates available for what to me should be a single form which is stored centrally and updated by the patient and their attending doctor at each appropriate encounter. All that would be stored would be essentially patient demographics, major current illnesses and problems, allergies and current medications, with maybe some free text for special items of warning or alert.

The standard of information I would suggest is appropriate is the amount of information a thorough GP would provide about a patient who as going for an overseas trip where they may need care from a doctor who had never seen them before.

If more detail is required, it is at that point reference is made to the owners of the patient’s detailed information – e.g. laboratory providers, specialists, local GP etc.

Any design that attempts more than this simple approach (of voluntary sharing of a basic information set agreed between the patient and their usual clinical adviser) will get tangled up with a range of issues.

These include:

• Concerns for privacy and lack of control of their personal information on the part of the consumer / patient

• Difficulties and delays in delivery of a workable system due to complexity if a more adventurous approach is attempted.

• Excessive cost in infrastructure requirements.

It seems to me such a basic standardised record would typically be able to be relatively easily read and created by quality GP and other relevant systems – and a secure messaging solution to and from a central repository would not be too difficult to devise within current standards.

Either the Access Card Identifier or the NEHTA Health IHI could be used to safely identify patients if either is available, or an alternative devised if required. Only one would be needed.

Under my approach all the heavy computational lifting – that promotes quality and safety in clinical care – would be done within client systems in the General Practice, Specialist’s Office or Hospital where clinicians engage with the details of care and where decision support is most valuable.

Such a model of a simple shared record and quality computing for the clinical workface (i.e. Local EHR) I find intrinsically appealing and doable today. I hope something practical, quickly implementable and workable emerges from NEHTA’s deliberations in this area.

I am firmly of the ‘walk before you run’ school in Health IT. Round the world we see simplification working and complexity confounding the most energetic. Let’s grasp that lesson and move forward.

David.

Sunday, March 11, 2007

Three Years Too Late – NEHTA Asks What’s Next?

A few days ago I heard about an 80 minute Panel Session that NEHTA is planning to conduct on 20 March 2007. (The date is one day before the Health E-Nation Conference being organised by CHIK Services on 21 March)

The information I received is as follows:
_________________________________

“Planned Panel Session

Title

Joining the Dots… What’s Next

Aims

To identify the priority areas for action to enable e-reforms to progress to national implementation.

To identify the most significant outstanding obstacles to progress and what must be done in the next 12 months to address these priority issues.

To enjoy a lively discussion with questions and comments from the audience.

Interview questions

What do you believe are the 1 or 2 key areas for action over the next 2 to 3 years? Please give brief, specific examples to illustrate your points.

What do you believe is the single most important thing we need to do to accelerate e-health in the next 12 months from the point of view of health consumers or patients? And also from the point of view of health professionals?

What is your organisation currently doing to accelerate e-health reforms? Example?

Is there any other significant issue you would like to raise?”
_______________________

I was also told it is planned there will be panellists from six to eight different relevant organisations.

What is to be made of this?

My first reaction was to ask – Why was this work, which is essentially aimed at setting strategic and short term directions, not undertaken three years ago?

Then it occurred to me ponder – hang on – isn’t NEHTA meant to be managing the delivery and implementation of e-Health in Australia? How is it they don’t know the answers to all these questions as part of their strategic plan? If the aim of this Planned Panel Session is to confirm current directions I would be re-assured – but for NEHTA to now be asking what the priorities and barriers are at this point – three years into the mission – seems just quite absurd.

As readers of this blog will know I have been banging on about the need for an action orientated National E-Health Strategy, Business Case and Implementation Plan for a good while now! My answer to NEHTA’s request therefore is quite straightforward. Put simply what NEHTA has to do is as follows:

1. Recognise that their customer is not the NEHTA Board but the Australian Health Sector, and the 20 million people who use the services provided by it.

2. Swiftly enrol competent expertise and find the resources and funds to develop a consultative, inclusive, National E-Health Strategy, Business Case and Implementation Plan.

3. Use the Business Case to secure the appropriate level of funding required to move forward

4. Implement the agreed and recommended plan nationally.

I have had a feeling in the last few months that I have been missing something, else we would be seeing more constructive activity than seems to be the case. I have formed the view that the lack of an agreed national strategy is fundamentally a major obstacle to progress. Broadly speaking what I think we are now seeing is the following:-

1. State Governments working to use Health IT to try to get their hospitals working better (albeit with different levels of success and urgency) and starting to try and communicate with the relevant GPs and Specialists.

2. Most GPs and Specialists lacking the motivation (or the right incentives and support) to move beyond basic practice computing and prescription printing until future directions become clearer. (Note: there are all sorts of good things happening at many Divisions but somehow the task of co-ordinating information and skill sharing seems less than ideal).

3. The medical software industry is responding where it can but it lacks confidence in the stability of the direction being taken and the preparedness by Government(s) and practitioners to invest.

4. Service providers (labs, radiology etc) are optimising internal operations and providing external messaging of results etc largely only when asked. Electronic ordering is still at a low level.

5. A significant and consistent lack of support for implementation of already developed standards as well as some caution around standards which exist on paper but are not yet demonstrably implemented.

6. An evolving but still non-interoperable secure electronic messaging environment which lacks certainty in the forward directions that will be successful resulting in slow investment and complexity of use for end users.

7. A clear sense that the HealthConnect proposal(s) is/are going no-where in the next 3-4 years at best and that in reality HealthConnect has been canned.

8. Scepticism regarding announcements in areas such as e-prescribing, supply chain and medicine terminology among others.

Development of a comprehensive National E-Health Plan can, if funded and sponsored at the right level, provide the confidence, financial security and direction to get over the log-jam.

There are a few critical requirements for national E-Health Plans to be successful. These include at least the following:

1. That the plan be designed for the way the Health Sector in a country works in terms of funding, service delivery and so on. The implication is that what is done in the US, UK, Canada or Europe will only offer ideas – not a comprehensive solution.

2. That the plan, once developed, be sponsored, funded and committed to on a bi-partisan national interest motivated mode. Implementation of a plan of the type required is a major long term project and as far as possible politicisation needs to be avoided.

3. The plan be conceived to address the health system as a whole – and not fall into all the traps of Commonwealth / State rivalry, friction etc.

4. Inclusiveness of all the relevant stakeholders (Consumers, Providers, Government, Health Funds etc)

5. Focussed on delivery of clinical benefits for patients along with facilitation of health sector safety, efficiency and effectiveness.

6. Recognition that the benefits from the use of Health IT are often not captured by those whose work practices are changed and who may also bear additional costs.

7. Recognition that significant incentives for change will be required.

8. Recognition that Health IT is an enabler of Health Sector Reform and Improvement and that leadership of and commitment to Health System redesign is also needed.

There are a number of major strategic choices that also need to be made. Among these are (in no particular order – they are all crucial):

1. The level of standardisation that is to be imposed and at what level(s) this is to happen – as there is a trade off between user choice and the degree of inter-operation and information sharing that can be achieved without undue complexity.

2. Whether the approach to development and implementation will be ‘top down’ (as broadly it is in the UK) or ‘bottom up’ (as broadly it is in the US). This will ultimately drive a strategic E-Health Architecture for the county and the route by which that architecture will be evolved in practice.

3. The respective place and role(s) of the Government(s), the health service providers, the private sector software industry and so on the overall mix of how things are achieved.

4. Whether a Shared EHR or a messaging paradigm will be adopted and whether a distributed or centralised model will be adopted. There are a huge range of shades of choice that may be made in this area.

5. The suite of standards that will be utilised and how compliance with those standards will be obtained, certified and maintained.

6. The level of local and regional autonomy that will be available and the areas of the strategy where this will operate.

7. The amount of system development, service provision etc that will be undertaken centrally by Government(s) versus the use of commercially provided software and services.

8. The approach to risk management and to issues such as the verification of solution suitability and piloting of proposed solutions.

9. The funding model to be adopted and the approach to be adopted to benefits identification, management, realisation and distribution.

10. What is preferred and the optimal method of software provider and user / public / consumer involvement in the selection, deployment and use of Health IT and what consultative approach should be used in development of the strategy.

11. The strategies to be used in gaining public confidence regarding the privacy and security of their personal health information.

12. How best to take most advantage of the useful work undertaken to date in the field, while not constraining an optimal long term outcome for Australia.

13. The optimal governance framework and management structure for delivery of such a large and complex national initiative.

The benefits of providing clarity to all stakeholders on the shape of the future and the part they can play in advancing towards that future are obvious in terms of the levels of investment and benefits that will flow.

The best thing that could happen would be that the new AHIC and NEHTA jointly approach COAG / AHMAC to get such a planning process initiated as soon as possible.

I wonder whether those bodies have the ‘intestinal fortitude’ needed to step back, accept we are not getting anywhere fast, and initiate a new planning process.

I am reminded of the following quote:

There is a tide in the affairs of men,
Which, taken at the flood, leads on to fortune;
Omitted, all the voyage of their life
Is bound in shallows and in miseries.

William Shakespeare, Julius Caesar
Greatest English dramatist & poet (1564 - 1616)

The tide is rising right now!

David.

Yes, It Really Can be Done!

Just a short posting to provide a URL for a fascinating ten minute downloadable video that explains what the Dutch have been up to in e-Health over the last few years!

The video describes AORTA which is the Dutch national infrastructure for the exchange of data between healthcare providers. The infrastructure specifications include a description of technical, organizational as well as implementation aspects. The focus of this program is to facilitate the realization of a national "continuity of care" oriented EHR. AORTA uses HL7 version 3 messages and documents as its core mechanism for information exchange.

Depending on your media preference you have a choice of formats.

AORTA introductory video (in English, 10 minutes),

http://www.uzi-register.nl/media/EMD_WDH_EN_256K.wmv (Windows Media file)

or

http://www.uzi-register.nl/media/EMD_WDH_EN_H264%20.mov (Apple Quicktime).

Vastly more information and detail on the project can be found at:

http://www.ringholm.de/docs/00980_en.htm

The author is René Spronk - Sr.Consultant, Ringholm GmbH

The current document status: Draft, version 0.5 (2007-01-01).

I commend this article and indeed the Ringholm site for a careful browse and review.

There are all sorts of lessons for Australia I believe here. The approach to security and privacy I found was especially pragmatic and robust.

I find it fascinating that the Dutch have committed so robustly to making HL7 V3.0 and CDA R2 work – despite it not being totally finalised – and seem to be having considerable success. This is encouraging news.

David.