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."

Tuesday, April 17, 2007

A Few Other Things Regarding the AFR Article on E- Health.

The Australian Financial Review Article of the 13th April, 2007 entitled “National e-health would save $30bn” by Julian Bajkowski makes a few comments I really don’t think should go through to the keeper.

The article states:

The study has increased pressure on the federal government to abandon a number of failing federal electronic initiatives, including the $128 million HealthConnect project, which has yet to deliver tangible results.”

I would suggest this is wishful thinking as we see the grossly overfunded non-strategic trials which are being still being conducted by HealthConnect SA and HealthConnect Tasmania. It would be good however if this was an outcome and they were canned.

The article states:

Doctors, clinicians and hospitals have long sought electronic health and medical records that could be used across Australia's different state health systems.

This really misses the mark. Most care (95%+) is delivered within a patient’s local area and virtually all care is delivered in the state of a patient’s residence. Doctors would be very keen to see records for their patients able to be used between the local practice, the local hospital and the local investigatory providers. The rest would be a cherry on the icing on the cake I would contend.

The article states:

But developing the standards has been a battle because of a series of bitter quarrels between technology suppliers and standards bodies.

This is largely just wrong. Between NEHTA and Standards Australia’s (SA) Health IT working parties there have been tensions and a lack of quality two way communication – but the Health IT industry has, for the most part, very good relations with SA. Relations between the Health IT industry and NEHTA are dodgy, at best, despite anything NEHTA may say.

The article states:

NeHTA recently recruited the former head of Queensland-based Cooperative Research Centre for the Distributed Systems Technology Centre, Mark Gibson, as its chief technology officer.

The hiring represents a coup as it will ease NeHTA's access to a vast repository of e-health-related intellectual property held in trust by the shareholders of DSTC after the group's funding was terminated by the federal government in 2005.

While not commenting on this particular appointment directly, I seriously doubt there is much useful intellectual property held in trust by DSTC given the failed and never properly reported HealthConnect trials it was involved in.

I hope these comments assist in understanding where things currently sit.

David.

Monday, April 16, 2007

A Headline To Die For - National e-health would save $30bn – Pity it’s a Wild Unsupported Bit of Speculation.

Friday 13 April, 2007 will go down in history as a very black day for e-Health in Australia. On that day, based on an apparent back door leak, Julian Bajkowski of the Australian Financial Review published an article entitled “National e-health would save $30bn”. This assertion is based on work undertaken by the National E-Health Transition Authority (NEHTA) under its Benefits Realisation work program and is based on a Systems Dynamic Model developed by modelling consultants. Before discussing the details it is important to keep in mind a very important fact about all such models. That is that ‘no models are correct, but some are useful’ (Robert Box)

Regular readers of the blog will wonder why I should be concerned by this claim of such huge net benefits. The reason is very simple. While I firmly believe there are major benefits to be harvested from the deployment and use of e-health – and I believe the literature makes it reasonably clear where they are to be found – such claims are simply unsupportable without very substantial additional evidence.

NEHTA talks of the model they have developed in the following terms:

Modelling approach used for the study
• System Dynamics Model:
- Increasingly preferred (e.g. NHS)
- 900+ variables, 300+ calculation nodes, 25 sectors
• National and international expertise engaged:
- Jurisdiction, consumer and clinician input
• Focuses on major e-health benefits, costs and relationship to demand, quality and safety as e-health initiatives are rolled out over a 10 year period

Additionally they cite a range of published evidence from CITL, RAND etc and claim that from 3400 papers published since 1980 that Adverse Drug Events can be reduced by 50% (or more) by using Computerised Physician Order Entry (CPOE) with effective interactive decision support – among a range of other benefits that have been identified for e-Health.

They also suggest that there are 500,000 years of life to be saved in the Australian Population over 10 years with the implementation of e-Health.

What is conspicuously absent from all the presentations is the ‘how’? We are not told any of the basics that are required to make this credible. Obvious questions are:

What is the strategy, transition and implementation plan to move from where we are now to this 10 year future nirvana? If you don’t have that properly understood, documented and agreed with stakeholders how can you make any sensible comments about possible benefits? This is serious cart before the horse material I believe!

What are the assumptions for the capabilities of the systems to be used in hospitals and ambulatory practice to achieve these benefits? (It should be noted CPOE is notoriously difficult and complex to implement in hospitals – to the extent that – when last I looked – no more than 5% of hospitals globally have such systems in place. They are also not cheap to buy and implement.)

How much will such systems cost and who is going to pay for them?

What is a realistic time frame for replacement of present systems with the new more capable systems assuming they are readily available?

Given the vast majority of patient care is delivered in the private sector just what incentives (from Government) will be required to get the private sector on board?

Do we have the doctors, nurses and pharmacists who are sufficiently well trained and skilled in IT to make the transition to the e-health way of doing things?

Who is going to capably manage and co-ordinate such a huge change management and technology implementation program?

Are the assumptions in the model regarding a Shared EHR strategy correct? Is that ultimately the right approach for Australia? There is certainly a case for a careful review of the options being deployed around the world.

So what do we have here? Essentially what we have is a model without a strategy for architecture, implementation, funding and subsequent benefits management. There is no point putting out a generic claim about a possible scale of benefits without laser like clarity on just what is being proposed – or the economic hard heads in Treasury will shoot you down before you get started. This is where my concern lies. We have a once in a generation chance to propose a major re-investment in e-health for Australia and for it to succeed we need a model of an implementable and stakeholder approved strategy and implementation approach. Without clear and totally credible answers to all the questions I pose above, this initiative will turn out to be an expensive waste of time and effort.

It is vital in all this that those managing this proposed implementation ‘under promise’ and ‘over deliver’. I see no evidence of that approach in all this.

It is all very well for the Financial Review to publish an exciting headline and it is always important not to let the facts get in the way of a good story but I really think a little more digging regarding the reliability of NEHTA’s numbers, the assumptions and risks involved, the underlying strategic assumptions and recognition that things are usually much more complicated than they appear in a proposed, and largely yet to be defined, project of this scale would have been useful.

I look forward to NEHTA’s release of the Strategy and Implementation Plan that the model assesses along with the model and its assumptions. I will not be surprised to find I am once again disappointed and that sadly it all turns out to be largely ‘smoke and mirrors’ which will get us nowhere.

A final point that should be made is that the NEHTA Benefits Case relies on the deployment of clinical decision support (CDS). That, CDS, is sadly not actually part of NEHTA’s work plan as currently published. If it is actually worth so much, focus is needed and fast! Whoops!

We will wait and see!

David.

Sunday, April 15, 2007

Useful and Interesting Health IT Links from the Last Week

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

http://www.reuters.com/article/healthNews/idUSN1236605720070412

Wal-Mart sees medical clinic boom in retail stores

Thu Apr 12, 2007 4:40PM EDT

ORLANDO, Florida (Reuters) - Wal-Mart Stores Inc. is forecasting more than 6,600 in-store medical clinics will open their doors in the next five years in retailers nationwide, a company official said on Thursday.

"I think it's an indication of how bullish individuals (chief executives of clinics and retailers) are," Alicia Ledlie, senior director for Wal-Mart's health business development, said at a health care retailers convention in Orlando.

With 75 clinics in Wal-Mart stores in 12 states, the company has ended its pilot program and plans a faster roll-out of additional clinics nationwide.

Ledlie said Wal-Mart is considering providing its in-store clinics with a common electronic medical records system so patient care can be tracked from store to store.
She said the system could ultimately be part of a universal electronic medical record system for the country

…...

See the rest of the article at the URL above. This is a really interesting development where the world’s largest retailer is developing both a huge number of medical clinics and, presumably for good commercial reasons, to utilise a sophisticated EHR system to provide seamless care to their customers no matter which store the seek care from. 6,600 clinics is an amazing number of clinics!

Second I noted this report from Europe. The value is in the second and third URLs that permit access to a wide range of information on e-health plans in all 27 member countries of the EU.

http://www.euractiv.com/en/health/report-shows-good-progress-health/article-163098

Report shows good progress on e-Health

Published: Thursday 12 April 2007

Member states have made good progress in implementing the EU's e-Health strategy but have failed to address education and socio-economic issues falling under their responsibility, a new progress report shows.

An EU report confirmed that good progress has been made across the continent following EU member states' commitment, in the European e-Health action plan to develop a national or regional roadmap for e-Health.

http://ec.europa.eu/information_society/activities/health/docs/policy/200703ehealthera-countries.pdf

"e-Health is increasingly becoming an integral element of national health system objectives. It is seen as a key enabler in wider contexts like improving the quality and efficiency of public services, or speeding up the development towards knowledge driven societies," states the report, drafted by a project entitled Towards the Establishment of a European eHealth Research Area (eHealth ERA).”
…..

A useful listing of European Approaches to E-Health

http://www.ehealth-era.org/database/database.html

The third is a short piece of Australian news.

http://www.computerworld.com.au/index.php?id=523856106&eid=-180

E-health authority appoints new chair

Sandra Rossi 10/04/2007 10:31:43

Director-general of the Queensland department of health, Uschi Schreiber, has been appointed chair of the National E-Health Transition Authority (NEHTA).
Schreiber will replace the outgoing secretary of the Victorian department of human services, Patricia Faulkner.”

There is but one comment to be made on this appointment. Ms Schreiber needs to be a hands on Chairperson of NEHTA and ask the hard questions about the appropriateness of the current NEHTA strategic directions. This is the core function of the NEHTA Board and especially its chairperson. If she does not do this – and listen to a broad range of voices who are not largely beholden to NEHTA for their income - she runs the risk she will be seen my many in the e-health domain as a dog who is being wagged by an organisational tail!

A good place to research for some had questions might be this very blog.

David.

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.