Apparently We Are to Have Electronic Health Records From the Budget. Be Alert but Not Alarmed!

The following appeared as an apparent budget leak this morning.

Revealed: Rudd's $2b budget lure

PHILLIP COOREY CHIEF POLITICAL CORRESPONDENT

May 7, 2010

EXCLUSIVE

ANOTHER $2 billion in health funding is expected to be revealed at Tuesday's federal budget to pay for changes to primary care, increase the number of nurses and the duties they perform, and to introduce a long-awaited system of electronic health records.

The money would be one of the few new spending measures in what is otherwise expected to be an austere, pre-election document. It takes the total expenditure on health measures allied to the federal government's proposed reform plan for hospitals to $7.4 billion.

The Herald understands most of the $2 billion will be dedicated to out-of-hospital services, or primary care. The government has promised to fund 100 per cent of primary care and GP services.

The changes will involve expanding the use and co-ordination of allied health professionals and integrating them with GPs. Nurses will be at the forefront, with more needed to staff the expanded out-of-hospital system.

The funding, spread over four years, would not include anything for the Denticare system proposed by the health and hospitals reform commission. It is believed this measure was considered too expensive.

Electronic health, or e-health, which will be funded, allows for the easier sharing of a patient's medical records by health professionals who would be able to view a privacy-protected database.

It allows for an easy transfer of records when a patients shifts residence or changes doctor.

More here:

http://www.smh.com.au/business/federal-budget/revealed-rudds-2b-budget-lure-20100506-uh2b.html

While we have yet to see any details the risk here is that we get another ‘out of the blue’ announcement like so many others we have seen which have been developed in secret and really do not reflect what might actually be needed or actually work.

We will all have wait and see, but given the Government’s track record on the ‘health reform’ to date I find it hard to be all that optimistic.

David.

IHE Australia Make Connectathon Presentation Slides Available.

Here is part of the page announcing the publication.

IHE Open Day Seminar Wednesday 21 April 2010

Australian Health IT vendors gathered in Canberra to develop and test their capacity to securely message key healthcare information at the 3rd IHE Australia Connectathon. During the event some 45 participants from industry, government and GP Divisions visited the Connectathon The objective of the seminar was to provide participants with an introduction to IHE Australia activities and an overview of developments in secure messaging.

Speakers were:

Vincent McCauley – Chair, IHE Australia

1. IHE Introduction VMcCauley IHE Open Day 2010.ppt

Bernie Crowe – IHE Australia, SMD Connectathon Manager

2. IHE Australia B Crowe SMD Connect Open Day 21 Apri 2010 V 4 .ppt

• Jon Hilton – IHE Australia, HISA Board

3. Jon Hilton - PCCP Profile.ppt

John McMillan NEHTA Manager Secure Messaging and Andy Berry – Specifications

4. ConnectathonOpenDay v1 2_NEHTA.ppt

Jane Gilbert -Director, Operations and Strategy at Australian Healthcare Messaging Laboratory (AHML)

Janine Bevan – Director Clinical Communications, Department of Health and Ageing (DoHA)

5. DoHA Connectathon slides 21 Apr 2010.ppt

Jon Hilton, HISA Board member and leader of the IHE Australia Patient Care Working Group, presented on the development of the Patient Centered Coordination Plan (PCCP) Profile to support Care Coordination and Planning across different healthcare organisations and information systems. This profile, based on the IHE Cross Enterprise Document Share (XDS) platform, supports the development of care teams, exchange of care plans, patient progress reports and tracking of key tasks and outcomes. Australia is an international leader in care planning, so it is not surprising that we are leaders in the systems used to support care management.

----- End Extract.

The full page is here:

http://ihe-australia.wikispaces.com/Event_21+April_Connectathon+Open+Day+09+report

The slides are well worth a browse.

David.

Major Study Confirms Value from E-Health In Australia. Mr Rudd and Ms Roxon Take Note!

The following was released today. Important stuff in my view!

MEDIA RELEASE

Booz & Company report identifies possible $7.6 billion in annual savings from Government investment in e-health

Sydney, 6 May 2010 — A report released today by leading global management consultancy, Booz & Company, has revealed Government investment in a comprehensive e-health system may generate more than $7.6 billion in annual healthcare savings by 2020.

The Booz & Company report, Optimising E-Health Value, outlines a comprehensive case for national investment in e-health to better connect GPs, hospitals and other points of care, so as to improve sharing of patient information.

The report points to reduced errors in medication as offering the greatest potential for savings ($2.6 billion), followed by improved care programs and prevention measures ($2.3 billion).

Adverse drug events from errors in medication are estimated to affect 10.4% of patients currently treated by GPs in Australia each year, of which half are classified as moderate to severe, 138,000 require hospitalisation, and as many as 18,000 may result in death according to some sources.

Booz & Company says a comprehensive commitment to e-health could help Australia avoid an estimated 5,000 deaths, two million primary care and outpatient visits, 500,000 emergency department visits and 310,000 hospital admissions each year.

Report co-author and Sydney-based Booz & Company Principal, Klaus Boehncke, said the analysis demonstrated clearly the benefits from significant investment in e-health, and the need to build such investment in the health reform agenda.

“E-health is the crucial missing piece of the health reform jigsaw presently, and it must not be allowed to slip from view,” Mr Boehncke said.

“Indeed, the success of some of the Government’s reforms, particularly the local hospital networks and primary care networks, and reduced Emergency Department waiting times, depends largely on the connectivity that a robust e-health system provides,” he said.

The report was based on Booz & Company’s global experience advising Governments and health authorities in countries overseas including the United States, Canada, Germany, Italy, Singapore, Hong Kong and the UAE. The e-health model outlined in the report draws on Australian health data and has been adjusted to reflect the characteristics of Australia’s health system.

The report says existing e-health investment in Australia has been patchwork, limited and often focused on acute care. It calls for a shift in e-health focus from hospitals to networking primary care settings – GP clinics - where the volume of patient interaction is high and the potential for flow-on benefits are greatest.

“GPs are increasingly at the sharp end of providing integrated and chronic care, and their role becomes more important under the Government’s reforms, with their initial focus on diabetes. There is a real opportunity to reap powerful gains by putting them at the centre of the e-health push,” Mr Boehncke said.

“Australia’s GPs – 95% of whom use computers - are among the most highly computerised in the world. However, they are not well connected with each other, or with other points of care such as hospitals, so the valuable patient information they hold is not shared with other care providers or indeed among their own community,” he said.

“With a national e-health infrastructure in place, we estimate an investment in information networking of $3,000 per annum per GP clinic could deliver up to $668,000 in annual savings per clinic, mainly through prevention and avoidable hospitalisation. Up to $5 billion of the total savings from e-health investment in our model would come from improving connectivity and dissemination of information to and from GPs.”

Booz & Company’s analysis argues the case for Federal and State Governments to fund the information networking of GPs, as they would be the beneficiaries of the resulting savings. The firm estimates Governments would share in 68% ($5.2 billion) of annual savings accruing from a national e-health investment.

Other e-health benefits identified within the Booz & Company report include:

• Better use of healthcare infrastructure
• Less duplication of diagnostics such as lab tests and X-rays
• Savings from optimised use of pharmaceuticals
• Enhanced productivity among healthcare workers
• Early warning from disease outbreaks

Based on current trends, the estimated total annual savings of $7.6 billion from e-health may represent 3% of total health expenditure. This figure does not include flow-on economic benefits to Australia, such as improved workforce productivity, which are estimated to be considerable.

Mr Boehncke said the health community was watching closely for signs from the Federal Government that it would commit to a significant investment in e-health.

“It did seem obvious that e-health would figure prominently in the reform agenda but there are now concerns it may have slipped off the table. That would be disappointing – there are good reasons why comparable countries overseas are investing heavily in this area, and the arguments for doing so here are irresistible,” he said.

ENDS

Media contacts:

Kristine Anderson

Booz & Company

kristine.anderson@booz.com

Ph: (02) 9321 1931

Nick Owens/ Hugo Shanahan

Sefiani Communications Group

hshanahan@sefiani.com.au

Ph: (02) 8920 0700

About Booz & Company

Booz & Company is a leading global management consulting firm, helping the world’s top businesses, government ministries, and organisations. With more than 3,300 people in 60 offices around the world, Booz & Company brings foresight and knowledge, deep functional expertise, and a practical approach to building capabilities and delivering real impact. Booz & Company works closely with clients to create and deliver essential advantage. For Booz & Company’s management magazine strategy+business visit www.strategy-business.com. Visit www.booz.com to learn more about Booz & Company.

This is a useful report in the pre-budget context.

I have been promised a link to the full report and will put it up as soon as it arrives.

This is the direct link. .pdf at bottom of text.

http://www.booz.com/anzsea/home/40212171/40212709/40213345/eHealth

David.

Use of Barcodes Dramatically Improves Medication Delivery Accuracy.

The following article appeared in the New England Journal of Medicine today.

Effect of Bar-Code Technology on the Safety of Medication Administration

Eric G. Poon, M.D., M.P.H., Carol A. Keohane, B.S.N., R.N., Catherine S. Yoon, M.S., Matthew Ditmore, B.A., Anne Bane, R.N., M.S.N., Osnat Levtzion-Korach, M.D., M.H.A., Thomas Moniz, Pharm.D., Jeffrey M. Rothschild, M.D., M.P.H., Allen B. Kachalia, M.D., J.D., Judy Hayes, R.N., M.S.N., William W. Churchill, M.S., R.Ph., Stuart Lipsitz, Sc.D., Anthony D. Whittemore, M.D., David W. Bates, M.D., and Tejal K. Gandhi, M.D., M.P.H.

ABSTRACT

Background Serious medication errors are common in hospitals and often occur during order transcription or administration of medication. To help prevent such errors, technology has been developed to verify medications by incorporating bar-code verification technology within an electronic medication-administration system (bar-code eMAR).

Methods We conducted a before-and-after, quasi-experimental study in an academic medical center that was implementing the bar-code eMAR. We assessed rates of errors in order transcription and medication administration on units before and after implementation of the bar-code eMAR. Errors that involved early or late administration of medications were classified as timing errors and all others as nontiming errors. Two clinicians reviewed the errors to determine their potential to harm patients and classified those that could be harmful as potential adverse drug events.

Results We observed 14,041 medication administrations and reviewed 3082 order transcriptions. Observers noted 776 non timing errors in medication administration on units that did not use the bar-code eMAR (an 11.5% error rate) versus 495 such errors on units that did use it (a 6.8% error rate) — a 41.4% relative reduction in errors (P below 0.001).> (other than those associated with timing errors) fell from 3.1% without the use of the bar-code eMAR to 1.6% with its use, representing a 50.8% relative reduction (P below 0.001).> errors in medication administration fell by 27.3% (P below 0.001), but the rate of potential adverse drug events associated with timing errors did not change significantly. Transcription errors occurred at a rate of 6.1% on units that did not use the bar-code eMAR but were completely eliminated on units that did use it.

Conclusions Use of the bar-code eMAR substantially reduced the rate of errors in order transcription and in medication administration as well as potential adverse drug events, although it did not eliminate such errors. Our data show that the bar-code eMAR is an important intervention to improve medication safety. (ClinicalTrials.gov number, NCT00243373 [ClinicalTrials.gov] .)

The abstract is found here:

http://content.nejm.org/cgi/content/short/362/18/1698?query=TOC

Full paper is available via the usual sources – subscription, CIAP and so on.

The paper speaks for itself and there is now no excuse for not deploying such technology as quickly as is reasonably possible!

David.

These Sort of Baby Steps Just Drive Me Crazy. We Can Do Heaps Better Than This.

The following press release appeared a few days ago

Improving patient medication safety in Australia World Health Organization’s High 5s Project

PDF printable version of Improving patient medication safety in Australia World Health Organization’s High 5s Project (PDF 43 KB)

20 April 2010

Today, the Australian Commission on Safety and Quality in Health Care (ACSQHC) has, with the participation of 28 hospitals across Australia, launched a program to improve the safety of patients receiving medicines in hospitals.

Under the program, the participating hospitals will introduce standardised procedures to collect and check information about each patient’s medicines much more rigorously and accurately, starting from when the patient is first admitted to hospital and continuing through each stage of the patient’s hospital treatment when medicines may change.

The procedures are also designed to make sure that when the patient is finally discharged, they and their doctor will also get an accurate and comprehensive list of the medicines they may need to take once they are back in the community.

Professor Chris Baggoley, the ACSQHC Chief Executive, said, ‘At the moment, we know that the information hospitals collect about patients’ medicines may be incomplete, and that important medication information can become disjointed as patients are transferred within a hospital.’

‘Errors creep in that can harm the patients. Medication errors are a major problem for hospitals worldwide. Australia and many other developed countries report that adverse medicines events are a leading cause of error, injury and death within their healthcare systems’ Professor Baggoley said.

‘Evidence suggests that a formal procedure for checking and reconciling medication information in hospitals is effective in reducing adverse medicines events as patients move from one stage of care to another.’

Hospitals will start implementing and evaluating the standardised procedures in high risk areas, beginning with patients 65 years and older who are admitted through the emergency ward to inpatient services. Subsequent phases will include all patients at all entry points and all transitions in care. ‘This process aligns with Australia’s National Medicines Policy and will improve patient safety’, Professor Baggoley said.

The Australian Commission on Safety and Quality in Health Care (the Commission) is the lead technical agency for Australia, coordinating and supporting participating hospitals and monitoring outcomes.

The initiative is part of a World Health Organization campaign to improve patient safety. Other countries participating in the initiative are Canada, the Netherlands, France, Germany and the United States.

The new standardised procedures lay out a systematic process for obtaining, at the time of admission, a complete and accurate list of each patient’s current medications – including name, dosage, frequency and route; using the list when writing admission, transfer or discharge medication orders; and comparing the list against the patient’s admission, transfer and discharge orders, identifying and bringing any discrepancies to the attention of the prescriber and, if appropriate, making changes to the orders.

For further information, please visit the Medication Safety Program page (under ‘Our Work’) at www.safetyandquality.gov.au or contact the Commission on (02) 9263 3633

The release is found here:

http://www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/MediaRelease_2010-04-20_Hi5s

Why, might you ask is David grumpy when this sort of stuff comes up?

Let me make a few points.

First, I would have thought it was incumbent on any clinician to show extreme diligence in getting an accurate picture of a patient’s current medications – both clinician and self prescribed. This is not even best practice – it should be basic standard practice and if it is not this initiative has a far more basic problem to address – called ‘clinician slackness’.

Second the other issue (communication between different places and branches of an organisation) would be much better addressed not by extra elaborate handover rules but by the use of electronic medical records that have the medications the patient is receiving driven by that record on an hour by hour basis. I.e. it is accurate because it is what is driving medication delivery and issues at an point are then picked up virtually as they happen.

Take it from me nurses are very good at picking up that a medication is being missed or overdone etc as they are the ones actually giving the medicines to the patient!

Third it is also meant to be standard practice to review and document discharge medications on discharge. This not being done is even optional – it is, and has been mandatory –since Adam was a boy.

What is going on here is pretending some rules – and not doing some major efforts in e-Health will make patients safer.

Just nonsense and totally lacking any vision.

David.

It Seems The Government Is To Pay Pharmacists for E-Prescribing. Who Knows about the Docs!

The following has just dropped into view.

Better Pharmacy Services

Source: Government of Australia Posted on: 3rd May 2010

The Government and Pharmacy Guild of Australia have finalised the Fifth Community Pharmacy Agreement, which will provide better pharmacy services for consumers and a stronger role for pharmacy at the front line of health care.

The Pharmacy Agreement will ensure all Australians continue to have easy access to essential medicines under the Pharmaceutical Benefits Scheme, by providing security and certainty for Australia’s network of 5000 community pharmacies.

Key features and reforms under the Fifth Community Pharmacy Agreement will include:

• Medication-management programs, under which pharmacists provide education and support to patients on how to best use their medications and avoid medication errors. This will include medication reviews for consumers, including at home and in residential aged care, and specific support for patients with chronic conditions, such as Type 2 diabetes and asthma.

• Support for pharmacists to provide dose administration aids to patients who experience difficulty remembering to use their medicines – preventing unnecessary adverse medication events.

• Safer prescriptions, through encouraging pharmacies to use electronic prescriptions.

• A new patient service charter that outlines the roles and responsibilities of the pharmacist and the pharmacy, and clearly identifies the level of patient care that can be expected from any pharmacy.

• Support for pharmacists to identify, resolve and document medicine-related issues experienced by patients. This will improve the health literacy of patients with regard to their medicines, and reduce the number of unnecessary adverse medication events.

• Simpler and safer dispensing processes in residential aged care, by eliminating the requirement for separate medication charts and prescriptions.

• Providing culturally-appropriate services to Aboriginal and Torres Strait Islander people, more support for pharmacies which provide medicines in bulk to the community-controlled Aboriginal Health Services, and supporting the Aboriginal and Torres Strait Islander pharmacy workforce.

The Pharmacy Agreement will also continue the rules that determine where pharmacies can be located, and Community Service Obligation arrangements. These arrangements ensure all PBS medicines are made available within 24 hours, no matter where people live.

The Pharmacy Agreement will provide community pharmacy more than $15 billion over five years, to deliver pharmacy services for all Australians.

The Agreement will yield savings of about $1 billion on forecast spending for community pharmacy, helping to maintain the sustainability of the health system.

The Government thanks the Guild, and in particular its President, Mr Kos Sclavos, for its constructive, fair and robust approach to negotiating this Pharmacy Agreement.

The Government and the Pharmacy Guild have signed the Agreement, and full details will be released in the near future in the Budget context.

The release is found here:

http://www.health.gov.au/internet/ministers/publishing.nsf/Content/mr-yr10-nr-nr079.htm

I have to say it will be interesting to see the details of Item 3 of the reforms.

I wonder what Standards are to be used?

I wonder how interoperation between all clinicians and all pharmacists will be assured?

I wonder if there will be some incentive for the doctors to actually transmit prescriptions?

There are a zillion other questions. I guess we will all have to wait for the Budget to see what the Government and the Guild have cooked up , essentially in secret!

I also wonder what the broader meaning of pharmacists being able to issue repeat prescriptions for statins and the OC pill is all about as reported at http://www.6minutes.com.au.

David.

Another Paper Showing How E-Health Can Make A Real Difference!

The following has just appeared in the US press.

Electronic medical orders may save lives

Frederik Joelving

Mon May 3, 2010 3:05pm EDT

NEW YORK (Reuters Health) - Doctors at a California children's hospital have found the first evidence that using an electronic system to communicate their orders may save lives.

After the system was introduced in 2007, the hospital witnessed a 20-percent drop in mortality rate, the equivalent of 36 fewer deaths over a year and a half.

"It's the lowest rate ever observed in a children's hospital," said Dr. Chris Longhurst, of Stanford University and Lucile Packard Children's Hospital in Palo Alto, California, whose findings are published in the journal Pediatrics. "It begs the question how many lives could be rescued on a national level."

In 1999, a report from the Institute of Medicine blamed medical errors for between 44,000 and 98,000 deaths per year in the United States. Many hospitals have since introduced so-called computerized physician order entry, or CPOE, in an effort to lower that number.

Such systems allow doctors to relay prescriptions to pharmacists without delay, and without the need for the pharmacist to decipher doctors' scrawl.

"What used to take 40 minutes or so now takes 20," Longhurst told Reuters Health.

Although close to three in ten U.S. hospitals use CPOE, no one had been able to show a decrease in mortality until now. In 2005, a Pittsburgh hospital even reported an increase in the number of child deaths after it implemented the system.

More here:

http://www.reuters.com/article/idUSTRE64216U20100503

There is also coverage here:

CPOE tied to lower mortality figures, study finds

By Maureen McKinney

Posted: May 3, 2010 - 12:01 am ET

Use of computerized physician order entry systems can correlate with significant drops in hospital mortality rates, according to results of a new study published in the journal Pediatrics.

In a joint collaboration, researchers from Lucille Packard Children's Hospital and Stanford University School of Medicine, both based in Palo Alto, Calif., reviewed nearly 100,000 patient discharges from the hospital from January 2001 through April 2009. In the 18 months following the hospitals' implementation of CPOE in 2007, there were two fewer deaths per 1,000 discharges, or a 20% decrease in mortality, according to the study.

The results come at a time when reports of CPOE's effects on quality and safety are varied, and some hospitals worry there may not be much of a return.

More here:

http://www.modernhealthcare.com/article/20100503/NEWS/305029987

The abstract to the original article is here:

http://pediatrics.aappublications.org/cgi/content/abstract/peds.2009-3271v1

Published online May 3, 2010
PEDIATRICS (doi:10.1542/peds.2009-3271

Articles

Decrease in Hospital-wide Mortality Rate After Implementation of a Commercially Sold Computerized Physician Order Entry System

Christopher A. Longhurst, MD, MS^a,b, Layla Parast, MS^c, Christy I. Sandborg, MD^a,d, Eric Widen, MHA^b, Jill Sullivan, RN, MSN^d, Jin S. Hahn, MD^e,f, Christopher G. Dawes, MBA^d, Paul J. Sharek, MD, MPH^f,g

Departments of ^aPediatrics,

^eNeurology, and

^fPediatrics, Stanford University School of Medicine, Palo Alto, California;

Departments of ^bClinical Informatics and

^gQuality Management,

^dLucile Packard Children's Hospital, Palo Alto, California; and

^cDepartment of Biostatistics, Harvard University, Boston, Massachusetts

Background Implementations of computerized physician order entry (CPOE) systems have previously been associated with either an increase or no change in hospital-wide mortality rates of inpatients. Despite widespread enthusiasm for CPOE as a tool to help transform quality and patient safety, no published studies to date have associated CPOE implementation with significant reductions in hospital-wide mortality rates.

Objective The objective of this study was to determine the effect on the hospital-wide mortality rate after implementation of CPOE at an academic children's hospital.

Patients and Methods We performed a cohort study with historical controls at a 303-bed, freestanding, quaternary care academic children's hospital. All nonobstetric inpatients admitted between January 1, 2001, and April 30, 2009, were included. A total of 80063 patient discharges were evaluated before the intervention (before November 1, 2007), and 17432 patient discharges were evaluated after the intervention (on or after November 1, 2007). On November 4, 2007, the hospital implemented locally modified functionality within a commercially sold electronic medical record to support CPOE and electronic nursing documentation.

Results After CPOE implementation, the mean monthly adjusted mortality rate decreased by 20% (1.008–0.716 deaths per 100 discharges per month unadjusted [95% confidence interval: 0.8%–40%]; P = .03). With observed versus expected mortality-rate estimates, these data suggest that our CPOE implementation could have resulted in 36 fewer deaths over the 18-month post implementation time frame.

Conclusion Implementation of a locally modified, commercially sold CPOE system was associated with a statistically significant reduction in the hospital-wide mortality rate at a quaternary care academic children's hospital.

Key Words: safety • electronic records • mortality rates

Abbreviations: IOM = Institute of Medicine • EMR = electronic medical record • CPOE = computerized physician order entry • ADE = adverse drug event • LPCH = Lucile Packard Children's Hospital • CMS = Centers for Medicare and Medicaid Services • PHIS = Pediatric Health Information System • O:E = observed-to-expected • ARIMA = autoregressive integrated moving average • RRT = rapid-response team • CI = confidence interval

---- End Abstract.

Just another reason we have to seriously start on the e-Health journey sooner rather than later. To get to these capabilities is years off, but the old journey of a thousand miles story applies!

One really wishes our political leaders could see the faces of the children who are dying needlessly as they just dither around!

Applying sensible figures there are say 10 major children’s hospital facilities in our country so that works out at say 240 unnecessary deaths a year. What do these politicians think a child’s life is worth I wonder?

David.

Certification and Compliance - Has this Been Made Just Too Complicated or Does it Have to Be?

NEHTA has just released a couple of documents covering what they term the Compliance, Conformance and Accreditation (CCA) stream of NEHTA’s overall work program.

The documents are found here:

http://www.nehta.gov.au/connecting-australia/cca

With the specific documents being here:

http://www.nehta.gov.au/component/docman/doc_download/995-cca-assessment-concept-of-operations-december-2009

and here:

http://www.nehta.gov.au/component/docman/doc_download/994-national-e-health-certification-capability-discussion-paper

The second document presents a possible framework for the operation of CCA and the first a concept of operations.

In part this work stream flow from the Deloittes National E-Health Strategy.

This is the relevant section.

R-2.2 Establish a National Compliance Function

Establish a compliance function and associated compliance processes and procedures to conduct testing and certification of E-Health solutions for compliance with E-Health standards

Description

A compliance regime is a key mechanism for driving adoption of standards within E-Health solutions. A key requirement for a compliance regime is the establishment of a compliance function that is responsible for testing E-Health solutions and certifying their compliance with Australian E‑Health standards.

There is a need to establish a national compliance function to drive the development of national E-Health solutions that comply with E-Health standards and can be integrated and scaled across the Australian health sector. A national compliance function will allow vendors and care providers to ensure that E-Health solutions that are developed and purchased are compliant with Australian E-Health standards.

Establishment of the compliance function will require the formation of an organisation with sufficient mandate and authority as well as the development of appropriate testing processes, procedures and testing criteria. The compliance function should also have responsibility for liaising with vendors together with development and publication of testing criteria, a testing schedule and progressive targets. Adopting a progressive approach to compliance testing will allow vendors to incrementally enhance their products as the use of E‑Health in the Australian health sector matures.

NEHTA has undertaken some research into different models that can be used for compliance functions. This research should be considered together with existing local and international compliance models such as the TGA (Australia), the FDA and the Certification Commission for Health Information Technology (USA), and Infoway (Canada) in determining the design of the E-Health compliance function.

Specific Actions

In order to establish an E-Health solutions compliance function it is recommended that the following actions be undertaken:

· Establish a compliance function that has sufficient authority, funds, infrastructure and resources to conduct an effective national E-Health solutions testing and certification program.

· Design and implement appropriate compliance testing processes and technical environments.

· Develop and publish the set of criteria against which IT systems will be certified as being E-Health compliant. These criteria should be based on the principle of setting progressive targets to be achieved over a rolling three year timeframe.

In browsing these documents the main response I had was that this whole work stream seemed to be a little disconnected from practicality and reality.

Let me say at the outset the objective of setting up some processes for qualifying products and implementations for utility, functionality, safety, reliability and so on is a more than worthy one.

The issues I see are in working out how to do it cost effectively and in a credible fashion.

It is fascinating that on Page 5 of the discussion document we read:

“Certification of e‑health products is a commercially sensitive undertaking and a growing trend within the global e‑health marketplace. Accredited certification is considered the ‘gold standard’ for product assurance, and there is no current example of this within the global marketplace for any information systems in any industry sector, let alone the e‑health sector (inclusive of CCHIT and Canada’s Infoway). As a consequence, it will take time and careful consideration to understand the operations of accredited certification and the requirements to design and operate this capability in-line with national and global marketplace standards and best practices.”

The Concept of Operations Document has a similar assessment that indicates to me this area is very difficult to address (Page 11)

"International capability

Conformity assessment of e-health products across international jurisdictions exhibits a diversity of approaches and levels of maturity in-line with national e-health programs. Due to the intrinsic heterogeneity of national economies and significant lack of parity across the levels of national investment for both e-health programs and their supporting conformity assessment frameworks, a standardised approach and degrees of international alignment are yet to be realised.

In contrast with other more mature sectors and globally traded industries, e-health has yet to establish and realise the benefits of internationally portable and nationally recognised conformity assessment results for both testing and certification. Accredited test results and accredited product certifications are able to use the international multilateral agreements and frameworks for mutual recognition through either the International Laboratory Accreditation Cooperation (ILAC) or the International Accreditation Forum (IAF) multilateral recognition agreements (MRAs).

Despite this limitation, there are still significant conformity assessment programs either in operation or under development in various national jurisdictions. Examples of some of the more mature and prominent e-health conformity assessment regimes are:

· Common Assurance Process (CAP) for the UK Connecting for Health program using the National Integration Centre;

· Certification Commission for Health Information Technology (CCHIT) in the USA; and

· Canada Health Infoway Certification Services

These conformity assessment programs rely predominantly on automated testing and inspection activities although none are at present accredited by their respective peak national accreditation bodies for testing and/or certification. More information on this and its implications may be found in the Discussion Paper for the National Certification Capability for E-Health: Towards a Concept of Operations [CCACERTCAP]."

What is read here is that this is a very complex area and that we are going to have to move pretty slowly and feel our way.

Maybe, just maybe, an good approach might be to carefully review what is working in the three international jurisdictions and then assess where the most value can be added to our overall health sector.

I have to say focus in ensuring already promulgated Australian Standards in areas like messaging would be a good area to start as we aim to develop capability.

I would also like to see any Certification and Conformance function be separated from NEHTA and guided by a board that has an appropriate mix of commercial, clinical and technical skills.

What is good about these documents is the recognition that a lot of consultation will be needed to get something workable, practical and cost effective.

If there is a major gap I see there seems to be a lack of clarity as to just what the likely costs of all this might be and what the benefits will be to each of the stakeholders. I think this area needs a bit more work.

There may also be a bit of a gap between the words and reality in what NEHTA is presently able to do (as stated on the website) – given the clear ‘work in progress’ nature of these just released document.

These documents will definitely make interesting reading once developed and released.

“Assessment scheme

NEHTA is creating an Assessment Scheme for each of its major e-health specifications. The documentation will describe the process for assessing compliance and conformance for NEHTA’s e-health specifications and the assistance that NEHTA provides to organisations performing the assessment.

The Assessment Scheme documentation will give the following information:

• who may perform assessment (eg the scope of self assessment and the role of independent test laboratories and inspection bodies)
• guidance concerning assessment methods, test specifications and test tools
• levels of conformance and the timeframes for achieving conformance
• guidance concerning conformance claims by implementers and the presentation of assessment results.

For most e-health specifications, NEHTA will also provide conformance test specifications and a comprehensive list of test cases to be used in conformance testing. NEHTA may also provide test software and assistance in understanding e-health specifications.”

I suggest those who are likely to be affected have a close read of the web site and the two documents – and form their own view!

David.