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, 2012

NEHTA Gets Carried Away With Spin And Looses It Utterly It Seems. They Are In Fantasy Mode On What They Have Achieved.

A day or so ago NEHTA published a February 10 dated submission on the Australian Safety and Quality Goals For Healthcare.
The consultation period is now closed. Here is the request for submissions. Apparently a report went to Health Ministers in late March, 2012

Australian Safety and Quality Goals for Health Care

Consultation period has commenced

The Australian Commission on Safety and Quality in Health Care has prepared a draft set of Australian Safety and Quality Goals for Health Care and is currently seeking comment on these via a consultation discussion paper.
The purpose of the Australian Safety and Quality Goals for Health Care is to describe high priority areas that should be the basis of coordinated national action to improve the safety and quality of care and achieve better outcomes for patients and a more effective and efficient health system.
You are invited to make a submission on one, or all, of the draft Goals, or any other aspect of the consultation paper.
A copy of the consultation paper is available to download here. (PDF 275 KB)
Submissions, marked ‘Australian Safety and Quality Goals for Health Care’, can be made by post or email, or by using an online survey.
Post: GPO Box 5480, Sydney NSW 2001
Email: goals@safetyandquality.gov.au
All submissions should be received by close of business on Friday 10 February 2012 to be considered in the consultation process.
All submissions will be published on the Commission’s website, including the names and/or organisations making the submission. The Commission will consider requests to withhold part or all of the contents of any submission made.
Copies of this paper can be obtained from the Australian Commission on Safety and Health Care. Contact details are:
Phone: (02) 9126 3600
Here is the link to the page and further information.
More information on the broader initiatives is here:
The Australian Commission on Safety and Quality in Health Care (ACSQHC) is a government agency which was established by the Commonwealth, with the support of State and Territory governments.
We lead and coordinate national improvements in safety and quality in health care across Australia.
Here is the link:
I thought the NEHTA submission might make for some interesting reading.
You can find it here:
Sadly I have to say what I found was what could be safely described as a ‘puff piece’.
On page 1 we read:
“The Personally Controlled Electronic Health Record (PCEHR) System is the next step in using eHealth to enhance the healthcare system. The PCEHR System enables the secure sharing of health information between an individual’s healthcare providers, while enabling the individual to access their own health information held in their PCEHR and control who else can access it.
The PCEHR will build on the range of eHealth products and services already developed by NEHTA, including the Healthcare Identifier Service, Secure Messaging, the National Authentication Service for Health (NASH), eReferrals, ePrescriptions, specialist letters and discharge summaries.”
I am sure it will come as a surprise to many to know NEHTA has all these products and services out there. They have written a few documents and have had Medicare put in place an IHI service which is still awaiting significant use after almost 2 years. The rest is just hopeful spin as far as I can tell.
On Page 2 we read:
“NEHTA is charged with delivering the Australian Government’s eHealth solutions that will underpin the secure electronic exchange of relevant clinical information across the health sector. The agenda for eHealth is moving beyond a singular focus on the delivery of information communications technology (ICT) solutions to focus on ensuring the safe, effective use of these tools in the real world of healthcare.”
One asks just solution NEHTA has delivered? I can’t see much as yet after almost six years.
If anything is being delivered it is by Accenture and its partners and the local health software industry. How long is it since we knew NASH was needed?
Page 3 contains even more fun:
“For Australians who choose to have one, the information in a PCEHR will be able to be accessed by themselves, their selected carers, and their authorised healthcare providers. With this information available to them, healthcare providers and consumers themselves will be able to make better decisions about the consumer’s health and treatment. Consumers will also be able to contribute their own information and add to the recorded information stored in their individual PCEHR via Consumer Entered Notes.
The PCEHR is not a duplicate or replacement for local clinical records; it will complement local records by allowing access to key information from other providers. As the PCEHR becomes more widely available consumers will be able to access their own health information anytime they need it, from anywhere in Australia and overseas where connection to the internet is possible.
Based on an in-depth review of international eHealth studies, shared electronic health records , such as the PCEHR have the potential to contribute to improvements in healthcare quality and safety through enhanced access to and use of best practice guidelines, reducing errors (e.g. medication prescribing errors) and enhanced public health planning outcomes. They can also generate efficiencies by reducing duplication of effort, facilitating timely access of information to chosen providers and generating wider indirect effects e.g. timely discharge results in better information to the General Practitioner (GP) resulting in less repeated admission to hospital. Together, these have the potential to result in a healthier population, reduced demand on both primary and acute care, and saved lives.”
I really wonder just where the evidence is for all that. Not in this document and given the architecture of the NEHRS is unique in the world as far as I know they are just making it up!
On page 8 we read the following:
“Strong clinical leadership in the development of the PCEHR and on-the-ground support throughout its implementation will ground this reality of personal control in better and patient centred health delivery.
NEHTA's Stakeholder Reference Groups comprise a range of organisations representative of Australia’s healthcare sector. These organisations join jurisdictional representatives to provide their input to NEHTA’s work program and importantly provide information back to their members.”
This is really just not true. The PCEHR concept was dreamed up by some IT people in NEHTA / DoHA and just dropped on the unsuspecting clinicians. It is the worst of all possible shared record types as far as clinician needs are concerned.
We also read the following:
“Potential enhancements to the PCEHR
The PCEHR will be available for registration from 1 July 2012. However, provider capability and uptake will develop over time, as evidenced in other local and international eHealth implementation projects of this nature. The National E-Health Strategy proposed that the PCEHR System rollout be undertaken via an incremental approach, with the capabilities of the system being expanded over a four-year implementation period.”
Given the National E-Health Strategy is a 2008 document that framed a totally different implementation approach this statement is just insulting to the authors of that strategy. It has been funded and ignored and now 4 years later suddenly another 4 years is needed.
This document is spin city gone mad. The benefits are grossly overplayed, adoption is not really encouraged and the one system for the docs and one for the patients is just rubbish no matter how you look at it. Worse still this mad intervention has sucked the life out of some practical, sensible initiatives which were underway.
Pretty sad.
David.

Monday, April 16, 2012

Weekly Australian Health IT Links – 16th April, 2012.

Here are a few I have come across the last week or so.
Note: Each link is followed by a title and a few paragraphs. For the full article click on the link above title of the article. Note also that full access to some links may require site registration or subscription payment.

General Comment

A really big week with lots of debate on e-Health regulations and mechanisms for payment of those who will be doing the work.
Secondly we also see some controversy around Orion in NZ - a major supplier to the PCEHR Program.
Next we see that Government is spending more on shredders rather than responding to Freedom of Information Requests and we also have some material on the cloud and some of its implications.
Last it was good to see the NEHTA Malaysian Junket seems to have been called off. Sensible in such tough economic times! 

This week looks like being caught up in the Safety Debate with discussion of just how much effort is being put in by NEHTA and DoHA to ensure what is being done first does not do any harm and secondly actually works as intended to reduce clinical errors and maximise patient safety. Of course with the way the NEHRS has been architected they already have removed a lot of the potential for benefit in such areas as interactive clinical decision support (CDS).

Blogs posted this morning will get you started and there is more to come during the week.
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E-health lead rollout sites lacking patients

THE three lead sites for the personally controlled e-health record rollout are yet to recruit patients for trials scheduled to end on June 30.
The Gillard government's PCEHR system is supposed to be operational from July 1.
But the National E-Health Transition Authority has revealed "activity in the e-health sites to date has focused on recruitment of (GP) practices and connection to the (Medicare-operated) Healthcare Identifiers service".
Three former GP divisions (now rebadged as Medicare Locals) -- in Brisbane North, Hunter Valley, NSW and in Melbourne East -- each received $5 million in mid-2010 to implement software supporting the PCEHR system and to trial the use of records by doctors and patients. "Those (lead) sites that are operating local repositories will commence operations over the coming weeks," NEHTA said in answers to questions put by senator Sue Boyce and released last Thursday. "NEHTA specifications are being used in the point-to-point exchange of clinical documents in the e-health sites. However, it is impossible to count how many of these documents are being exchanged."
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Ehealth records: too important to muck up

, by Melissa Sweet
In 2009 the National Health and Hospitals Reform Commission recommended that by 2012 every Australian should be able to have a personal electronic health record that they would own and control.
The PCEHR (personally controlled electronic health records) system is due to launch on July 1.  The plan is for everyone to have the option of registering for an eHealth record and choosing who will be able to access it, and to what level.
But we have been warned not to expect any whizz bang launches or ambitious targets. As DOHA secretary Jane Halton has made clear, the last thing the Government wants is a rush of registrations.
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AMA secretary-general Francis Sullivan demands regulations be changed

  • by: Sue Dunlevy, Patricia Karvelas
  • From: The Australian
  • April 11, 2012 12:00AM
HEALTHY patients who go to their doctor simply to get their e-health record set up will not receive a Medicare rebate.
The decision has outraged doctors and comes as the body in charge of the personally controlled e-health records has pulled out of a taxpayer-funded roadshow to Malaysia next month to show the system to Australian surgeons at a conference in Kuala Lumpur because of the "tight fiscal environment".
The National e-Health Transition Authority, which has a multi-million-dollar travel and entertainment budget, had announced on its website it was planning to send four doctors to the Royal Australasian College of Surgeons conference in the Malaysian capital to promote the scheme.
NEHTA has a Model Healthcare Community, a mock up of how the e-health computer system is meant to work, that it planned to take to the surgeons' conference in Malaysia.
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Health department reversal on PCEHR liability

12th Apr 2012
The health department will rewrite the “unfair” conditions of registration for the personally controlled e-health records (PCEHR) system which required practices to assume all liability and grant unrestricted access to premises and records.
The draft conditions were panned by health insurers and industry experts after MO last week broke the news that the AMA had warned the health department that the “unfair” requirements would “deter every medical practice in Australia from participating”.
MDA National president Associate Professor Julian Rait said any lawyer would say the condition requiring access to a practice’s premises, IT systems, records and staff was “a dealbreaker”.
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Doctors will not be liable for PCEHR breaches: DoHA

Written by Kate McDonald on 13 April 2012.
The terms and conditions for healthcare provider participation in the PCEHR will not require them to assume all legal liability for breaches of the system, according to the Department of Health and Ageing (DoHA).
The Australian Medical Association (AMA) had rejected an early draft of the PCEHR participation agreement, saying it appeared healthcare providers would be liable for failures and breaches of the PCEHR and that health department officials would demand access to medical practices and records.
The AMA said the proposed registration conditions “place extraordinary obligations on healthcare provider organisations for matters that are largely out of their control”.
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GPs face 'extreme obligations' with e-health

12 April, 2012 Sarah Colyer
GPs would be forced to open up their practices and hand over records to health department investigators under draft powers to police the national electronic health records system.
The conditions, circulated for comment this month, would be mandatory for any practice wanting to take part in the personally controlled electronic health records (PCEHR) scheme due to commence on July 1.
The success of the system is dependent on GPs agreeing to create and manage patient health summaries on the records.
But the AMA has warned that the conditions create such "extraordinary obligations" that they would deter every medical practice in Australia from taking part.
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E-health: not just a flick of a switch for overworked doctors

13 Apr, 2012 04:00 AM
THE Rural Doctors Association of Australia (RDAA) has cautioned the Federal Government that the Personally Controlled E-Health Record (PCEHR) system will fail unless doctors and practices are fairly compensated for the time and risk involved in establishing and maintaining e-health records for their patients.
RDAA has joined a range of other medical organisations in calling for better support for doctors and practices in implementing the new system.
“RDAA strongly supports the PCEHR system—it will bring enormous benefits to patients and the health system, and we want to see it work” RDAA president, Dr Paul Mara, said.
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E-health set to roll despite software hiccup

Updated April 13, 2012 08:34:27
First patients being recruited for E-health system
The Hunter GP organisation delivering a new electronic health system for the region says the program is on track despite problems with the national software rollout.
Newcastle, Melbourne and Brisbane are the lead sites for the E-health system that the Federal Government intends to eventually roll-out across the country.
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GPs want cash for e-health input

THE doctors who underpin the Medicare Locals system say the government will have to provide incentive payments to GPs if they want them to write the records for the $467 million e-health system.
The Australian General Practice Network says the Gillard government's approach of paying for the records to be set up when patients visit a GP is "piecemeal" and won't facilitate solid as well as rapid enrolments.
AGPN chairman Emil Djakic says the government should provide service and practice incentive payments to establish the records for the Personally Controlled e-Health Record system.
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AMA sets its own items for managing a shared health summary for the Personally Controlled Electronic Health Record (PCEHR)

The AMA has introduced its own items for preparing and managing a shared health summary for the Personally Controlled Electronic Health Record (PCEHR).
AMA President, Dr Steve Hambleton, said today that the Government had not created new items for doctors’ time and work with patients on the PCEHR and had not allocated any new funding in the Medicare Benefits Schedule (MBS) to cover this new clinical service to be provided by doctors.
“The public announcements from the Government suggest that patients will only get a Medicare rebate if the shared health summary is prepared as part of an existing MBS consultation,” Dr Hambleton said.
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AMA proposes PCEHR consult items and fees

10th Apr 2012
GPs have been advised to charge each patient up to $210 when preparing a shared health summary for the government’s personally controlled e-health record (PCEHR) system, which will be rolled out from 1 July.
AMA president Dr Steve Hambleton said government had not created any new MBS items, and had not set aside any new funding, to remunerate GPs for the work they would put into creating shared health summaries.
“The public announcements from the government suggest that patients will only get a Medicare rebate if the shared health summary is prepared as part of an existing MBS consultation,” Dr Hambleton said.
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AMA prices e-health record creation

By Suzanne Tindal, ZDNet.com.au on April 10th, 2012
The Australian Medical Association (AMA) has laid out a payment scheme for how it thinks doctors should be compensated for creating a patient's health-record summary.
A health-record summary is a quick fact sheet of a patient's health that their GP will create and keep up to date. The health summary is a key element of the government's personally controlled electronic health record (PCEHR) scheme, which the government is starting from 1 July.
GPs have been concerned about the amount of time it will take to manage the shared e-health summary, and are looking for compensation for the time that they will spend on updating them. At the end of last month, Health Minister Tanya Plibersek said that the government will accede to this wish by providing funds to GPs for managing the records.
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Australia leads the way in health products management

3 April 2012. National E-Health Transition Authority (NEHTA) CEO, Mr Peter Fleming has recognised Australia’s National Product Catalogue, for being the most comprehensive of its type in the world, during a speech at the 21st Global GS1 Healthcare Conference held in Sydney from 20-22 March.
Mr Fleming said Australia’s world-leading National Product Catalogue (NPC), is one of the first in the world to focus exclusively on the needs of the healthcare industry, while meeting the needs of healthcare purchasers by allowing for provision of data about products from other sectors, and is endorsed by all state, territory and federal health departments.
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NEHTA and GS1 to host NPC webinars

Written by Kate McDonald on 10 April 2012.
GS1 Australia and the National E-Health Transition Authority (NEHTA) are holding webinars each day next week to help suppliers understand how to use the National Product Catalogue (NPC).
The 'Realise the Efficiency of the NPC' webinar will show how to use the NPC to bring new business efficiencies to their organisation and provide essential information on how to get involved, the organisers said.
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Electronic alert to end abuse

THE suicide of James - from an overdose of prescription morphine and diazepam he obtained during daily runs to various GPs and pharmacies - proved one tragic death too many for Victorian coroner John Olle.
Unusually, Olle has used his powers to recommend the state introduce a real-time prescription monitoring and alert system within 12 months to reduce the deaths and harm caused by such doctor-hopping or prescription-shopping by vulnerable patients.
At present, state and territory governments rely on monthly submissions of paper-based records of controlled (Schedule 8) drugs prescribed by doctors and dispensed by pharmacists. A move from manual to electronic recording, and then real-time reporting, will give providers the information needed to make clinically appropriate prescribing decisions.
But some critics fear a national alert system being developed by the Gillard government may not deliver the desired outcomes.
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Concerns over breast screening software

By Elspeth McLean on Thu, 12 Apr 2012
In January, the Otago Daily Times revealed systems failures in the national breast-screening service BreastScreen Aotearoa, discovered in 2009, resulted in delayed routine two-yearly screening mammograms for 241 women, five of whom were found to have cancer. Documents released under the Official Information Act reveal more about the issues, as Elspeth McLean reports.
The report on the 2009 discovery some women were waiting too long for breast screening invitations brings to light concerns about the performance of software provider Orion Health at that time.
The 2010 report, released under the Official Information Act, shows BreastScreen Healthcare (BSHC) was dissatisfied with Orion's performance and sought legal advice on its contract. It was advised it had "limited options" to address performance.
BSHC, which covers Otago and Southland, expressed concern at Orion's "lack of responsiveness. Testing has shown many gaps/risks".
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DCA and Communicare forge alliance to accelerate community eHealth initiatives

Tuesday, 10 April 2012 18:05
Two of Australia’s leading healthcare solutions organisations, DCA and Communicare, are joining forces to support health and community services organisations to improve the quality of service to healthcare consumers.
“The acquisition is a strong strategic fit for DCA,” said Declan Ryan, DCA’s Chief Executive Officer. “Communicare provides further expansion into the community services sector and a strong presence in Western Australia. It’s also an excellent fit with DCA’s existing health and community services business division and enables both companies to increase their service delivery capability”
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Video spares patients as it assists students

Amy Corderoy
April 9, 2012
ASHLEY ALLUM has seen a lot of doctors. But if there's one thing more unnerving than hospital tests it is having them watched by a roomful of students.
Ms Allum has cerebral palsy and recently also developed a gastrointestinal disorder which has meant a drastic change in diet and numerous medical appointments.
But the 24-year-old was totally relaxed during her most recent trip to Blacktown Hospital's clinical school - partly because instead of having students in the room, the consultation was beamed live to their class, a couple of doors away.
"It meant I was able to forget about that, really," she said. "I was able to feel comfortable".
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Australian data breach costs rise to $2.16 million per incident in 2011

April 10, 2012
The average cost of a data breach reported by Australian organisations has risen steadily for the third consecutive year, reaching $2.16 million in 2011, according to research released  by Symantec Corp. (NASDAQ: SYMC) and Ponemon Institute. The study also found that malicious or criminal attacks were the most common cause of data breaches and the most expensive type of breach overall for Australian businesses. The 2011 Cost of Data Breach Study: Australia report is based on the actual data breach experiences of 22 Australian companies from ten different industry sectors.
“The large volume of data breach incidents occurring over the last year has put data breaches high on the agenda for Australian executives,” said Craig Scroggie, vice president and managing director, Pacific region, Symantec. “As local organisations embrace new technologies, businesses need to focus on processes, policies and technologies that improve their ability to prevent and detect data breaches. Taking steps to keep customers loyal and repair any damage to reputation and brand after a data breach has occurred, can help to significantly reduce the cost of a data breach”.
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Reform on FOI bogs down

Philip Dorling
April 9, 2012
FEDERAL freedom of information reforms have stalled, with government spending on high-performance shredding machines easily outstripping funding for public servants to handle requests for information.
A review of published government contracts by The Age has revealed that government agencies spent close to $10 million on new shredding machines over the past three years.
By comparison, annual freedom of information reports show that the government spent only $764,000 in the same period training public servants to process freedom of information applications from the public. The understaffed FOI watchdog, the Office of the Australian Information Commissioner, is facing budget cuts.
There is also a growing backlog of FOI decision reviews, a state of affairs that is being exploited by agencies seeking to delay the release of sensitive information.
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Matrix magic makes veterinary surgery less intimidating

Deborah Smith
April 10, 2012
THE ''patient'' has no head and no limbs, but her belly is creepily realistic to the touch, thanks to the special effects company that also created the gooey pod scene in The Matrix.
Sophie Moffat, a final-year veterinary student at the University of Sydney, carefully makes an incision in the pink, three-layered ''skin'' of this life-like model of a dog's abdomen.
She begins to search inside for the uterus and ovaries. ''They're not easy to find,'' she explains, probing around near the bladder.
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Risks of putting digital life in cloud

April 13, 2012 - 7:04AM
Don't let a cloud burst leave your data all washed up, writes David Braue.
Later this month Google will close the shutters on Picnik.com, a popular online photo-editing site that Google bought in 2010 and is now being absorbed into the web giant's Google+ social-networking venture.
Picnik's users, many of whom have built up significant portfolios of work created with Picnik's Flash-based image editing tools, have been exhorted to download their images using Picnik Takeout – a feature that compresses all of a user's images into a compressed, downloadable .ZIP file. It's a one-time offer: once the site goes dark on April 19 (US time), every picture stored in the service will be gone.
Picnik isn't the first cloud service to close its doors, but it's a textbook example of the risks inherent in entrusting too much of your digital life to cloud-computing services. Web-based services like Apple's iCloud; file-sharing site DropBox; Adobe's Photoshop Express; Microsoft's new Office 365 apps and Windows Live services; photo-sharing sites like Facebook, Yahoo's Flickr and Smugmug; and Google Docs and related apps – these, and hundreds of other online services, are built around the idea that the software providers will look after your data for you, forever.
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Migration to the cloud ecosystem: Ushering in a new generation of platform competition

Chaim Fershtman   Neil Gandal
13 April 2012
Cloud computing – services that are accessed directly over the Internet – is the new ‘game-changer’ in the information technology world. Yet cloud computing is still in its infancy. This column explores what it might mean for competition among service providers.
Cloud computing – services that are accessed directly over the Internet – is the new buzzword in the information technology world. The ‘cloud’ label comes from the fact that the computing infrastructure is not in your hands; it is located far away ‘in the clouds’, as it were. The device in your hands (personal computer, tablet computers, mobile devices, etc) is akin to an old-fashioned computer ‘terminal’ linked to a mainframe. (Readers who finished university after the 1980s will need to look this up on Wikipedia.)
Cloud computing is often called a 'game-changer', something that will dramatically change the industry, yet there is virtually no research on the economics of it. The literature that exists has primarily focused on the technical aspects of cloud computing (Ambrust et al 2009).1 Another branch of the literature focuses on the macroeconomics effects: creation of jobs, changes in output, etc (Etro 2009).
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US cloud firms should get off the soap box

By Suzanne Tindal, ZDNet.com.au on April 13th, 2012
A recent US report on trade barriers has revealed a hissy fit by US companies about the Australian government's caution on cloud.
The report (PDF), released last month by the Office of the United States Trade Representative, says that US companies have voiced concerns that various Australian government departments are "sending negative messages about cloud computing services to potential Australian customers in both the public and private sectors, implying that hosting data overseas, including in the United States, by definition entails greater risk and unduly exposes consumers to their data being scrutinised by foreign governments".
Departments that the report singled out as being the bad eggs included the Department of Defence, the National Archives of Australia, the Department of Finance and Deregulation, the Australian Government Information Management Office (AGIMO) and the Office of the Victoria Privacy Commissioner.
The report goes on to say that many of these concerns, when directed at US firms, "appear based on a misinterpretation of applicable US law, including the US Patriot Act and regulatory requirements".
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Enjoy!
David.

AusHealthIT Poll Number 117 – Results – 16th April, 2012.

The question was:
What Proportion Of The Population Do You Think Will Have An Active NEHRS (PCEHR) Record Two Years After System Start Up?
10% or less
- 33 (78%)
11-20%
- 5 (11%)
21-30%
- 1 (2%)
31-50%
- 2 (4%)
51-75%
- 1 (2%)
76-100%
-  0 (0%)
Votes: 42
A pretty clear outcome - The vast majority see a  less than 10 % adoption of the NEHRS in the next two years.
Enough said.
Again, many thanks to those that voted!
David.

NEHTA Is Really Being Called On Its Efforts In Patient Safety. Even From Their Clinical Lead!

The following appeared this morning.

Concern for patient safety with e-records

Mark Metherell
April 16, 2012 - 12:07AM
PATIENT safety under the proposed electronic health records system cannot be guaranteed less than three months before it is scheduled to start.
Safeguards to prevent and correct snafus with doctors' software, such as medication mistakes, have yet to be provided for in the national e-health scheme beginning on July 1.
The warning has come from three experts, including Mukesh Haikerwal, chief clinical adviser to the e-health transition agency.
They warn that the lack of a national clinical safety system to deal with glitches in doctors' desktop computers and electronic devices such as iPhones and iPads means that "it is not yet possible to make any definitive statement about whether the personally controlled electronic health record is safe or not".
"There is no guarantee that harm events will be rapidly identified or remediated when it is in operation," they write in an editorial, published in the Medical Journal of Australia today.
Their warning is the latest challenge to confront the e-health plan, which has attracted growing criticism about security and privacy concerns spurred by the uncertain performance of the body responsible for the e-health rollout, the National e-Health Transition Agency.
Lots more here:
The original paper is here:

A call for national e-health clinical safety governance

Enrico W Coiera, Michael R Kidd and Mukesh C Haikerwal
Med J Aust 2012; 196 (7): 430-431.
doi:  10.5694/mja12.10475
The benefits of technology should not be overshadowed by avoidable patient harm
Sadly this paper is behind a paywall so it won’t get the full coverage it deserves. Here are the principles is recommends. (Prof Coiera has just let me know anyone who wants a copy can e-mail him to obtain a copy. He is findable via UNSW)

Principles for national e-health clinical safety governance

  •  E-health clinical safety governance must be national but independent of government or industry, to avoid conflicting interests that may lead to resisting change for commercial, professional or political reasons. It must be expert-based rather than organisationally representative.
  • Safety is an emergent property of a whole system. Certification of individual components does not guarantee that the whole system is safe.
  • E-health clinical safety governance should integrate with mainstream patient-safety processes. Harms arise from sequences of events involving both technical and non-technical elements.
  • Governance must assure all components are safe, both alone and in combination with pre-existing elements. Standards and regulatory processes such as accreditation should underpin this, with full legislative backing.
  • The safety of the whole system must be monitored in routine use to detect potential risks and actual harm events, as well as clusters. Open disclosure should be paramount.
  • Governance must build defences against harm, including safety processes, system redundancies and training, to minimise unsafe use or the creation of unsafe settings.
  •  Any governance body must have a capability to investigate, analyse and act upon significant risks in the system.
I have to say it would be hard to argue with any of those. How many of these do you see NEHTA following at present?
They are in pretend mode as far as I can tell. Their heads are planted firmly in the sand.
Again we see the lack of leadership and governance in the Australian e-Health effort is being seen for what it is - utterly inadequate.
More evidence on all this over the next few days.
David.

An Alert On Potential Emerging Problems With Mobile Devices and E-Health.

The following appeared very recently.

Clinical software on personal mobile devices needs regulation

Juanita I E Fernando
Juanita Fernando says clinicians need some legal certainty around phone and tablet use
The regulation of clinical software for personal mobile devices (PMDs) has increased in relevance for physician practice.1 The plausible benefits of using software such as iStethoscope, Flipboard, Skype or MedCalc on smart phones and tablets include up-to-date access to health data, support for distributed health care and improved quality of interactions with patients. Recent World Health Organization (WHO) survey findings confirm that use of PMDs by clinicians offers tangible patient-care benefits including the integration of mobile health into existing services regardless of geography, connection to an electrical grid and income level. And yet, the legal vacuum in guidelines governing smart phone and tablet use is a key implementation barrier in upper-middle income regions such as Europe (reported by 56% of countries) and the Americas (50%).2 Increasingly, governments overseas are at least thinking about, if not acting upon, this challenge — but Australian governments remain silent.
Software on computers, and portable memory, such as USB sticks, share several security risks associated with software on a PMD that are not addressed by legislation. These include transmission of user log-ons and address-book details, message interception and activity tracking. Professional self-regulation has begun to fill legislative gaps but does not guide the clinical use of PMDs.
One security risk related to PMDs concerns “root-kits” — software applications that are hidden by manufacturers to monitor program performance or installed by attackers for malicious purposes. Unknown to the person using a PMD, root-kits can log key-presses and user locations and can receive messages without notification. They often transmit data in unprotected clear text, too.
Another danger concerns the mix of more than 600 000 software applications, both personal and professional, that people, including physicians, install on mobile devices. Almost 70% of American doctors have downloaded and installed 1500 types of clinical software applications, and Australian physicians are close behind.
Much more with references found here:
doi: 10.5694/mja11.11390
The paper will be available at www.mja.com.au on Monday 16th April.

Author details

Juanita I E Fernando Grad Cert BusSys, MA, PhD Researcher, Mobile Health Research Group,1 and Chair, Health Sub-Committee2
1 Faculty of Information Technology and Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC.
2 Australian Privacy Foundation, Canberra, ACT.
juanita.fernando@monash.edu
I think Dr Fernando has an important set of points here - especially around the need for some clear accountability as to who needs to be accountable for regulation of this area - especially if we start to see any patient harm or privacy breach result from device use.
Well worth a browse.
David.

Sunday, April 15, 2012

The Australasian College Of Health Informatics (ACHI) and Others Weigh In On NEHRS Regulations. This Area Is Becoming Quite Controversial and Messy.

Last  week submissions on the Rules and Regulations covering the NEHRS (PCEHR) were due.
Here is the background.

PCEHR System Regulations and Rules

The PCEHR System: Proposals for Regulations and Rules describes the proposed regulations and rules which will be put in place to support the national personally controlled electronic health record (PCEHR) system and the legislation which is currently before Parliament. The Personally Controlled Electronic Health Records Bill 2011 (PCEHR Bill) and Personally Controlled Electronic Health Records (Consequential Amendments) Bill 2011 (Consequential Bill) were introduced into the Parliament on Wednesday 23 November 2011.
The paper has been developed by the Commonwealth in consultation with a working group of representatives from Commonwealth, state and territory health departments. It takes account of feedback and submissions received by the Department of Health and Ageing during the public consultation processes for the PCEHR system.
The PCEHR System: Proposals for Regulations and Rules describes the provisions that are proposed to be included in the regulations and rules, explains the reasons behind those proposals and describes how they are intended to operate.
You can find out more about the paper by reading the frequently asked questions.
The paper is intended to promote discussion within the community about how well the proposed regulations and rules would operate in conjunction with the PCEHR Bill and Consequential Bill, and support the PCEHR system.
The period for making comments and submissions on the PCEHR System: Proposals for Regulations and Rules closed at 5 pm on Wednesday, 11 April 2012.
Here is the link to the page:
Earlier I commented here:
and later here:
where the is some extra input on the issues provided
With the deadline for submissions due we have seen some reaction.

GPs face 'extreme obligations' with e-health

12 April, 2012 Sarah Colyer
GPs would be forced to open up their practices and hand over records to health department investigators under draft powers to police the national electronic health records system.
The conditions, circulated for comment this month, would be mandatory for any practice wanting to take part in the personally controlled electronic health records (PCEHR) scheme due to commence on July 1.
The success of the system is dependent on GPs agreeing to create and manage patient health summaries on the records.
But the AMA has warned that the conditions create such "extraordinary obligations" that they would deter every medical practice in Australia from taking part.
This is on top of the apparent lack of financial support for curating the records.
More here:
There is also some reporting Government may have backed off.

Health department reversal on PCEHR liability

12th Apr 2012
The health department will rewrite the “unfair” conditions of registration for the personally controlled e-health records (PCEHR) system which required practices to assume all liability and grant unrestricted access to premises and records.
The draft conditions were panned by health insurers and industry experts after MO last week broke the news that the AMA had warned the health department that the “unfair” requirements would “deter every medical practice in Australia from participating”.
MDA National president Associate Professor Julian Rait said any lawyer would say the condition requiring access to a practice’s premises, IT systems, records and staff was “a dealbreaker”.
More here:
We have also had a submission from ACHI.
Here are the recommendations:
----- Begin Extract
In summary, there are a number of areas where the College believes clarification and improvements are required and has formulated 13 recommendations for the Department's consideration, namely that:
Recommendation 1:  further time be allowed for consultation on the PCEHR Regulations and Rules in advance of the passage of the draft legislation currently before Parliament.
Recommendation 2:  the PCEHR Regulations and Rules provide policy guidance to the system operator by setting the terms and conditions for technical access to the PCEHR system.
Recommendation 3:  the PCEHR Regulations and Rules should consider mechanisms to provide medico-legal protection for users acting in good faith to accepted clinical standards.
Recommendation 4:  the relationship between the Jurisdictional Advisory Committee (JAC) and the Independent Advisory Council (IAC), and their respective roles, be further clarified in consultation with stakeholders, including ACHI.
Recommendation 5:  the PCEHR Regulations and Rules provide further detail with respect to privacy and security and the management and control of audit trails.
Recommendation 6:  the concept of “a minimum data set for PCEHRs” be removed from the document.
Recommendation 7:   in addition to consultation with the JAC, the Minister be required to consult  with the IAC prior to making Rules under the PCEHR legislation.
Recommendation 8:  DoHA consider initiating action to establish the Independent Advisory Council in advance of the legislation coming into effect as soon as practicable.
Recommendation 9:  the Rules described in relation to access controls within healthcare provider organisations be substantially revised to take account of existing practice and legislation.
Recommendation 10:  the system operator and DoHA assure themselves, through testing, that the identification of consumers wishing to access the PCEHR is fully fit for purpose and meets consumer expectations.
Recommendation 11:  the Rules provide further clarity on the concept of document authors/authorisers and their obligations with respect to uploading to the PCEHR.
Recommendation 12:   the Rules dealing with risk mitigation for gaining participation take account of the scale and complexity of the provider organisation.
Recommendation 13:  the Rules dealing with risk mitigation emphasise the critical nature of encrypting all PCEHR data.
----- End Extract.
The full document is found here:
Interestingly there does not seem to be many other submissions yet on line from people like the AMA, RACGP and so on.
The Australian Privacy Foundation has a lot to say here:
http://www.privacy.org.au/Papers/DoHA-PCEHR-Regs-120411.pdf
I do however note that AVANT - a major Medical Defence Organisation - is running webinars on the NEHRS - warning clinicians about the risks.
See here:
While very much supporting what is being said by the various spokespeople and ACHI I am getting the feeling that in the rush for July 1 implementation date there may not be much notice taken of some pretty serious concerns.
I guess we will have to wait and see if another draft, or even possibly some actual regulations become available in due course.
It is clear there will need to be a great deal more work and consultation done to have many of the medical profession touch this system - which I have to say is looking more and more like strategic overreach as every day passes.
This whole thing could certainly do with less haste and more speed.
David.