Tuesday, December 12, 2017

Informed Consent Is A Bit Of A Slippery Fish Or A Moveable Feast Whichever You Prefer!

This appeared a few days ago and bears on a lot of discussion we have here on Consent.

How much is too much information? The dose response curve of informed consent

Australia November 9 2017
“While the over-informed person is inconvenienced, the under-informed has his/her autonomy violated.” – United States Medical Ethicist, Robert Veatch.
“A patient may make an unbalanced judgment because he is deprived of adequate information. A patient may also make an unbalanced judgment if he is provided with too much information and is made aware of possibilities which he is not capable of assessing because of his lack of medical training, his prejudices or his personality.” - Lord Templeman in Sidaway[1] (1985)).
It has now been 25 years since the High Court of Australia[2] decided the case of Mrs Whitaker – the unfortunate lady who developed sympathetic ophthalmia in her left eye following an operation on her right eye. The High Court held that the surgeon, Dr Rogers, was liable for failing to warn Mrs Whitaker specifically about this rare, but devastating, risk of the procedure.
And so, it became established law in Australia that a medical practitioner has a duty to inform a patient of material risks inherent in treatment, so that the patient can make an informed decision about whether to undergo the treatment. This obligation has since been restated – and reworded – in legislation[3], professional standards[4] and government policy[5].
A risk will be material if a reasonable person in the patient’s position would be likely to attach significance to the risk. It will also be material if the medical practitioner knows, or should reasonably be aware, that the particular patient is likely to attach significance to the risk.
However, the concept of informed consent goes beyond the obligation to warn of the risks of a proposed treatment. Truly informed consent to medical treatment involves a two way discussion between doctor and patient of all of the information reasonably necessary for the particular patient to make an informed decision about the treatment.
How much information?
The Clinical Excellence Division of Queensland Health has published comprehensive guidelines[6] about the information that should be provided to patients or decision makers so that they can make an informed decision.
The list of information is long and is set out at the end of this article. It includes information about the condition, the proposed treatment, alternatives, and the potential risk and benefits of all options.
Scrolling through the list, it is hard to dispute that the information listed is important. Some issues will be more important to one patient than another. The consenting practitioner is expected to identify these individual differences and tailor the information accordingly[7].
The amount of information required varies depending on the circumstances. Generally a greater level of detail and discussion is expected for complex interventions, treatment involving greater risk or uncertainty, and elective or cosmetic procedures.
The courts have also considered the types of information that is required for informed consent, finding that the patient should be advised about factors impacting the nature and character of the act to be performed. In some situations, the courts have held that this includes the identity of the surgeon that will be performing a procedure - read Consent to surgery - who will be my surgeon? here . Commentators suggest that this may also extend to disclosing performance data in certain circumstances[8].
Too much information!
Hospital based clinicians may feel a degree of apprehension when considering these requirements. How does this obligation sit with the practical reality of a busy hospital? Time - especially that of the most experienced clinicians who are best placed to meet the information requirements - is at a premium.
Also, there seems to be a real risk of information overload. There are a number of factors that can limit the amount of information that a patient can take in. These include:
  • Patient specific factors, such as language and education levels.
  • Cultural factors. In some cultures, providing too much or too explicit information can be detrimental. For example, it has been suggested that in “high context” Spanish and Arabic speaking cultures providing too much information during the consenting process can paradoxically cause the patient to suspect that the doctor is withholding information.[9]
  • Psychological factors during the consultation, including the impact of stress and emotion on the patient’s capacity for comprehension and memory. A patient’s willingness to ask questions may be impacted by deference to the doctor, or by not wanting to appear ignorant.
  • The manner in which the information is presented. Even an educated and intelligent patient may struggle to absorb pages of printed text, particularly if medical terms are not clearly explained.
  • Timing and context. Patients need time to process and weigh up options for what can potentially be a life changing decision. The issues presented when a patient is consented for a procedure on the trolley outside the operating theatre need little explanation.
  • The ability of the consenting doctor to answer questions or anticipate areas of concern. As a matter of resources, the consenting process can often be delegated to the more junior doctors. The consenting doctor may or may not have performed the relevant procedure before.
  • Individual doctor factors. Currently, the amount and nature of information provided can vary considerably depending on the doctor. Discussions may be influenced by physician bias, including an unconscious bias toward providing a particular treatment (rather than doing nothing)[10], or concerns about limiting information about risk to avoid “putting the patient off” undergoing a procedure.
The answer?
Effective communication is the key. Informed consent requires a two-way process as the information must be tailored to the particular patient’s circumstances, and the patient’s understanding should be confirmed.
More here (including detailed discussion of the Qld. Health approach)
For the purposes of the Health Record is seems to me consent to having a record involves a risk / benefit analysis.
The risks are around breach, trust in the data custodian, data error or loss, omitted data, loss of privacy etc.
The potential benefits are around not having to remember all those details when consulting your doctor and so on.
I have to say it would be nice to see all relevant issues clearly laid out to assist in making up one’s mind!
David.

Monday, December 11, 2017

Weekly Australian Health IT Links – 11th December, 2017.

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

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A really big week with the regulations to enable myHR opt-out gazetted and now in operation with various start up dates and implications.
Otherwise the wind down to Christmas seems to be rapidly taking over!
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Federal Government authorises itself to collect Australians’ health information

Lynne Minion | 05 Dec 2017
The Australian Digital Health Agency has been given the authority to collect the health information of Australians in the My Health Record system, including for those who have not signed up and prior to the availability of an opt-out function.
The Federal Health Minister has registered the legal instrument required to switch My Health Record to opt-out, allowing for all Australians to be signed up to the national repository for individuals’ medical information unless they choose to be excluded.
“Consumers support the concept of an opt-out model for the My Health Record system,” Minister Greg Hunt’s explanatory statement to the My Health Records (National Application) Rules 2017 says.
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Online consults result in more work, not less

5 December 2017

TECH TALK

What lessons can we draw from an experiment in the UK?
The idea of offering online consultations might be total anathema to some GPs. But if anything could persuade you that they really are the future, how about the idea they would save that most valuable commodity: time?
For example, what if the patient could fill out an online questionnaire with plenty of room to detail their complaint, which was then printed and delivered to you by your staff?
Voila, no face-to-face appointment required and time saved. Of course, there may be some medicolegal issues to contend with.
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6 December 2017

Wild Health: Pay GPs to create health record

Posted by TMR Staff
My Health Record won’t take off without economic incentives for GPs to use the system, says Dr Tony Sara, the medical adviser at the South Eastern Sydney Local Health District.
“We all want it to work,” Dr Sara told The Medical Republic at the Wild Health Summit.
“Given that there is no fundamental economic model, then my sense is that there needs to be some sort of payment to incentivise GPs to create the record.”
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8 December 2017

Wild Health: Is AI making headway in medicine?

Posted byTMR Staff
AI has crept into many areas of medicine already, says Professor Enrico Coiera, the director at the Centre for Health Informatics at Macquarie University’s Australian Insititute of Health Innovation.
“AI has been with us for 20 years or more,” Professor Coiera told The Medical Republic at the Wild Health Summit.
“We don’t even know that behind the scenes we’ve got intelligence algorithms doing everything from interpreting our blood tests [to] helping radiologists look at CT scans,” he said.
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Pharmacy boost for My Health Record

Thursday, December 7, 2017 - 16:23
Every Australian pharmacy will be able to use My Health Record, with the final software provider about to connect to the system, reports industry newspaper Pharmacy News.
Corrum point of sale (POS) and script dispensing software, which is used by 1000 pharmacies nationally, will connect to the system next year.
Pharmacy uptake has also been boosted by Chemist Warehouse, which says it plans to roll out My Health Record in all of its pharmacies.
There are reportedly just over five million Australians with a My Health Record, and nearly 13 million prescriptions and dispensing records have been added to the system.
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This suicide prevention app is a good idea, but needs work

5 December 2017

APP REVIEW

Product: My Coping Plan 
Price: Free 
Pros: Simple and easy to use, would remind some patients what to do when it becomes difficult to cope
Cons: Unlikely to garner enough interest to regularly use and therefore may be forgotten when needed 
Verdict: ★★★☆☆
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1 December 2017

Mind the private and public procedures health gap

Posted by Jeremy Knibbs
The days of angry private health patients blaming their GP for sending them to hospital only to discover they have an out-of-pocket fee in the many thousands many be nearing an end.
If you’re a privately insured patient about to undergo a hospital procedure, one of three things can happen. Your specialist can be participating with one of the insurers in a “no gap” or a “known gap” scheme, or they can be non-participating.
Depending on the specialist you are directing a patient to, even the clinical aspects of your referral can be overridden by the financial settings if they are dire, which sometimes they can be.
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CSIRO’s start-up accelerator selects AI, virtual reality and genomics health innovations

Lynne Minion | 08 Dec 2017
AI for gut disorders, virtual reality aids for carers, and genomics to develop drugs faster are among the emerging technologies selected for the latest intake of CSIRO’s sci-tech accelerator ON.
A fast-track to market, ON brings together researchers, entrepreneurs and mentors, and the new batch of innovators are tackling some of Australia's greatest challenges in energy, food and agriculture, water quality, wildlife conservation and health, according to CSIRO Chief Executive Dr Larry Marshall.
“Establishing ON was about bringing the Australian research sector closer to Australian industry – creating a pathway to help our scientists turn their excellent science into real-world solutions,” Marshall said.
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  • Dec 6 2017 at 6:26 PM

Doctors asked to not include ‘grief reactions’ in medical records

Doctors say patients are asking them to exclude "ordinary grief reactions" from medical records because they don't want this information passed onto insurers as the insurance industry seeks to deal with what it describes as a 'tsunami' of mental health related claims.
The president of the peak body for general practitioners, Dr Bastien Seidel, said patients asking doctors to omit instances of grief, anxiety and other mental health information from their medical record is "not an issue for insurers" but is a significant problem for GPs.
With the banking royal commission likely to investigate cases relating to discriminatory practices in insurance cover, including the denial of cover and denial of claims, and a spike in mental health claims risking the sustainability of the sector, insurers are being forced to look at the quality of their risk profiling, as well as their underwriting and claims processes.
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8 December 2017

Where are we at with real-time monitoring?

Posted by Julie Lambert
GPs will play a central role in the first serious attempt to stop doctor shopping and illicit use of pharmaceutical drugs on the Australian mainland.
Under legislation passed on October 19, Victoria will have the distinction of becoming the first state to impose a mandatory real-time prescription monitoring regime, giving doctors, pharmacists and nurse practitioners ready access to a patient’s prescription history.
The initiative rides on the back of Tasmania’s successful DORA monitoring system, which has been in place since 2011. But the challenge for Victoria is to cover a population 12 times larger, and an expanded list of medications. Not to mention the problem of bordering jurisdictions that have yet to get on board with real-time monitoring.
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Depression and mental health apps: How to tell the good from the bad

RN
Posted Wed at 11:12am
There are currently more than 10,000 depression and anxiety-related self-help apps available to download, the American Psychiatric Association estimates. But less than 1 per cent have been professionally evaluated.
Cause for concern? Well, yes. But not a cause for depression, says Harvard Medical School's John Torous, who leads the association's working group on smartphone app evaluation.
In fact, he sees great promise in digital mental health technologies.
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GPs: Install the latest version of clinical information systems (CIS) to get the most of out of My Health Record

5 December, 2017
Dr John Aloizos AM shares his views on how digital health benefits him as a GP, plus how important it is to ensure clinical information systems (CIS) are updated to get the most out of My Health Record.
As a GP, I often find myself in conversation with colleagues who are in general practice about My Health Record and initiatives that the Australian Digital Health Agency is leading to connect other parts of the sector in the lead up to national opt-out.
One of the frequent comments I hear is:
I’ve tried using the My Health Record in my CIS but it’s too cumbersome to locate useful information. We were told usability improvements had been made – but I’m not seeing them! When will the My Health Record be fixed? When will the usability issues be fixed?’
In response, my question is: ‘When did you last upgrade your practice CIS?’
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Ethics, regulation and the medical devices boom

Editor: Amy Coopes Author: Amy Coopes on: December 04, 2017
In an era of medical apps, remote-controlled biomedical devices and 3D printing, regulatory and quality-control challenges will enter unprecedented territory, the latest Consumers Health Forum journal explores.
In a special edition of Health Voices on medical devices, the ethical, practical and personal dimensions of this runaway industry’s frenetic expansion comes under the spotlight.
Australia has seen a number of scandals involving implants in recent years, including metal-on-metal hip replacements, breast inserts and, perhaps most famously of late, trans-vaginal mesh, which is the focus of a paper by Health Issues Centre chief Danny Vedasz.
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Queensland research into hospital digital systems finds the benefits outweigh the risks

Lynne Minion | 04 Dec 2017
Ehealth technologies can improve patient care, lower costs, increase efficiency and prevent duplicated tests in Australian hospitals but they risk causing “alert fatigue” and prescription errors, according to new research published in Australian Health Review.
 Conducted by a team of authors involved in the digitisation of Brisbane’s Princess Alexandra Hospital, Going digital: a narrative overview of the clinical and organisational impacts of eHealth technologies in hospital practice claims ehealth systems can improve healthcare processes and patient outcomes but much is still to be learned about best practice design and use.
The study by PAH and Queensland’s Metro South Hospital and Health Service evaluated recently published research reviews of electronic medical records, electronic prescribing, computerised decision support systems and computerised physician order entry technologies, and found the benefits outweighed the risks.
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Digital platform GoShare rolls out in NSW health service to help chronic patients help themselves

Lynne Minion | 05 Dec 2017
Reassuring patients they are not alone and providing resources for them to better manage their conditions are among the aims of the Western Sydney roll-out of a digital platform designed to help the chronically ill.
WentWest and Western Sydney Local Health District have signed up the patient education tool GoShare to provide multimedia guidance for people living with chronic disease, with the view to improving health outcomes, preventing complications and reducing avoidable hospitalisations.
Following a successful 12-month pilot with WentWest, this new agreement will allow all healthcare professionals across the continuum of care in the region to use GoShare with patients, including those requiring cardiac rehab.
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It’s time to talk about who can access your digital genomic data

December 4, 2017 6.18am AEDT

Authors

  1. Caitlin Curtis  Honorary Research Fellow, The University of Queensland
  2. James Hereward  Post  Doc Ecological and Evolutionary Genetics, The University of Queensland
We are approaching a time when you might be too scared to have your genome sequenced.
Only last week, a US senator called for an investigation into the privacy policies of direct-to-consumer DNA companies. But this is only one piece of a puzzle that is about to get much more connected.
As with any kind of personal data there are a number of concerns regarding collection, transmission, storage and use. But unlike most other data, your genome reveals intimate information about not only you, but also the people to whom you are related.
It’s time to talk about who can access that data, how, when and why.
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Avatars put a face to schizophrenic voices

Wednesday, 06 December, 2017
Therapy using avatars appears to help reduce auditory hallucinations for people with schizophrenia.
An experimental therapy which involves a face-to-face discussion between a person with schizophrenia and an avatar representing their auditory hallucination may help reduce symptoms when provided alongside usual treatment, according to a study published in The Lancet Psychiatry.
The randomised controlled trial compared the avatar therapy to a form of supportive counselling (adapted specifically for the study). It found that avatar therapy was more effective at reducing hallucinations at 12-week follow-up, and had a large effect size.
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Consumer-centred digital health on the horizon

Thursday, 07 December, 2017
The Australian Digital Health Agency and Consumers Health Forum of Australia have signed a memorandum of understanding to ensure that digital health solutions are consumer centred.
It is hoped that the ongoing development of My Health Record will enable improved safety and quality of patient care.
“Our unique partnership with the Australian Digital Health Agency will ensure health consumers have a real voice in developing Australia’s digital health capability,” said CHF CEO Leanne Wells.
“Importantly, the MoU supports the national effort to promote increased use of the My Health Record system by consumers and carers.”
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Consumers’ voice drives digital health

7 December 2017Media release
Health consumers are central to the design and delivery of a digital transformed health sector and the ongoing development of My Health Record, a digital system that enables improved safety and quality of patient care.
A Memorandum of Understanding signed between the Australian Digital Health Agency and the Consumers Health Forum of Australia (CHF) will ensure that digital health solutions are consumercentred and advance the efficiency, quality, and delivery of healthcare in Australia.
“Our unique partnership with the Australian Digital Health Agency will ensure health consumers have a real voice in developing Australia’s digital health capability. “Importantly, the MoU supports the national effort to promote increased use of the My Health Record system by consumers and carers,” CHF CEO Leanne Wells said.
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Senior Telstra executive Cynthia Whelan to depart

  • The Australian
  • 12:47PM December 8, 2017

Supratim Adhikari

Telstra has lost another senior executive, with group executive of its new business division, Cynthia Whelan, leaving the telco.
Ms Whelan, who has headed Telstra’s new business portfolio since 2015, is also the chairman of Foxtel and a director on Telstra Ventures and Telstra Health.
At Telstra (TLS), Ms Whelan has had responsibility for driving growth initiatives into new markets.
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Freedom of information: Australians are losing the battle against government secrecy

Richard Mulgan
Published: December 5 2017 - 12:15AM
The information commissioner survived abolition but FOI remains nobbled.
Government policy on freedom of information remains in limbo. In 2014-15, thanks to resistance from the Senate, prime minister Tony Abbott and his Attorney-General, George Brandis, failed in their initial aim of fully abolishing the Office of the Australian Information Commissioner. But they certainly succeeded in reducing its resources and public standing.
Though the office's statutory functions were later fully restored under the leadership of the privacy commissioner, Timothy Pilgrim, who took on the extra role of information commissioner, funds available for FOI functions remain well below former levels. Throughout this period, the office has kept a low profile on FOI issues while concentrating more on privacy and access to government data.
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This GP isn't slowing down in his specialist fee crusade

7 December 2017

ANALYSIS

Earlier this year, we wrote about Dr Richard Zhu, the revolutionary Sydney GP on a mission to list the fees of every specialist in Australia.
His resulting website, SeekMedi.com.au, made national media headlines with praise from both GPs and patients for fighting for greater fee transparency.
What has happened since? Do doctors and patients use it? Is it making a difference? 
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How much is too much information? The dose response curve of informed consent

Australia November 9 2017
“While the over-informed person is inconvenienced, the under-informed has his/her autonomy violated.” – United States Medical Ethicist, Robert Veatch.
“A patient may make an unbalanced judgment because he is deprived of adequate information. A patient may also make an unbalanced judgment if he is provided with too much information and is made aware of possibilities which he is not capable of assessing because of his lack of medical training, his prejudices or his personality.” - Lord Templeman in Sidaway[1] (1985)).
It has now been 25 years since the High Court of Australia[2] decided the case of Mrs Whitaker – the unfortunate lady who developed sympathetic ophthalmia in her left eye following an operation on her right eye. The High Court held that the surgeon, Dr Rogers, was liable for failing to warn Mrs Whitaker specifically about this rare, but devastating, risk of the procedure.
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Google and others lead AI revolution in machine learning

  • The Australian
  • 12:00AM December 7, 2017

Chris Griffith

We’ve seen the beginnings of artificial intelligence in the world around us. But AI could also reside inside us. The idea ­exists that microscopic nano­machines could be injected into our bloodstream, scouting for ­disease and repairing cells through the use of artificial intelligence, within 20 years.
Senior inventor John McNamara discussed the idea at a British House of Lords AI committee meeting in October, so I was keen to hear the views of another of the world’s most eminent AI experts about the concept during an interview last week.
Jeff Dean is senior fellow at Google and last week was key speaker at Google’s AI conference in Tokyo. The conference revealed a plethora of AI projects that ­Google, Dean and the company’s engineers are involved with.
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HFC network will need work to be fit for NBN: experts

Technical experts who have closely followed the rollout of the NBN say Telstra's HFC network will need considerable work done on it to meet the needs of NBN customers.
Last week, NBN Co, the company rolling out the national broadband network, said that network issues would mean a delay in HFC connections of anything from six to nine months.
Dermot Cox, an HFC expert and business consultant, told iTWire the HFC platform was fine, but "running out of capacity, yes. In need of field workforce training, yes; in need of robust NBN Co workforce craft practices, yes".
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NBN Co will have to maintain HFC network no matter what

The NBN Co will have to continue maintaining the Telstra HFC cable network even if the condition of the cable network makes it impossible to be used for the national broadband network.
This is one of the conditions of the deal which NBN Co signed with Telstra for use of its HFC network, the Australian Financial Review reported.
NBN Co is paying Telstra $5 billion in infrastructure payments, $4 billion in disconnection payments and $2 billion in Commonwealth agreements for the HFC network.
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Alan Kohler: how to fix the NBN

  • The Australian
  • 6:32AM December 4, 2017

Alan Kohler

Last week NBN Co took its first faltering step towards some kind of adulthood. There’s a long way to go.
The decision to delay HFC cable connections so the technology could be fixed was its first assertion of independence from the government, which is on the hook politically for a quick rollout of the network. That’s because speed of rollout was part of the reason given for downgrading it, the real reason being that it had to be different from the ALP’s idea.
Actually, the press release last Monday was a pretty phony piece of spin, and was rightly described as “glitter on a turd” by journalists the next day.
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Enjoy!
David.

Sunday, December 10, 2017

I Am Getting The Feeling Things Are Not Going Well With The Roll-Out Of The myHR and The ADHA.

Why do I think this?

First the poll published earlier today makes it pretty clear that the confidence of the savvy audience in this blog that the myHR will be a success has pretty much evaporated.
See here:
Second we are seeing furious defensive reactions of the ADHA CEO to critical articles in the popular press, which are based on interviews with AHDA staff, being published. I am told this correspondence is being circulated to virtually every editor in the country while some odd claims are being made.
See here:
The letter does not seem to me to be 100% accurate.

As an example of probable error, from the letter:
“My Health Record requires each clinical professional to have unique identity credentials as well as conformant clinical software to open a My Health Record. This is not available to any medical receptionist. “
Last time I looked many practices used practice wide certificates that allow virtually all practice staff access to the myHR and that the Department has no real way of knowing who in a particular practice is accessing the myHR via that credential.
This is confirmed here:
Yes. The staff at your Healthcare Provider Organisation can access My Health Records as long as they are authorised users, even if they do not have an Healthcare Provider Identifier-Individual (HPI-I) identifying them as a healthcare provider. The My Health Record system entrusts a participating organisation to grant access to ‘authorised users.’ An authorised user must be an employee who has a legitimate need to access the My Health Record system as part of their role in healthcare delivery. When authorised users without a HPI-I access the My Health Record system, they are only permitted to access the records of patients with whom they are involved in delivering healthcare services. All access to the My Health Record system is with the patient’s initial consent and is audited. Authorised users without an HPI-I cannot be listed as the author of a clinical document submitted to the My Health Record system.”
Here is the link:
So anyone a practice authorises can access relevant records.
Also note that the myHR is internet connected (be it open or closed – whatever that means) and is so subject to breach – security experts say when not if. I tend to agree with the experts.
As for this:
“My Health Record places Australians in control of their healthcare and gives authorised healthcare providers secure digital access to key health information at the point of care, wherever that may be. Benefits include reduced hospital admissions, reduced duplication of tests, better coordinated care, and better informed treatment decisions.”
We have been waiting for evidence that this is true for 5 years and just saying it does not make it so!
Third was are seeing all sorts of non-technical people lined up to assist with getting more users.

Consumers’ voice drives digital health

7 December 2017Media release
Health consumers are central to the design and delivery of a digital transformed health sector and the ongoing development of My Health Record, a digital system that enables improved safety and quality of patient care.
A Memorandum of Understanding signed between the Australian Digital Health Agency and the Consumers Health Forum of Australia (CHF) will ensure that digital health solutions are consumercentred and advance the efficiency, quality, and delivery of healthcare in Australia.
“Our unique partnership with the Australian Digital Health Agency will ensure health consumers have a real voice in developing Australia’s digital health capability. “Importantly, the MoU supports the national effort to promote increased use of the My Health Record system by consumers and carers,” CHF CEO Leanne Wells said.
More here:
Note the sentence I have bolded.
Fourth there is increasing recognition that the current myHR is close to being past its use by date in its present form and will either need to be expensively re-developed / replaced or abandoned.
Last it is becoming clear that the roll-out of opt-out is only likely to be completed around the same time as there are cheaper and better ways to provide patient access to their data in the next 2-3 years rendering the entire effort redundant. (Think maybe the NBN and 5G). Also think the movement of GP Systems to the cloud.
To me the myHR is an idea (now 7 years old) whose time has passed.
What do you think?
David.