Mandatory reporting of health professionals: has COAG delivered on its promise?

On the one hand patients must be certain that health practitioners are fit to practice in a competent and ethical manner, but on the other hand practitioners should be able to seek treatment without fear of being reported, penalised or losing their jobs. Has the Council of Australian Governments (COAG) found the right balance?

The National Law contains mandatory reporting obligations for registered health practitioners, employers and education providers to protect patients. However, if you’re for example a midwife, psychologist, pharmacist, doctor or student with a mental health condition, it can be a challenging decision to seek help. Many don’t out of fear that the treating practitioner may believe they have to notify authorities.

Concerns have been raised that practitioners and students don’t seek or delay treatment – and when they seek care, there may be a reluctance to be open and honest with the treating practitioner, leading to suboptimal treatment eventually putting the health and safety of the practitioner and the public at risk.

For years the AMA, RACGP and other professional bodies have argued that the regulation needs to change to ensure health practitioners can, just like others, seek help.

In October 2018 an Amendment Bill was introduced to the Queensland Parliament, which if passed will automatically be applicable to most other States and Territories. The Bill introduces a higher threshold for mandatory reporting in an attempt to give registered health practitioners greater confidence to seek treatment for health issues.

Western Australia exempts treating practitioners from mandatory reporting for all forms of notifiable conduct if their patient is a registered health practitioner. The WA model or similar has always been the preferred option of health providers. There is no evidence to suggest patient safety in WA is worse.

In addition to mandatory reporting requirements, practitioners have ethical and professional obligations to report other practitioners who may pose a risk to the public.

Brief history

On 13 April 2018, after the COAG Health Council meeting in Sydney, the federal, state and territory Health Ministers, issued a press release stating that the law regarding mandatory reporting of health professionals would be strengthened ‘to remove barriers for registered health professionals to seek appropriate treatment for impairments including mental health.’

The ministers further agreed to a nationally consistent approach to mandatory reporting which would propose exemptions from the reporting of notifiable conduct by treating practitioners, noting Western Australia’s current arrangements would be retained.

Explicitly mentioned in the COAG press release was the fact that in WA health practitioners in a treating relationship based on the reasonable belief can make a voluntary notification as part of their ethical obligations in relation to any type of misconduct.

Health Ministers agreed that the reforms should ensure that registered health practitioners can seek help when needed, but must also protect the public from harm. On 12 October 2018, COAG Health Council approved the reforms to mandatory reporting by treating practitioners in the Amendment Bill. The WA model was not adopted.

The Council concluded that the amendments would achieve the right balance between encouraging practitioners with an impairment to feel confident that they can seek treatment, while protecting the public from harm by requiring treating practitioners to make mandatory reports about other registered health practitioners that pose a substantial risk of harm to the public or are engaging in sexual misconduct in connection with the practice of their profession.

What’s good?

A treating practitioner will only be required to make a mandatory report if their practitioner-patient’s conduct involving impairment, intoxication or departure from professional standards meets a higher threshold of risk of placing the public at substantial risk of harm (this threshold does not apply to mandatory reporting of sexual misconduct).

Only serious impairments that are not being appropriately managed through treatment or mitigation strategies need to be reported if the safety of patients would be at risk.

The amendments also include guidance factors; in considering whether the public is at substantial risk of harm, a treating practitioner may consider the following matters relating to an impairment of the health practitioner or student:

  • the nature, extent and severity of the impairment;
  • the extent to which the health practitioner or student is taking, or is willing to take, steps to manage the impairment;
  • the extent to which the impairment can be managed with appropriate treatment;
  • any other matter the treating practitioner considers is relevant to the risk of harm the impairment poses to the public.

According to the explanatory note a treating practitioner may make an overall assessment about a practitioner-patient’s conduct relating to impairment, intoxication or departure from professional standards in deciding whether a mandatory report should be made. All three types of conduct are measured against the same threshold for reporting.

If an impairment issue is connected to, or a significant cause of, intoxication or departure from professional standards, a treating practitioner is able to take into account the effectiveness of treatment or engagement in treatment of an impairment by the practitioner-patient in deciding whether there is likely to be an ongoing risk of harm to the public.

“Also, in cases where an impairment may be impacting on, or causing, instances of intoxication at work or departure from professional standards, a treating practitioner may consider the guidance factors related to the impairment first, such as the extent to which treatment is likely to be successful and the practitioner-patient’s engagement with treatment. If the treating practitioner is satisfied the impairment issue is being managed appropriately and does not reach the threshold of ‘substantial risk of harm’, the treating practitioner would not be required to make a mandatory report for the impairment.

“The treating practitioner could then consider, in light of the impairment issue being managed, whether future instances of intoxication at work or departure from professional standards are likely to recur. If, given appropriate management of the impairment, they are not likely to recur, the mandatory reporting threshold of ‘substantial risk of harm’ would not be met. In this way, the current provisions provide adequate flexibility for a holistic assessment of risk.

“It would be possible for a practitioner to have a substance abuse or dependence disorder, but it may be something that only affects their personal life or only occurs while they are away from their workplace. This type of conduct should be considered as an ‘impairment’ for which it is appropriate to apply the guidance factors. However, the risks associated with a practitioner being intoxicated at work are considered significant, so that if a treating practitioner becomes aware that a person is practising while intoxicated, they should be subject to mandatory reporting if their conduct reaches the threshold.

Source: Health Practitioner Regulation National Law and Other Legislation Amendment Bill 2018 — Explanatory Note.

The explanatory note further states that the guidance factors included in the legislation send a clear signal to practitioners and students that, provided they are engaged in treatment and willing to take steps to address their impairment, a treating practitioner is not required to make a mandatory report, unless the safety of patients would be at risk.

Seeking treatment may indeed become easier as the explanatory note of bill explicitly states that the test of ‘substantial risk of harm’ is not intended to require reporting of low-level or trivial types of harm or mere inconvenience. Only serious impairments which are not being appropriately treated are intended to require reporting. This means that harm would need to be ‘material’ to reach the threshold of ‘substantial risk of harm’.

What’s not so good?

Some have argued that although the wording ‘substantial risk of harm’ may have increased the risk threshold, the harm threshold is low, and it appears that all levels of harm, including trivial harm and inconvenience, need to be reported even though the explanatory note states the opposite.

The explanation may be reassuring but the bill itself raises questions. The wording has the potential to create confusion around the interpretation of the legislation and, worse, may prevent health practitioners from seeking help or being open and honest with their treating practitioner.

Doctors and other health workers have the highest suicide rate in Australia’s white-collar workforce. Legislation is of course not the cause of mental illness and suicide and we need to continue to look at other factors, including our professional cultures and how we communicate and treat each other. This is a shared responsibility of the profession and policy makers.

It remains vital that health practitioners can seek help without fear of repercussion no matter where they live and work. The Health Practitioner Regulation National Law and Other Legislation Amendment Bill 2018 is a welcome step in the right direction, but there is room for improvement if the COAG Health Council wants to deliver on its promise to remove barriers for registered health professionals to seek appropriate treatment for impairments including mental health.

It is time to leave the Machiavellian era of Australian healthcare behind

Community pharmacy groups are lobbying for pharmacy prescribing, a topic that has been on the wish list for a long time. Medical groups are concerned about patient safety and fragmentation and are pushing back. Is this Australian conflict model what we want or is there a better way forward?

Some pharmacists want to be able to write prescriptions as they believe it is in the scope of practice of a pharmacist and more convenient for patients.

Examples from abroad are used as an argument why Australia must follow suit. A ‘collaborative prescribing pilot’ is underway and the pharmacy sector is looking forward to the soon-to-be released results.

Pharmacists expect that their proposal will be cost-saving as people will not need to see the family doctor for prescriptions.

Pushback

Not surprisingly, medical groups are upset and believe the proposal is not helpful and not in the best interest of patients.

Doctors are concerned that soon the head doesn’t know what the tail is doing or, in other words, that more prescribers will lead to more fragmentation and adverse health outcomes.

Concerns have been raised that warning signs or significant (mental) health conditions will be missed and screening opportunities lost. Some have also argued that pharmacists prescribing and selling medications at the same time creates commercial conflicts of interest.

As a result there will likely be pushback from medical groups. It is to be expected that when the debate heats up some unpleasant words will be said in the media before the Health Minister of the day makes a decision based on evidence, opinion or political expedience.

Then there will be a loser (usually not the Health Minister) and a winner, and the relationship between pharmacists and doctors remains sour at the expense of patient care.

A better way

This series of events has become a familiar scenario in Australian healthcare. What’s missing is of course a joint strategy or a solution that would benefit both parties as well as our patients (a win-win-win solution).

Community pharmacists play an essential role within primary care teams. The pharmacy sector is under pressure and is attempting to implement strategies to remain viable into the future, such as introducing services currently provided by doctors, nurses and others.

An obvious way forward would be for pharmacists and doctors to explore models that are not competitive but complement each other. This is a joint process that requires broad support from both parties.

We desperately need genuine collaborative models of care, such as pharmacists working in general practice, but there may be other models too.

This is of course easier said than done. It is, however, time to leave the Machiavellian era of Australian healthcare behind. Who’s going to take the first step?

A victory for common sense (and patient care)

Yesterday Sonic Healthcare pulled out of their deal with Sigma’s AMCAL pharmacy chain to sell blood tests to pharmacy customers. I believe it was a wise decision to withdraw from this so-called ‘screening program’.

Just think about it. If it is up to AMCAL pharmacies their customers will be able to purchase for example a vitamin D blood test for $89.50 to ‘screen’ for vitamin D deficiency.

Initially the president of the Royal College of Pathologists of Australasia (RCPA) said: “They are all valid tests and they can all be done on patients without symptoms or abnormalities in those areas.”

But look at the recent Choosing Wisely recommendation by the RCPA:

Vitamin D screening

The RCPA’s position statement on the use and interpretation of vitamin D testing also clearly states: “The testing of healthy individuals will reveal a significant subgroup with low 25OH‐D (vitamin D) levels. This leads to treatment and perpetuates repeat testing without information as to whether such patients will benefit from vitamin D supplementation.”

Although I am sure that AMCAL’s ethical standards would not have allowed staff to push vitamin D pills for customers with low levels, I understand why Sonic has withdrawn from the initiative as it wasn’t exactly the best example of ‘screening’.

It looks like it was just about commercial stand-alone pathology testing without pre-agreed collaboration with doctors. There was no medical involvement or integration with other healthcare providers and the out-of-pocket costs for patients would have been high – with no Medicare rebate.

I imagine there were also some ethical dilemmas. Take the RCPA’s Code of Ethics, which contains the following principle:

To protect patients from harm. This includes commitment by each individual to the achievement and maintenance of clinical competence and professional standards; to referring issues beyond their clinical competence, scope of practice or accreditation; and, taking appropriate action when the conduct or lack of competence of others places patients at risk of harm.”

I really like the online RCPA library. For example, I found an excellent document titled ‘Making sense of testing; a guide to why scans and health tests for well people aren’t always a good idea.’ It explains why and how testing can cause harm (see image).

Why and how medical tests can cause harm
Source RCPA Library: ‘Making sense of testing; a guide to why scans and health tests for well people aren’t always a good idea.’

The RCPA Code of Ethics further urges fellows and members of the pathology college to “maintain professional integrity” and to “recognise and eliminate conflicts of interest that interfere with free and independent medical or scientific judgment.” As it happens, the President of the RCPA is also CEO of one of Sonic’s pathology companies.

I congratulate Sonic Healthcare on its decision and I’m pleased to see that a corporate giant in Australia seems to have made the decision to follow ethical principles instead of prioritising commercial interests over professional standards. Let’s see what the pharmacy sector will do next.

Blood tests at the chemist is like getting your car serviced at the lawn mower shop

Pharmacies are the right place to get your medicines and receive medication advice, but they are the wrong place to get a blood test.

AMCAL chemists are offering customers pathology tests at a cost of up to $220.

Ordering a test through a pharmacy chain rather than your local GP creates risks for patients including fragmentation of care, unnecessary duplication of tests, confusion about the interpretation of the results and increased out-of-pocket costs.

It may lead to incorrect, incomplete and unnecessary tests as well as wrong conclusions and false reassurance.

A pathology test should be recommended based on a medical assessment which may include your personal medical history, symptoms and a physical examination. Pharmacists do not have the diagnostic skills required to provide this kind of care safely.

AMCAL customers will be paying out-of pocket and are not eligible for a Medicare rebate. For example, a vitamin D blood test will cost $89.50, a ‘fatigue screening’ $149.50 and a ‘general health screening’ $219.50.

Our Australian Medicare system reimburses patients for a range of pathology tests after an appropriate assessment by a doctor.

The standard packages sold by AMCAL may not include the tests that are required for your unique circumstances or health problems.

We really need better integration of health services in Australia. We need pharmacies to work together with GP teams, not introduce more commercially driven duplication and fragmentation of services.

Ordering a pathology test through the chemist is like getting your car checked at the lawn mower shop. Nothing wrong with the lawn mower shop but it just isn’t the right place.

A great quality tool for health bloggers, podcasters and patients

A while back I came across a new tool for those who, like me, use Dr Google but are concerned about the quality of some of the available online health information.

The tool contains two checklists and has been designed for medical education resource producers, editors, end-users, and researchers. I’ll let the authors explain:

“Through a rigorous research process, a list of 151 quality indicators for blogs and podcasts was formed and subsequently refined to elicit the most important quality indicators. These indicators are presented as Quality Checklists to assist with quality appraisal of medical blogs and podcasts.”

The checklists have three domains: credibility, content and design, and cover topics such as avoiding bias and conflict of interest, providing clear information about the identity and qualifications of the author, and referring to sources. The checklists also focus on design and didactic value.

I believe they can be useful for patients to assess the quality of online health resources. For more information read about the 6 warning signs that will help you stay clear from quackery sites.

This tool has the potential to take many health blogs and podcasts to the next level. It is available at no cost and can be found here.

Quality checklist
A quality checklist for blogs. A separate checklist is available for podcasts. Source here.

Source: Colmers IN, Paterson QS, Lin M, Thoma B, Chan T. The Quality Checklists for Health Professions Blogs and Podcasts. The Winnower 2:e144720.08769 (2015).

The Danish health IT solution: small-scale brilliance

When his wife attended a conference in Copenhagen, Adelaide GP and RACGP board member Dr Daniel Byrne took the opportunity to find out why Denmark is one of the world leaders in the use of e-health.

One of Australia’s problems is the reliance on paper documents. For example, almost every healthcare organisation designs their own referral forms and we still fax and post a lot of documents. In Denmark a ‘one-letter solution’ was introduced years ago: one electronic form used by thousands of health organisations.

“No patient ever left the surgery with any paper,” said Dr Byrne. “It seemed very well organised with a great e-health network. No faxes were used as everything is connected via secure networks – prescriptions, referrals, pathology and radiology ordering, even email consults.”

E-mail consultations

Dr Daniel Byrne
Dr Daniel Byrne about the Danish e-health system: “The live medication list was too good to be true.” Image: Linkedin.

There are no incentives for Australian GPs to communicate with their patients by phone and email, whereas Danish GPs are paid to to take calls from patients every morning. They are also paid for e-mail communications with patients.

Dr Byrne: “The email consults are excellent. The patient has to send their email via a government secure email system. Every citizen in Denmark has a government email address – maybe similar to our MyGov system.”

“Only simple non urgent requests are done by email. I think the GP has three days to answer. The payment was around $10 per email for the GP and this seemed to work fine. If there is a bit of to and fro with a patient via email the GP asks the patient to come in for a proper consult.”

Shared medication record

National databases exist for medications and laboratory results. Dr Byrne: “The live medication list was too good to be true! Click on the medication list in any GP software or hospital system and within 2-3 seconds up pops the same real-time live medication list.”

“The GP I was with could see the prednisolone dosing schedule for a patient with polymyalgia from hospital and then just take over future prescriptions. Everyone is working off the same list. I am sure it is not perfect but a pretty good starting point compared to our nothing.”

It appears the system encourages continuity of care. After hours medical services use the same computer system as GPs and hospital discharge summaries arrive electronically at the GP surgery within two days. Scripts are sent electronically to the patient’s preferred pharmacy.

Patient access

Compared to many other European countries Denmark has a high public satisfaction with the health care system.

An interesting aspect is the access patients have to the system. Via the Danish National Health Portal patients can access hospital discharge information, laboratory results, the live medication list and waiting list information.

Patients can electronically schedule GP appointments, send e-mails to their GP and renew prescriptions. They can also see who has accessed their health records.

All doctors are allowed to access the health records, but other health professionals require patient consent first. Danish law does not allow the interconnection of IT systems across sectors, such as health and taxation.

Miles ahead

With a population of 5.6 million Denmark is one of the smaller European countries, which may make it easier to roll out e-health. The system is not perfect and there are always issues, such as interoperability.

Overall Denmark seems to be miles ahead of many other countries, including Australia where we still rely heavily on the fax machine. Dr Byrne: “In Denmark it is illegal to fax anything as the system works on a national ID number that has to be kept secure.”

5 questions to ask your doctor (before you get any test or treatment)

The National Prescribing Service (NPS) has made an interesting list of 5 questions patients should ask their doctors. The aim is to be well informed about the benefits and potential harm before you undergo medical tests, treatments, and procedures.

I think the list is useful and I’d encourage people to ask these questions. At the same time I suspect I will not be able to answer all the questions. For example, I don’t know the costs of all available tests, and the exact risks of certain interventions is something I may have to look up.

I have been told NPS is planning to develop resources for doctors so they can better help their patients with these queries. This would indeed be helpful. But in the meantime, feel free to ask! I hope it will lead to less unnecessary interventions.

Here are the 5 questions to ask your doctor before you get any test, treatment, or procedure:

5 questions NPS

Source: Choosing Wisely Australia

Don’t go to your doctor, the minister wants you to see the pharmacist instead

Pharmacies will be handed $1.26 billion for delivering healthcare services. Good for them. But meanwhile the government is not prepared to increase the Medicare rebates patients receive when they see a doctor.

As a result of the new health policies, visits to the doctor will become more expensive in the years to come, whereas pharmacies will be paid more to deal with health problems. With this move Health Minister Susan Ley seems to make a clear statement: Don’t go to your doctor, see the pharmacist instead.

A vague agreement

It could be me but I’m not entirely sure what the Health Minister will sign off on – it’s all still a bit vague:

The Pharmacy Guild says on its website: “The Government has committed to $50 million over the Agreement for a Pharmacy Trial Program to trial new and expanded community pharmacy programs which seek to improve clinical outcomes for consumers and extend the role of pharmacists in the delivery of healthcare services through community pharmacy.”

National President of the Pharmaceutical Society of Australia Grant Kardachi says: “PSA particularly welcomes the doubling in this agreement to $1.26 billion of funding for the provision of patient-focussed professional services.”

According to Australian Doctor magazine, “some $600 million will be spent on ‘new and expanded’ services, but there is no detail on what services this will cover.”

One thing is certain: Pharmacies are going to deliver more healthcare services – and at the same time the freeze on indexation of the Medicare rebates comes at a cost for patients.

Questions

Here re my questions:

  • Is Minister Ley’s decision helping to improve teamwork within primary care, or is it creating more confusion and frustration for patients and their doctors?
  • Can pharmacists and their assistants offer the same quality healthcare as doctors and practice nurses?
  • Can the person who is selling the drugs give independent health advice?
  • Why not spend part of the money on increasing the rebate patients get back from Medicare after visiting their doctor?
  • Why not spend part of the money on improving access to practice nurses and GPs?
  • Does this mean that doctors will miss opportunities to pick up on health problems, because patients will see the pharmacy assistant instead?
  • When the Pharmacy Guild talks about ‘evidence-based’ services, what do they mean? (given the fact that many community pharmacies also sell unproven remedies and products).

What do you think, is this good policy or not?

7 simple strategies to avoid eHealth fiascos

In healthcare we’re often confronted with poor quality software. Bugs and security issues are common, and the design is usually not intuitive. I spoke to Frank (not his real name), an insider in the health IT industry. Frank gives us an interesting look behind the scene and seven strategies for developing or implementing new software.

“Any industry can be a target for poor software,” says Frank, “but healthcare certainly has its fair share. Believe it or not, medical software is unregulated. Medical software that runs on a computer, mobile phone or tablet does not fit the definition of a medical device in section 41BD of the Therapeutic Goods Act 1989, as they were not intended by the manufacturer to be used for therapeutic purposes.”

“How many software developers have clinical employees? Do these employees have input into design or are they there to sell the dream?

“There is a serious gap between software design and the real-world application. Often software developers do not fully understand what is actually required by the healthcare industry to support the services that they provide.”

“Far too often, developers over-promise and under-deliver. What software can do often does not live up the expectations of the customer. How many software developers have clinical employees? Do these employees have input into design or are they there to sell the dream?”

Causes of poor quality

Some argue that developers should test their product better before it can be used in patient care. Is this an issue?

Frank: “Quality must be incorporated into the entire software development life cycle, from inception through implementation and this is not always happening.”

“A lot of the actual coding occurs overseas, in countries like India, where the employment costs are much lower. Code may be written cheaply and quickly overseas but it isn’t necessarily quality code.”

“Testing is often an after thought and done quickly due to time constraints

“Testing is often an afterthought and done quickly due to time constraints. The most crucial functionality usually gets tested but bugs can still slip though.”

“On the other hand, sometimes the client is not specific about their requirements. This could be a result of not engaging the organisation to understand what requirements need to be met. How often are clinical and other front line staff asked what they need before software arrives?”

The PCEHR 

Talking about client requirements: Let’s look at the Australian national E-health records database, the PCEHR. The Government wants to use the data and eventually save money (even though so far they have wasted millions of dollars on the project). Consumers want full control of the data, and doctors need a reliable, safe, secure and easy-to-use tool. Is it possible to develop a national product that ticks all these boxes?

Frank: “Highly unlikely. There are too many competing interests and egos with those that have been involved. In the early days, NEHTA was an interesting organisation to observe. It was obvious that they didn’t understand the complexity of system interoperability or consumer expectations on how information is to be shared and stored.”

“Fear, uncertainty, and doubt also play a part in the slow uptake of the PCEHR

“The reality is that software used in healthcare is effectively a closed shop, and it’s difficult for different systems to be integrated. Once you’ve bought a solution from one vendor, it’s incredibly difficult – but not impossible – to walk away from it.”

“Also in recent years, there has been a seismic shift in patient expectations overseas and we’re starting to see the rise of patient advocates and patient hackers. These are savvy people who aren’t going to sit back and be a passenger in their personal health journey.”

“Fear, uncertainty, and doubt play a part in the slow uptake of the PCEHR. Some providers don’t want patients to be able to access reports on the PCEHR, others are concerned that patients may choose to make some information not sharable or viewable which may compromise care. I think the truth lies somewhere in between.”

7 tips to avoid fiascos

I asked Frank what doctors, healthcare managers and business owners can do to avoid disappointments. Here’s his list of 7 tips:

  1. Be as clear as possible about your expectations and needs. Make sure you discuss the features you’re looking for and categorise them: absolutely essential, must have, good to have, nice to have, can live without. Ask how many features the software developer can provide in your first 3 categories.
  2. Make sure that the software vendor understands your requirements. Get them to provide their understanding in writing so that you can see that they’ve understood.
  3. Does the organisation hold certification for both ISO 9001 (Quality Management Systems) and ISO 27001 (Information Security Management) across all business units?
  4. Find out where the software is being developed and supported from.
  5. What is the quality like? Is it secure?
  6. Don’t pay anything to a software developer before you are sure what you’ve been given is fit for purpose and what you asked for.
  7. What contingencies are in place if the software fails to deliver as promised?

Software glitches: Are you keeping your head cool?

Healthcare around the world is plagued by software problems. To give just a few examples:

Issues with the Obamacare website caused user frustration, but also security breaches. Personal information was disseminated over the internet, affecting millions of people.

Closer to home, the Australian PCEHR has difficulties getting off the ground because of concerns at various levels. Major security problems with the Australian MyGov website – which also gives access to our eHealth records – were exposed by a researcher who was able to hack into the secure part of the website.

Queensland Health has an unfortunate track record of software problems, most recently with Metavision, an intensive care software package that created medication errors.

Why is the healthcare industry prone to these software debacles?

I caught up with Australian health IT experts to get some answers. In this post I’m talking to Sydney professor Enrico Coiera, who has extensive experience in the field of health informatics and bioinformatics. He’s got interesting things to say about eHealth, the PCEHR, and Telstra’s plans to enter the healthcare market.

What’s the cause of e-health fiascos?

Professor Enrico Coiera
Professor Enrico Coiera: “I think we will be seeing that government gets out-of-the-way in e-health, while still protecting the rights of citizens via law.” Image: Twitter

Coiera: “Today in Australia there is still, inexplicably, no governance system for e-health safety. No one is looking at your GP desktop system to make sure patients will not be harmed through its use.”

“Yet, look at what has been achieved in the airline industry, and then compare their safety governance processes to those that we have in healthcare IT. A functional and effective governance system needs a rapid reporting arm, and a rapid response arm.”

“If something goes wrong it must be reported, and rapidly communicated back to all other users who might be experiencing the same issue, and then quickly repaired.”

“The other thing is of course that while we are fiddling and doing nothing, clinical software is getting more complex, with more functions and more opportunities for failure, and as a result, patient harm.”

“In the past, software failures weren’t always seen as a patient safety issue. IT glitches were regarded as annoying, perhaps time-wasting.”

“It’s only in the last decade that we’ve realised that unsafe IT makes for unsafe care. And now that we know that e-health is a patient safety issue, people are not putting up with it anymore. They do want to know that their clinical systems are safe.”

Man vs machine

I often wonder if software solutions are tested thoroughly enough before they are introduced in the clinical setting, but according to professor Coiera I’m underestimating human factors as a cause for errors:

“I’m not sure that improving software testing is the only challenge with e-health safety. Having said that, in Australia there are no requirements on testing for clinical systems, so we don’t know whether or not even this basic requirement is being met by software vendors.”

“My biggest criticism of the e-health industry is that their software is often not very innovative.

“Keep in mind that there is no such thing as a safe system: While about 50% of e-health incidents are primarily technical in origin, the other 50% of incidents are caused by a human factors, for example someone selecting the wrong medication or medication dose from a drop down menu.”

“This means that to have a safe system, both our software needs to be built to appropriate standard, but also that clinicians must be trained to be safe users of the technology. Implementations of software in clinical settings also need to be carried out with an eye to risk reduction.”

“My biggest criticism of the e-health industry is that their software is often not very innovative, and not designed with human factors in mind. It is hard to comprehend how unusable some clinical systems are, with too many clicks to achieve even simple tasks, and user interfaces simply adding in new functions and becoming complex over time, rather than focusing on clarity and simplicity in design.”

“This lack of innovation is probably a function of the size of the e-health market, and the ability of vendors to lock in customers by making it hard to move from their system to others. Innovation comes from true competition, as well as customers who reward innovation.”

How do we fix the PCEHR?

Many people are calling for a rethink of the PCEHR, saying that a massive data repository is not the answer.

Coiera: “There has never been a strong case to develop a centralised national record. The main issue with the PCEHR design is that its explicit clinical purpose has never been clear.”

“GPs should have access to hospital patient data, but that can happen by logging on directly to the hospital system.

“There are actually many compelling reasons to move data around the system, using more interoperable records and networks. GPs for example should have access to hospital patient data, but that can happen by logging on directly to the hospital system, not looking at some extract of the data in a central repository.”

“Wasn’t that the whole point of the Internet, for goodness sake? Data needs to be fluid, it should move around.”

Big business vs big government

Frustrated with the government’s PCEHR, some are hoping big business will solve the problems. Telstra has announced plans to get involved in telemedicine and e-health. The question is whether this will be an improvement, as Telstra has had its fair share of software malfunctions – including at least one security breach affecting one million BigPond customers. But Coiera is positive:

“We should welcome big companies, it’s good for us. The government’s job is to protect privacy and security through regulation and law. The government should stick to what it’s good at, and leave software development to industry. Government is used to being in charge and driving change top down, whereas businesses are usually better at listening to the client.”

“I think we will be seeing that government gets out-of-the-way in e-health, while still protecting the rights of citizens via law. With the arrival of industry should come competition and innovation. The companies that listen best to what we want as clinicians and consumers will win.”