cfDNA, ala NIPT

Oh no another acronym change!

Technically non-invasive prenatal testing aka NIPT was always a misnomer as a needle into your arm is still invasive. Now it seems we need to get used to cell free DNA testing or cfDNA. Again  technically the test is done on circulating cell-free fetal DNA which is really ccffDNA, but lets keep it shorter. An important consideration is most of the DNA comes from dead placental cells which means a discordant NIPT  oops cfDNA, may arise with mosaicism.

For a great update on what this tests and what it does have a look at this ANZJOG paper published this month.

Some highlights for cfDNA:

  • screening is suitable as a primary screening test for all women – if they can afford it (see below)
  • screening has a sensitivity of ~99% and specificity of >99% for trisomy 21 ie.,  very high detection rate and very low false positive rate (0.1%). It is only marginally less sensitivity for trisomy 18 and 13
  • sensitivity and specificity are less precise for twin pregnancies
  • does not correct guarantee correct gender and may not be as useful for sex chromosome aneuploidy
  • less sensitive for microdeletions and trisomies
  • is a screening test, it is not diagnostic. Victorian women with a high probability cfDNA result, fetal aneuploidy was confirmed by invasive fetal testing in 64%, with 36% of results being false positives
  • is useful as follow‐up screening following non-reassuring combined first trimester screen (CFTS) prior to an invasive diagnostic testing, ie. amniocentesis
  • first trimester ultrasound has benefits in addition to aneuploidy detection, including confirmation of dates, viability, number of fetuses and detection of structural anomalies. Although many women will have an ultrasound prior to paying for the cfDNA test to ensure accurate dates.
  • the required fetal fraction threshold for cfDNA ranges from 2–4%. The higher the fetal fraction the more accurate the test, hence the test is recommended after 10 weeks. Maternal weight may reduce the fetal fraction (7% in women over 100 kg and 50% over 160 kg)
  • delaying cfDNA until 12 weeks will reduce the costs of screening aneuploid pregnancies that are destined to miscarry eg., 6% of trisomy 21 pregnancies
  • cfDNA screening performs better than CFTS for aneuploidy detection thus CFTS is not recommended as this increases the false positive rate but not the detection rate
  • ultrasound ‘soft markers’ of aneuploidy need no longer be considered indications for invasive testing if the woman has had a low probability cfDNA result
  • meta‐analysis has shown procedure‐related miscarriage risks following invasive as 0.11% (one in 909) for amniocentesis and 0.22% (one in 454) for chorionic villus sampling. If doing an invasive test, I would always ask the doctor doing it what their own rates are.

Cost for the basic NIPT/cfDNA test do vary a little but have become a lot less expensive since they were introduced into Australia.

Percept from Victorian Clinical Genetic Service $449 (but needs to be done as a specific collection centre, so travelling to the collection centre needs to be factored in)

Harmony from Sonic Genetics (and 12 affiliated pathology labs) $425

Generation from Dorovitch/Laverty/QML/Western Pathology $395

Panorama from IVF Australia and (affiliated IVF services in NSW, Qld and Victoria) $450

The expanded tests for each of these assessing gender and microdeletion etc, obviously cost more. None offer a money back guarantee for errors in gender assessment! Some offer a free retest if fetal fraction is too low and no result can be give.

The cost of a cfDNA is however a considerable expense for many patient. For example, Lisa Hui has has shown that over 90% of referrals for an NIPT in 2013 were from private practice. Susan Maxwell in an editorial in the ANZJOG has called for consideration of public funding for NIP/cfDNA testing.  MBS provides a subsidy for maternal serum screening and combined first trimester screening as well as invasive prenatal diagnostic procedures and karyotyping. Although, as many families may discover there may be a considerable gap to these tests too.

I do wonder given there are 300,000 successful pregnancies in Australia each year, what cost the various pathology labs would charge if there was public funding available. Economy of scales that work for pizza should provide a more equitable solution to providing a better quality test to Australian families.

 

 

 

I need a scan for my back, doc!

You may be surprised but you probably do not need an X-ray, CT scan, or MRI for acute back pain. There are some good reasons for this.

Radiation from x-rays and CT scans can cause harm

The image obtained is the end results of how various tissues absorb radiation to prevent passage of the radiation to a detector. An x-ray provides a two dimensional image from a flat film. Although, now a digital detector is used rather than wet chemistry, just like photography. The radiographer positions you and the machine up to takes the image, whilst a radiologist is a doctor who interprets the image.

A CT or computed tomography scan, makes use of computer-processed combinations of many x-ray measurements taken from different angles to produce cross-sectional (tomographic) images. Hence, you lie down in a machine that looks like a giant donut. The virtual slice of your body are in reproduced in various shades of grey depending again on how much the tissue absorbed the radiation. Some illness or injury will affect the degree of absorption of the radiation affecting the final image. CT scans, through more computerised processing can be reconstructed in a 3-D image of parts of the human body. Here is a link to Radiopedia’s page on what a normal CT and x-ray of the lumbar spine looks like.

There are no published studies that prove a direct link between medical imaging and increased cancer risk. The assumed increased risk of cancer from CT scans and x-rays is based on individuals exposed to high doses  due to atomic bombs and nuclear accidents.

Things have moved on from the early days of x-rays such as shown in the illustration where both doctor and patient are receiving a massive dose of radiation.  This article talks about some of the early injuries from x-rays.

Here is a table that shows the relative amount of radiation required for various x-ray and CT scans. Radiation exposure is measured in millisieverts or mSv. The average radiation dose to a person in Australia from natural sources is about 1-2mSv per year.

There are calculators used to determine the risk from a radiological study. So for a lumbar spine x-ray series I would receive a dose of 1.5 mSv of radiation, which is equivalent to back ground radiation I am exposed to over a whole year.

What about an MRI?

MRI or magnetic resonance imagining uses strong electromagnets and radiowaves to make water molecules move in a specific way. The information collected at a detector then enables computers to build up an image on internal structures in thin slices. An MRI allows a better image of soft tissues, hence it is more useful than x-rays and CT-scans to view nerves, ligaments and intraverbral discs. There may be no radiation risk from an MRI, but it is not without physical hazards; it can be difficult to tolerate the tunnel if you are claustrophobic, it would be wise not to be in the way of metals objects being attracted to the magnets, and movement or heating of metallic implants can cause tissue damage, and pigments in tattoos can cause burns.

Here is a link to Radiopedia that shows a normal MRI of the lumbar spine.

Imaging tests can be expensive

Here is the Medicare rebate for three studies of the lumbar spine. Of course the cost to you may include a gap set by the radiology practice. It may pay to shop around. Remember, you pay not only for the quality of the scan, but also the radiologist’s interpretation of what may be wrong. l have to confess that I have NOT done five year of training to be a fellow of the Royal Australian and New Zealand College of Radiologists, and so am not be the best person to interpret an MRI done by “MRI R US”.

  • X-ray  $47
  • CT scan $177
  • MRI  $358.40, (but be aware that a GP may not be able to order an medicare rebatable MRI)

Imaging may lead to the unnecessary

As mentioned above, a radiologist will interpret the x-ray or scan to answer a clinical question posed to them. Hopefully it will more than “what is the cause of this chaps back pain?” An incidentaloma is a shadow that is seen that represents a lesion of dubious or uncertain clinical significance. This may leads to increased anxiety on the part of the doctor or the patient and may well lead to more scanning, extra tests, surgery or a biopsy to find out if the spot is of clinical significance. In some cases, it may be a “lucky” find such as a resectable pancreatic cancer, but more often is just a distraction. 

Sometimes, incidental findings can be quite enlightening. In this case from Radiopedia, the patient did not know about the pregnancy.  Two months later she gave birth to a healthy child.

And now to the elephant in the room

As suggested by this review paper, “these imaging findings must be interpreted in the context of the patient’s clinical condition”.

Low back pain is common in Australia, affecting over two-thirds of adults at some point in their lifetime. Findings such as disc degeneration, facet hypertrophy, and disc protrusion are often interpreted as causes of back pain, triggering medical and surgical interventions in the hope of alleviating suffering. Sometimes, this does works, but for some it doesn’t, leaving a person worse off after surgery, addicted to opiate pain relievers, believing that they will never get better.

Several studies have demonstrated that imaging findings of spinal degeneration are present in a large proportion of asymptomatic individuals. I have taken this table from a 2016 paper in the American Journal of Neuroradiology that studied the age-specific prevalence of the following imaging findings in asymptomatic individuals: disk degeneration, disk signal loss, disk height loss, disk bulge, disk protrusion, annular fissures, facet degeneration, and spondylolisthesis. You can see that as you age, a scan is more likely to pick up abnormal findings. But even in a 20 year old, a third of people scanned had a disc bulge which is often blamed for that annoying sciatica.

Age-specific prevalence estimates of degenerative spine imaging findings in asymptomatic patients

So are there times when I may consider imaging?

Indeed there are things which may increase the the chance of finding an significant abnormality which may indicate a scan. These are often clumped together as red flags and may indicate the four serious causes that is cancer, infection, a fracture or spinal cord damage (cauda equina). This then leads your doctor to consider a serious of questions that at first may seem odd and not connected before going on to examine your back.

  • Duration of pain
  • Nighttime pain affecting sleep
  • Progressiveness worsening pain
  • Trauma
  • Osteoporosis
  • Sudden back pain with spinal tenderness
  • Recent surgery
  • A history of cancer, immunocompromise, corticosteroid use (eg prednisolone) or intravenous drugs use
  • Unexplained weight loss
  • Age under 22 or over 55
  • Fever, chills or rigors, sweats
  • Loss of bowel control, inability to pass urine or loss of sensation in the saddle or perineal area
  • Altered sensation or strength the legs
  • Diminished or absent deep tendon reflexes, like a patella jerk
  • Blood tests that suggest infection , eg elevated ESR or CRP.

A review in the European Spinal Journal in 2016, of these and other red flags, however did find their usefulness is also limitted. This was backed up by a Cochrane review of red flags for malignancy due to lower back pain. This article recently published in the The Journal of Bone and Joint Surgery, suggests that maybe the red flags should be recoloured. For instance, for patients with no recent history of infection and no fever, chills, or sweating, the presence of night pain was a false-positive finding for infection in over 96% of the time. The authors recommendations were

  1. Recent trauma should raise the vertebral fracture, in patients who are over 50 years old and especially in those over 70 years old. The presence of both recent trauma and an age of over >50 years carries a 13.1% probability of a vertebral fracture  and 20.5% probability of vertebral fracture in an over 70 years.
  2. The presence of a history of cancer in the setting of low back pain carries a 10.6% probability of having a spinal malignancy. A history of unintentional weight loss, alone, carries a 3% probability of having a spinal infection; however, when both red flag were present, the probability of having a spinal malignancy was 14.3%.
  3. A recent history of infection in the setting low back pain carries a 10.2% probability of having a spinal infection. A history of fever, chills, or sweating, alone, carries a 2% probability of having a spinal infection; however, when both red flag questions were present, the probability of having an infection in the setting of low back pain was 13.8%.
  4. A loss of bladder control and loss of bowel control has a the probability of having cauda equina syndrome of 1.2%.
  5. Classically, night pain has been associated with malignancy and infection; however, this symptom was a false positive >85% of the time for malignancy, and >96% of the time for infection when no other associated red flag symptoms were present.
  6. Other than an age of >50 years and a diagnosis of vertebral fracture, the absence of any individual red flag or combination of red flags does not help to rule out a particular red flag diagnosis, as noted by the low change in probabilities, sensitivities, and negative likelihood ratio of red flag questions.

So back to the original request for an x-ray, CT or MRI, it is therefore not unreasonable to suggest that imaging the back is of such low yield that you are better off being reassured that your back pain is likely to be self-limited and benign. 

Updates on MyHR.

Here is an updates on MyHR from the news. Remember you know have until November 15 to opt out if you haven’t already been opted in without knowing…

In chronological order.

21/7/18

Staying in or opting out: My Health Record goes viral for all the wrong reasons by Dr Ruth Armstrong and Dr Trent Yarwood from Croaky

This is an opinion blog from Dr Trent Yarwood myHR Secondary Use Framework

Why I am opting out of MyHealthRecord – for now by Dr Tim Leeuwenburg of Kangaroo Island

Top 10 most awkward questions about the MHR from Jeremy Knibbs at the Medical Republic.


22/7/18

My Health Record ‘identical’ to failed UK scheme, privacy expert says, a Guardian report which suspects MyHR and the failed UK care.data may be evil twins? Tim Kelsey who has been involved in both projects suggests otherwise. Here is his address to the National Press Club in May 2018.

Australian Health Information Technology is also a useful site to peruse. According to its author, it intends to inform readers of news and happenings in the e-Health domain, both here in Australia and world-wide. To provide commentary on e-Health in Australia and to foster improvement where he can. And, thirdly to encourage discussion of the matters raised in the blog so hopefully readers can get a balanced view of what is really happening and what successes are being achieved.


23/7/18

If you want to read the report on the Opt-out North Queensland/Blue Mountains trial have a look here.
The key outcome measures for this trial were;

  • increased awareness and understanding of the My Health Record system
  • increased confidence to use the My Health Record system
  • increased participation in, and use of, the My Health Record system
  • increased understanding of the effectiveness of different approaches for driving participation and use of the My Health Record system.

The outcomes were

  • the opt-out approach to increase both individual and healthcare provider participation and use is the preferred option (which is what have now)
  • continuation of current or accelerated opt-in approaches is considered to be unsustainable
  • the opt-out trial sites achieved better outcomes, in terms of participation, understanding and some aspects of use of the My Health Record system
  • key lessons were learned to inform Government’s understanding of the effectiveness of different approaches for driving participation and use of the My Health Record system

As a doctor, here’s why My Health Record worries me by former AMA President, Kerryn Phelps.

If you want to read the My Health Record Act 2012 you can find it here.

Section 70 is a controversial part which permits access to your record without the need for a court warrant. I have copied the section below. Many believe that this part needs to be changed to require a court warrant prior to anyone aside from you and your doctor accessing the MyHR.

Disclosure for law enforcement purposes, etc.

(1) The System Operator is authorised to use or disclose health information included in a healthcare recipient’s My Health Record if the System Operator reasonably believes that the use or disclosure is reasonably necessary for one or more of the following things done by, or on behalf of, an enforcement body:

(a) the prevention, detection, investigation, prosecution or punishment of criminal offences, breaches of a law imposing a penalty or sanction or breaches of a prescribed law;

(b) the enforcement of laws relating to the confiscation of the proceeds of crime;

(c) the protection of the public revenue;

(d) the prevention, detection, investigation or remedying of seriously improper conduct or prescribed conduct;

(e) the preparation for, or conduct of, proceedings before any court or tribunal, or implementation of the orders of a court or tribunal.

(2) So far as subsection (1) relates to paragraph (1)(e), it is subject to section 69.

(3) The System Operator is authorised to use or disclose health information included in a healthcare recipient’s My Health Record if the System Operator:

(a) has reason to suspect that unlawful activity that relates to the System Operator’s functions has been, is being or may be engaged in; and

(b) reasonably believes that use or disclosure of the information is necessary for the purposes of an investigation of the matter or in reporting concerns to relevant persons or authorities.

(4) If the System Operator uses or discloses personal information under this section, it must make a written note of the use or disclosure.

(5) This section does not authorise the System Operator to use or disclose healthcare recipient-only notes.

For reference the system operator is defined as the Secretary of the Department; or if a body established by a law of the Commonwealth is prescribed by the regulations to be the System Operator–that body.

From ZDNet, The My Health Record story no politician should miss written by Stilgherrian a freelance journalist. ZDNet is a tech website, not health. Another of his opinion pieces is entitled My Health Record opt-out debate is getting silly but government is at fault.

The list of politicians opting out seems to be growing Liberal MP Tim Wilson opts out of e-health record. (worth also looking through the comments for this article. I do hear that Malcolm Turnbull has opted in and favours access by insurance companies!

Why My Health Record can’t have ‘military-grade’ security, an opinion pieces by Peter Moon, technology lawyer calls out Minister Greg Hunt on discussion about MyHR security and the difference between no breaches versus no known breaches.

Crikey adds Peak GP body’s alleged support for My Health Record called into question. Here Ben Grubb gets me a little confused about the RACGP position on MyHR.

On Monday last week, the Australian Digital Health Agency (ADHA) issued a statement claiming “Australia’s peak GP, pharmacy, and healthcare bodies support My Health Record and the government’s decision to move the system to an opt out model”, listing various groups below it which included Australia’s peak GP body, the Royal Australian College of General Practitioners (RACGP). But when asked if it supported opt-out, the RACGP initially said in a statement: “The RACGP has never established a position on My Health Record being an opt-in or opt-out service.”Shortly after I put the RACGP’s response to Health Minister Greg Hunt’s office on Friday, who reiterated the RACGP’s incorrect statement of support of opt-out, the peak GP body contacted the author to issue an additional statement “clarifying our position”, which said: “The RACGP has never said that it does not support the opt out model of My Health Record.”


24/7/2018

My Health Record agency adds ‘reputation’, ‘public interest’ cancellation options to app contracts.

From the article

“My Health Record is scrambling to put tough new restrictions on mobile phone apps that use its sensitive patient data, including an option to cancel if the companies damage the system’s reputation. Companies Telstra, HealthEngine, Tyde and Healthi already have access to My Health Record information such as Medicare records, test results, scans and prescriptions, for their app users to view on mobile phones.”

Personally, I don’t think I would trust accessing my personal health information through a smart phone app. HealthEngine is also facing a massive crisis of confidence when users find adverts from lawyers pop up in their app. An article in the Guardian by author and oncologist Dr Ranjana Srivastava discusses some of the concerns of on-selling private data. It pays to read the fine print.

AMA president, Dr Tony Bartone, suggest that maybe your MyHR may save your life one day! Technically it would be the health care professional, doctor, nurse paramedic who does the actual saving. But if your MyHR contains vital information about a critical allergy or health problem, and if it can be seen by the doctor , nurse paramedic and they take heed then yes it may save your life.

Cassandra Cross a Senior Lecturer in Criminology from Queensland University of Technology discusses What could a My Health Record data breach look like? And, although Cassandra talks about how to upgrade you security in this article, obviously if the government is in charge of your data, having cryptic and regular password changes may not help.

Australia’s Human Rights Commissioner, Edward Santow, has urged the Federal Government to make changes to the My Health Record to restore confidence in the privacy and security of the system.

Now I don’t think comment from our Health Minister is real (it is from The Shovel), but then again maybe?


25/7/18

Article in the Guardian reinforces that Section 70 implies a court order is not necessary to access MyHR. This is at odds with what the Health Minister says. I think that is one of the biggest issues safeguarding MyHR and maintain public confidence that the Minister won’t know about your herpes.

This is also discussed by Nigel Brew in an article entitled Law enforcement access to My Health Record data on the Australian Parliament website. I agree with his suggestion that medical records registered in the MHR system need to be legally protected from access by law enforcement agencies to at least the same degree as records held by a doctor.

I am sure that Section 70 can be changed to assure security. This would mean that police investigating a crime, etc would need a court order to access data. I do wonder how often the judiciary deny a court order to police in this setting?  Then all we need to keep identifiable data out of third party users like health insurance companies.


26/7/18

Dr Edwin Kruys, recently RACGP Chair for Queensland is a keen blogger. In his latest Blog, Doctor’s Bag he highlights how much the Government wants your data.

Dr Tim Leeuwenburg is a rural GP who I used to work alongside on Kangaroo Island. We often had conversations across the hall when our doors were open about life, politics and healthcare. He is an active blogger and to be honest probably inspired me to join in. He is an active advocate for the “Opt Out until its fixed” group of citizens. His Blog KI Doc is worth looking reading.

Dr Tony Bartone, AMA president has suggested AMA says it will do ‘whatever it takes’ to ensure privacy. Dr Bartone revealed the Minister Greg Hunt, and the Australian Digital Health Agency had given him written undertakings that “without a court order … there is no way of access to the system for anyone other than the people nominated by the patient”.  Which of course is great but not binding, while Section 70 of the Act stands unchanged (see above).

In the same article, Greens leader, Dr Richard Di Natale, has been quoted as saying “If you want to access someone’s medical records, you should have to have a warrant, simple as that.”

The digital health project My Health Record could undermine the ability of young people to access confidential medical care, critics have warned in this ABC Science article. Access may be difficult for kids whose parents have split, particularly if parents are not on talking terms, or if there are domestic violence issues. The other question can a 14 year old navigate My Health Record?

Dr Harry Nespolan, new to the job as RACGP  President has made public that he has opted out as highlighted in this article form The Advertiser.  News from the Australian that Tanya Plibersek is not Opting out!

Malcolm Turnbull is try to bolster support for MyHR, and hopefully the politicians will be perusaded to make MyHR more secure.

Opting means business as usual. This article from The Conversation suggests there are benefits to the Health care system with MyHR which I think we can all agree on. Now if Section 70 can be reframed and some other issues sorted out well. Maybe the NQ trial wasn’t asking the right people the right questions?

The Police Union have expressed concern to their members about the lack of warrant to access MyHR. The Queensland Police Union told Guardian Australia it has “legal advice that there is nothing in the legislation that requires any enforcement body to obtain a warrant to access My Health Record”.

The article mentioned on the 25/6/18, has been edited as described in this Guardian article. Sorry if you click on the link to Nigel’s Brew’s paper you get a 404 message now. Dissent will not be tolerated? But can be found here…..nothing ever disappears fully on the internet!!


28/7/18

As the opt-out period for the My Health Record continues, so too does the debate surrounding issues of confidentiality. While possible data breaches have generated widespread concern, for one group – teenagers – it may not just be hackers they want to keep out. It may be their parents. Drs Mellisa Kang and Lena Sanci explain in an article from The Conversation. They are calling for a campaign to educate young people aged 14 to 18 to explain what the My Health Record will mean for them and how they can have the benefits of a record, without losing their rights to confidential health care.

This article by James Bullen publised by the ABC explains one of the potential benefits from data mining. A summary of the article mentioned in the news article

Heritability is essential for understanding the biological causes of disease but requires laborious patient recruitment and phenotype ascertainment. Electronic health records (EHRs) passively capture a wide range of clinically relevant data and provide a resource for studying the heritability of traits that are not typically accessible. EHRs contain next-of-kin information collected via patient emergency contact forms, but until now, these data have gone unused in research. We mined emergency contact data at three academic medical centers and identified 7.4 million familial relationships while maintaining patient privacy. Identified relationships were consistent with genetically derived relatedness. We used EHR data to compute heritability estimates for 500 disease phenotypes. Overall, estimates were consistent with the literature and between sites. Inconsistencies were indicative of limitations and opportunities unique to EHR research. These analyses provide a validation of the use of EHRs for genetics and disease research.

This Saturday paper article (which can be the one free article you read in this newspaper, unless you subscribe), discussed the the positives and perils of My Health Record.


29/7/2018

MHR debacle week 2, electric boogaloo, is an article by Pulse IT to summarise the last week in the MyHR story.

If you are interested in looking how the Government deals with privacy before MyHR and Section 70, the Privacy Act 1988, can be accessed here. If you want to see the specifically how health information and medical research is managed go here. The whole Act can be accessed here. This is not just about one’s health but all about what privacy we have from organisations that employ or services, represent us professional, sell stuff, buy stuff, insure against mishaps, fund our needs and wants or interact with us on a daily basis.

A number of Unions have advised members to Opt out. These include Mark Burgess, the chief executive of the Australian Police Federation, The Queensland Police Union, and the Electric Trade Union. Here is a responce from Tim Kelsey to Electric Trade union trying reassure that there are adequate securities in place. The Australian Council of Social Service has added its voice to change.

From earlier this month, this article was published on the MJA INsight. It’s title probably tells the opinion of the author, My Health Record: on a path to nowhere? by Bernard Robertson-Dunn from the Australian Privacy Foundation.

Here is a power point on the interaction between My Health Record, Pathology companies and several contentious issues, such as standing consent, and what to do if you do not wish to have your pathology tests uploaded to My Health Record. The default approach as per the ADHA is to have a standing consent to upload pathology results. Healthcare providers do not need to explicitly obtain permission from the patient before accessing or uploading information to their My Health Record. However controls need to be in place to prevent information (such as a diagnostics report) being sent to the My Health Record if the patient tells their provider that they don’t want it sent. You may notice a new tick box on pathology request forms. If you don’t want to upload, tick the box.

Remember not to read just the headlines WHY AMA CHIEF REFUSED TO GET A MY HEALTH RECORD shouts the Herald Sun . In fact if you read the article it actually says

“I don’t have a My Health Record because I haven’t had the time or opportunity and there hasn’t been the inclination to use it until now,” he said. Dr Bartone said he will automatically get a My Health Record when the opt out period ends in October.


30/07/2018

Australia’s former privacy commissioner, Malcolm Crompton, warned government officials about the dangers of an opt-out My Health Record system six years ago, but said his cautions were ignored. Mr Crompton now runs a private consultancy firm dealing with data protection. The article suggests, Mr Crompton, who has himself opted out, said he had little faith in the government’s ability to resolve the myriad of privacy and security issues. He would also like an audit on close to the million private practice computers that would link into My Health Record. He however didn’t comment on the 10 million of so that may link in from people’s homes as they review their My Health record.

Also in the Guardian, Ranjana Srivastava oncologist and author, writes patients trust their secrets to doctors, not the government or the tax office.

COAG health ministers are meeting in Alice Springs on Thursday and Qld Health Minister Steven Miles said a suspension of the three-month opt out period should be on the table, with the roll out to resume when concerns about the current legislation, which provides access to My Health Record by law enforcement agencies without warrants, have been resolved. This is fine, but he seems to forget that a big chunk of his state was opted in and has been for 2 years. And dare I say the system seems to be working pretty good at the coal face.

A surgeons opinion. Although I think drawing a parallel between Dutch records, Nazi Germany and My Health Record is a bit tenuous. Remember, the Government has a lot of data already and the basis of MyHR will be a shared health summary and drawing in health information already stored on disparate computers. Australian’s are not unique in having concerns about a centralised repository of health information. The Dutch have expressed angst over their model.

A rundown of MyHR data breaches in 2017. “This year we received six data breach notifications from the My Health Record System Operator,” the Office of the Australian Information Commissioner’s annual report says.

A predictable left wing opinion in Red flag. “My Health Record a sick joke”

And just to show others have the same idea here is a compilation of opinions and articles from Trent Yarwood.


31/07/2018

For broken families, there are concerns raised about who can access and what information may be gleaned from a child’s My Health Record. Terese Edwards, chief executive of the National Council of Single Mothers and their Children, said she had “serious concerns” about the privacy and safety of vulnerable women under the My Health Record system, “especially if they have had an abusive or controlling person in their life and particularly if there’s children involved”.

How may you My Health record be breached. As above, one unknown is how secure your health care provider or home computer may be. This ABC article explained why health service providers suffer the most data breaches. Private health insurer’s data is not necessarily safe either as discussed in these ZDNet and HealthcareIt article . And remember private insurance companies are salivating after access to your My Health Record.

As an aside consider how secure your fitness app may be. It may not transmit your medical history but the data shared may put some users at risk as this article explains, Fitness tracking app gives away location of secret US army bases.


1/8/2018

Well, it seems the work of the AMA, RACGP amongst others have helped sway the politicians when it comes to strengthening My Health Record. My Health Record will need a court order for access, Greg Hunt says.  This is also discussed in this Guardian article. The RACGP president-elect Dr Harry Nespolon said Hunt’s amendments were necessary. “Changes to the legislation that remove any questions about who may be able to access the records ensure that the records will be able to be used in line with the RACGP’s position statement on My Health Records”

Says Minister Hunt in his media release dated 31/07/2018


3/8/2018

From The Conversation, My Health Record: Deleting personal information from databases is harder than it sounds. By Robert Merkel, a software engineer from Monash University in which he calls for a much longer hiatus to the opt out period. He explains what “deletion” may really mean, whilst the record may be kept in original state in a system backup and who may have access to this information.

The ABC has an article entitled, My Health Record still isn’t safe enough to proceed. It needs more than a band-aid fix. Suggesting that “medical records are far more valuable than credit card details as a means of identity theft, due to the massive amount of personal information they contain about you, your family and your life history. They are a jackpot for hackers, fetching a high price on the dark web.” Whilst also appearing on an ABC JJJ website it the story of medical being found in a derelict building. The documents contain deeply intimate information of more than 400 vulnerable patients’ personal profiles, medical conditions, behaviours, accidents, treatments, and medical history. This is a much richer source of information that anything contained on your My Health Record. In recent past there have been several incidents were record have been found discarded. In Alice Springs, Sydney, Adelaide and Sunshine Coast.

My Health Record: Canberra is still missing the point by Stilgherrian who has written several criticisms on My Health Records continues in Zdnet. In this article he focuses on the potential for misuse by the 900,000 healthcare workers who can access the system, ill-thought privacy controls, complex access control that will be difficult for ordinary humans to operate and the as-yet-unspecified “secondary use” of the data. “Even if the Commonwealth department that looks after My Health Record is locked down to the nth degree, and it probably is, a GP in any GP office throughout Australia can access that data and do whatever they want with it. Or any disgruntled dentist, nefarious nurse, or enraged endocrinologist.” Will have to watch out for those enraged endocrinologist wielding syringes of insulin!

Dr Kerry Phelps who has publically spoken out against the MyHealth Record hasn’t been convinced by Minister Hunt’s prospective changes. My Health concessions ‘woefully inadequate’, says former AMA president she suggests in this SMH article.


8/8/2018

How are GP’s using MyHR was a title for a Norman Swan podcast with Dr Ewen McPhee is a rural general practitioner who says My Health Record is invaluable to his practice. He says it helps to provide continuity of care to people moving across the region who see multiple practitioners and don’t necessarily keep good records. Dr McPhee says there are legitimate concerns around privacy issues, especially for minors and people with dementia, and argues there’s a need for further careful thought around how those areas are addressed.

The SMH is trying to scare people by raising the spectre of linking your genetic information to MyHR in this article. That is not to say that ADHA plans on collecting a swab from all Australians and hosting the results on MyHR, but if you have a genetic test done then the pathology company will upload it to your MyHR, unless you tell them not to by ticking the option on the pathology form. This raises the question as to why you want to have genetic testing done. It may open a can of worms which if insurance companies get hold may prejudice future health-related policies and lead to discrimination. This was discussed by Jane Tiller and Paul Lacaze in an article in The Conversation.

David Hunter write Using My Health Record data for research could save lives, but we must ensure it’s ethical in this article also in The Conversation.


11/8/2018

Great news you now have longer to opt-out. My Health Record opt-out period extended to November 15th, which will be a Thursday if you wanted to know. More time to procrastinate, but hopefully more time to sort out Section 70.

Meanwhile more unions are advising members to opt-out. Although I don’t see a media release on the ACTU wesbite, the Rail, Bus and Tram union does say post this media release.

ADHA had posted a media release reinforcing that access by insurers and employers My Health Record is prohibited. The relevant legislation, states

Healthcare Identifiers Act 2010
14  Collection, use and disclosure—providing healthcare to a healthcare recipient
(2)  This section does not authorise the collection, use or disclosure of the healthcare identifier of a healthcare recipient for the purpose of communicating or managing health                                  information as part of:
(a)  underwriting a contract of insurance that covers the healthcare recipient; or
(b)  determining whether to enter into a contract of insurance that covers the healthcare recipient (whether alone or as a member of a class); or
(c)  determining whether a contract of insurance covers the healthcare recipient in relation to a particular event; or
(d)  employing the healthcare recipient.

Meanwhile in Denmark, their citizens, we are told are embracing the Viking version of My Health Record. This was the take on the Danish system printed in the Medical Republic last year. And an article detailing the differences and similarities in the Australian and Danish system from prior to the opt-out change. Denmark and Estonia were both opt-out.


15/08/2018

Reports suggest a Parliamentary inquiry will be undertaken to examine security of My Health Record system have been in the latest news. This follows on calls from the opposition for a senate inquiry. HealthcareIt has a post of the twitter conversation between the health minister Greg Hunt and and his shadow Catherine King. Catherine King said these changes don’t go far enough, and a senate inquiry is needed to investigate the myriad problems surrounding My Health Record. You would of course remember that both parties have contributed to setting up of My Health Record. The respective legislation was written in 2012 when Labour, under Julia Gillard was leading the government. Still politicians like to do what they do best , and that is blame each other rather than fix the problem. We shall see what comes from the Senate inquiry, and we’ll just foot the bill for the cost of that.

If you are interested in what the Australian Senate are making inquiries into have a look at this page. Have a look here. They seem to be a busy bunch of people with 47 counted, ranging from red tape in private school education and electric vehicles to obesity and stillbirths. My Health Record isn’t actually mentioned on this page yet!

Meanwhile, a former Pentagon cyber chief says hackers could exploit My Health Record flaws. Jonathan Reiber hasn’t suggested he would be doing the hacking, but like all computerised databases, My Health Record would have attractions to criminals, just like your bank account, Facebook details, etc. Not that the Pentagon computer system has been safe. From a 2016 report, Meet the 18-Year-Old Who Hacked the Pentagon. Although apparently this hacker was encouraged to reveal security deficiencies there have been real hacks by IranRussians and Chinese, as well as some bored English dude with Aspergers.

It should be My Health Record by Dr Harry Nespolon, RACGP President (CIO, my college) provides his opinion on MyHR.


 

MyHR…. opt out, opt in but don’t just ignore? A rolling review….

PS I changed the title (last updated 15/8/18)

In case you haven’t heard, you will have to decide whether you want to opt-out of the Government My Health Record (MyHR) before the 15 October 2018 or you will be have one created for you.

MyHR is a great idea.

MyHR allows your GP to write a shared health summary and collates data from a disparate number of sources. These will eventually include blood tests, radiology reports, medication and allergy lists and discharge summaries. It is also a spot where track immunisations and keep your achievement diary!

I have one. For those living in North Queensland and the Blue Mountains you probably already have one too. Didn’t you recall getting a note from the Government that you could opt out about 2 years ago. Don’t worry a lot of people didn’t hear you had to either. I use MyHR for my patients several times a week. “I take those little blue tablets, doc”

There are however some issues with MyHR. A lot of my colleagues have decided to opt-out because of privacy and security concerns. There is a lot of media reports pushing the the opt-out option for example this article in Sydney Morning Herald by Ben Grubb. Ben was interviewed by Marc Fennel on Download This Show

There are legitimate questions about how secure the data will be, who will be able to access, will it be sold on for commercial use. Will insurance companies be able to access the data? Third party use of data is obviously controversial as discussed in this post.

For a run down of the negatives, the Australian Privacy Foundation may be a good site to have a look, although I suspect they have a bias.

ABC has a series of articles worth reading before you decide.

My Health Record: Your questions answered on cybersecurity, police and privacy

Here is a sensible discussion from ABC radio about its utility.

The Conversation has run an opt in and opt out article.

The Guardian has run a couple of articles, mostly pushing the opt-out line. The What is My Health Record is worth watching. A link to their commentary is below.

There is no social licence for My Health Record. Australians should reject it

My Health Record: privacy, cybersecurity and the hacking risk

There are obvious real concerns about any information stored on the internet. recently Singapore Health was the victim of sophisticated hacking. Just to not reassure you Wikipedia has a list of known data access breaches!

You will find other useful information about MyHR at the website of the Australian Digital Health Agency.

So, if you feel you are now better informed, go and either opt out of MyHR or opt-in and explore what is there and please don’t forget the privacy settings.

mhr-logo_large


I’ll try to keep a list of opinions as they spring forth from various sources.

21/7/18

Staying in or opting out: My Health Record goes viral for all the wrong reasons by Dr Ruth Armstrong and Dr Trent Yarwood from Croaky

This is an opinion blog from Dr Trent Yarwood myHR Secondary Use Framework

Why I am opting out of MyHealthRecord – for now by Dr Tim Leeuwenburg of Kangaroo Island

Top 10 most awkward questions about the MHR from Jeremy Knibbs at the Medical Republic.


22/7/18

My Health Record ‘identical’ to failed UK scheme, privacy expert says, a Guardian report which suspects MyHR and the failed UK care.data may be evil twins? Tim Kelsey who has been involved in both projects suggests otherwise. Here is his address to the National Press Club in May 2018.

Australian Health Information Technology is also a useful site to peruse. According to its author, it intends to inform readers of news and happenings in the e-Health domain, both here in Australia and world-wide. To provide commentary on e-Health in Australia and to foster improvement where he can. And, thirdly to encourage discussion of the matters raised in the blog so hopefully readers can get a balanced view of what is really happening and what successes are being achieved.


23/7/18

If you want to read the report on the Opt-out North Queensland/Blue Mountains trial have a look here.
The key outcome measures for this trial were;

  • increased awareness and understanding of the My Health Record system
  • increased confidence to use the My Health Record system
  • increased participation in, and use of, the My Health Record system
  • increased understanding of the effectiveness of different approaches for driving participation and use of the My Health Record system.

The outcomes were

  • the opt-out approach to increase both individual and healthcare provider participation and use is the preferred option (which is what have now)
  • continuation of current or accelerated opt-in approaches is considered to be unsustainable
  • the opt-out trial sites achieved better outcomes, in terms of participation, understanding and some aspects of use of the My Health Record system
  • key lessons were learned to inform Government’s understanding of the effectiveness of different approaches for driving participation and use of the My Health Record system

As a doctor, here’s why My Health Record worries me by former AMA President, Kerryn Phelps.

If you want to read the My Health Record Act 2012 you can find it here.

Section 70 is a controversial part which permits access to your record without the need for a court warrant. I have copied the section below. Many believe that this part needs to be changed to require a court warrant prior to anyone aside from you and your doctor accessing the MyHR.

Disclosure for law enforcement purposes, etc.

(1) The System Operator is authorised to use or disclose health information included in a healthcare recipient’s My Health Record if the System Operator reasonably believes that the use or disclosure is reasonably necessary for one or more of the following things done by, or on behalf of, an enforcement body:

(a) the prevention, detection, investigation, prosecution or punishment of criminal offences, breaches of a law imposing a penalty or sanction or breaches of a prescribed law;

(b) the enforcement of laws relating to the confiscation of the proceeds of crime;

(c) the protection of the public revenue;

(d) the prevention, detection, investigation or remedying of seriously improper conduct or prescribed conduct;

(e) the preparation for, or conduct of, proceedings before any court or tribunal, or implementation of the orders of a court or tribunal.

(2) So far as subsection (1) relates to paragraph (1)(e), it is subject to section 69.

(3) The System Operator is authorised to use or disclose health information included in a healthcare recipient’s My Health Record if the System Operator:

(a) has reason to suspect that unlawful activity that relates to the System Operator’s functions has been, is being or may be engaged in; and

(b) reasonably believes that use or disclosure of the information is necessary for the purposes of an investigation of the matter or in reporting concerns to relevant persons or authorities.

(4) If the System Operator uses or discloses personal information under this section, it must make a written note of the use or disclosure.

(5) This section does not authorise the System Operator to use or disclose healthcare recipient-only notes.

For reference the system operator is defined as the Secretary of the Department; or if a body established by a law of the Commonwealth is prescribed by the regulations to be the System Operator–that body.

From ZDNet, The My Health Record story no politician should miss written by Stilgherrian a freelance journalist. ZDNet is a tech website, not health. Another of his opinion pieces is entitled My Health Record opt-out debate is getting silly but government is at fault.

The list of politicians opting out seems to be growing Liberal MP Tim Wilson opts out of e-health record. (worth also looking through the comments for this article. I do hear that Malcolm Turnbull has opted in and favours access by insurance companies!

Why My Health Record can’t have ‘military-grade’ security, an opinion pieces by Peter Moon, technology lawyer calls out Minister Greg Hunt on discussion about MyHR security and the difference between no breaches versus no known breaches.

Crikey adds Peak GP body’s alleged support for My Health Record called into question. Here Ben Grubb gets me a little confused about the RACGP position on MyHR.

On Monday last week, the Australian Digital Health Agency (ADHA) issued a statement claiming “Australia’s peak GP, pharmacy, and healthcare bodies support My Health Record and the government’s decision to move the system to an opt out model”, listing various groups below it which included Australia’s peak GP body, the Royal Australian College of General Practitioners (RACGP). But when asked if it supported opt-out, the RACGP initially said in a statement: “The RACGP has never established a position on My Health Record being an opt-in or opt-out service.”Shortly after I put the RACGP’s response to Health Minister Greg Hunt’s office on Friday, who reiterated the RACGP’s incorrect statement of support of opt-out, the peak GP body contacted the author to issue an additional statement “clarifying our position”, which said: “The RACGP has never said that it does not support the opt out model of My Health Record.”


24/7/2018

My Health Record agency adds ‘reputation’, ‘public interest’ cancellation options to app contracts.

From the article

“My Health Record is scrambling to put tough new restrictions on mobile phone apps that use its sensitive patient data, including an option to cancel if the companies damage the system’s reputation. Companies Telstra, HealthEngine, Tyde and Healthi already have access to My Health Record information such as Medicare records, test results, scans and prescriptions, for their app users to view on mobile phones.”

Personally, I don’t think I would trust accessing my personal health information through a smart phone app. HealthEngine is also facing a massive crisis of confidence when users find adverts from lawyers pop up in their app. An article in the Guardian by author and oncologist Dr Ranjana Srivastava discusses some of the concerns of on-selling private data. It pays to read the fine print.

AMA president, Dr Tony Bartone, suggest that maybe your MyHR may save your life one day! Technically it would be the health care professional, doctor, nurse paramedic who does the actual saving. But if your MyHR contains vital information about a critical allergy or health problem, and if it can be seen by the doctor , nurse paramedic and they take heed then yes it may save your life.

Cassandra Cross a Senior Lecturer in Criminology from Queensland University of Technology discusses What could a My Health Record data breach look like? And, although Cassandra talks about how to upgrade you security in this article, obviously if the government is in charge of your data, having cryptic and regular password changes may not help.

Australia’s Human Rights Commissioner, Edward Santow, has urged the Federal Government to make changes to the My Health Record to restore confidence in the privacy and security of the system.

Now I don’t think comment from our Health Minister is real (it is from The Shovel), but then again maybe?


25/7/18

Article in the Guardian reinforces that Section 70 implies a court order is not necessary to access MyHR. This is at odds with what the Health Minister says. I think that is one of the biggest issues safeguarding MyHR and maintain public confidence that the Minister won’t know about your herpes.

This is also discussed by Nigel Brew in an article entitled Law enforcement access to My Health Record data on the Australian Parliament website. I agree with his suggestion that medical records registered in the MHR system need to be legally protected from access by law enforcement agencies to at least the same degree as records held by a doctor.

I am sure that Section 70 can be changed to assure security. This would mean that police investigating a crime, etc would need a court order to access data. I do wonder how often the judiciary deny a court order to police in this setting?  Then all we need to keep identifiable data out of third party users like health insurance companies.


26/7/18

Dr Edwin Kruys, recently RACGP Chair for Queensland is a keen blogger. In his latest Blog, Doctor’s Bag he highlights how much the Government wants your data.

Dr Tim Leeuwenburg is a rural GP who I used to work alongside on Kangaroo Island. We often had conversations across the hall when our doors were open about life, politics and healthcare. He is an active blogger and to be honest probably inspired me to join in. He is an active advocate for the “Opt Out until its fixed” group of citizens. His Blog KI Doc is worth looking reading.

Dr Tony Bartone, AMA president has suggested AMA says it will do ‘whatever it takes’ to ensure privacy. Dr Bartone revealed the Minister Greg Hunt, and the Australian Digital Health Agency had given him written undertakings that “without a court order … there is no way of access to the system for anyone other than the people nominated by the patient”.  Which of course is great but not binding, while Section 70 of the Act stands unchanged (see above).

In the same article, Greens leader, Dr Richard Di Natale, has been quoted as saying “If you want to access someone’s medical records, you should have to have a warrant, simple as that.”

The digital health project My Health Record could undermine the ability of young people to access confidential medical care, critics have warned in this ABC Science article. Access may be difficult for kids whose parents have split, particularly if parents are not on talking terms, or if there are domestic violence issues. The other question can a 14 year old navigate My Health Record?

Dr Harry Nespolan, new to the job as RACGP  President has made public that he has opted out as highlighted in this article form The Advertiser.  News from the Australian that Tanya Plibersek is not Opting out!

Malcolm Turnbull is try to bolster support for MyHR, and hopefully the politicians will be perusaded to make MyHR more secure.

Opting means business as usual. This article from The Conversation suggests there are benefits to the Health care system with MyHR which I think we can all agree on. Now if Section 70 can be reframed and some other issues sorted out well. Maybe the NQ trial wasn’t asking the right people the right questions?

The Police Union have expressed concern to their members about the lack of warrant to access MyHR. The Queensland Police Union told Guardian Australia it has “legal advice that there is nothing in the legislation that requires any enforcement body to obtain a warrant to access My Health Record”.

The article mentioned on the 25/6/18, has been edited as described in this Guardian article. Sorry if you click on the link to Nigel’s Brew’s paper you get a 404 message now. Dissent will not be tolerated? But can be found here…..nothing ever disappears fully on the internet!!


28/7/18

As the opt-out period for the My Health Record continues, so too does the debate surrounding issues of confidentiality. While possible data breaches have generated widespread concern, for one group – teenagers – it may not just be hackers they want to keep out. It may be their parents. Drs Mellisa Kang and Lena Sanci explain in an article from The Conversation. They are calling for a campaign to educate young people aged 14 to 18 to explain what the My Health Record will mean for them and how they can have the benefits of a record, without losing their rights to confidential health care.

This article by James Bullen publised by the ABC explains one of the potential benefits from data mining. A summary of the article mentioned in the news article

Heritability is essential for understanding the biological causes of disease but requires laborious patient recruitment and phenotype ascertainment. Electronic health records (EHRs) passively capture a wide range of clinically relevant data and provide a resource for studying the heritability of traits that are not typically accessible. EHRs contain next-of-kin information collected via patient emergency contact forms, but until now, these data have gone unused in research. We mined emergency contact data at three academic medical centers and identified 7.4 million familial relationships while maintaining patient privacy. Identified relationships were consistent with genetically derived relatedness. We used EHR data to compute heritability estimates for 500 disease phenotypes. Overall, estimates were consistent with the literature and between sites. Inconsistencies were indicative of limitations and opportunities unique to EHR research. These analyses provide a validation of the use of EHRs for genetics and disease research.

This Saturday paper article (which can be the one free article you read in this newspaper, unless you subscribe), discussed the the positives and perils of My Health Record.


29/7/2018

MHR debacle week 2, electric boogaloo, is an article by Pulse IT to summarise the last week in the MyHR story.

If you are interested in looking how the Government deals with privacy before MyHR and Section 70, the Privacy Act 1988, can be accessed here. If you want to see the specifically how health information and medical research is managed go here. The whole Act can be accessed here. This is not just about one’s health but all about what privacy we have from organisations that employ or services, represent us professional, sell stuff, buy stuff, insure against mishaps, fund our needs and wants or interact with us on a daily basis.

A number of Unions have advised members to Opt out. These include Mark Burgess, the chief executive of the Australian Police Federation, The Queensland Police Union, and the Electric Trade Union. Here is a responce from Tim Kelsey to Electric Trade union trying reassure that there are adequate securities in place. The Australian Council of Social Service has added its voice to change.

From earlier this month, this article was published on the MJA INsight. It’s title probably tells the opinion of the author, My Health Record: on a path to nowhere? by Bernard Robertson-Dunn from the Australian Privacy Foundation.

Here is a power point on the interaction between My Health Record, Pathology companies and several contentious issues, such as standing consent, and what to do if you do not wish to have your pathology tests uploaded to My Health Record. The default approach as per the ADHA is to have a standing consent to upload pathology results. Healthcare providers do not need to explicitly obtain permission from the patient before accessing or uploading information to their My Health Record. However controls need to be in place to prevent information (such as a diagnostics report) being sent to the My Health Record if the patient tells their provider that they don’t want it sent. You may notice a new tick box on pathology request forms. If you don’t want to upload, tick the box.

Remember not to read just the headlines WHY AMA CHIEF REFUSED TO GET A MY HEALTH RECORD shouts the Herald Sun . In fact if you read the article it actually says

“I don’t have a My Health Record because I haven’t had the time or opportunity and there hasn’t been the inclination to use it until now,” he said. Dr Bartone said he will automatically get a My Health Record when the opt out period ends in October.


30/07/2018

Australia’s former privacy commissioner, Malcolm Crompton, warned government officials about the dangers of an opt-out My Health Record system six years ago, but said his cautions were ignored. Mr Crompton now runs a private consultancy firm dealing with data protection. The article suggests, Mr Crompton, who has himself opted out, said he had little faith in the government’s ability to resolve the myriad of privacy and security issues. He would also like an audit on close to the million private practice computers that would link into My Health Record. He however didn’t comment on the 10 million of so that may link in from people’s homes as they review their My Health record.

Also in the Guardian, Ranjana Srivastava oncologist and author, writes patients trust their secrets to doctors, not the government or the tax office.

COAG health ministers are meeting in Alice Springs on Thursday and Qld Health Minister Steven Miles said a suspension of the three-month opt out period should be on the table, with the roll out to resume when concerns about the current legislation, which provides access to My Health Record by law enforcement agencies without warrants, have been resolved. This is fine, but he seems to forget that a big chunk of his state was opted in and has been for 2 years. And dare I say the system seems to be working pretty good at the coal face.

A surgeons opinion. Although I think drawing a parallel between Dutch records, Nazi Germany and My Health Record is a bit tenuous. Remember, the Government has a lot of data already and the basis of MyHR will be a shared health summary and drawing in health information already stored on disparate computers. Australian’s are not unique in having concerns about a centralised repository of health information. The Dutch have expressed angst over their model.

A rundown of MyHR data breaches in 2017. “This year we received six data breach notifications from the My Health Record System Operator,” the Office of the Australian Information Commissioner’s annual report says.

A predictable left wing opinion in Red flag. “My Health Record a sick joke”

And just to show others have the same idea here is a compilation of opinions and articles from Trent Yarwood.


31/07/2018

For broken families, there are concerns raised about who can access and what information may be gleaned from a child’s My Health Record. Terese Edwards, chief executive of the National Council of Single Mothers and their Children, said she had “serious concerns” about the privacy and safety of vulnerable women under the My Health Record system, “especially if they have had an abusive or controlling person in their life and particularly if there’s children involved”.

How may you My Health record be breached. As above, one unknown is how secure your health care provider or home computer may be. This ABC article explained why health service providers suffer the most data breaches. Private health insurer’s data is not necessarily safe either as discussed in these ZDNet and HealthcareIt article . And remember private insurance companies are salivating after access to your My Health Record.

As an aside consider how secure your fitness app may be. It may not transmit your medical history but the data shared may put some users at risk as this article explains, Fitness tracking app gives away location of secret US army bases.


1/8/2018

Well, it seems the work of the AMA, RACGP amongst others have helped sway the politicians when it comes to strengthening My Health Record. My Health Record will need a court order for access, Greg Hunt says.  This is also discussed in this Guardian article. The RACGP president-elect Dr Harry Nespolon said Hunt’s amendments were necessary. “Changes to the legislation that remove any questions about who may be able to access the records ensure that the records will be able to be used in line with the RACGP’s position statement on My Health Records”

Says Minister Hunt in his media release dated 31/07/2018


3/8/2018

From The Conversation, My Health Record: Deleting personal information from databases is harder than it sounds. By Robert Merkel, a software engineer from Monash University in which he calls for a much longer hiatus to the opt out period. He explains what “deletion” may really mean, whilst the record may be kept in original state in a system backup and who may have access to this information.

The ABC has an article entitled, My Health Record still isn’t safe enough to proceed. It needs more than a band-aid fix. Suggesting that “medical records are far more valuable than credit card details as a means of identity theft, due to the massive amount of personal information they contain about you, your family and your life history. They are a jackpot for hackers, fetching a high price on the dark web.” Whilst also appearing on an ABC JJJ website it the story of medical being found in a derelict building. The documents contain deeply intimate information of more than 400 vulnerable patients’ personal profiles, medical conditions, behaviours, accidents, treatments, and medical history. This is a much richer source of information that anything contained on your My Health Record. In recent past there have been several incidents were record have been found discarded. In Alice Springs, Sydney, Adelaide and Sunshine Coast.

My Health Record: Canberra is still missing the point by Stilgherrian who has written several criticisms on My Health Records continues in Zdnet. In this article he focuses on the potential for misuse by the 900,000 healthcare workers who can access the system, ill-thought privacy controls, complex access control that will be difficult for ordinary humans to operate and the as-yet-unspecified “secondary use” of the data. “Even if the Commonwealth department that looks after My Health Record is locked down to the nth degree, and it probably is, a GP in any GP office throughout Australia can access that data and do whatever they want with it. Or any disgruntled dentist, nefarious nurse, or enraged endocrinologist.” Will have to watch out for those enraged endocrinologist wielding syringes of insulin!

Dr Kerry Phelps who has publically spoken out against the MyHealth Record hasn’t been convinced by Minister Hunt’s prospective changes. My Health concessions ‘woefully inadequate’, says former AMA president she suggests in this SMH article.


8/8/2018

How are GP’s using MyHR was a title for a Norman Swan podcast with Dr Ewen McPhee is a rural general practitioner who says My Health Record is invaluable to his practice. He says it helps to provide continuity of care to people moving across the region who see multiple practitioners and don’t necessarily keep good records. Dr McPhee says there are legitimate concerns around privacy issues, especially for minors and people with dementia, and argues there’s a need for further careful thought around how those areas are addressed.

The SMH is trying to scare people by raising the spectre of linking your genetic information to MyHR in this article. That is not to say that ADHA plans on collecting a swab from all Australians and hosting the results on MyHR, but if you have a genetic test done then the pathology company will upload it to your MyHR, unless you tell them not to by ticking the option on the pathology form. This raises the question as to why you want to have genetic testing done. It may open a can of worms which if insurance companies get hold may prejudice future health-related policies and lead to discrimination. This was discussed by Jane Tiller and Paul Lacaze in an article in The Conversation.

David Hunter write Using My Health Record data for research could save lives, but we must ensure it’s ethical in this article also in The Conversation.


11/8/2018

Great news you now have longer to opt-out. My Health Record opt-out period extended to November 15th, which will be a Thursday if you wanted to know. More time to procrastinate, but hopefully more time to sort out Section 70.

Meanwhile more unions are advising members to opt-out. Although I don’t see a media release on the ACTU wesbite, the Rail, Bus and Tram union does say post this media release.

ADHA had posted a media release reinforcing that access by insurers and employers My Health Record is prohibited. The relevant legislation, states

Healthcare Identifiers Act 2010
14  Collection, use and disclosure—providing healthcare to a healthcare recipient
(2)  This section does not authorise the collection, use or disclosure of the healthcare identifier of a healthcare recipient for the purpose of communicating or managing health                                  information as part of:
(a)  underwriting a contract of insurance that covers the healthcare recipient; or
(b)  determining whether to enter into a contract of insurance that covers the healthcare recipient (whether alone or as a member of a class); or
(c)  determining whether a contract of insurance covers the healthcare recipient in relation to a particular event; or
(d)  employing the healthcare recipient.

Meanwhile in Denmark, their citizens, we are told are embracing the Viking version of My Health Record. This was the take on the Danish system printed in the Medical Republic last year. And an article detailing the differences and similarities in the Australian and Danish system from prior to the opt-out change. Denmark and Estonia were both opt-out.


15/08/2018

Reports suggest a Parliamentary inquiry will be undertaken to examine security of My Health Record system have been in the latest news. This follows on calls from the opposition for a senate inquiry. HealthcareIt has a post of the twitter conversation between the health minister Greg Hunt and and his shadow Catherine King. Catherine King said these changes don’t go far enough, and a senate inquiry is needed to investigate the myriad problems surrounding My Health Record. You would of course remember that both parties have contributed to setting up of My Health Record. The respective legislation was written in 2012 when Labour, under Julia Gillard was leading the government. Still politicians like to do what they do best , and that is blame each other rather than fix the problem. We shall see what comes from the Senate inquiry, and we’ll just foot the bill for the cost of that.

Meanwhile, a former Pentagon cyber chief says hackers could exploit My Health Record flaws. Jonathan Reiber hasn’t suggested he would be doing the hacking, but like all computerised databases, My Health Record would have attractions to criminals, just like your bank account, Facebook details, etc. Not that the Pentagon computer system has been safe. From a 2016 report, Meet the 18-Year-Old Who Hacked the Pentagon. Although apparently this hacker was encouraged to reveal security deficiencies.

Thinking about procreating?

Whatever you call it – up the duff, knocked up, a bun in the oven or eating for two, before getting pregnant there are a couple of things worth considering. Now because I am a doctor and I’m not supposed to get judgmental, I’m not questioning whether it is a good thing for you at this time in your life career or relationship, nor will I question the choice of you partner, I’ll leave that discussion to your Mum. What I would like to suggest is the opportunity to chat about some of the medical issues around pregnancy and if there are tests or other things that need to be done beforehand.

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If this is your first pregnancy, there is a lot of information out on the internet. You will find everyone has their own opinion on many aspects of pregnancy from trying to predict the gender of your baby, what foods to eat and avoid, how generally how to live your life.

If this is not your first pregnancy, many authorities suggest waiting at least 18 to 24 months before planning to try again.

New technology means you can and your partner can undertake genetic screening. Certainly if there a family history of a chromosomal or genetic disorder, testing has been recommended by RANZCOG.

For everyone else, screening for carrier status for common genetic conditions are available at a price.  These may include conditions such as cystic fibrosis, spinal muscular atrophy and fragile X syndrome. This article from The Conversation discusses whether you may or may not want to spend your money. And what would you do if you discovered both of you were carriers?

Although having a pap smear during pregnancy is not difficult and wont cause a miscarriage, it may be worthwhile getting it done beforehand. Remember that this year how we do cervical cancer screening has changed. And whilst we are talking about pap smears we should mention preventing, screening for and treating sexual transmitted infections, viral hepatitis and HIV.

Do you both need to make some lifestyle changes? Remember, to make a healthy baby it is often said you need healthy sperm and a healthy egg, Not unsurprisingly, a lot of things that many people do on a daily basis can have an adverse effect on a pregnancy. There are some obvious things, like smoking tobacco and cannabis, drinking alcohol and using other drugs.

If you are eating a healthy diet then this is a good start. You may need to be a bit more careful with food preparation to avoid germs such a Listeria and Toxoplasma. The “avoid food list” usually contains paté, soft cheeses (eg feta, brie, blue vein), prepackaged salads, deli meats and chilled or smoked seafood. In addition some fish may contain high levels of mercury which is toxic.

Should you take extra vitamins? Currently there is good evidence for taking extra folic acid and iodine, but if you are eating a healthy diet then multivitamins, including those pregnancy vitamins, are probably a waste of money.

Challenging yourself to keeping to a healthy weight through regular exercise and a healthy diet can help make pregnancy safer. Maintaining a healthy weight may improve the chance of getting pregnant or fecundity. For some women this may mean gaining weight or for others loosing weight.

Prescriptions medications, and I’m not just talking about the contraceptive pill can affect a pregnancy and may need to changed. Medications available over the counter or from the naturopath may also need to be discussed.

We should also talk about known medical illness like asthma, epilepsy, high blood pressure and diabetes before embarking on a pregnancy. How’s your mental health. Are there any pregnancy problems that seem to run in your family?

Do you need to see a dentist? There is some evidence that having periodontal disease can can have an adverse effect on your pregnancy.

Are your immunisations up to date? Some immunisations can’t be used in pregnancy as they contain live virus. These include Rubella and Chickenpox. Both of these illnesses can cause harm to your developing baby and a vaccination will provide protection from these illnesses. Other vaccinations such as influenza and whopping cough (pertussis) are recommended in pregnancy.

Have you planned an overseas holiday when you could be pregnant? Will it be safe to fly, will the airline let you fly. Would you travel insurance cover you having a baby out side of Australia. What would you do if you went into premature labour in Mongolia? Malaria can be bad for a pregnancy. There are some uncertainties around other infectious diseases such as Zika and Dengue fever, to name but a few.

Are there any test that need to be done apart from those mentioned already? I would usually check your blood group and consider other tests as guided by the consultation.

Now lets talk about how you need to have sex to get pregnancy…..oh you already know that. And when is the best time to have sex for a baby not just fun? Great.

 

 

 

 

 

 

Please ask!

Too often I am told whatever you think doc.

I can see the point of this question, after all, I spent four years training to be a pharmacist, then another four to be a doctor, and six more years to pass my fellowship exams to become a GP with ongoing active education. Not a day goes by when I cant say I learn’t something new. My patients are often my greatest teachers.

But may I encourage you to questions your doctor, because it is after all your health we are talking about.

Choosing Wisely Australia is helping healthcare providers and consumers start important conversations about improving the quality of healthcare by eliminating unnecessary and sometimes harmful tests, treatments, and procedures.

Here are 5 questions to ask your doctor

1. Do I really need this test, treatment or procedure?

Tests may help you and your doctor or other health care provider determine the problem. Treatments, such as medicines, and procedures may help to treat it.

I have been taught that you order a blood test to answer a clinical question, for example, could this patient have an over active thyroid? Tests are not for fishing expeditions!

I have had some challenging consultation after a patient has seen a naturopath trying to determine which tests might be clinically necessary. The RACGP has come out with this document to support the decision making process.

2. What are the risks?

Will there be side effects to the test or treatment? What are the chances of getting results that aren’t accurate? Could that lead to more testing, additional treatments or another procedure?

Some tests, treatments and procedures provide little benefit. And in some cases, they may even cause harm. For example, for most lower back pain an x-ray may lead down a path of ending up with more invasive treatments which may not help. 

Even blood tests are not without risk. Any sharp instrument going through the skin can lead to infection!  An imperfect screening test for prostate cancer, Prostate Specific Antigen may lead a bloke on the pathway to a painful biopsy, then surgery which may leave him impotence and incontinent for the rest of his life. All for removal of a potentially slow growing cancer that he may have died with rather than from.

3. Are there simpler, safer options?

Are there alternative options to treatment that could work.

To reduce the risk of a heart attack, should you take a cholesterol lower medication with the risk of side effects or cut back on fast foods and exercise more?

Is it safer to take a tablet or injection to improve you B12 or iron levels?

4. What happens if I don’t do anything?

Ask if your condition might get worse — or better — if you don’t have the test, treatment or procedure right away.

This is a most challenging question because a doctor is trained to do something. Push on a chest, give a drug, order an x-ray, cut out badness…..
But sometimes doing nothing is all that is required. Recently, I chatted with a palliative care nurse who told me about a patient’s distress that the doctor who operated on her cancer didn’t visit in her final week. I replied it was probably because the doctor felt he had nothing to offer, that he had failed to cure her. But the patient wasn’t angry that the surgery didn’t work, she didn’t want more procedures, tests or medicine, she just wanted him to be present for a moment, to be seen at her door, to care. That was all. Sometimes it is okay to do nothing.

5. What are the costs?

Costs can be financial, emotional or a cost of your time. Where there is a cost to the community, is the cost reasonable or is there a cheaper alternative?

I meet people who seem genuinely surprised that they don’t necessarily need to see a specialist dermatologist for a skin cancer check; that a GP is able to do this usually then and there.

 

Why I don’t see Drug Reps

It’s not just about the pen!

A very small part of the Dr Caren’s collection of Drug company pens

Should I continue to use drug reps as my primary source of information about new drugs?

There is certainly support out there if I do go down this path. There are doctors out there who already say no to drug representatives.  http://www.nofreelunch.org/ and http://noadvertisingplease.org/

Dr Brett Montgomery has written on the subject here  https://theconversation.com/why-i-dont-see-drug-reps-a-gps-take-on-big-pharma-spruiking-32435

And it’s not just doctors that they target, nurses are also seen as a way into the prescribing sphere of influence. https://theconversation.com/invisible-influence-why-sales-reps-are-forming-relationships-with-nurses-57061

Here is the New Zealand perspective https://theconversation.com/drug-ads-only-help-big-pharmas-bottom-line-so-why-are-they-allowed-45317

As this paper entitled Following the Script: How Drug Reps Make Friends and Influence Doctors from a few years ago suggests

“Reps may be genuinely friendly, but they are not genuine friends. Drug reps are selected for their presentability and outgoing natures, and are trained to be observant, personable, and helpful.”

Dr Ben Goldacre has blogged on his BadScience website and written on the influence of pharmaceutical companies on drug utilisation.  After eventually making it through his book, Bad Pharma I felt a very pessimistic about the whole process. It’s a bit like House of God, essential junior doctor reading.

A list of problems include

  • Missing clinical data which the rep probably doesn’t know about either
  • Positive paper publication bias
  • Ghost writers instead of academics
  • No decent independent head to head studies, so what if me2 is better than placebo is it better than the first drug?
  • Kick backs to medical journals
  • Half blind public agencies
  • Statistical manipulations and sub-subgroups analysis
  • Glossed over serious adverse effects. “The risk of thyroid cancer with Saxenda is over rated!” or “No that only happens in beagles”
  • Glossy brochures and advertising in journals.
  • Pushy drug reps and their inducements – which do seem limited to lunch rather than international flights these days.
  • Leaving behind drug samples as starter packs
  • Subsidising patients support groups and turning them into pharmaceutical lobby groups
  • Product familiarisation campaigns
  • Breaking news on popular media dressed up as “news” stories
  • Chatting in the ear of the clinic nurses, who also look after the sample cupboard. I wonder if any rep has suggested that the oppositions product be pushed to the back or even in the bin?
  • Paying specialists to “educate” GPs
  • Creating a “disease” to sell a product, eg fibanserin for a woman’s poor libido

As a health professional am I impervious to drug rep propaganda? I think the evidence suggests NO.

A few hints include the average sales force expenditure for pharmaceutical companies is $875 million annually and that is just in the USA. Being Australian, I am of course more skeptical and cynical but even so it has been estimated that in 2012, $30 million was spent by pharmaceutical companies trying to persuade doctors to use their product. I think it safe to assume no one would spend that kind of money if there wasn’t some return.

So where to find unbiased information?

National Prescribing Service would be a good place to start in Australia.

This paper by Richard O Day and Leone Snowden details other useful sources of drug information.

I have also listened to this podcast about conflict of interest. Sam Manger talks about how we may be able to immunise ourselves against drug rep influence.

 

I think these are pretty good reasons why we have decided drug reps don’t visit the clinic I work in.