This Week Has Seen A Lot Of Reviews On The Issue Of Software And/As Medical Device Regulation.

First we had this:

Need a doctor? There's an app for that, but new TGA risk classification rules apply

Johnson Winter & Slattery - Christine Ecob and Stanley Yu

Australia

March 5 2021

Apps that treat, diagnose or monitor a condition are likely to be subject to more stringent pre-market requirements under newly implemented reforms.

Standalone software (which is not attached to any physical medical device), commonly in the form of a mobile app, is increasingly becoming one of the means upon which we treat, diagnose or monitor a condition.

Such an app (if its intended purpose is medical and it is not an excluded product) may constitute a medical device (Software as a Medical Device or SaMD) under the Therapeutic Goods Act 1989 (Cth) and must be registered on the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

The documentation required to register a SaMD onto the ARTG will depend on its risk classification, and there have been changes to the way SaMD is classified since 25 February 2021.

Importantly, if your SaMD has already been registered on the ARTG, you will have until 25 August 2021 to re-apply for ARTG entry (and as part of that, re-assess your SaMD under the new classification rules) or notify the Therapeutic Goods Administration to get more time to do so.

So what has changed?

New classification rules applying to SaMD have been inserted into the Therapeutic Goods (Medical Devices) Regulations 2002. SaMD covered by the amended regulations includes software that:

(a) recommends treatment or intervention (e.g. specifying exercises to treat a back pain injury);

(b) screens or diagnoses a condition (e.g. melanoma detector);

(c) provides therapy through provision of information (e.g. posture corrector providing exercise instructions); and

(d) monitors a condition (e.g. monitoring sleep to predict risk of sleep apnoea).

Lots more here:

https://www.lexology.com/library/detail.aspx?g=bf6f1690-3053-4aa8-9f9f-56b08803f238

Second we have this:

TGA implements stricter regulation of software-based medical devices

Australia March 10 2021

DLA Piper - Joanne Lim and Eliza Jane Saunders

The Australian Therapeutic Goods Administration (TGA) has implemented reforms to the regulation of software-based medical devices, including software that functions as a medical device in its own right (i.e. it is not attached to any physical medical device).

Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 (Regulations) include:

• clarifying the boundary of regulated software products;
• introducing new classification rules for software based medical devices that:
• provide a diagnosis or screens for a disease or condition;
• monitor the state or progression of a disease or condition, or the parameters of a person with a disease or condition;
• specify or recommend a treatment or intervention; or
• provide therapy through the provision of information; and
• providing updates to the essential principles to more clearly express the requirements for software-based medical devices.

The new classification rules will subject these software-based medical devices to more stringent pre-market requirements (such as external conformity assessments) depending on the function of the device, risk of harm and whether the user is a health professional or patient. Software-based medical devices are classified from Class I (low risk) to Class III (high risk).

The changes came into effect from 25 February 2021 and all applications for inclusion of software-based medical devices in the ARTG made after this date must meet the amended classification rules.

More here:

https://www.lexology.com/library/detail.aspx?g=e68db991-b4b1-4071-bacf-2a24de53a7cc

And third we have this as a release from the industry:

New regulation for software-based medical devices

By Bronwyn Le Grice*
Monday, 08 March, 2021

Changes to the regulation of ‘software as a medical device’ (SaMD) by the Therapeutic Goods Administration (TGA) mark a coming of age for the healthcare system of the future — one which is connected, asynchronous, data-driven and patient-centric.

Under these changes, software-based products that make health claims are now subject to a medical device classification aligned to the risk level to the patient. This includes devices that:

• provide a diagnosis or screen for a disease or condition;
• monitor the state or progression of a disease or condition, or the parameters of a person with a disease or condition;
• specify or recommend a treatment or intervention; or
• provide therapy through the provision of information.
   

From 25 February, products not listed on the Australian Registry for Therapeutic Goods (ARTG) will be prevented from being sold in Australia.

The TGA has worked closely with ANDHealth and the industry over the last two years to usher in this new regulatory framework. This puts us in step with global markets like the US who already have similar regulation structures in place and is the first step to wide-scale adoption and acceptance of technologies that have the potential to significantly reduce healthcare inefficiencies while simultaneously improving patient outcomes.

The TGA has created ‘carve outs’ for certain products that are considered low risk, present a low risk to users, or are subject to other mechanisms of oversight, including an exemption for clinical decision support software (CDSS) that meets the definition of a medical device. This allows health system software providers to continue with their important work in improving connectivity within the healthcare system, but brings a regulatory oversight component into play when technologies are claiming to directly impact the diagnosis, prevention, monitoring, treatment or alleviation of diseases, injury or disability.

Overcoming the challenges of outdated regulation

Rapid innovation has driven significant changes to software function and adoption, giving rise to a larger number of software applications (with or without connected devices) able to inform, drive or replace clinical decisions, or directly provide therapy to an individual, including via sustained patient behavioural change and engagement. Patient and clinician access to patient-generated data has become much easier with personal devices such as smartphones, wearables and tablets. These rapid advances in technology have led to a large increase in the number of software-based medical devices, including digital therapeutics, available globally.

Most therapeutic and medical device regulatory frameworks were developed before the internet and smartphones, meaning existing regulatory frameworks have often lagged behind modern digital health innovations. This regulatory uncertainty has made it difficult for digital health to flourish. In a survey of over 50 digital health growth companies in Australia, undertaken by ANDHealth in 2020, only 25% felt completely confident navigating digital health regulation in Australia. At the same time, regulators and governments need to preserve the necessary quality and evidence thresholds with respect to safety, efficacy and value of healthcare products.

Regulation improves safety and access, and paves the way for reimbursement

Like any health products, software can have adverse effects. We don’t accept pharmaceuticals, vaccines or medical devices that aren’t approved by our medical regulator, so why would we treat digital interventions that make similar health claims any differently?

Digital health companies need to provide robust clinical evidence on efficacy and safety, verified by an independent regulator, to substantiate the claims they make about the impact of their products and services on patients. At the same time, patients and users should be able to trust that the product does ‘what it says on the box’ (or on the app store). If a software application claims it can help patients with type 2 diabetes reduce their HbA1c levels, or that it can provide support and management of complex medication regimes for serious illness, then the manufacturers should have robust clinical evidence to support that claim.

A strong regulatory environment increases the availability of products that benefit the health of Australians, whilst providing the right level of regulatory rigor for safety, quality and efficacy, which allows clinicians and patients to have trust in the products and their likely outcomes. This type of regulation also creates an important distinction between evidence-based digital health products, digital therapeutics and general consumer wellness products, and prevents those in the latter category making more serious health claims when they do not have sufficient data or necessary regulatory approvals.

Third-party authentication of clinical evidence, claims, product quality and patient outcomes through established regulatory mechanisms provides clinicians with trust in claims made by software and app providers. This opens the door for clinicians to use and prescribe safe, evidence-based digital health technologies to their patients (including those already approved overseas) and paves the way for reimbursement frameworks in the near future, which will make these new types of interventions cost-effective for patients and clinicians alike.

Evolution of our healthcare industry

The establishment of a clear and well-communicated regulatory pathway for digital health applications is a critical step in the evolution of our healthcare industry and recognises the role that digital health will play in the health system of the future, supporting the safety of current and emerging digital health technologies.

We welcome the introduction of these regulatory changes, which mark a critical first step in supporting the uptake of technologies that can improve the efficiency and impact of the healthcare system in Australia.

*Bronwyn Le Grice is the founder and CEO of ANDHealth, an Australian digital health accelerator and incubator.

Here is the link:

https://www.hospitalhealth.com.au/content/technology/article/new-regulation-for-software-based-medical-devices-508576514

It is going to be interesting to see how this all plays out and what the practical, real world outcomes are.

This paragraph from the third article has me a little confused.

“The TGA has created ‘carve outs’ for certain products that are considered low risk, present a low risk to users, or are subject to other mechanisms of oversight, including an exemption for clinical decision support software (CDSS) that meets the definition of a medical device. This allows health system software providers to continue with their important work in improving connectivity within the healthcare system, but brings a regulatory oversight component into play when technologies are claiming to directly impact the diagnosis, prevention, monitoring, treatment or alleviation of diseases, injury or disability.”

Surely CDSS is just the sort of system you would want to be confident that it is both reliable and fit for purpose!

I am taking a wait and see approach to all this for now!

David.

 

It Is A Pity That We Don’t See More Balanced Views On Clinical Software Errors.

This appeared las week:

Medical software blamed for fatal anticoagulant double-dosing error

Hospital doctors relying on the Cerner system accidentally prescribed an additional dose of apixaban

11th March 2021

By Antony Scholefield

A hospital software system has been blamed for a fatal anticoagulant double-dosing error after it displayed a prescribing icon so small that it could not be seen on a standard computer screen. 

In 2019, Ian Fraser was admitted to the Sunshine Hospital in Melbourne with an exacerbation of his congestive cardiac failure as well as community-acquired pneumonia.

He had a complex medical history ranging from rheumatoid arthritis and COPD to hypertension, AF and osteoporotic spinal crush fractures, with the result that he was on 14 different regular medications, including anticoagulants.

The 68-year-old eventually underwent a pleural tap. His condition improved slightly and he was restarted on enoxaparin.

During this time however, a respiratory registrar using the hospital’s Cerner electronic medical records system attempted to prescribe Mr Fraser apixaban as a discharge medicine.

He initially made a mistake, inadvertently writing the script as an inpatient order.

The registrar realised what had happened two minutes later and tried to correct it. Thinking that he had been successful, he remained unaware that the inpatient order was still active.

Soon after his pleural tap, Mr Fraser was transferred to the nearby Footscray Hospital for a pleurodesis and decortication.

Since the registrar’s script was in the Cerner system, just before Mr Fraser was due to undergo the procedure he was given an additional dose of apixaban on top of the enoxaparin. 

According to the Victorian coroners court, he subsequently developed a large retroperitoneal haematoma and died two weeks later.

Following the death, a hospital review concluded the incident was a result of the medical software, a system used in multiple public hospitals in Victoria.

The review said the electronic medical record had displayed both the inpatient and discharge medication on the same screen.

However, the icon used to differentiate inpatient from outpatient medications was "too small to be appreciated on a standard computer monitor".

This resulted in the doctor inadvertently suspending the discharge script rather than the inpatient script.

The review also discovered that the Cerner system had no alert to warn that a patient was being prescribed two medications of the same class

It also said the system's terminology was unnecessarily confusing.

"Medications are 'ordered' for inpatients and 'prescribed' for discharge. Medication orders/prescriptions can be either 'discontinued', 'suspended' or 'withheld'."

The Sunshine Hospital originally planned to prevent a repeat of the adverse event by updating its version of the Cerner software and giving more training to doctors on how to use it.

The hospital also said it would ask the Cerner Corporation, a $20 billion US-based company, to fix the problem globally.

But an expert report given to the coroners court said offering more training to doctors implied Mr Fraser’s death was the result of a “user error” when in reality it was a "user interface design induced error".

"Training without addressing the underlying usability issues is relatively ineffective, particularly considering the high staff turnover rate of the public hospital system," the expert report said.

…….

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More information: Coroner's findings

More here:

https://www.ausdoc.com.au/news/medical-software-blamed-fatal-anticoagulant-doubledosing-error

It really seems to me that coroners and others are all to quick to blame software for patient harms and deaths without considering that in pretty much every case the cause of a problem is multifactorial.

In this case we have all sorts of factors involved for example.

There are pretty much always user unfamiliarity or training issues found.

There are potentially local system configuration issues which my have affected the display of medication and possibly purchase of less than optimal monitors to display the screens ideally.

There are very often UI design issues which may or may not be important.

As the last line of defence against problems remember someone has to actually administer medications – are they not at least partially for giving two similar medications, without checking.

Any expert who says an issue is “user interface design induced error" as a sole cause of death is not worthy of being called an expert IMVHO.

All this said we need to remember 2 things:

1. Cerner is involved in supporting the delivery of care to 1000’s of patients each year and very few come to harm! Many more errors originate elsewhere in the system.

2. Analysis of each of these sorts of events should be a ‘teachable moment’ for all those involved in software systems so sensible overall incremental improvement can be fostered in a sensible and controlled fashion.

The essential truth to remember is that every software system assisting care has a human telling it what to do!

David.

Commentators and Journalists Weigh In On Digital Health And Related Privacy, Safety, Social Media And Security Matters. Lots Of Interesting Perspectives - March 16, 2021.

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This weekly blog is to explore the news around the larger issues around Digital Health, data security, data privacy, AI / ML. technology, social media and related matters.

I will also try to highlight ADHA Propaganda when I come upon it.

Just so we keep count, the latest Notes from the ADHA Board were dated 6 December, 2018 and we have seen none since! Its pretty sad!

Note: Appearance here is not to suggest I see any credibility or value in what follows. I will leave it to the reader to decide what is worthwhile and what is not! The point is to let people know what is being said / published that I have come upon.

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https://www.smh.com.au/technology/the-good-bad-and-the-ugly-of-our-hyperconnected-world-20210311-p579v2.html

The good, bad and the ugly of our hyperconnected world

By Tim Biggs

March 14, 2021 — 12.01am

Imagine what COVID-19 would have been like had it hit 15 years ago, before smartphones, video calls and social media. No Slack and Zoom to keep the workers busy in their home offices and no Netflix to keep us entertained.

For better or for worse the digital tools that have kept us connected and informed through COVID now also hold us captive. And as the pandemic and our response to it enters its next phase, it’s worth reflecting on the pros and cons of our hyperconnected world.

Digital is not infallible and the pandemic has also exposed a fragility in the web of technologies working to deliver the services. From network outages to cyber attacks, it’s been a steep learning curve for many of us to get comfortable with the primacy of devices.

Home offices to the rescue

The most obvious impact of the internet on the pandemic response was that keeping almost everybody at home and not physically interacting, while keeping many industries and the economy in general from collapsing, was a viable possibility for perhaps the first time in history.

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https://digitalhealth.org.au/blog/advocating-in-aged-care/

Advocating in aged care

Mar 9, 2021 | Aged care, AIDH news

Message from the CEO: The final report of the Royal Commission into Aged Care Quality and Safety released last week highlighted a need for digital advancement as part of the overall transformation of the aged care system.

Aged care has long been on our digital health agenda and I’m pleased to announce today we are going to be collaborating with the Aged Care Industry Information Technology Council (ACIITC) to work together and leverage the progress we have made in digital health, sharing what we have learnt for the benefit of the aged care sector.

We believe aged care is entering the same journey taken by healthcare for over 20 years. While we are still facing challenges, there are many practical ways digital health successes, learnings and innovation can be applied to the aged care system. Working with ACIITC, which is led by Dr George Margelis, we will engage Fellows and Members in specialist areas including workforce development, data use, standards and interoperability.

Look out for updates and notice of our first online information session. You can download the media release here.

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https://www.theaustralian.com.au/weekend-australian-magazine/the-rise-of-ecommerce-king-ruslan-kogan/news-story/72999d51a5251be8de5d57bf2a7bbf08

The rise and rise of Ruslan Kogan

Ruslan Kogan it isn’t entirely joking when he admits his $1.5bn business is really a data analytics company masquerading as an online retailer.

By John Stensholt

·         From The Weekend Australian Magazine

March 12, 2021

The person at the vanguard of the Australian e-commerce ­revolution is a 38-year-old tech nerd who is talking about ­lavender-infused memory foam mattress toppers and snake repellent. It is not that Ruslan Kogan is an expert in either product, and it is highly unlikely that he would be able to show how either worked should he ever knock on your front door. But Kogan is the modern online equivalent of the travelling salesman going from house to house selling encyclopedias or vacuum cleaners.

Kogan will tell you he knows exactly what you want and why you want it. But it isn’t gut feel. In his case he has the data to back it up, and it isn’t entirely a joke when he admits his business is really a data analytics company masquerading as an online retailer. Winning in the cut-throat world of e-commerce is all about the data, and the founder and boss of Kogan.com has done plenty of winning lately, combining dotcom smarts with sales skills at a time when Covid-19 sent online buying into overdrive.

The ringing of the doorbell and the thud of a cardboard box on the front doorstep became a ubiquitous part of the day for many Australians in lockdown. Spending on household goods generally rises by about one per cent a year, but in March last year it spiked 10 per cent compared to March 2019. By May, the Australian Bureau of ­Statistics reported that spending on household ­electronics, hardware and garden items had risen 29 per cent ­compared to the previous May; June was another 29 per cent rise, and on it went.

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https://www.theaustralian.com.au/inquirer/learning-all-about-you-in-the-snap-of-an-app/news-story/efe446e127e403567d416628a8d31084

Learning all about you in the snap of an app

·         By Jon Fasman

·         12:00AM March 12, 2021

Clearview AI developed a facial recognition app that when a user snaps and uploads a picture of anyone they see, the app tells them who that person is, thanks to Clearview’s database of more than three billion images scraped from the public domain, including Facebook, YouTube and other widely used sites. That’s more than seven times as big as the FBI’s facial recognition database.

To put it another way, if you are an American, there is a one in two chance that you’re in an FBI-accessible database. If you are in a First World country, you’re probably in Clearview’s. Anyone who has Clearview’s app on their phone can learn in a few seconds who you are, and with a little sleuthing they can find out your address, employer, friends, family members and any other information about you that may be online.

Hundreds of law enforcement agencies use it, as do some private companies. Some of Clearview’s investors — and their friends — have used it as well: John Catsimatidis, a grocery store magnate, happened to see his daughter on a date with someone he didn’t recognise. He asked a waiter to take the guy’s picture, which he then ran through Clearview. Within seconds, the app told him who his daughter was eating dinner with — a venture capitalist from San Francisco. Catsimatidis also used it in his stores to identify ice-cream thieves.

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https://medicalrepublic.com.au/healthengine-back-in-hot-water-with-gps/41647

12 March 2021

HealthEngine back in hot water with GPs

Comment Political TheHill

Posted by Jeremy Knibbs

HealthEngine, winner of a commonwealth contract to provide a centralised COVID vaccination booking engine, has confused a lot of practice managers with a marketing email that competitors claim is misleading.

CEO Marcus Tan has conceded the confusion and told TMR that a clarification is forthcoming.

Last week HealthEngine announced with much fanfare to the media that it had won the Department of Health contract to provide a booking engine service for free to any GP practices that had been approved to provide COVID vaccinations, but which still does not have a booking engine.

Immediate complaints surfaced about the company’s press release, which fails to make any mention of the fact that the contract is only meant to service GP practices which do not currently use a booking engine, and which does not point out that practices with existing booking engines would not be able to drop their current booking engine provider for on the basis that the government is now offering a booking engine service which is effectively free.

Emma Hossack, CEO of the Medical Software Industry Assocation (MSIA), confirmed last night to TMR that the DoH contract is only meant for those practices which do not already have a booking engine service, that the centralised service being offered by the Commonwealth through HealthEngine is temporary only, and that as the service is free, practices could not swap out their existing service for the free service.

Despite this HealthEngine sent a marketing email to all the practices on its email list. This list included many practices with existing booking engines, practices which are using competitive booking engines to their own. That email is reproduced below.

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https://www.ausdoc.com.au/news/medical-software-blamed-fatal-anticoagulant-doubledosing-error

Medical software blamed for fatal anticoagulant double-dosing error

Hospital doctors relying on the Cerner system accidentally prescribed an additional dose of apixaban

11th March 2021

By Antony Scholefield

A hospital software system has been blamed for a fatal anticoagulant double-dosing error after it displayed a prescribing icon so small that it could not be seen on a standard computer screen. 

In 2019, Ian Fraser was admitted to the Sunshine Hospital in Melbourne with an exacerbation of his congestive cardiac failure as well as community-acquired pneumonia.

He had a complex medical history ranging from rheumatoid arthritis and COPD to hypertension, AF and osteoporotic spinal crush fractures, with the result that he was on 14 different regular medications, including anticoagulants.

The 68-year-old eventually underwent a pleural tap. His condition improved slightly and he was restarted on enoxaparin.

During this time however, a respiratory registrar using the hospital’s Cerner electronic medical records system attempted to prescribe Mr Fraser apixaban as a discharge medicine.

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https://itwire.com/government-tech-policy/accc-investigates-mobile-search-and-browser-choice.html

Thursday, 11 March 2021 12:33

ACCC investigates mobile search and browser choice

By Stephen Withers

The Australian Competition and Consumer Commission (ACCC) has published an issues paper on the impact of default settings for search engines and browsers on mobile devices, and is seeking submissions from consumers and the industry.

The ACCC's Digital Platform Services Inquiry – September 2021 Report on market dynamics and consumer choice screens in search services and web browsers issues paper sets out the issues and invites input on:

• The impact of pre-installation and default settings on consumer choice and competition particularly in relation to online search and browsers;

• Trends in digital ecosystems and supplier behaviour in search services, browsers and operating systems that may impact the supply of search and browsers to Australian consumers;

• The extent to which existing consumer harm can arise from the design of default arrangements;

• The effectiveness of Google's choice screen roll out in Europe and whether it is fit for purpose within Australia; and

• Whether there are any proposals, other than choice screens, that may facilitate competition and improve consumer choice in the supply of general search services and browsers in Australia.

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https://www.theaustralian.com.au/business/technology/accc-to-investigate-if-google-is-rail-roading-us-into-search/news-story/85456d9f644115d5ddaf5c15efe62f63

ACCC to investigate if Google is rail roading us into search

John Durie

·         March 11, 2021

The contrast could not be more vivid between the ACCC’s well based concerns about the lack of choice on internet searches and Epic Games founder Tim Sweeney who now has antitrust actions filed against both Apple and Google over their operating system controls.

Both actions are before Federal Court judge Justice Nye Perram with the second against Google filed on Wednesday.

There is a difference between a study to explain how the monopoly power works and actual litigation to attempt to break open power.

Apple and Google control the operating systems in over 90 per cent of mobile phones and use this power to charge app developers 30 per cent of revenues.

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https://www.itnews.com.au/news/govt-agencies-struggle-to-contain-scope-creep-fears-around-surveillance-powers-561989

Govt, agencies struggle to contain scope creep fears around surveillance powers

By Ry Crozier on Mar 10, 2021 7:03PM

Telco metadata laws cast a long shadow.

Australian authorities that would benefit from new powers aimed at curbing online crime were largely unable to assuage concerns that use of the powers could ultimately extend beyond what is intended.

The surveillance legislation amendment aims to create three new types of warrants for network intelligence gathering, data “disruption” (including the ability to “add, copy, delete or alter data”), and online account takeover.

At a hearing on Wednesday afternoon, representatives from Home Affairs, the Australian Federal Police (AFP) and the Australian Criminal Intelligence Commission (ACIC) faced repeated questions over the potential for scope creep.

The committee's concern is for a repeat of the scope creep seen under telecommunications metadata collection laws, where over 100 agencies used the powers to enforce all manner of state and local laws, well outside the intended use of those powers.

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https://www.croakey.org/shifting-gears-success-stories-and-way-points-on-the-road-to-consumer-centred-health-care/

Shifting Gears: success stories and way-points on the road to consumer-centred health care

Editor: Dr Ruth Armstrong Author: Jennifer Doggett on: March 10, 2021

What would our health systems look like if consumers were in the driving seat – if consumer experiences and leadership were enabled to seamlessly transform health and social care to better serve their needs?

In Australia we do have successful models that have arisen from genuine consumer co-design, such as the Aboriginal Community Controlled Health Services.

Aotearoa/New Zealand has integrated consumer and community representation into key health funding and service delivery organisations, such as District Health Boards.  But in other areas both countries have a long way to go.

A summit hosted by the Consumer’s Health Forum of Australia next week (17-19 March) starts off by asking speakers and participants why such reform is needed, and goes on to showcase success, and provide inspiration for future efforts.

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https://www.hospitalhealth.com.au/content/technology/article/new-regulation-for-software-based-medical-devices-508576514

New regulation for software-based medical devices

By Bronwyn Le Grice*
Monday, 08 March, 2021

Changes to the regulation of ‘software as a medical device’ (SaMD) by the Therapeutic Goods Administration (TGA) mark a coming of age for the healthcare system of the future — one which is connected, asynchronous, data-driven and patient-centric.

Under these changes, software-based products that make health claims are now subject to a medical device classification aligned to the risk level to the patient. This includes devices that:

• provide a diagnosis or screen for a disease or condition;
• monitor the state or progression of a disease or condition, or the parameters of a person with a disease or condition;
• specify or recommend a treatment or intervention; or
• provide therapy through the provision of information.
   

From 25 February, products not listed on the Australian Registry for Therapeutic Goods (ARTG) will be prevented from being sold in Australia.

The TGA has worked closely with ANDHealth and the industry over the last two years to usher in this new regulatory framework. This puts us in step with global markets like the US who already have similar regulation structures in place and is the first step to wide-scale adoption and acceptance of technologies that have the potential to significantly reduce healthcare inefficiencies while simultaneously improving patient outcomes.

The TGA has created ‘carve outs’ for certain products that are considered low risk, present a low risk to users, or are subject to other mechanisms of oversight, including an exemption for clinical decision support software (CDSS) that meets the definition of a medical device. This allows health system software providers to continue with their important work in improving connectivity within the healthcare system, but brings a regulatory oversight component into play when technologies are claiming to directly impact the diagnosis, prevention, monitoring, treatment or alleviation of diseases, injury or disability.

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https://medicalrepublic.com.au/how-better-data-management-can-negate-rising-healthcare-costs/41519

9 March 2021

How better data management can negate rising healthcare costs

COVID-19 Finance KnowCents Technology

Posted by Nick Hoskins

COVID has taken a lot from us, but something it has given back is enormous volumes of data.

Throughout the world, across a range of industries, that data is being collected, analysed and served up to organisations and governments hungry to understand what’s happening.

The healthcare sector is no exception.

Vast quantities of health data are generated in Australia every day, stemming from a variety of patient sources such as wearable devices, medical appointments, tests and results, as well as medicines taken. With the rapid roll out of the COVID vaccination program, the country’s healthcare system is being put to the test in terms of its capacity to ingest and analyse significant volumes of patient data.

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https://www.lexology.com/library/detail.aspx?g=bf6f1690-3053-4aa8-9f9f-56b08803f238

Need a doctor? There's an app for that, but new TGA risk classification rules apply

Johnson Winter & Slattery - Christine Ecob and Stanley Yu

Australia

March 5 2021

Apps that treat, diagnose or monitor a condition are likely to be subject to more stringent pre-market requirements under newly implemented reforms.

Standalone software (which is not attached to any physical medical device), commonly in the form of a mobile app, is increasingly becoming one of the means upon which we treat, diagnose or monitor a condition.

Such an app (if its intended purpose is medical and it is not an excluded product) may constitute a medical device (Software as a Medical Device or SaMD) under the Therapeutic Goods Act 1989 (Cth) and must be registered on the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

The documentation required to register a SaMD onto the ARTG will depend on its risk classification, and there have been changes to the way SaMD is classified since 25 February 2021.

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https://www.theaustralian.com.au/business/technology/googles-secret-data-trade-must-stop/news-story/6130f7a57521e146a95aa74e61d5ecad

Google’s secret data trade ‘must stop’

David Swan

·         9:00AM March 9, 2021

Google’s dominance of Australia’s $3.4bn digital advertising market has come under further pressure, with new calls to end the secret trade of personal information and for the government to appoint an independent consumer advocate to assist people wanting to assert their legal rights over their personal information.

The Australian Competition and Consumer Commission is currently pursuing Google‘s monopoly position in Australia’s ad tech market, and a submission to its probe says tech companies including Google should be prevented from selling and sharing users’ personal information across platforms.

The submission, from the Australia Institute’s Centre for Responsible Technology, is also calling on the government to enact limits on the use of data gathered on the tech giants‘ platforms and that a new advocate to be appointed to better support citizens when it comes to their privacy.

Peter Lewis, director of the Australia Institute’s Centre for Responsible Technology, said Australia‘s ad tech market is dominated by Google, which purchased the DoubleClick ad-serving engine used by most Australian websites. He said that despite assurances to the contrary, Google has allowed DoubleClick to access other information collected by users including Google Search, Google Maps and Gmail.

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https://www.smh.com.au/world/north-america/russia-disinformation-targeting-western-covid-19-vaccines-flagged-by-white-house-20210309-p578x6.html

White House monitoring Russia disinformation that targets Western COVID-19 vaccines

By Patricia Zengerle

March 9, 2021 — 5.31am

Washington: White House spokeswoman Jen Psaki said on Monday (Tuesday AEDT) that President Joe Biden’s administration was monitoring efforts tied to Russia’s intelligence services aimed at undermining the Moderna and Pfizer coronavirus vaccines.

“We are aware of it, we are monitoring it and we are taking steps to address,” Psaki said at a news briefing.

The United States has identified three online publications directed by Russia’s intelligence services that it says are seeking to undermine COVID-19 vaccines produced by Pfizer and Moderna, a State Department spokeswoman said on Sunday.

The outlets “spread many types of disinformation, including about both the Pfizer and Moderna vaccines, as well as international organisations, military conflicts, protests, and any divisive issue that they can exploit,” Psaki said.

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https://www.afr.com/technology/tech-sector-warns-of-dangers-in-rushed-online-safety-laws-20210305-p5788h

Tech sector warns of dangers in rushed Online Safety laws

John Davidson Columnist

Mar 9, 2021 – 12.00am

Online safety laws being rushed through Parliament are so broad and offer so little recourse for appeal that any Australian company with a digital presence could get caught up in them and have their website taken down by court order, major technology and telecommunications companies and digital rights advocates have warned.

The Online Safety Bill, which was introduced to federal Parliament on February 24 and is being reviewed by a Senate committee, has been so rushed that few if any of the recommendations coming out of its hasty public consultation period have been written into the bill, which will have unintended consequences for almost all Australians if it is passed into law, the same companies and advocates complain.

The bill was first proposed by Communications Minister Paul Fletcher in December 2019, as a way to crack down on cyber ills such as trolling, child exploitation and the sharing of images without consent.

“When people interact in the physical town square, they take it for granted that the rule of law applies,” Mr Fletcher said at the time. “If they are assaulted, or defrauded, or otherwise harmed, they can go to the police and seek assistance, or they can go to court and seek redress.

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https://www.afr.com/companies/media-and-marketing/treasurer-s-facebook-victory-lap-is-too-soon-20210308-p578oz

Treasurer’s Facebook victory lap may be too soon

News publishers such as Nine and News Corp are struggling to get Mark Zuckerberg and his Facebook friends to pick up the phone to negotiate commercial deals.

John Kehoe Economics editor

Mar 8, 2021 – 11.34am

Treasurer Josh Frydenberg did a victory lap last month, heralding game-changing concessions granted to Facebook’s Mark Zuckerberg on the federal government’s media bargaining code that helped restore the social media giant’s services in Australia.

Two weeks on, major news publishers Nine and News Corp are struggling to get Zuckerberg and his Facebook friends to pick up the phone to negotiate commercial deals.

Nine is the publisher of The Australian Financial Review, The Sydney Morning Herald and The Age, while News Corp publishes The Australian, The Wall Street Journal and state-based tabloids such as Melbourne’s The Herald-Sun and Sydney’s The Daily Telegraph.

There is growing frustration and cynicism among local news media executives about the willingness of Facebook to bargain in good faith.

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https://www.theaustralian.com.au/business/technology/how-tech-can-repair-australias-broken-aged-care-system/news-story/37969828ec1f37a13347423a3181359b

How tech can repair Australia’s broken aged care system

Marc Caltabiano

·         March 8, 2021

The aged care system is generally behind other sectors in the use and application of technology, and there’s a clear opportunity for a more defined technology strategy moving forward.

According to the final report from the Royal Commission into Aged Care Quality and Safety, the aged care sector is facing significant challenges. The sector is battling a number of issues and struggling to provide higher quality care for one of society’s most vulnerable yet often overlooked groups, the elderly. The report includes 148 wide-ranging recommendations calling for reform in the sector. Among the extensive plan to overhaul aged care is the recognition of technology’s role in transforming the sector and in improving the experience of its residents.

Last year, we witnessed the acceleration of digital transformation initiatives across many sectors. Despite being one of the sectors hardest hit by COVID-19, aged care was left behind. In 2021, it’s critical that the sector, with government support, looks to the role technology can play in improving Australia’s aged care system and, most importantly, Australia’s elderly population’s quality of care and life.

In the report, Commissioner Lynelle Briggs highlighted major limitations with the current technology infrastructure and architecture for aged care, including patchy use of digital record keeping and a lack of interoperability between systems across government, aged care services, hospitals and other health care providers. These flaws are not only inefficient but increase the risk of errors.

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https://www.theaustralian.com.au/world/the-times/firestorm-erupts-inside-google-and-across-artificial-intelligence-field-over-algorithmic-dangers/news-story/1b33eaaf2e49ca77ab24d2e08579632c

Firestorm erupts inside Google and across artificial intelligence field over algorithmic dangers

·         By Danny Fortson

·         The Times

·         11:00AM March 7, 2021

On Wednesday, Emily Bender, a professor of linguistics at Washington University, will present what may appear to be just another academic paper, aside from its somewhat quirky title: “On the Dangers of Stochastic Parrots: Can Language Models be too Big?”

The paper is just one of about 80 to be presented at the ACM FAcct Conference, an annual event for computer scientists focused on algorithmic bias and accountability. Yet it has ignited a firestorm inside Google and across the field of artificial intelligence over how the powerful technology is being developed, by whom and its potential dangers.

In December, Timnit Gebru, one of the co-authors of the paper and co-head of Google’s ethical AI research team, abruptly left the company — she claims she was fired, Google said she resigned — after she refused to retract the research.

The company claimed it “didn’t meet our bar for publication”, though it had been peer-reviewed and accepted for the conference. Meg Mitchell, founder of Google’s ethical AI team, rushed to Dr Gebru’s defence.

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Comments more than welcome!

David.