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Blog: Regulating AI in healthcare: the next steps

11 October 2024
| 24 comments
By Kate McDonald
Image: iStockphoto

Pulse+IT found itself a big bogged down this week amid the rather boring but entirely necessary area of government consultations on things relating to healthcare, in this case on how or whether to regulate AI in healthcare in Australia.

The Department of Health and Aged Care was a guest of a webinar earlier this week on its consultation paper relating to the safe and responsible use of AI in Australia’s health and care system, which comes hot on the heels of a similar one by the Department of Industry, Science and Research and another by the Therapeutic Goods Administration.

It seems clear that such has the early responses been to those consultations that a separate one purely on regulating AI in healthcare beyond the remit of the TGA is necessary, so here we are with another one. (The nice lady from DoHAC mentioned that if you have already made a submission to the other two, you can just reuse what you’ve already written for this one if you like.)

The webinar was hosted by the Australian Alliance for Artificial Intelligence in Healthcare (AAAiH), which itself has held various consultations and released a policy document at the Australasian Institute of Digital Health’s inaugural AI.care conference in Melbourne last year. (Another one is being held next month.)

The AAAiH policy paper called for the establishment of a National AI in Healthcare Council, the development of a shared code of conduct for the safe, responsible and effective use of AI by health professionals, and the development of a National AI Capability Centre in Healthcare to assist industry to bring products to market, which we are rather keen on.

For DoHAC, the consultation is quite broad, but the main area of contention seems to revolve around whether AI in healthcare needs specific oversight, perhaps through an Australian body specifically dedicated to overseeing AI in healthcare.

We get the feeling that most agree. The AMA for one has submitted a response to the DISR consultation that calls for an overarching national regulatory framework for using AI in high risk contexts, as long as it is accompanied and integrated with sector specific AI regulation.

When you’re talking high risk use of AI, it doesn’t get that much higher than in healthcare so we think that a separate body should be set up specifically for managing and giving advice on regulating AI, but just how this body should be constituted we’re not sure.

The UK looks like it will bundle healthcare in with other sectors, all the while selecting healthcare as one of the priority areas. The UK government announced this week that it will launch a regulatory office that will support the healthcare sector to safely deploy AI innovations, sitting within the Department of Science and Technology.

This could be one option, but we think an agency within DoHAC, or even the Australian Digital Health Agency, would be a better bet, as long as it draws on the expertise of the clinical colleges, the professional organisations and an industry representative group as well.

A quick resolution to the regulation question will become more and more important as the industry moves at pace to introduce AI-based products to the market, and looks for guidance on what it can and can’t do when training its models.

Also this week, the RACGP released its full Health of the Nation 2024 report, having last month released some of its more critical findings through some rather hyperbolic press releases. The actual report paints a picture that is a touch more rosy than made out by the college, and it also contains some extremely useful information on the views of GPs on innovation and technology.

There was some good news with almost half of Australian GPs saying they were enthusiastic about adopting new digital technologies in within general practice – which is very much news to us – but the vast majority did admit they did not feel as if they were well informed about these new technologies. They should get a subscription to Pulse+IT where they can learn all about it.

It was a substantial survey of 3475 GPs, 3006 of whom were practicing, and was very well worthwhile. We’d like to see in future perhaps some more detail on what exactly the tools are being used and a clear delineation between tools that they are required to use and those they choose to use.

The majority of the report though looked at concerns about the viability of general practice in Australia, including workforce challenges but also the worries of general practice owners about the viability of their practice. It’s interesting that there is now growing evidence that the viability of practices has quite a bit to do with their digital maturity. We had a very interesting story on that too.

It comes as the UK details its new plan to create a single patient record in a decade by removing some of the burden on GPs to control and curate their patients’ medical records and information, and open it up for research. This has been a fraught area for the UK for well over a decade, so good luck to the new government in trying to solve the problem, particularly given heightened fears of data being accessed by or sold to commercial entities.

It’s something we had a look at last week in our poll, when we asked if anonymised data held in the proposed HIE be accessible to commercial ventures in future.

Definitely not, three quarters of respondents said, although it might be ok with the right consents. Here’s what you said.

That brings us to our poll question for this week:

Should there be a separate oversight body for AI in healthcare?

Vote here or leave your thoughts below.

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24 comments on “Blog: Regulating AI in healthcare: the next steps”

  1. If it is to be funded by the government (I hope so) then the TGA is already set up to do regulatory approvals and should add AI to its arrows.

    • Name - Paul C
  2. Yes – Within DoHAC so that it can take a systemwide view of deployment and give consideration to holistic and consistent adoption of ethics, standards and regulation, the necessary workforce upskilling and other macro implications for the health system, including how these enormous changes for the health system can be managed and funded.

    • No – We have sufficient bodies providing oversight across all aspects of Healthcare including technology. Spending more money on a separate body is not efficient use of money to time. Technology will continue to evolve and existing governance arrangements must do the same. Continually adding to it is not the answer

      • Yes – Independent- Considerable COI with DoHAC and ADHA. OAIC and ACSC led with service delivery professional peaks, health consumer peaks and MISA representing.

        • No – The Commonwealth is always setting up independent bodies for all manner of things and most of the time they are ineffective. Not sure how this would be any different. It’s about time they came up with a different approach rather than looking after superannuated MP’s or other highly paid individuals who can talk the talk but don’t walk the walk.

          • Yes – “In 2023 we ran the first national Citizens’ Jury on using AI in healthcare. 30 Australians chosen by democratic lottery worked together over a month to learn about AI and then deliberate on what Australia should do next.
            They recommended a charter to underpin the development and implementation of AI in healthcare. They also recommended an independent body with an independent chair to manage the charter, because AI was too potentially disruptive to allow vested interests to drive decision-making. They argued that all relevant stakeholders should be represented on this decision-making body. DoHAC and ADHA are pivotal stakeholders for such a body, as are professional bodies, various regulatory agencies, state and territory health ministries, researchers/academics, and the local AI technology industry.
            An independent body would provide transparency regarding AI oversight, and could drive activity to coordinate and integrate AI governance into the existing complex health legislation and regulation landscape.

            More details about the jury in MJA here: https://onlinelibrary.wiley.com/doi/epdf/10.5694/mja2.52283

            and in Pulse+IT here: https://www.pulseit.news/australian-digital-health/ai-care-2023-citizens-jury-convened-for-consumer-view-of-ai-in-healthcare/

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