16 March 2023

Govt will legislate to drive digital health changes

Big Data DoH Government

The federal government has said it will legislate digital health standards and likely mimic aspects of the US 21st Century Cures Act strategy to accelerate Australia’s health data sharing capability.

The federal government is in the planning stages of developing legislation covering digital health standards according to Daniel McCabe, the DOHAC’s First Assistant Secretary Medicare Benefits and Digital Health.

The purpose of such legislation would be to drive faster and more effective changes to Australian healthcare providers’ ability to share meaningful data in real time, both with each other and with patients. 

“At the Commonwealth level, we’ve got a government that is serious about integrated multidisciplinary care, and enabling digital health,” McCabe told a panel on Wednesday at Healthcare Week in Sydney.  

“We are going to look at regulatory and legislative levers to enable [data] sharing and use of standards across our healthcare systems. 

“We know that we need to, we can’t just keep incentivising and hoping that everyone will come together and do this,” he said.

“We’re going to have to create an environment where everyone is heading in the right direction”. 

McCabe also said that the Commonwealth government would likely be taking some lessons from the legislative process that led to the US 21st Century Cures Act in how it approached building out such standards and legislation. 

“If we have the political will, and I think we will, we will replicate some of the things that US has done in due course,” he said. 

The 21st Century Cures Act is a landmark piece of digital health legislation in the US that was passed into law in that country in 2016, which required that all healthcare software vendors and providers upgrade their technology to a common set of modern cloud based healthcare data sharing standards. 

In the US, the government gave vendors and providers five years from 2016 until April 2021 to meet the standards of sharing which were mandated. If they failed to do so, the ramifications within the law included the possibility of a jail term. 

But the reality of the US process was not so harsh, as the government gave the vendors two years to work out how to meet the requirement of widespread meaningful and secure data sharing, and then for the next three years assisted those vendors and providers to meet the bar that had been set for sharing standards. 

Today in the US, nearly every vendor and provider in the system can share data meaningfully via FHIR and open cloud based APIs, and the sharing is happening on mass both between providers and directly to patients. 

McCabe was at pains to point out that before we get to legislation the government still has to do a lot of consultation work to do with vendors and providers to ensure any legislation is sensible for Australia, particularly with respect to the unique commercial and cultural issues faced by Australian software vendors and healthcare providers. 

He also said there is a lot of work still that needs to be done around data privacy, particularly in respect to state by state legislation on data privacy and sharing, in order for a national standards of data sharing framework to work. 

While this is nominally the first time that the federal government has publicly stated it intends to make legislation a part of its strategy to drive change in our healthcare system, there have been plenty of hints that such a process has been under way for a while in the bowels of government for some time now. 

A huge hint came on February 9 this year when the DOHAC updated a fact sheet on the Strengthening Medicare Taskforce GP grants program, which listed the first of three things grants up to $50,000 per year will be paid for, including:  

  1. enhance digital health capability – to fast-track the benefits of a more connected healthcare system in readiness to meet future standards (our underline). 

“What standards?” Wild Health quickly asked the DOHAC, which replied to us at the time: 

“The Australian Government is committed to supporting the availability of safe, secure, trusted and consistent clinical information that can be used and shared across different health service providers and across the health system. Program guidance relating to the GP Grants Program will be released shortly and will include examples of possible investment activities under each stream as a guide for practices. 

“These investments will enable GP practices to invest in and uplift their existing digital health services and provide safer, more secure and more integrated service offerings. This will help ensure GP practices are ready to support a transition to open standards-based health information sharing environment, over the coming years. 

“The Department is actively considering the technical and data sharing standards required as a part of the wider health interoperability program.” 

So, no actual admission of formal standards or legislation there. 

Interestingly, the title of Healthcare Week panel which McCabe spoke on this week was ‘How Will the New National Interoperability Standards Move Our Connected Health System Vision Forward?’   

But strangely, neither McCabe nor fellow panelist and international FHIR and HL-7 expert Grahame Grieve were aware that this was the title of their panel they were appearing on. 

Grieve told Wild Health that the panel title he had been given was completely different, and confirmed that at this point of time there aren’t actually any “new national interoperability standards,” and that there needed to be a fair bit of work between various parties still if there was going to be nationally mandated standards regime. 

It is unclear who came up with the title, but it seems to have been a last minute alteration to the program by one of the organisers. 

Regardless, McCabe confirmed in the panel that legislation to mandate standards in some manner was on the table and likely coming and that as a part of that process government was in conversation with various stakeholders and looking , at least in part, at how the US managed this process with the 21st Century Cures Act. 

What now? 

The timing on the introduction of such legislation will almost certainly be on the minds of most stakeholders – software vendors and providers in particular – but McCabe did not give any specific indication on timing.

Given the complexity of the process required to construct such legislation and make it politically palatable, and commercially acceptable to the local software community, most pundits Wild Health asked suggested that it most likely would be early in the second term of a federal Labor government, if it gets a second term. 

But it is possible we will learn a lot more about a timetable within a few weeks. 

Herbert Down, the Clinical and Digital Health Standards Governance Branch Manager, at the Australian Digital Health Agency, said that the agency’s final version of the National Healthcare Interoperability Plan is nearly ready and should be released in a few weeks. The draft of the plan was released almost a year ago now. 

Down hinted to the audience that the report would contain a lot more specific detail about the process around which interoperability standards and a governance framework could be developed and implemented as a part of the agency’s overall strategy. 

Referring to the upcoming release of the final version, Mr Down said “I think it is a nationally agreed plan. It’s probably the strongest signal that we have for Australians that everybody involved in this conversation is very much interested in paying attention and wants to move this forward [at] pace”. 

In addition to this report being published, April is said to be the timeframe in which GPs will be able to start applying for Strengthening Medicare Taskforce grants.  

Given that one of the three ways you can get a grant is upgrade your digital health infrastructure to meet “future standards”, you’d have to expect that the DOHAC will need to provide GPs planning to apply some idea of what those standards might be, and when they might be in place. 

Whether legislation occurs after the next election or before, it appears clear that the federal government is now going to move to mandate alignment on healthcare data sharing technology and standards in the near term. 

This has enormous implications for the software vendor community in Australia. Every vendor that creates and stores data, from big hospital EMRs through to GP, specialist and allied care patient management systems, will be tasked with upgrading their offerings to provide appropriate functionality for sharing to the new standards. 

But the biggest impact will ultimately be for patients via their providers, who presumably will be able to share data much more seamlessly in time.   

We will be discussing those implications along with reactions of key industry stakeholders to this news next week. If you have any thoughts you’d like to share please let me know at jeremy@medicalrepublic.com.au. 

This topic will be one of many key health reform issues discussed at the upcoming Wild Health Canberra Health Leaders Reform Summit, to be held in Canberra on May 3 and 4. Program and speaker details and tickets can be accessed HERE.