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Navigating the Digitalisation of Healthcare

Creating real impact from evidence-based digital health was the theme of four industry workshops we hosted with ANDHealth in Sydney and Melbourne last week. The workshops were facilitated by the team at LEK consulting and covered investment, regulation, implementation and commercialisation of evidence-based digital health technologies or, as Sue MacLeman from MTPConnect put it, the 'digitalisation of healthcare'.

In total the workshops included around 100 C-suite executives from industries as diverse as health insurance, global pharmaceuticals, hospitals, health services, research institutes, product development, education, and state and federal government. Equally diverse were the were the views on what a successful Australian digital health industry looks like, what is needed to achieve that success and how the industry can get there.

There were some fascinating discussions during the day and despite the diversity of opinion a few common themes emerged.

The right type of regulation

Regulation is often viewed as a barrier to innovation in digital health, particularly when considered in the context of uncertain regulatory routes and the capacity of the regulator to deal with the sheer number of digital health solutions. However, key players in the industry view regulation in a much more positive light – as a way to achieve a competitive advantage and defend that advantage as competitors enter the market.

Regulatory uncertainty due to the lack of a dedicated regulatory framework for digital health was acknowledged as a hindrance to the acceptance of evidence-based digital health technologies. The industry wants and needs the regulatory 'stamp of approval'. One model for an appropriate regulatory framework that was the topic of much discussion was the adoption of an FDA-style risk-based approach including certification of vendors of lower risk digital health technologies (like adherence technologies) which could market their products without a premarket review. Higher risk products, particularly those that provide a diagnosis or treatment regimens, could be marketed with a streamlined premarket review.

Employing a pre-certification program for software as a medical device (as opposed to software that controls a medical device) could reduce the cost and time to market. The certification could be used to assess, for example, whether a company consistently and reliably engages in high quality software design and testing (validation) and ongoing maintenance of its products.

Implementation is complicated

Digital technologies have been around for years but are not yet publicly viewed as truly transformative. The sector is inordinately complex, fragmented and fraught with implementation risks that companies do not always fully grasp. The economics of supply and demand in healthcare is complicated by the fact that the purchaser of a digital technology (e.g. a hospital system) is not the user (e.g. a physician) or the beneficiary of the technology – the patient, consumer or 'punter' in the words of one of our more irreverent participants in reference to the chances of getting the most appropriate treatment!

The role of doctors in digitalising healthcare is crucial and providing them with evidence based technology that can reduce their workload and benefit patients is key to having them engage fully with digital technologies. In addition, providing the right type of incentives for doctors to embrace digital technology is considered a key component to adoption of technologies that can bring informational power that digital technology can brings to healthcare.

Commercialisation pathways for digital health are unique

It is clear that pharma is making serious investments in digital health. The executives at the workshops talked about the need for initiatives with real potential for broad commercialisation. In particular we need to be more focused on 'making the right tech' by dealing with the questions of 'What are we going to bring to market and which partners will help get us there?'. This necessarily entails dealing with the complexities of the healthcare system, business models, procurement pathways and identification of the right partners which ANDHealth is facilitating by creating a co-ordinated non-duplicative digital health ecosystem. One of the industry’s opportunities is to utilise this ecosystem in order to achieve scale and this will require adaptation of existing procurement pathways to allow agile digital health companies equitable access to large health care providers.

Focused investment is key

Australia's first-class healthcare system, cost-effective clinical trials, a deep talent pool, globally recognised research institutes and the availability of assistance for startups were all identified as positive factors that help facilitate investment in Australia's digital health companies. It is clear that investors want to get involved with digital health, and want to get involved early.

While there is certainly Australian-based expertise that can make and manage significant investments into digital health there is not yet a dedicated digital health fund, surely one is needed.


Tony Shaw

Patent Attorney at Allens