Some takeaways from the webinar launch of ICLG – Digital Health 2023

Last month it was a pleasure to gather Roger Kuan , David Wallace , Lincoln Tsang and Christian Lopez-Silva following the publication of the 2023 edition of the International Comparative Legal Guide – Digital Health to discuss some of the most pressing issues in the digital health industry today. For what it’s worth, here’s my key takeaways from the discussion:

The digital health industry really came alive during the COVID-19 pandemic - we found ourselves in virtual waiting rooms and using telehealth to get medical assistance. As such over the last few years, digital health has become an attractive market, not only to patients, but to tech giants, software companies and pharma incumbents alike. So much so it's predicted that the digital health industry is valued at over US$200 billion, and by 2030 that will have risen to US$800 billion.

Running before walking

A point raised early on in the conversation was: with the rapid adoption of digital health solutions in the healthcare industry, what issues have been somewhat glossed over when it comes to adoption and implementation within the industry?

Both David and Lincoln discussed that amongst the hype of digital health, there’s been lack of focus on business fundamentals – it’s one thing to have the technology, but it's another thing to ensure it’s being monetised and is driving efficiencies.

David Wallace: “Efficiencies lead to deeper clinical trials, deeper clinical trials lead to more affordable therapeutics that can address a broader group of people and get there more quickly and be more accessible. Those business fundamentals do not change, you still have to have a very strong pipeline before you can invest in these other technologies. The fundamental science is still very very very important, it always will be. I think those companies that are focusing on how to translate that technology into incremental improvements to the fundamentals are going to do much better as opposed to sort of chasing the rainbow like I see a lot of companies doing.”

Christian went on to explain that law firms need to be proactive in organising themselves too, because digital health crosses a number of practice areas, i.e. IT and healthcare. He explained that although clients appear to be fairly clued up on the IT side of things, there seems to be a lack of knowledge on the health regulatory side, and so the firm must work cross-departmentally to communicate all the relevant information smoothly to clients. ?

Christian Lopez-Silva: “Clients do not divide their obligations into different fields of law, they just want to get it done and do their business."

Are we ready?

Another point raised revolved around the front (let’s say patient-facing) and back end (for example, data processing) aspects of digital health technologies. Roger commented that in the US there’s a fairly uniform agreement that the so-called backend technologies are “good”. This can’t necessarily be said for those patient-facing technologies – diagnostic tools, for example. Lincoln took the question highlighting that there’s a huge amount of regulation that needs to be reviewed and applied to the area, and with technology developing at a rate much quicker than the legislation, there's still catching up to do on how to regulate this technology. One point he added was to question whether this technology should be considered a product or a service? This then brings about new challenges in terms of product liability law, because strict liability law applies to products, it doesn't apply to services.

Data is King

Talking of regulation, our speakers turned to our old friend data. For machine learning and AI to thrive in the digital health space, it needs data – biometric data. Not only do jurisdictions have different regulations and requirements when it comes to handling data processing, but healthcare providers will collect and store data in different ways. David emphasised here the need for companies to really nail down their data governance policies. After all, you can have all these fantastic AI tools, but they still have to generate revenue in a way that's not going to create unnecessary and inappropriate risk.

Many more points were covered in the discussion, which can be watched here: ?? https://www.youtube.com/watch?v=3-qxHn6C39A

The latest edition of the International Comparative Legal Guide – Digital Health can also be accessed here ???https://iclg.com/practice-areas/digital-health-laws-and-regulations