In a column Lucy Robertshaw reflects on how AI and new regulations will affect healthcare, innovation and the lives of future patients.

Recently I bought “Hacking Health Care”, a book written by Tom Lawry who serves as National Director of AI for Health & Life Sciences at Microsoft. It starts like any informative book by telling you the history, did you know that predictive science was born in 1687 by Sir Isaac Newton? But fast forward to 2023 and now we think that this is really going to change how healthcare is going to revolutionised.

Digital health is already here to help us, there are many digital apps which want to help with understanding how we have slept, what we have eaten, and you can have an apple watch to see your heart rate – this is all collecting data from us which have algorithms. During the Covid pandemic, people were able to see their doctor via the computer via virtual consultations and even have a smear test which you could do in the privacy of your own home.

So what stands in our way for AI and intelligence revolution which is supposed to reboot an ailing system?

Our government in Sweden is currently performing an inquiry into what a national system could look like, as today we currently have 21 regions which then would have to agree to have the same IT infrastructure system to share patient data.

I wonder how long this is going to take and if we have time to wait as the burden on the healthcare system increases every year with needing to be more reactive and it would take many years to implement and of course someone would have to pay for this, well i.e., me and you.

There is also another issue that is heading our way in Europe which is the EU AI Act which is supposed to be coming into effect around 2026. This means that any manufacturer of a medical device that is taking data from patients in the way of patient monitoring or medical imaging must find a notified body and will need to comply before getting a CE mark.

Companies who are working in this area now need to engage with a notified body on assessing which category their device comes under and to understand what quality management system they will need to work with and what documentation they will need to produce.

I am wondering what this means for innovation. We in Europe have spent so much money on innovation in digital start-ups, and ultimately who is going to pay for the added regulatory landscape?

So how are the robots really going to take over life sciences and make a patient´s life better and how many more years is this going to take?

Artificial intelligence – is this really going to transform a patient’s life? (lifesciencesweden.se)