AI regulation should be agile and adaptable

One of the main themes at Labquality Days 2022 will be developing health technology. The programme is packed with interesting speeches by experts in the field.

We are delighted to welcome a true health tech regulation expert to speak at the event. Koen Cobbaert works as Senior Manager for Quality Standards and Regulations at Philips and is specialized in health software.

– At Philips, I see myself as a translator. I translate laws and standards so that the business units within Philips understand what they mean – what regulators had in mind when they wrote the regulations, and what can be read between the lines, which is not always explicitly stated, Koen explains.

In the legislative domain, Koen chairs COCIR’s and DITTA’s software focus groups, representing their members at different European Commission MDCG workgroups and at the international level at the IMDRF workgroup on artificial intelligence. Currently, Koen is engaged in various proposed EU legislation relating to artificial intelligence and data.

– My role is making sure that the legislation that is being prepared is smart legislation that adds value to our field, he explains.

Originally, Koen wanted to work in software in the medical space because it can profoundly help improve people’s health. On the other hand, he acknowledges that the merging of machines and humans can be a scary concept.

– I wanted to be there at the frontline to see where this merge of technology with humans, or transhumanism as people call it, is going to bring us and contribute my own little thing to that domain. I have a master’s in risk management so this is something that really comes close to my heart to make sure that this can all be done in a way that’s safe and not harmful to society or patients. That is what drove me to be in healthcare and the software space, Koen says.

A big challenge when creating regulations related to AI and MLMD is a lack of health tech experts, according to Koen.

– I see a lot of people in these meetings that have a long history with standardisation, but they haven’t necessarily worked in AI before. That provides a risk of wanting to do too much or putting requirements into standards that are too prescriptive, Koen explains.

Standards that are too prescriptive or restrictive would hinder innovation or the uptake of certain applications.

– It also creates a risk because you’ve got these standardisation bodies that all want to be as quick as possible to claim their turf, so they try to issue a work item as fast as possible so that the other standardisation bodies cannot claim that domain or terrain, Koen adds.

That, again, creates a risk of standards that are too prescriptive, not really adding true value or are too high level. Overregulation is something Koen is wary of, and he emphasises the importance of legislation that is smart, agile, and able to adapt as needed.

At Labquality Days, Koen will give two talks in which he will explore these themes further. He will shed his light not only on the opportunities but also on the trust and regulatory challenges of MLMD and what can be done to overcome these. He will also give an overview of the proposed AI Act, highlighting its impact on the health sector focusing on its impact on laboratories as professional users of high-risk AI systems and biometric categorization systems, as potential in-house manufacturers of high-risk AI systems, but also as health data custodians.

Koen is really looking forward to Labquality Days, as it is the first face-to-face conference he will be speaking at since the pandemic began. As a speaker, he is also looking forward to the insights he can get from other speakers and visitors.

– I really like that it’s a face-to-face meeting. The fact that I’m able to speak at Labquality Days gives me an opportunity to be face-to-face and in contact with people that are probably working on things where the law, standards or the legislation may break down or they may simply not work in that area. So, it’s great to be able to be at the [event] to hear about those issues so that I can take those back to legislators.

At events like Labquality Days, you can get the latest insights from key opinion leaders and experts who are involved in legislative work. Koen finds this very valuable.

– They can give you a behind the scenes view of the reasoning that is going on when they put legislation in place, he explains.

It is the exchange between the audience and the speakers that Koen is most looking forward to.

– We can learn of certain needs in the sector that we may not have been previously aware of.

Both experienced people and those who are new to the field will benefit from Koen’s speeches, as he will make sure that everyone understands the bigger picture in an accessible way. At the same time, he wants to ensure that seasoned experts will get finer insights into the implications of AI and the field of health tech.


You can hear Koen Cobbaert’s speeches in the Digital Future II – Artificial Intelligence session on 11 February 2022 at Labquality Days.

Check out the full international programme and get your tickets now! >>