This European Union Progress has been made on the long-awaited European Artificial Intelligence (AI) legislation. In December, an agreement was reached to strengthen it. In this standard, the European body classifies medical devices with this technology in the category of High risk AI systems. But what should regulations include in relation to the health sector? Ignacio H. Medrano, a neurologist and expert in this tool, summarizes the essential elements in three aspects. First, it demands that AI not be classified as a medical device, as is the case in other regulations. “Algorithms created with AI, with Machine learning It doesn’t have to be a medical device, but it’s decided.” Furthermore, he proposes a kind of pre-certification, or ‘fast track’, as it would help encourage agility in development.
“In my opinion, in USA A mistake is made, which is then replicated in United Kingdom, which is to classify artificial intelligence as a medical device. That is to say, I don’t have a regulatory box to put it in, so I incorporate it just as I would a catheter or an electrocardiogram device so I can start it. Decision support algorithm. I have to do a clinical trial, and the FDA (US Drug Agency) has the same seal that the machine has to take to the hospital. It doesn’t make any sense, Algorithms are information“, he explains. Furthermore, this path ensures that it is neither sustainable nor scalable.
Therefore, the expert maintains that Europe “has an opportunity to understand this better because it is late to the party.” This does not mean that AI algorithms are regulated: “Naturally, artificial intelligence algorithms need to be approved, monitored and regulated, but not by themselves. CE marking As if it were a physical device, that delays innovation a lot,” he says.
‘Fast Track’ to promote speed
Furthermore, it proposes a kind of establishment ‘Fast Track’ Or pre-certify companies or organizations to act quickly. “That will be very important to the development of this technology and the opportunity to do that.”
To these two components we add a third, which is related to the principle of data minimization European Data Protection Law (GDPR, for its acronym in English). This regulation, as it maintains, advocates using the minimum possible data for each investigation. “The problem is when you work Machine learning, sometimes you find correlations between data that you don’t know a priori. So, really the more data, the better,” explains Ignacio H. Medrano.
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“AI algorithms need to be approved, monitored and regulated, but they have to pass with CE marking”
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This doesn’t mean companies have an excuse to take ownership of the data, he says. “You can actually find associations in the data that aren’t known until the machine starts looking at them.” So, consider that a Artificial Intelligence and Health Law I have to consider this theory to make an “exception” so that it doesn’t represent a break.
The expert assures that this path is not free of difficulties, but that innovation cannot be slowed down, as it affects the technology reaching patients. “We have to make guarantees, but the problem with moving forward with this is that we’re not putting algorithms in the hands of people who really need them in time because they have a disease today, not in five years,” he says.
Although it may contain statements, data or notes from health institutions or professionals, the information contained in medical writing is edited and prepared by journalists. We recommend the reader consult a healthcare professional with any health-related questions.
