Artificial intelligence has long since found its way into medicine and medical technology.

Content

This page provides an overview and links to relevant articles:

  1. Definitions
  2. Articles on the regulatory requirements for AI-based medical devices
  3. Articles on the application and functioning of AI in healthcare and medical devices
  4. Support with the approval of AI-based medical devices and IVD

1. Definitions

The terms artificial intelligence (AI), machine learning, and deep learning are regularly used imprecisely or even synonymously.

a) General definitions

The term artificial intelligence (AI) itself leads to discussions, for example, about whether machines can have intelligence at all.

We will use this definition in the following:

Definition: Artificial Intelligence

“A machine’s ability to make decisions and perform tasks that simulate human intelligence and behavior.

Alternatively

  1. A branch of computer science dealing with the simulation of intelligent behavior in computers.
  2. The capability of a machine to imitate intelligent human behavior”

Source: Merriam-Webster

So it is about machines ability to take on tasks or make decisions in a way that simulates human intelligence and behavior.

A lot of artificial intelligence procedures use machine learning, which is defined as follows:

Definition: Machine Learning

“A facet of AI that focuses on algorithms, allowing machines to learn and change without being programmed when exposed to new data.“

Source: Arkerdar: Business Intelligence for Business

Deep learning is part of machine learning and is based on neural networks (see Fig. 1).

Definition: Deep Learning

“The ability for machines to autonomously mimic human thought patterns through artificial neural networks composed of cascading layers of information.“

Source: i.a. HCIT Experts

This gives us the following taxonomy:

artificial intelligence - Taxonomy of procedures
Fig.. 1: Artificial intelligence is based on numerous procedures, of which machine learning is only one part. Neural networks and, thereby, deep learning, are part of machine learning.

b) Definition of the EU

The EU defines the term “AI system” in the AI Act:

“An AI system is a machine-based system designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments.”

AI Act, Article 2 (Definitions), Section 1

This definition reveals three conditions that make a “machine-based system” an “AI system“:

condition comment
designed to operate with varying levels of autonomy The word “varying” is vague, so that this condition hardly restricts what falls under this definition.
may exhibit adaptiveness after deployment The word “may” means that this adaptability can exist but does not have to. This partial condition, therefore, does not restrict what falls under this definition.
infers, from the input it receives, how to generate outputs … The system derives how it generates the outputs from the inputs. So, it is not a question of the system deriving the outputs from the inputs, but how (i.e., the way?) it does this.

Conclusion: It seems that only the third condition effectively defines what an AI system is. And this condition is difficult to understand.

Example

In a neural network (NN), the inputs do not determine the way in which the outputs are generated. That is because this is already predetermined by the architecture of the NN and the weights and biases of the neurons before an input reaches the system.

The inputs, on the other hand, determine the outputs. But that is also the case with any conventional software algorithm.

2. Articles on the regulatory requirements for AI-based medical devices

Several articles discuss the regulatory requirements for medical devices and IVD that use artificial intelligence procedures, such as machine learning, and provide tips for implementation:

When implementing the regulatory requirements, these articles are also helpful:

3. Articles on the application and functioning of AI in healthcare and medical devices

An overview article describes the application and use of artificial intelligence in medicine and in medical devices and IVD.

4. Support with the approval of AI-based medical devices and IVD

Do you have any further questions about the qualification or classification of medical devices? Then benefit from our free micro-consulting.

The Johner Institute’s AI guideline is the basis of TeamNB’s questionnaire.

Online courses in the Medical Device University guide manufacturers on their way to “AI-Act-compliant” medical devices and IVD.

The experts at the Johner Institute specialize in developing a regulatory strategy that allows you, as a manufacturer, to bring your AI-based devices to market worldwide as quickly and flexibly as possible. Contact us right here