BAYOOMED @DMEA 2021

The possible application scenarios of artificial intelligence in medical technology seem endless. As an independent learning software, it is capable of abstract thinking. But in order to be allowed to use AI in the development of medical technology products, manufacturers must observe various requirements.

Which regulations apply in the EU? And what do you have to consider in order to get the product approved in the USA? We give you an overview of the regulatory requirements.

Since digital health applications (DiGA) have been included in the catalogue of standard provisions of statutory health insurance, the market is booming. The rapid development of a DiGA seems tempting. But in order to be included in the nationwide DiGA directory, manufacturers have to consider a number of things.

We present pitfalls and clever solutions. We look at the specifics of data privacy, “interoperability” and what is important in terms of usability and accessibility.