Rainer Rothe, Scientific and Regulatory Affairs Officer at Asphalion, attended the online session “Improving Human Health Through Artificial Intelligence” organised by CataloniaBio & HealthTech in collaboration with BioCat. Rainer Rothe shared with us a summary of this session:

Artificial Intelligence (AI), in particular Machine Learning (ML), have a deep-seeded foundation in the future of healthcare:

The rapid development of ML, with applications going from drug design scenarios to the treatment of radiological images, has made it an attractive focus of many companies. However, software manufacturers are facing several challenges with regards to this novel technology. Firstly, the collection and curation of data is necessary for the proper functioning of an AI application, it is clear to the manufactures that the quality of the outputs of this software is only as good as the data that feeds it. As a result, a lot of resources are being dedicated towards the research of new data and the curation of existing databases. Furthermore, some collaborative efforts are being made with physicians in order to generate quality data for future applications.

On the other hand, with the imminent arrival of Regulation (EU) 2017/745 on Medical Devices (MDR), many software will qualify as medical devices, meaning they will be obliged to comply with the General Safety and Performance Requirements (GSPR) of this Regulation. In particular, the regulation gives special attention to the cybersecurity aspects of such software medical devices, therefore manufacturers must integrate ways of maintaining a patient’s anonymity and encrypting the data being handled.

This session was very insightful and allowed participants to share their experience and reflect on the strategic areas of development, with the objective of boosting the competitiveness of companies.

Asphalion closely follows the news and movements around the medical devices industry to better assess manufacturers and stakeholders on their implementation. If you have questions do not hesitate in contacting us at info@asphlaion.com.

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