The AI Act is officially translated into all EU languages and published. From that moment, the clock is started ticking for all AI-based software manufacturers. But what about medical devices that utilize AI-based software? In the following weeks, we will continue to explore the main topics related to these upcoming changes. Much like the traditional wedding adage of „something old, something new, something borrowed, something blue,“ the merging of the AI Act with the MDR holds similar symbolism. This week, we will look into „something new.“ Check out our „something old“ publication.
The European AI Act’s intersection with the already intricate software as medical devices (SaMD) landscape is akin to one of those legendary weddings. Some might call it a match made in heaven by the EU Commission; others see it as an arranged marriage. But what about the extended family—the manufacturers, notified bodies, consultants, suppliers, users, and customers—who must now adapt to these new arrangements?
This week something new: Data governance
Data governance is a part of the act that is completely new. As a manufacturer you are expected to create processes on how:
These procedures should be added to the QMS.
The concept of Data Governance
Data governance refers to the management of data availability, usability, integrity, and security within an organization. It encompasses the policies, procedures, and standards that dictate how data is collected, stored, and utilized. Effective data governance is critical in AI, where data quality and integrity directly impact the outcomes of AI models.
New Aspects of Data Governance in the AI Act
SO updating of the existing relevant processes in the QMS (like Risk Management, Improvement etc) and creating new (Data governance) will be a first step on your way to compliance.
In other words it is a completely new concept: your training data is in fact part of your software now, as it has a huge impact on the algorithm, and therefore has to undergo the same level of control.