Joint Principles for AI in Medical Processes Unveiled by EMA and FDA
The European Medicines Agency (EMA) and the American Food and Drug Administration (FDA) have collaboratively established ten overarching principles deemed essential for the effective integration of artificial intelligence (AI) within medical practices. These tenets encompass critical domains such as evidence monitoring and risk assessment.
The laid-out principles emphasize a human-centric design ethos alongside a risk-aware approach. Additionally, they insist on adherence to established standards, a transparent context of usage, and the necessity for multidisciplinary proficiency in supervising both the technology and its deployment.
Furthermore, these principles mandate stringent data governance and meticulous documentation, the design and implementation of models fit for their intended purposes, comprehensive life-cycle management, and the use of straightforward language for disseminating information to relevant stakeholders.
Nils Rauer, an AI authority at Pinsent Masons in Frankfurt, remarked that while the principles proffer a high-level framework, further elaboration on practical execution is indispensable.
“The broader concept aligns closely with the legislative framework advocated by the European authorities,” he elaborated.
“We observe a convergence of thought when juxtaposing the EU AI Act with the newly published principles. Both frameworks adopt a risk-based strategy, underscore the significance of robust data governance and AI literacy, and highlight the necessity for thoughtful model design and development.”
“A pivotal principle states that AI technologies must possess a clearly defined context for use. It is paramount to delineate precisely what AI is intended to accomplish within a broader framework. Regulatory obligations can substantially vary based on the AI’s functionality and the responsibilities ascribed to the company.”
This initiative by the two agencies emerges against a backdrop of escalating AI adoption within the pharmaceutical and life sciences sectors, spurred by recent legislation enabling wider applications of AI in developmental and regulatory decision-making.
The announcement also follows a bilateral dialogue conducted between EU health executives and the FDA in April 2024, as the EMA endeavors to formulate AI regulations within the pharmaceutical sector, adhering to the continent’s guidelines and legal stipulations.
Catherine Drew, a specialist in life sciences at Pinsent Masons, noted that the collaborative nature of this guidance signifies a recognition by both agencies of the imperative for global cooperation and synchronization regarding AI utilization.
“It is crucial to ensure that the advancement of medicine development and approval evolves in tandem with the rapid technological landscape, particularly with AI being a significant player, so that innovative treatments reach patients without delay,” she stated.
“Achieving this while maintaining the highest standards of safety and efficacy, as underscored in the principles, is essential, and is further bolstered by the advocated risk-based approach.”
Source link: Pinsentmasons.com.
