Regulatory changes in the EU are reshaping the clinical trial landscape, emphasizing the need for greater data transparency and compliance. Biopharma companies that leverage AI and adapt to these changes will be better positioned to drive innovation and improve patient outcomes in clinical research.
The World Health Organization (WHO) has launched a global initiative to establish a unified governance framework for artificial intelligence (AI) in healthcare, focusing on safety, ethics, and accessibility. This initiative aims to support low- and middle-income countries in effectively integrating AI into their health systems while addressing ethical concerns and regulatory challenges.
The regulatory landscape for AI-enabled MedTech in the Asia Pacific region is still developing, with existing frameworks primarily governing other technologies. While countries like China, Japan, and Australia are making strides towards comprehensive regulation, the U.S. currently relies on traditional medical device regulations for AI products.
The Colorado AI Act aims to regulate the use of artificial intelligence in health care, addressing concerns about algorithmic discrimination and ensuring compliance among providers. As AI becomes more integrated into health care operations, health care organizations must evaluate their AI systems and prepare for forthcoming regulations to mitigate risks and maintain patient trust.
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