Experts at the 2025 European Digital Technology and Software conference expressed concerns that the EU AI Act could hinder the launch of new medtech products in the European market. They emphasized the need for manageable regulations to foster innovation while ensuring patient safety and equality in healthcare.
The EU Artificial Intelligence Act (AIA) is set to revolutionize the development and approval of AI-enabled medical devices, making compliance essential for manufacturers and innovators in the European market. This upcoming webinar will clarify the AIA’s requirements and provide practical steps for aligning with new compliance obligations.
The article emphasizes that while AI is rapidly transforming healthcare, it must be implemented responsibly and with a focus on human needs, rather than merely adopting new technologies. It argues for the necessity of frameworks like HITRUST’s AI Assurance Program to ensure accountability and ethical standards in AI deployment within patient care settings.
This article presents an AI readiness assessment framework tailored for the pharmaceutical industry, emphasizing the importance of aligning AI initiatives with regulatory standards and ethical practices. It highlights the critical need for transparency, data integrity, and accountability in adopting AI technologies to ensure patient safety and scientific integrity throughout the drug development lifecycle.
This article presents an AI readiness assessment framework tailored for the pharmaceutical industry, emphasizing the importance of aligning AI initiatives with regulatory standards and ethical practices. It highlights the critical need for transparency, data integrity, and accountability in adopting AI technologies to ensure patient safety and scientific integrity throughout the drug development lifecycle.
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.