The Canadian Artificial Intelligence and Data Act
In an era where artificial intelligence (AI) is rapidly transforming industries and societal norms, Canada has taken a significant step forward by introducing the Artificial Intelligence and Data Act (AIDA). This landmark legislation aims to establish a robust framework for the development and use of AI technologies while ensuring ethical standards, transparency, and accountability. What […]
The Global Regulatory Landscape for AI/ML-Enabled Medical Devices
As artificial intelligence (AI) and machine learning (ML) technologies rapidly evolve, their integration into medical devices is transforming healthcare. From diagnostic tools to treatment algorithms, AI/ML-enabled devices offer significant benefits but also pose unique regulatory challenges. Technology in medical device applications is shifting and digital health is becoming more a part of every-day healthcare, through […]
CDER Emerging Drug Safety Technology Program
The Emerging Drug Safety Technology Program (EDSTP) is dedicated to the integration of artificial intelligence (AI) and emerging technologies within pharmacovigilance (PV) to advance drug safety and lifecycle management. This program fosters communication with the pharmaceutical industry to enhance the FDA’s understanding of AI-enabled tools and other technologies in PV, aiming to assess their performance, […]
The EU AI ACT: Implications for the Medical Device Industry
The European Union’s recent strides in regulating artificial intelligence (AI) have garnered significant attention, particularly with the introduction of the EU AI Act. This landmark legislation aims to establish a comprehensive regulatory framework for AI systems across various sectors. Among those affected, the medical device industry finds itself at a crucial crossroads, as the implementation […]
MHRA Launches AI Airlock: Pioneering Innovation in Regulatory Oversight
The Medicines and Healthcare products Regulatory Agency (MHRA) has taken a bold step into the future of regulatory oversight with the launch of the AI Airlock initiative, a new regulatory sandbox designed to help understand risks related to AI as a Medical Device (AIaMD). This groundbreaking endeavor marks a significant leap forward in harnessing the […]
FDA Whitepaper: Artificial Intelligence & Medical Products – What You Need to Know
Artificial intelligence (AI) holds immense potential to revolutionize healthcare, offering advancements in medical product development, improving patient care, and augmenting the capabilities of health care practitioners. With a shared commitment toward fostering innovation and upholding quality, safety, and effectiveness, FDA plans to align their efforts to advance the responsible use of AI for medical products. […]
