Digitization in the new Public Procurement Code: New technological frontiers and artificial intelligence
The digitization of tendering procedures is one of the most important issues addressed by the new Public Procurement Code, which introduces systematic reorganization and significant changes.
AI and machine learning in the medicine lifecycle: EMA publishes first draft of reflection paper
The first draft of EMA’s “Reflection paper” contains the authority’s latest considerations on the application of AI and machine learning methods in each phase of the medicinal product lifecycle.
The AI Act: What will the impact be on the medical device industry?
The European Parliament approved the “AI Act” (June 14, 2023), a proposal for a regulation providing a uniform legal framework for the use of artificial intelligence in the EU.
The metaverse in healthcare: What are the legal implications?
For some time now, there has been talk of the metaverse as a tool with great potential for increasing opportunities for treatment, research, and training in healthcare.
Medical devices and artificial intelligence: FDA issues first guidelines for developing Good Machine Learning Practices
On October 27, 2021, the U.S. FDA, in collaboration with the Canadian regulatory agency, Health Canada, and the United Kingdom’s MHRA, released a document containing 10 guiding principles to promote the development of Good Machine Learning Practice.
Artificial Intelligence and Machine Learning in Clinical Trials: Regulatory attempts by European and national authorities
In the last few years, use of Artificial Intelligence and Machine Learning systems in the performance of Clinical Trials has increased.