“Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products” and “Artificial Intelligence in Drug Manufacturing” were developed to support the use of AI/ML while addressing concerns related to security, bias and risk, and spur feedback and discussion from stakeholders.
The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in the UK market.
“The innovation, security and reliability of AWS helps us accelerate the delivery of high-quality clinical documentation. Our overarching goal is to create a better, more sustainable solution and to continue to be a trusted partner that our clients can rely on to reduce administrative tasks and prioritize patient engagement.”
The CDRH notes that the goal of the guidance is to put safe and effective advancements in the hands of healthcare providers and users more quickly to help increase the pace of medical device innovation in the U.S. and enable more personalized medicine.
The chronic, progressive presentation of COPD, symptom overlap, and nature of patient self-reporting make it hard to identify exacerbations. We need more specific guidelines around, as well as tools for, assessing a patient’s progression from day to day. AI-supported diagnostic systems represent a potential breakthrough technology that could help us overcome significant knowledge gaps.
The world of medicine has long centered on the central maxim laid out in the Hippocratic Oath, “Do no harm.” When we look at the growth of AI in health care, I say let’s also include a 21st-century addendum, “Do not deceive.”
Rama Chellappa, PhD, John Hopkins University Bloomberg Distinguished Professor in electrical, computer, and biomedical engineering, and co-author of “Can We Trust AI?” looks at the promise of AI in health care and how we can best utilize this extraordinary tool to save lives and improve health equity.
Digital transformation requires a clear vision, buy-in at every level, and significant investment. Here are three steps to streamline the process.
Anthony Fernando, CEO and president of Asensus Surgical, discusses the potential benefits of augmented intelligence in robotic surgery for both patients and physicians.
As data, rather than document-based dossiers, become the focus for regulatory processes, regulatory affairs managers need to consider whether team skill sets need to be refreshed to reflect new ways of working.
