Artificial Intelligence: US FDA Plans Guidances On Algorithm Bias, Product Development

“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”

Bayer Consumer Health hopes its new InflammAge saliva-based biomarker can help “revolutionize self-care and how people can manage their aging journey.”

AI prowess “will not be a competitive advantage long-term. It's going to be table stakes. But there are people who are going to get there sooner and they will have an advantage for a while,” says C&D CEO Matthew Farrell. P&G’s investment in AI, meanwhile, produced its “Great Idea Generator proprietary platform.”

Electronic product information should be “fully operational” within four years after the entry into force of the revised EU pharma legislation and should precede the phasing out of paper leaflets, proposes the Inter-Association Taskforce (IATF) on ePI. Once the new system is up and running, ePI should be implemented across the EU in a harmonized way, with all EU member states adopting the same standard, it says.