On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published a statement of policy intent for UK recognition of international regulatory approvals of certain medical devices (the “Statement”). The Statement follows the Government response to the 2021 consultation on the future regulation of medical devices in the UK that details an
Ten years after American Farm Bureau Federation first publicized the Ag Data Core Principles, the Ag Data Transparent organization undertook the effort to update the principles to reflect changes in the ag data market. This post explores some of the significant changes to the updated Core Principles.New Simple Contracts Principle. The original principles were
Yesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that will phase out the Agency’s previous policy of enforcement discretion for Laboratory-Developed Tests (“LDTs”). The final rule was issued at an astonishing speed compared to
In 2014, American Farm Bureau Federation led industry roundtable discussions about collection, use, and sharing of agricultural data from farmers. The result of those discussions was the creation of a document called the Privacy and Security Principles for Farm Data, what later became knowns as the “Core Principles” for ag data. Over 37 companies quickly
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although there was no single moment like the passage of the Affordable Care Act in 2010, there are numerous
Artificial intelligence (AI) use is on the rise in agriculture and elsewhere, thanks to generative AI platforms like OpenAI’s ChatGPT. AI is often described as a Black Box, where data is fed into the box and decisions are made, without anyone knowing exactly how the Black Box arrived at the result. Considering that the AI
I was fortunate to be asked to testify before the US Senate Agricultural Committee recently about the impact of artificial intelligence (AI) on agriculture. Although AI and its simpler cousin machine learning (ML) have operated behind the scenes for years already, 2023 is the first time that AI and ML really entered the public discourse.
FBN recently unveiled “Norm,” an artificial intelligence (AI) advisor for FBN members. Norm may be the first dedicated artificial intelligence platform for farmers, but it will not be the last. AI is definitely on the rise in agriculture and elsewhere. This post explores questions about AI’s use in general and for agriculture. What
Artificial intelligence (“AI”) will likely drive many complex medical devices in the near future. But as with all things, AI can sometimes fail. Companies relying on AI to elevate their medical devices above the competition should be mindful of four common AI failure modes: AI functional errors, software rot, unexplained programming glitches, and the ever-present
ChatGPT is all over the news lately. If you missed it, ChatGPT is a form of artificial intelligence (AI) operated by OpenAI. ChatGPT is trained on data from various sources, including books, articles, websites, and other publicly available text type data. Users can ask ChatGTP questions in a search bar about nearly anything and ChatGPT