The text of the European Commission’s proposed AI Act is expected to enter the EU high-level negotiation stage within weeks, yet many questions remain as to what the final regulation will entail. Lawyers from Cooley LLP tell Medtech Insight why considerable changes to the text are possible, and what the new law is likely to mean for medtech.
Last month, members of the European Parliament voted in favor of substantial changes to the draft AI Act – a key step towards this landmark legislation being adopted in the EU.
The compromise amendments set out significant updates to the original proposal – although many of these changes are not...
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.
Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.
