ARTICLE SUMMARY:
In this week’s Pathways Picks: The EU unveils comprehensive plans to simplify its digital and data laws, including the AI Act; ISO finalizes key updates to widely cited biocompatibility standard for devices; Brazil addresses review waitlists; lawmakers introduce Medicare Advantage bills, and more.
Editor’s note: Pathways Picks will take a break for the Thanksgiving holiday. Look for the next edition on December 3.
EU AI Act Reforms
EU Digital Omnibus includes flexibilities for AI
The European Commission published a widely anticipated Digital Omnibus package November 19 proposing to “simplify” the EU’s patchwork of rules governing digital- and data-related activities, including the nascent AI Act. The comprehensive proposal, which requires approval by the European Parliament and Council, would have broad-based impacts on all sectors of the economy, including medtech. It would loosen and streamline requirements on a range of broadly applicable laws including the General Data Protection Regulation (GDPR) that has impacted online patient privacy practices globally. The segments of the proposal that are most specific to regulatory expectations for medtech firms are those that would revise the AI Act. Makers of AI-enabled devices and IVDs are currently facing the start of extra AI Act conformity assessment requirements in August 2027. Industry has concerns about whether the new law might inadvertently constrain companies’ ability to perform studies necessary to comply with MDR/IVDR requirements and whether notified bodies will be designated to perform the necessary assessments in time. Under the new proposal:
