The FDA is set to publish new draft guidance on January 7 aimed at developers of AI-enabled medical devices, offering recommendations for marketing submissions and regulatory oversight throughout the product life cycle. This guidance represents a comprehensive framework for the management of these devices, emphasizing the importance of early and continuous engagement between developers and the agency. It builds on previous guidance regarding change control for AI and machine learning components, which helps facilitate device updates without requiring new marketing submissions. The FDA's initiative also focuses on ensuring transparency and addressing bias in AI systems, providing developers with essential resources for navigating the complexities of integrating AI in healthcare.

FDA Unveils Groundbreaking Guidance for AI-Enabled Medical Devices Healthcare IT News

In this article, Sue Schade reflects on a piece written for Becker’s Hospital Review in which Michael Dowling, President and CEO of Northwell Health, outlines six critical priorities for healthcare leaders in light of the recent political shifts following the November 5th election. He emphasizes the necessity of positivity, truthfulness, and support for access to care while urging leaders to combat misinformation and uphold core values such as decency and integrity. Dowling stresses that preserving trust in scientific advancements is crucial for maintaining credibility during a time of change, and he calls on healthcare leaders to foster unity and serve as role models within their communities.

Healthcare Leaders Urged to Embrace Truth and Values Post-Election sueschade.com

Digital twin technology is increasingly being recognized as a significant advancement in patient care, enabling the creation of digital replicas that simulate treatment options and predict health outcomes. A recent study of over 1,800 patients with type 2 diabetes demonstrated that digital twins could provide personalized recommendations based on real-time data, leading to improved patient outcomes such as lower hemoglobin A1c levels and reduced medication needs. Furthermore, research suggests that this technology could also reshape cardiovascular medicine by integrating diverse health data to offer real-time insights and allow for the simulation of treatment scenarios, thereby enhancing chronic condition management.

Digital Twin Technology Transforms Patient Care and Chronic Disease Management Mayo Clinic Platform

Sanford Health and Marshfield Clinic Health System have merged to create a unified nonprofit integrated health system operating under the Sanford Health name, aimed at improving patient-centered care in the Midwest, particularly in rural areas. This merge adds 13,000 employees from Marshfield and expands health services to the Marshfield region in Wisconsin and Michigan's Upper Peninsula, while maintaining operations for Sanford Health Plan and Security Health Plan. Dr. Brian Hoerneman has been appointed president and CEO of the Marshfield Clinic region, reflecting the commitment to enhance healthcare access in these areas. The combined organization will support a broader geographic service area, including multiple states, with nearly 56,000 employees and 56 hospitals.

Sanford Health and Marshfield Clinic Merge to Transform Rural Healthcare Sanford Health