LONDON – France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) has published draft guidelines on the cybersecurity of medical devices, becoming the first national regulator in Europe to specify what manufacturers should do to protect devices against malicious attacks. Read More
Information technology and connectivity have transformed productivity and costs in nearly every industry. Health care, however, has remained persistently immune to this transmogrification. Electronic health records (EHRs) have been particularly disappointing on this front, with time-consuming and inconsistent physician data entry as well as poor integration across complex and emerging data sources from medical devices, imaging, genomics and wearables and, as a consequence, a lack of usefulness in improving population health analytics or personalized care. Read More
The U.S. FDA has cleared the way for Physiq Inc., of Naperville, Ill., to market its continuous ambulatory respiratory rate algorithm, adding to the company's portfolio of cloud-based analytics for biopharma and health insurance companies. The 510(k) notification will allow Physiq to boost its higher-level artificial intelligence (AI) platform with validated vital signs inputs. Read More
