Open Letter on the Implementation and Readiness Status of the New Medical Device Regulation 745/2017 (MDR) Critical review of the new Medical Device Regulation from Medtech Europe. Source: https://www.linkedin.com/feed/update/urn:li:activity:6525149926949781504
First randomized study indicating beneficial effects with a clinical decision support (CDS) in patients with AF. — Read on www.ncbi.nlm.nih.gov/m/pubmed/29534063/
Intelligente Maschinen fällen in heiklen Fragen oft präzisere Urteile als das geschulte Fachpersonal. Doch wer ist verantwortlich, falls etwas schiefgeht? Read more: amp.handelsblatt.com/unternehmen/it-medien/kuenstliche-intelligenz-wer-traegt-die-verantwortung-wenn-der-algorithmus-sich-irrt/23828718.html
Have you heard of European electronic health records (EEHR) exchange format yet? — Read on www.himssconference.org/updates/interoperability-electronic-health-records-europe-facilitating-cross-border-cooperation
The company was founded last year and has developed technology that analyzes data from a combination of clinical and commercial devices to monitor and track the health status of patients at home. — Read on medcitynews.com/2018/12/san-francisco-startup-raises-6-75-million-for-remote-health-monitoring/
New prescription drug-use related software proposed by FDA will help companies and develop an efficient pathway to help increase safety and effectiveness. Read on: www.natlawreview.com/article/significant-fda-digital-health-policy-development-prescription-drug-sponsors
European Reference Network: Clinical Practice Guidelines (CPG) and other Clinical Decision Support Tools (CDSTs) — Read on etendering.ted.europa.eu/cft/cft-display.html;eTenderingPublic=0kVGmcqTLa8xpic1H9nFAzo1BcwyFyk7G_CUr0-QG7ag_XNCvGqM!629740168
Brigham and Women's to apply deep learning to medical records and images Hospitals say the AI method is in use today automating things humans do well but don't have the time for – and there's much more to come. Read on: www.healthcareitnews.com/news/mass-general-brigham-and-womens-apply-deep-learning-medical-records-and-images
Until May 31, the U.S. Food and Drug Administration (FDA) has open for comment from the public a proposal for precertification of software as a medical device. Its 17-page proposal is located at https://www.fda.gov/downloads/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm605685.pdf. Some trade press commentary is at http://www.mobihealthnews.com/content/fdas-pre-cert-plan-takes-shape-worries-emerge-about-overreach. This is part of FDA’s Digital Health Software Precertification (Pre-Cert) Program (https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/default.htm). Source: GARY CAPISTRANT, PATH Policy Advisor, Capistrant Consulting
Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21 Clinical Trial Optional) The purpose of this Funding Opportunity Announcement (FOA) is to encourage exploratory/developmental research applications that propose to conduct research to develop or adapt innovative mobile health (mHealth) technology specifically suited for low and middle income countries (LMICs) and determine the health-related outcomes associated with implementation of the technology. Of highest interest are innovative, well-designed multidisciplinary projects that aim to generate generalizable knowledge for the field. The overall goal of the FOA is to contribute to the evidence base for the use of…