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
On 5 November 2018 the Wellcome Trust in the UK and the Gates Foundation in the United States with more than €2 billion research grants volume in total in 2017 announced that they were joining the open-access initiative, Plan S. They said their move was intended to “ensure that research findings are shared widely and are made freely available at the time of publication. Read on: https://www.nature.com/articles/d41586-018-07300-
“It is a breakthrough to be able to make progress in an area like this. I think that is something that is really worth celebrating.” — Weiterlesen www.forbes.com/sites/matthewherper/2018/10/17/researchers-behind-spinraza-win-breakthrough-prize/amp/
Thinking out loud is often less arduous than writing. And it’s now easier than ever to combine the two, thanks to recent advances in speech recognition technology. — Read on medium.com/descript/overcoming-writers-block-with-automatic-transcription-f85bbb30eda6
The 11. Edition of the International Classification of Diseases (ICD 11) of the World Health Organization (WHO): All World Health Organization Member States are expected to use the most current version of the ICD for reporting death and illness (according to an international treaty, the ‘WHO Nomenclature Regulations’, adopted by the World Health Assembly in 1967). ICD–10 has been translated into 43 languages, and ICD–11 has been available in all 6 official languages since its publication (English, French, Spanish, Russian, Chinese, Arabic). ICD-11 — Read on icd.who.int/
New steps in Horizon 2020 Current LERU activities for Horizon Programme are published. Read on: https://www.leru.org/news/universities-united-for-the-best-horizon-europe
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
Multiple Function Device Products: Policy and Considerations FDA: Draft Guidance for Industry and Food and Drug Administration https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm605683.pdf
Open Access Journal on Healthcare Transformation www.linkedin.com/feed/update/urn:li:activity:6387339630995472384