Affichage des articles du avril, 2020

Google veut faciliter l'analyse des données sur la santé dans le cloud

Google a étendu la disponibilité de son API "Cloud Healthcare" dans le but d'améliorer l'interopérabilité des soins de santé et d'aider les fournisseurs à obtenir des informations à partir d'une myriade de sources de données médicales. L'API Cloud Healthcare de Google permet aux organismes de santé de collecter et de gérer différents types de données médicales via le cloud, notamment les normes DICOM (Digital Imaging and Communications in Medicine),  Health Level 7  et  Fast Healthcare interoperability Resource . Ces données peuvent être alimentées par des programmes d'analyse et de machine learning afin que les prestataires de soins de santé puissent identifier des modèles qui pourraient les aider à améliorer les soins aux patients. Link to article - CLICK HERE

Implementing Data Quality By Design For Improved Data Integrity

By  Kip Wolf , Tunnell Consulting,  @KipWolf To begin, it is important to understand that data quality and data integrity are not the same thing. Data quality may be defined as the general utility of a data set as a function of its ability to meet the requirements for its use. This definition includes relativity that may also be explained as bias, which simply means that context is necessary to fully interpret and understand the data. Data quality is very specific to the data set and the data itself and, if measured to be poor, may be improved through verification, transformation, and/or cleanup. Data integrity is about trust and is as much about the supporting systems and processes as it is about the data set and the data itself. Data integrity relates to the state of the data or the sensitivity of data to external influence or change... Link to article - CLICK HERE

WL Guangzhou Tinci Materials Technology Co., Ltd. JANUARY 23, 2020

3. Failure to establish an adequate quality control unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)). Your quality unit (QU) did not have adequate procedures describing the appropriate oversight of your manufacturing operation. For example, you lacked written procedures describing the review of test records, raw electronic data, and batch production records prior to approval and release...

Commission postpones application of the Medical Devices Regulation to prioritise the fight against coronavirus

Today, the European Commission has adopted a  proposal  to postpone by one year the date of application of the  Medical Devices Regulation  to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic. This decision takes into account the unprecedented challenges of the coronavirus pandemic and the need for an increased availability of vitally important medical devices across the EU whilst continuing to ensure patient health and safety until the new legislation becomes applicable. Vice-President for Promoting our European Way of Life, Margaritis  Schinas , said:  “Shortages or delays in getting key medical devices certified and on the market are not an option right now. The Commission is therefore taking a pragmatic approach and delaying the entry into application of new EU rules on medical devices, so we can have our medical industries pouring all their energy into what we need them to be doing: helping fight the p