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Trump Administration Announces MyHealthEData Initiative at HIMSS18

by chuck_ltd | 30 Mar, 2018 | 21 Century Cures Act, Cures Act, EHR, Real Word Evidence, Virtual Clinical Research

The Trump Administration is launching the MyHealthEData initiative which aims to empower patients by ensuring that they control their healthcare data and can decide how their data is going to be used, all while keeping that information safe and secure CMS is committed...

New FDA Draft Guidance – Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11

by chuck_ltd | 8 Jul, 2017 | EHR, eletronic Signatures, GCP, News

The FDA  released a new draft guidance document on 21 June 2017.  Comments should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. >>>Link to Draft Guidance Document: Use of...

Implementation of the Hong Kong Electronic Health Record Sharing System

by chuck_ltd | 29 Apr, 2016 | CHCUK News & Articles, Data Privacy, EHR, Virtual Clinical Research

The Electronic Health Record Sharing System Ordinance came into effect on 2 December 2015. The Ordinance provides the legal framework for public and private hospitals and other healthcare providers to collect, share and keep patient’s electronic health record...

London Based Collaboration to Improve Access to Digital Health Market

by chuck_ltd | 16 Feb, 2016 | CHCUK News & Articles, Digital Health Technology, EHR, Virtual Clinical Research

An initiative launched on Wednesday, DigitalHealth.London, is aiming to accelerate the development, commercialisation and uptake of digital health technologies in the UK by improving access to the market for companies and entrepreneurs.  It is hoped that this will, in...

UK: NHS to be ‘Paperless’ by 2020

by chuck_ltd | 15 Feb, 2016 | CHCUK News & Articles, EHR, News, NIS

Health secretary Jeremy Hunt announced earlier this week that more than £4 billion will be invested to bring modern technology into the NHS. It is thought that £1.8bn will be set aside to digitise records, removing the reliance on paper and outdated technology such as...

EU: New Agreement to Make EU Online Environment More Secure

by chuck_ltd | 8 Dec, 2015 | CHCUK News & Articles, Data Privacy, EHR, GCP, Medical Apps, News, NIS, Real Word Evidence, Virtual Clinical Research

Commission Welcomes Agreement to Make EU Online Environment More Secure European Commission – Press release Brussels, 8 December 2015 Negotiators of the European Parliament, the Council and the Commission have agreed on the first EU-wide legislation on...

UK: MHRA's Position Statement and Guidance on Electronic Health Records

by chuck_ltd | 7 Dec, 2015 | CHCUK News & Articles, Data Privacy, EHR, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research

NHS trusts and health boards sponsoring a clinical trial, or hosting a trial sponsored by a commercial company need to ensure their electronic health record systems comply with legal requirements for good clinical practice. This guidance covers common inspection...

Ireland: eHealth Ireland – The Future is Paperless!

by chuck_ltd | 1 Dec, 2015 | CHCUK News & Articles, EHR, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research

Background A national Electronic Health Record (EHR) has been identified by HSE National Directors and clinical leaders as a key capability requirement for the future delivery of healthcare. While technology solutions are a key component, there will be a primary focus...

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