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...
by chuck_ltd | 1 Jan, 2017 | CHCUK News & Articles, Digital Health Technology, GCP, News, Virtual Clinical Research
Finalised FDA Guidance Published December 2016 This guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). This guidance is intended for...
by chuck_ltd | 10 May, 2016 | CHCUK News & Articles, Data Privacy, News, Virtual Clinical Research
The EU Data Protection legislation has been reformed. On 15 December 2015, the European Parliament, the Council and the Commission reached agreement on the new data protection rules, establishing a modern and harmonised data protection framework across the EU. The...
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...
by chuck_ltd | 16 Mar, 2016 | CHCUK News & Articles, Digital Health Technology, News, Patient Centricity, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research
Davis, CA. – March 07, 2016 – Mytrus, a pioneer in innovative technologies for improving patients’ participation in clinical trials, has announced that its Enroll® and Engage™ technology infrastructure will support the ADAPTABLE (Aspirin Dosing: A...
by chuck_ltd | 1 Mar, 2016 | CHCUK News & Articles, GVP, Pragmatic Trials, Real Word Evidence, Registry, Virtual Clinical Research
Summary The European Medicines Agency is consulting stakeholders on an amended risk management plan (RMP) template, to be used by medicine developers. The revision of the template is based on the principles described in the updated good pharmacovigilance practices...
by chuck_ltd | 1 Mar, 2016 | CHCUK News & Articles, Cybersecurity, Data Privacy, Digital Health Technology, Medical Apps, News, Virtual Clinical Research
Strasbourg, 2 February 2016 The European Commission and the United States have agreed on a new framework for transatlantic data flows: the EU-US Privacy Shield. Today, the College of Commissioners approved the political agreement reached and has mandated...
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...
by chuck_ltd | 26 Jan, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Registry, Virtual Clinical Research
Starting from January 1st 2016 the online-platform BASEC (Buisness Administration System for Ethics Committees) to submit research project to Swiss Ethics Committees is mandatory. Link: https://submissions.swissethics.ch/en/ No submissions or updates outside of BASEC...
by chuck_ltd | 24 Dec, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Professional Standards, Real Word Evidence, Registry, Virtual Clinical Research
On 17 December 2015, the French National Assembly adopted a law on modernisation of the French health system (the “Public Health Law”). Key provisions will bring changes to how the pharmaceutical and medical device industries interact with HCPs, by...
by chuck_ltd | 16 Dec, 2015 | CHCUK News & Articles, Consultation, GVP, News, NIS, Real Word Evidence, Registry, Virtual Clinical Research
Latest EMA GVP (XVI) Module Update The final Addendum I to Module XVI on educational materials is published, taking into account comments from the public consultation. Further, revision 1 of Module XV on safety communication, with revision 1 of the template for Direct...
by chuck_ltd | 14 Dec, 2015 | CHCUK News & Articles, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Registry, Virtual Clinical Research
Human Rights Day – 10 October Herbert Smith Freehills LLP – Stéphane Brabant Beyond the traditional judicial fora where business enterprises can be challenged for human rights violations, they now also face ‘new judges’ such as NGOs, consumers, financial...
by chuck_ltd | 11 Dec, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Real Word Evidence, Virtual Clinical Research
On 16 October 2015, CMS hosted a conference on the implications of the European Commission’s plans to create a Digital Single Market. The conference generated meaningful discussions on the true impact, reality and consequences of the proposed framework. Key figures...
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...
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...
by chuck_ltd | 4 Dec, 2015 | CHCUK News & Articles, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research
Industry-changing technology will help break down healthcare and clinical research silos, empowering organizations to connect and share verifiable information in real time. Texas-based healthcare and clinical research networking-technology company HealthCarePoint...
by chuck_ltd | 4 Dec, 2015 | CHCUK News & Articles, GCP, News, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research
HealthCarePoint BlueCloud Enhances Collaborations Between Institutional Review Boards and Investigators to Help Site Sustainability HealthCarePoint (HCP) announces its collaboration with independent institutional review boards (IRBs). The announcement follows a...
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...
