by Stuart McCully | 19 Nov, 2018 | Brexit, CHCUK News & Articles, Data Privacy, Digital Health Technology, eConsent, eletronic Signatures
MHRA/HRA Joint statement on seeking eConsent – A joint MHRA/HRA statement (eConsent Statement) has been published which sets out the legal and ethical requirements for seeking and documenting consent using electronic methods. It has become apparent that eConsent...
by Stuart McCully | 19 Nov, 2018 | CHCUK News & Articles, Digital Health Technology, Real Word Evidence
Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation Source: Pacurariu A, Plueschke K, McGettigan P, et al. Electronic healthcare databases in Europe: descriptive analysis of characteristics...
by chuck_ltd | 15 Apr, 2018 | CHCUK News & Articles, Data Privacy, Digital Health Technology, eConsent
While the shift to digital technologies is pervasive across multiple industries, the informed consent process for clinical trials has been historically paper-based. Given the inefficiencies in the traditional process and the increasing complexity of clinical studies,...
by chuck_ltd | 24 Mar, 2018 | CHCUK News & Articles, Digital Health Technology, FDA Guidance
This DRAFT guidance addresses how to comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603, hereafter the “combination product PMSR final rule,”...
by chuck_ltd | 9 Jan, 2017 | CHCUK News & Articles, Cybersecurity, Digital Health Technology, Medical Apps, Medical Devices, News
On 28 December 2016, the Food and Drug Administration (FDA) issued guidance to inform industry and FDA staff of the Agency’s recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical devices. In addition to the specific...
by chuck_ltd | 6 Jan, 2017 | CHCUK News & Articles, Digital Health Technology
Largely overlooked in the 900+ page 21st Century Cures Act (the “Cures Act”) signed into law on December 13, 2016, was a directive from Congress for further study into the use of technology for the delivery of health care services. A second bill signed into law the...
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 | 21 Nov, 2016 | CHCUK News & Articles, Digital Health Technology, Medical Apps
‘In 2016 users will trust health apps more than their doctors’. So predicted Forbes Magazine in 2015 in reference to Mobile Health (“mHealth”) apps, which are becoming increasingly popular to monitor health and well-being. However, the rapid...
by chuck_ltd | 14 Nov, 2016 | AI, CHCUK News & Articles, Digital Health Technology
Last month, three life sciences giants announced new or deepening partnerships with IBM, to capitalise on IBM’s supercomputer, ‘Watson’, an artificially intelligent computer system. There has been a lot of buzz recently about how big data can be meaningfully applied...
by chuck_ltd | 24 Mar, 2016 | CHCUK News & Articles, Digital Health Technology, HTA, News, Real Word Evidence
Kick-off meeting of the third HTA Joint Action: 3 March 2016 The kick-off meeting of “EUNetHTA 3” (2016-2019) – the third Joint Action which aims to pave the way for sustainable cooperation on Health Technology Assessment (HTA) in Europe takes place in Amsterdam...
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, 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, Consultation, Cybersecurity, Digital Health Technology
Is Your Medical Device Cybersecure? FDA Issues Draft Guidance on Postmarket Cybersecurity in Medical Devices Recently, the U.S. Food and Drug Administration (FDA) issued draft guidance outlining the agency’s recommendations for Postmarket Management of Cybersecurity...
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...
