by chuck_ltd | 6 Jul, 2017 | CHCUK News & Articles, Medical Apps, Medical Devices, News
Source: Osborne Clarke It is widely known that in some circumstances, software may fall within the category of medical device and so have to comply with the associated regulations as regards its marketing. But deciding exactly when software will be categorised as...
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 | 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 | 31 Aug, 2016 | CHCUK News & Articles, Medical Apps, Medical Devices, News, Real Word Evidence
Updated guidance issued to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe. From counting steps to helping healthcare professionals prescribe treatment for burns injuries, healthcare apps and...
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 | 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 | 16 Nov, 2015 | CHCUK News & Articles, Medical Apps
Buchalter Nemer – Rebecca M. Freed On July 10, 2015, Congress passed H.R. 6, the 21st Century Cures Act, with a bipartisan vote of 344 to 77. The 352-page bill seeks to make the U.S. Food and Drug Administration (FDA) drug and device approval process less...
by chuck_ltd | 16 Nov, 2015 | CHCUK News & Articles, Data Privacy, Medical Apps, News, Pragmatic Trials, Real Word Evidence
Buchalter Nemer – Kathleen Juniper Smart medical devices that can deliver health care services are increasingly consumer friendly. Using the latest technologies and sophisticated algorithms, some devices are capable of collecting data directly from consumers...
by chuck_ltd | 14 Oct, 2015 | CHCUK News & Articles, HTA, Medical Apps, News, NIS
Article by: Florian Eichmann, PhD, Principal Late Stage, Scientific Affairs and Real World Evidence, inVentiv Health Clinical, Munich, German Regulators and Health Technology Assessment (HTA) agencies – and thus manufacturers and research stakeholders –...
by chuck_ltd | 22 Mar, 2014 | Medical Apps
Many manufacturers, software developer, academics, clinicians and organisations are using software for both healthcare and social care needs. This guidance explains how this technology is regulated. It covers stand-alone software (also known as software as a medical...
