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How far do the medical device rules affect health-related apps?

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...

Postmarket Management of Cybersecurity in Medical Devices

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...

EU Commission Proposes mHealth App Assessment Guidelines

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...

Is your App a medical device? It’s healthy to know: MHRA issues updated guidance

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...

EU-US Privacy Shield

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...

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...

USA: Drug and Device Companies May Soon Face Less Burdensome FDA Approval Process

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...

USA: Delivering Health Care Services to Consumers Through ehealth Devices

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...

EU: Evidence from Direct-To-Subject Study Designs for Health Outcomes Research (Oct 2015)

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 –...

UK: MHRA Guidance on Medical Device Stand-Alone Software – Including Apps (22/03/2014)

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...

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