Yearly Archives: 2013

UK Healthcare CIOs Cite Mobile Health As Top Priority

67 percent of Healthcare CIOS in the UK select mobile health solutions and electronic patient records as top priorities for the next 12 months, according to a recent industry report by Healthcare IT Exchange. The report investigates the key themes

Posted in Apps, News, Software Development, Technology, Uncategorized

The Potential for Mobile Apps in Evaluating the Effectiveness of Risk Minimization Tools

A therapeutic risk management system is defined as a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimize risks relating to medicinal products. Regulators also require the system to be capable of determining the effectiveness of

Posted in Apps, Patient Safety, Regulation, Software Development, Technology, Validation

Potential for Mobile Apps in Post Authorisation Safety Studies

Post-authorisation safety studies (PASS) are either described in the risk management plan at the time of application for marketing authorisation and become post-marketing commitments for the company; or they are required by the regulatory authorities if they consider that there

Posted in Apps, Design, Patient Safety, Software Development, Technology, Validation

FDA finally publishes final guidance for mobile medical apps

Two years after the FDA first published its draft guidance on how it regulates mobile medical applications, the agency announced that it had published its final guidance on the regulation of mobile medical apps.[ See guidance document at link below.]

Posted in Uncategorized

The Increased Use of Medical Apps

Doctors, nurses and patients are increasingly using medical apps to support a range of health conditions including: smoking cessation, weight loss and diet as well as gathering useful data on treatment adherence and disease management. This development has occurred  over

Posted in Apps, Software Development, Validation

Apps in healthcare – 2013

Below is a bibliography of articles published so far in 2013 relating to the use of mobile Apps in healthcare. 1. A comparison of the reliability of smartphone apps … [Drug Saf. 2013] – PubMed – NCBI [Internet]. [cited 2013

Posted in Apps, News, Software Development, Technology

Launch of Adverse Event Reporting App

Virtual PV aims to launch its validated mobile app for iPhone and iPad at the 2014 DIA EuroMeeting in Vienna but a pre-release ‘white-paper’, including screen-grabs for the App, is available here. The App is aimed particularly at Marketing Authorisation

Posted in Apple, Apps, Events, News, Patient Safety, Technology

Mobile Apps − A Regulatory Perspective

On 14 June 2013, Phil Tregunno of the MHRA presented at our seminar on apps in pharmaceutical development on the subject of ‘Mobile Apps − A Regulatory Perspective’. Phil first introduced the role and organisation of the MHRA in regulating

Posted in Apps, Events, Regulation, Software Development, Technology, Validation

Creating the Digital Glue between Life Science and Healthcare

On 14 June 2013, Maiken Hedegaard of NNIT presented at our seminar on apps in pharmaceutical development on the subject of ‘creating the digital glue between life science and healthcare’. Maiken drew on her experience as an IT consultant and pharmacist to

Posted in Apps, Design, Events, Software Development, Technology

New Adventures in Pharmacovigilance

On 14 June 2013, Dr Nabaran Dasgupta of Epidemico gave a presentation, ‘New Adventures in Pharmacovigilance — Mobile Apps, Social Media and a Step Outside the Comfort Zone’, at our seminar on apps in pharmaceutical development. Dr Nabaran Dasgupta’s presentation

Posted in Apps, Design, Events, Patient Safety, Regulation, Software Development, Technology