Monthly Archives: October 2013

Under-reporting of ADRs – why not use an app?

Whilst the reporting of spontaneous adverse drug reactions (ADRs) is recognised as an important tool in building a drugs pharmacovigilance profile it is poorly supported by healthcare professionals (HCPs) and under-reporting is a major problem. Various initiatives have been introduced

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

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Two years after the FDA first published its draft guidance on how it regulates mobile medical applications, the agency announced that it had published its final guidance on the regulation of mobile medical apps.[ See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