Blog Archives

Apps as medical devices – UK regulator updates its guidance

The MHRA has updated its guidance on whether a health app should be subject to medical device oversight. A number of apps and pieces of stand-alone software that are already on the market have so far been classified as medical

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

Better pharmacovigilance through social media

Monitoring conversations on Facebook, Twitter, and patient forums to identify and assess adverse drug reactions (ADRs) is becoming very popular with pharma companies and healthcare organisations providing useful data for strategy development, competitive research and patient segmentation. But what remains

Posted in Patient Safety, Regulation, Technology

AZ and NCI to develop a mobile app to manage side effects

It has been reported that AstraZeneca and the NCI will test whether a mobile app can improve treatment for women who are taking AstraZeneca’s Lynparza and cediranib cancer drug combo. The smartphone app links to a web portal that allows doctors and

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

It’s now official – using a mobile app can improve pharmacovigilance

A recent study has shown that by using a mobile app the time taken to prepare and submit a voluntary adverse event (AE) report can be reduced significantly. The study also showed that reports received via the mobile app were

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

MHRAs mobile app for adverse event reporting

The MHRA has moved its Yellow Card Scheme into the mobile age, launching a smartphone app that allows patients to report potential side-effects and adverse reactions directly to the regulator. The medicines regulator’s free new app – which is also

Posted in Apple, Apps, Patient Safety, Software Development, Technology, Uncategorized, Validation

FDA turns to Google for help spotting adverse events

The FDA has approached Google for help identifying adverse drug events in search data. The regulator hooked up with Google to access the insights of Evgeniy Gabrilovich who has published papers on the subject of mining search queries for adverse event

Posted in Patient Safety, Regulation, Software Development, Technology

Poor quality reproductive health apps

Reproductive health care providers need recommendations on applications (apps) for patient use, particularly apps for menstrual cycle and fertility tracking, because these apps are frequently downloaded by women and can be used by clinicians when evaluating menstrual problems. However, a

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

Mobile Apps and Real World Evidence

The randomised clinical trial (RCT) has long been the gold standard in drug development but this tightly controlled environment provides a poor picture of how a new therapy will fare in the real world. So-called real-world evidence (RWE) may not

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

Unreliable Asthma Apps

An early study of first generation asthma diagnostic apps identified many were unvalidated, contained errors and offered therapeutic interventions that were not evidence based. Since those early days clinicians, policy groups and regulators have actively discussed the quality and safety

Posted in Apps, Patient Safety, Software Development, Validation

Insulin dosing apps are unreliable and prone to error

A recent study led by the Global eHealth Unit at Imperial College London has found that the majority of insulin dosing apps are unreliable and put patients at risk of getting incorrect doses of insulin. Huckvale and colleagues found 46

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