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

mHealth in Clinical Trials: Benefits and challenges

A recent article showed that whilst it is still rare for wearable devices and smartphones to be used in clinical trials there is growing evidence of some major benefits, including: Real-world, continuous measurement of health status as subjects follow their

Posted in Apps, Regulation, Security, 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

Too many mHealth apps, too little verification

Concerns about the safety and reliability of mHealth apps are growing and recent articles in JAMA and JMIR provide evidence to support these concerns. But not everyone believes deeper review and critique of apps is necessary. An ex-Food and Drug Administration deputy commissioner and

Posted in Apps, Design, Functional programming, Regulation, Software Development, Systems Thinking, Technology, Validation

EU Convenes mHealth app Working Group

The European Commission is working towards improving the safety and transparency of health information collected by mobile apps. Its newly set up mHealth app working group will be tasked with assessing the validity and reliability of the data that is

Posted in Apps, Regulation, Security, Technology, Uncategorized

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

NHS to re-launch its app store

Lets hope this means they are going to put more effort into protecting users’ data since a report co-authored by researchers from Imperial College London, revealed that several NHS-approved apps leaked data about their users. The study, which assessed all

Posted in Apps, Regulation, Security, Technology, 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

Smartphone connected spirometer gets FDA Approval

Cohero Health has received FDA 510(k) clearance for its mobile connected spirometer that measures critical lung function with comparable accuracy to clinical-grade spirometers, and sends the data to a smartphone or tablet. The spirometer allows users to track their lung

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

Too many mHealth apps, too little verification

The mHealth app industry faces some major challenges with data security, user privacy and regulatory concerns often cited as top worries. Despite this, consumer downloads of mHealth apps hit 660 million in 2013, according to a report from the IMS

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