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Mobile health apps need new regulatory framework

Last month, a mobile phone app became the first of its kind to be registered by the Medicines and Healthcare products Regulatory Agency (MHRA) as a medical device.

The app was developed by the team at the Mersey Regional Burns and Plastic Surgery Unit and is designed to help medical staff assess burn damages. This neat bit of kit is listed by the MHRA as a class 1 medical device and is available for free in the Apple app store.

According to research, 81% of healthcare professionals own a smartphone and as a result the Mersey Burns app will no doubt be useful by sharing the specialist knowledge from the burns unit with their medical colleagues. However, the licensing of the app has raised all kinds of questions on the future registration of mobile phone apps for use in the healthcare professions.

On the face of it, registration is eminently desirable; in healthcare accuracy is everything, so it is important that diagnostic, treatment and monitoring apps are rigorously tested to ensure their suitability for public release. Unregulated mobile health apps have the potential to put the public at risk.

However there is concern, particularly in the US, that excessive regulation of mobile apps will vastly increase the costs of app development and slow market availability down to such an extent that the technology could be out of date by the time it hits the market.

As a result, on both sides of the Atlantic, web and app developers and healthcare and pharmaceutical companies are calling for a new regulatory framework which will allow the testing and processing of relevant mobile apps at speeds equal to the pace of rapid technological change.

Internet and smartphone-based nursing can help diabetic patients

Nursing via the internet and smartphones can be an effective way to help patients with uncontrolled diabetes to manage their care.

According to a new study conducted by McGill University, Canada for the Public Health Agency of Canada, tele-monitoring is also increasingly seen as a workable way of delivering care to patients with chronic conditions who live in remote places, or who require monitoring on a long-term basis.

During the pilot project, diabetic patients in four regions of Quebec submitted their blood sugar readings to a nurse every day using a secure website.

Patients also answered a series of questions online about their exercise, diet and food care.

Their nurses then monitored their responses, providing appropriate advice as and when required. If a patient’s readings were a cause for concern, then they appeared in red text and triggered an alarm.

Nurses also emailed their patients educational material to help them manage their conditions.

Antonia Arnaert, professor of nursing at McGill University, said: “Patients with chronic diseases like diabetes, or who have gone through surgery, often have lots of questions and the doctors and nurses don’t always have the time to answer them.

“With tele-nursing, whether using video-conferencing or text-messaging, patients say they feel they get lots of attention from their nurses, because they know that they have their full attention for an hour.”

“They said that tele-monitoring provided them with a sense of confidence in their ability to manage their diabetic condition themselves.”