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Danish Medicines Agency urges caution on health app use

Says mobile applications on their own cannot make a diagnosis

Danish Medicines Agency Facebook social media health mobile apps campaign

The Danish Medicines Agency wants consumers to be more critical about the health apps they use and says patients should usually consult their doctor when using the technology.

The calls come as part of a new online and social media campaign, based on depression diagnosis and whose central message is that not all apps are reliable.

The regulator said the same level of caution should be exercised as when consulting self-help books and websites.

“Apps generally represent a huge potential in relation to future types of treatment and the use of data in treatment,” said Thomas Senderovitz, director general of the Danish Medicines Agency. He added: “The market is still very new and has huge potential that is not yet fully exploited.”

As the types of health apps available become increasingly varied, with tests for HPV, depression and genetics just some of those to reach the market in recent years, the Agency says consumers should apply common sense and natural scepticism.

Disease diagnosis apps were one of the areas singled out by Senderovitz for caution.

“We have to be honest, so if you feel unwell, you should always consult your doctor. An app alone cannot make a diagnosis,” he said.

The campaign, which was launched in response to media and consumer pressure for the Agency to provide guidance on whether apps work or not, also takes aim at those apps classified as medical devices.

To be classified as a medical device an app must be able to make a diagnosis or treat a patient, and also be CE marked, the Agency explained.

Although they only account for a very small proportion of the apps on the market, Senderovitz said “generally they must be used with care”.

His words were echoed by Katrine Lema, scientific officer at the Danish Medicines Agency’s Medical Devices unit.

”In general, we do not recommend to use apps in connection with the treatment of a disease without having consulted a doctor. If it makes sense to use an app in a specific situation, it is important that the doctor or patient makes sure that the app is CE marked, which means that the app works as intended and is safe to use.”

To date the Danish Medicines Agency has not received any reports of failure in CE marked apps, but it stressed that may be because of the relative newness of the market.

The campaign features on the Danish Medicines Agency’s website, YouTube channel and the Facebook page it launched earlier this month.

31st March 2017

From: Marketing

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