FDA to create new guidelines for mobile medical apps

The US Food and Drug Administration (FDA) is set to propose new regulations for smartphone apps.

The regulations affect a small number of medical apps in the States and provide a clue as to how regulation might develop in the UK.

Around 150 medical apps have been produced to date. These include patient diary apps and calculators for those working in the health sector.

The FDA has now launched a three month consultation in order to devise how it will oversee what it calls “mobile medical apps”. It is focusing on the apps that could present a risk to patients if they fail to work as planned.

These types of apps include those which enable doctors to see medical images on an iPad with a view to making a diagnosis from them.

Other apps that could come under the regulations include those which allow doctors to use their smartphone as an electrocardiography (ECG) machine, apps that calculate the maximum dosage of local anaesthesia based on a patient’s weight and age and apps that collect blood glucose readings to help manage diabetes.

The FDA has already approved a small number of apps for use. These include a smartphone-based ultrasound device and a medical iPhone/iPad app that lets doctors view medical images and X-rays.

Bakul Patel, FDA policy advisor, said: “There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks.”

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