TGA eyes tougher regulation for smartphone health apps

Endocrinologists say most glycaemic control apps pose a risk of inappropriate dosing

Smartphone apps that offer therapeutic advice, such as insulin dosage calculations, will be assessed by the TGA for safety under a new proposal to protect patients.

Health app

The national medicines watchdog is preparing to examine the regulation of health apps following criticism from clinicians that most apps used by patients have not been proven to be efficacious or accurate.

Writing in the MJA, endocrinologists say glycaemic control apps are categorised as Class I (low risk) devices, and therefore escape independent assessment.

In contrast,