TGA eyes tougher regulation for smartphone health apps
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.
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, medical devices such