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Diabetes apps: regulation concerns grow

Diabetes apps: regulation concerns grow - Featured Image

PATIENTS with diabetes should be warned about the potential for insulin dosing errors with glycaemic control smartphone apps, experts warn, as regulators struggle to oversee the rapidly growing sector. There are over 1500 diabetes apps available online – a number growing faster than any other health care sector, according to Dr Rahul Barmanray and Dr Esther Briganti, Melbourne endocrinologists writing in this week’s MJA. “Although apps increasingly advise on insulin doses, there is minimal published information on safety and efficacy, despite these apps effectively providing drug treatment recommendations without health care professional oversight,” they wrote. Most diabetes apps are not listed with the Therapeutic Goods Administration (TGA), but even those that are have not been required to undergo third-party assessment as they are only Class I devices. Dr Barmanray and Dr Briganti wrote that as a result, the Australian public were not receiving the health and safety protection they ought to reasonably expect from the regulator. A spokesperson for the TGA told MJA InSight it was considering stricter regulation of the sector, consistent with reforms in Europe. “The new rules [in Europe] capture decision making software like dosage calculators … [These] apps will now be a higher classification requiring third-party certification.…