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Can Standards and Regulations Keep Up With Health Technology?

Can Standards and Regulations Keep Up With Health Technology?

Everyday life and a glucose meter (image credit Aisling Ann O'Kane; image license CC-BY). Mobile health care technologies used for self-management, such as glucose meters used by people with diabetes, are medical devices and are regulated as such. Standard usability engineering process applies, such as IEC 62366 [14], for these cases.

Christopher James Vincent, Gerrit Niezen, Aisling Ann O'Kane, Katarzyna Stawarz

JMIR Mhealth Uhealth 2015;3(2):e64

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