Validation, accuracy and security requirements

«The document originates from need to read up on what technology offers us from the point of view of wearable sensors ”, explains the professor Gianfranco Parati, Professor of Cardiovascular Medicine at the Milano-Bicocca University and scientific director, Irccs Istituto Auxologico Italiano (Mi), who together with Enrico Caiani, Polytechnic of Milan, and Marco Di Rienzo, Don Gnocchi foundation, participated in its drafting. «If we want to move from the purely wellness area of ​​their use to healthcare, then from play to health management, these devices must respond to precise validation and accuracy requirements. They must be certified in safety and they must not for any reason represent a problem for the patient’s health », adds Parati, who is also elected president of the Council on Hypertension of Esc.

Weaknesses and guidelines

“We tried to give an overview of the situation: what is still missing for wearables to become truly reliablethe; what are the weak points on which the technology still has to make progress, such as the analysis of the signals, the reproducibility of the information, the accuracy of the detections, the instructions on how to use: And then we made particular reference to use of these sensors for measure heart rate and motor activity as a preventative tool“. The Position paper could serve as a “blueprint” for national scientific societies for the drafting of guidelines that are currently lacking. «The wearable is a game changer, which requires further validation. Potentially it is a very useful tool, but as it is it still has problems to be used in the routines of clinical practice. The proposal of their use must be discussed with the doctor who, in addition to indicating the most reliable tools to the patient – where available – will have to explain how to use them, and educate him », he concludes.

April 2, 2021 (change April 2, 2021 | 4:53 pm)

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