Compl Prof C

Pagina 1

m-Health, mobile applications and regulation 1 m-Health, mobile applications and regulation Class EHApp Type Lecture Materials Date Riguardare Smartphones are incredible devices because they have capatibilites to be transformed into a medical device for a number of reasons, or to exploit GPS location from the phone for emergency services. The potential for smartphones is on decision support systems, telemedicine, lifestyle wearables, patient education, remote monitoring etc.; the applications could be a lot. @23/09/2021 Barriers for physicians to adopt digital health Software as Medical Device What is a medical device What is an Active device Defining a medical device Medical Device Software Guidance on qualification and classification of software Classification process of medical devices Conformity assessment procedure When is clinical evaluation needed? Clinical data What is equivalence? Clinical evidence of MDSW Scientific validity T echnical validation Clinical V alidation Expert Panels Post-Market Surveillance m-Health, mobile applications and regulation 2 📖m-Health: a medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants, and other wireless devices. Wearables are part of mobile health and they increase in popularity since they contain additional sensors for more advanced applications, always using the smartphone as an interface of a smartwatch with the display embedded. All these devices are not meant for medical conditions but for fitness purposes, but anyway they are capable of ECG recording capabilities. This leads to misunderstandings because the consumers might be misled to think that it is a medical technology even though it is not. 💡The mobile health is the future of…