The perspectives of telehealth and medicine for the benefit of patients and other caregivers are great. Indeed, eHealth is on the top of the agenda of policymakers since many years. Yet, the actual implementation is often disappointing.
One of the reasons is that there is not sufficient clarity about the requirements that must be met by users and manufacturers of telehealth devices.
The devices in telehealth are intended to be used for medical purpose and so, telehealth devices are medical devices by definition. The medical device standards apply. These standards should be combined with other relevant standards, such as ISO 13131. The recently revised ISO 13031 is the leading international standard on quality planning of telehealth services.
For the participants in telehealth to ensure quality and safety of telehealth services, it must be clear how these combined standards should be used concurrently and consistently. However, there is a lack of guidance on how to apply these combined standards.
What is needed, is guidance for the different participants in telehealth: users and manufacturers.
Such guidance, that is now being developed by QAEH, requires an international ecosystem of experts and stakeholders. QAEH aims at collaboration with like-minded parties for further improving healthcare.
This challenge will require a joint international effort. QAEH aims at contributing to such an effort.