Crucial to telehealth are the quality and safety of the processes and devices. Quality and safety requirements are described in international standards. However, for the participants of telehealth, a challenge is to comply with international quality standards and regulations. So, QAEH is developing a tool for all participants to comply with the quality standards.
The toolkit concerns telehealth, eHealth and medical devices. Telehealth devices are medical devices and so, medical device standards apply.
The toolkit also covers eHealth, that is a wider term than telehealth: the use, in the health sector, of digital data – initiated, transmitted, processed, stored and retrieved electronically – in support of healthcare, both at the local site and at a distance.
The toolkit will be freely available in summer 2021. By using the toolkit, you are enabled to comply with international and national standards and regulations.
Also QAEH can give advice that is tailored to your organization. For instance, we have experience in assisting organizations to comply with the European Medical device Regulation.
If you are interested in the toolkit, please send in the form below and we will keep you up-to-date.