The MHRA page on ‘Assistive Technology‘ mentions telecare, but gives no answers. For all device developers there are issues of EU CE marking, US FDA regulation and device regulation in other main markets to consider.
It seems that the problem is that experts in the regulations do not understand the range of what is possible with telecare/telehealth devices and experts in the devices do not (or do not want to…) delve too much into the regulations.
If any device manufacturer or consultant has a document on the topic that they would be willing to share with Telecare Aware readers, that would be some good publicity for them. Alternatively, if a consultant wanted to produce a guidance paper for sale through the site, that would be welcomed too.
UPDATE Friday 23 March: Links to useful introductory documents have been posted by a reader – see the second set of comments by Alistair Baker, below. One of the things that strikes this editor is that the regulations mostly concern confirming that the devices will not harm people in physical contact with them and they are not about whether or not harm arises by their use. The documents cited also show the difference between the European (CE) approach and that of the FDA. Thanks, Alistair.