When is a telecare/telehealth device a 'medical device'?

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.

6 thoughts on “When is a telecare/telehealth device a 'medical device'?

  1. I think there’s a difference between telecare and telehealth. Telecare would be a service such as Consultadoc, Teladoc and http://www.Ringadoc.com. A service that connects you to physicians.

    Telehealth is an actual device that a patient can have in their home and vital signs are processed and emailed/alert to the online doctor with another device at his office, hospital or clinic.

  2. Hi Evan

    Thanks for your comment, which is extremely useful but, perhaps, not in the way you anticipated.

    Your reference to services that connect you to physicians as ‘telecare’ illustrates something about terminology that I have been going on about for years, especially when it comes to speakers at conferences who do not define their terms.

    When it comes to using the word ‘telecare’ the US and the UK are often way out of step. We are not quite so misaligned for ‘telehealth’ – except with the Canadians, of course.

    See the ‘Our Definitions’ panel in the right hand sidebar for the way the UK (and this site) uses the term.


  3. The world of regulatory in the medical devices market is an area that ANY company wishing to service the healthcare market with products has to understand – fundamentally – or risk falling foul of the laws standing in the EU or other countries where regulations for market access apply.

    In the EU the MDD is a rules based system and the regulators have done an incredible job in a unbelievably complex area to allow product development companies to understand the regulatory pathway to successful – and legal market access. The regulations are there TO PROTECT THE PATIENT as the consumer and the procuring healthcare organisation/healthcare professional as the customer by ensuring products are developed, manufactured and serviced with stringent quality controls laid down by ISO/EN standards to achieve this.

    Should innovation in the medical device market be allowed to flourish – of course – should innovation take precedence over patient safety – never – can both be achieved by understanding and conforming to the regulations – yes they can – but the conformance to standards and risk management must never be side-lined for the advantage of speed, “coolness” or ignorance of the law especially if the products will be used by either the patient or clinician for care pathway decision making.

    Am I a stool-pigeon for the regulator? Nope – I run a 70 person ISO 13485 accredited medical device engineering company in the UK that builds hardware and software telehealth products. The Regulatory, Standards and Quality team is 7 people strong, 10% of our total headcount. Do I look at their payroll costs every month and think “overhead” – never – the engineers ensure we build brilliant products, the regs team ensure we build brilliant products that are FIT FOR PURPOSE, legal and allow me to sleep at night knowing that our products are doing their job properly for the patient and healthcare professional.

  4. Most remote vital signs monitors sold in the telehealth space have three parts, one of which is likely to have its origins in a bedside monitor. This part will almost certainly have been subject to the required process of approval for a medical device. The third part will be a viewing and records platform – essentially a service and software for displaying and flagging up problems to a physician (or to the patient maybe?). There are suitable methods in place for quality assuring medical software of this type.
    The third element is the communication system. However good it is (and I mean fixed and mobile systems), nobody can totally guarantee availability of access and performance – and certainly not to the levels required of a medical device. Does it not follow that a telehealth system will struggle in this space unless a special case is made and the system is deemed to be acceptable if those elements that are used by the patient and those used by the remote professionals are both approved and safe? No wonder people are keeping quiet!

    Telecare systems are a different case because most of the sensors and alarm devices in the homes of patients or service users do not measure clinical parameters and are therefore not medical devices in their own right – even though they often perform safety critical tasks.

  5. Agreeing with Anon’s comments that the regulatory requirements for telehealth devices are quite distinct from those for telecare devices – but we are starting to see devices that incorporate both elements (eg prompting meds at same time as taking daily vital signs readings) where will regulation sit in that case? presumably at the higher of whichever regulation applies – which may make it undesirable for producers to combine the two into one device?

    Regulation of the devices is one thing, but standards for the systems that connect them to monitoring centres is also required. Unlike Anon I would argue that telecare devices require a higher level of system availability than telehealth but in either case this is rarely within the total control of either patient or monitoring organisation.

    With resilient systems, which come at a price, monitoring organisations [b]can[/b] readily ensure “four nines” (less than an hour of downtime per annum)levels of telecoms/computer availability within the organisation; I emphasise can because in practice this will only be achieved if the IT professionals understand the nature of the system. Maintaining high availability requires a different approach to that of most organisational systems ie if the office phones are down for a working day per annum (three nines) because they rely on a VOIP protocol we are not desperately upset. I recently overheard an account by a social worker of the chaos at a local hospital when the electronic appointments system had gone down so perhaps there is still work to do with the organisational systems?

    However, the weak (in that neither organisation nor patient have any control) link is between the patient’s home and the organisation. All too often telephone service providers do not prioritise engineering calls for those dependent on a Community Alarm system. I live in a rural area and twice in the past 60 days my landline service has been unavailable, without warning, for several hours at a time; now I do have a mobile and I am not relying on a Community Alarm – but my phone provider doesn’t know that … and quite frankly does not care! However regulated the devices are we need to address this aspect as well.

  6. [b]EU MDD docs and FDA primer[/b]

    Hi Steve these are the docs I think you are looking for re EU MDD:

    [url]http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007490.pdf[/url] (PDF)

    [url]http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007495.pdf[/url] (PDF)

    and links to the Europa general MEDDEV docs:


    The FDA have a pretty good 101 primer:


    And the following article from Ken Hall (Technical Director at Triteq Ltd) explains both the standards required for medical device development (the diagram which is excellent at positioning the standards under MDD) and specifically goes into software development standards for medical devices under IEC 62304

    [url]http://www.emdt.co.uk/article/developing-medical-device-software-iso-62304 [/url]



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