COCIR concerns in the event of a no-deal Brexit

If anybody had any doubts of the damage that Brexit is doing to our UK and EU economies, the following official announcement today from COCIR, should be a wake up call that is already too late.

The date of withdrawal of the United Kingdom from the European Union – 29 March 2019 – is drawing ever-closer. While we sincerely hope that both parties will continue to do their utmost to find an agreement, our industry is increasingly concerned over preparations for a “no-deal scenario”. Such an outcome means that the UK will no longer remain part of the European Single Market. Given recent communications by the European Commission (1), this will have detrimental consequences for our industries in the European Union. Our major concerns are that:
–    UK Notified Bodies, which currently play a critical role in certifying medical devices placed on the EU-27 market, will no longer be able to issue EU certificates. 
–    Non-EU manufacturers that currently have an Authorised Representative based in the UK will have to change to one based in the EU-27.
–    Manufacturers transferring to a new – EU-27-based – Notified Body will need to change how their devices are labelled to reflect the new Notified Body number or face non-compliance with the Medical Device Directives. 
Unfortunately, it appears that the European Commission and the EU-27 Member States are currently not planning to adopt a specific transition period for medical devices (similar to the one planned by the UK). However, we would like to point out that the current timing is insufficient to allow for manufacturers to receive certification by a new Notified Body. Even where a transfer is possible, and new CE certificates from EU-27 based Notified Bodies have only been issued in the last few weeks, re-labelling all their devices would be challenging at best and unfeasible in many cases, particularly for manufacturers with large product portfolios. If devices are not available, even temporarily, the resulting impact on European healthcare systems – and the safety of EU citizens – could be substantial. 
Therefore, in the best interest of citizens, we call on the European Commission, together with Member States, to agree on a limited transition period. This will allow those manufacturers directly impacted by any no-deal Brexit to continue to place devices certified by a UK Notified Body on the market. 
Standard practice for medical devices (2) when changing to a different Notified Body would be to provide six months following the Date of Withdrawal. This would allow the re-labelling of devices after the certificates transition to a new Notified Body. Even 12 to 18 months could be necessary in case manufacturers have to switch to a completely new Notified Body to ensure the necessary time for the re-certification process.
Such a transition would give manufacturers much-needed certainty and ensure that hospitals, healthcare professionals and citizens in the EU see reliable and predictable access to these devices. 
This, however, provides a short-term solution to a long-term challenge. We therefore encourage the EU and the UK to expedite negotiations on a trade agreement that includes the mutual recognition of medical device certification. 

 1 – ec.europa.eu/info/sites/info/files/qa_brexit_industrial_products_en.pdf 
 2 – www.doks.nbog.eu/Doks/NBOG_BPG_2006_1.pdf

Is the EHR in Terminal Decline?

We ask the question that nobody wants to admit..

When the slides failed during Mahad Huniche’s erudite address on the personalisation of healthcare at the recent HIMSS eHealth Europe Conference – he did what every speaker should do.  He ad-libbed, and carried on.  And in doing so – he said two things that were seismic in their importance.

The first – that we are entering an era of disruptive clinical IT – everybody “got”.  The second – that healthcare will now be driven by you and I as “consumers”, and as such, will be governed by eCommerce technology, rather than clinical technology – nobody got.

Whether we like it or not, the wearable technology that is ever more prevalent, will be the source of our own health data – and it will be transmitted, in real time, to wherever we want to send it – i.e., to places where they can monitor this and do something about it.  In short what this means is a reversal of the current necessity of a/having to travel to a place called a hospital;  and b/ having to use monolithic IT called “EHR Solutions” – to manage said information. It also means that the driver of future health improvements will be you and I, as we will insist that our healthcare givers can monitor us remotely; and that the hospital importance of people like CIOs etc, will fade into one of support. We just don’t need it any more.

This will do two things;  first, at a General Doctor level, fewer people will need to see their local GP – he will already know their info; this means that the GP (according to one that was discussing this with me on the plane recently) – can now spend as much time as they wish, sorting out the patients who are truly sick, as opposed to those who just “think”  they are.  It means less people coming into the A&E areas of hospitals (for the above same reason). And more important – less people requiring on demand beds in hospitals.  Our doctors will be able to tell us straightaway, remotely, if we need to be admitted as such.

The interesting point about all this – is that it;’s not like this technology is not available already,  Even places such as Turkey have their own regional connected patient record App, that will be the platform for the sort of enhanced personalisation we describe above – and this explains why Steve Leiber, CEO of HIMSS was already on a plane to Turkey even before the applause had died down from his opening Conference keynote speech.

The other interesting point, is that this consumer driven change – flies in the face of existing Hospital wisdom, who are continuing to invest in ever larger and all embracing “big patient record systems” – that will both be too cumbersome to give any actual clinical benefit, and too inflexible to cope with the personalisation that is not just required by the mobile wearable world we are all embracing, but by even now, some of the key modules that need to be stand alone in their own right – Theatre Management is a good example – if they are to cope with how individual communities want their healthcare.

What is worse – is that very few “communities”  are geared up at a bureaucratic level – to handle this. When we talked to several Kommuns in Scandinavia recently, their assessment was that it will be at least twelve months before they could look at a “Procurement” to put in place relevant services.

The result – is that not only will you and I start to define our own healthcare needs – but that we will go to places called Supermarkets, to obtain this.  The ICA supermarket  in Scandinavia is deep in expansion of its Apotek chain of walk in healthcare shops.  It can only be a matter of time before those services expand.

How so?

Because retail and supermarkets are the bedrock of eCommerce. And the very technology that drives the analysis of every purchase that you and I make in a store, is already being used to calculate the personalisation of Genomes and Genomics, as well as manage the health data wirelessly sent, all the time from yours and my Apple Watch.

Which brings me back to Mahad and his unfortunate slides. Sometimes you need to get to the horses mouth, the deeper vision. Who needs powerpoint anyway?

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