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

Raising your Voice

The things that we already take for granted in our private lives, the “hey Siri” – the access to Alexa, – and untold information simply by asking a machine that sits by our bedside or we carry in our pocket – also can deliver big savings in time and costs when used in healthcare.

It’s been a while in coming; but now that clear uses have been developed that deliver benefits for the man in the street – now is the time for Community clinics and Hospital Outpatient areas, to take this seriously.

We focus on the latest, that is already clinically proven across the USA; this is what they say…

-Orbita, Inc., provider of the only HIPAA-compliant platform for voice and chatbot applications in healthcare, today announced through its collaboration with Mayo Clinic, the availability of Mayo Clinic’s award-winning first-aid voice application on two additional platforms:  Google Assistant and voice-powered web chat. This takes Mayo Clinic beyond its initial foray into voice with the Mayo First Aid skill for Amazon Alexa, and provides new capabilities to deliver first aid content via Google Assistant-enabled devices and a voice chatbot offered at www.mayoclinic.org.

“Expanding the delivery of Mayo Clinic content through more voice channels helps give consumers ready access to trusted health information where and when they need it,” said Sandhya Pruthi, M.D., general internal medicine physician and associate medical director of Mayo Clinic Global Business Solutions. “We’re pleased to continue innovating with voice and exploring its value to enhance patient and consumer engagement.”

Research shows consumer adoption of voice devices is exponentially faster than web and mobile predecessors. This bodes well for value-based health care where improved patient engagement aims to translate into quality improvements and cost reduction. 

“Mayo Clinic is sharing these new offerings just weeks after buzz at CES that the AI-powered virtual assistant, Google Assistant, would be on more than one billion devices by January 31, 2019,” said Orbita CEO Bill Rogers. “Clearly, voice is here to stay. Orbita is honored to collaborate with Mayo Clinic in exploring new voice opportunities for health care.”

At HIMSS, the health IT event bringing more than 45,000 attendees to Orlando, Fla. this week, Mayo Clinic and Orbita are highlighting:

  • Mayo First Aid for Google Assistant: Users of Google Assistant can tap “account”, then explore to access the “Mayo First Aid” action. After saying “Hey Google, Talk to Mayo First Aid,” they proceed with asking a question such as “How do I treat my baby’s fever?” 
  • Mayo First Aid Web-based Voice Chat : The same content and experience currently available through the Mayo First Aid Alexa skill and now Google Assistant, is also available via web-based voice and chat at  www.mayoclinic.org/voice/appswww.mayoclinic.org/symptoms, andwww.mayoclinic.org/diseases-conditions on web and mobile browsers that support voice input. Unlike most of today’s chatbots, which are only keyboard driven, this new Mayo First Aid Voice Chat experience offers an integrated voice and text-based interface.

These solutions join the Mayo First Aid Alexa Skill. Last month at the Chattanooga-based Alexa Conference, event organizers selected Mayo Clinic First Aid for the 2019 Alexa Skill of the Year for Healthcare Award. Orbita received the 2019 Best of Show Bronze Award and the 2019 Best Third Party Tool Award. 

Patient Engagement makes the Difference

We publish the first of a series of HIMSS2019 key articles about healthcare technologies you need to know about!

There is no doubt that getting the patient him/herself engaged in their own process, creates better and faster outcomes.

Allen Technologies, probably the leader in interactive patient engagement solutions for 40 years, announced today that its E3 Patient Engagement Solution has been selected as a featured product in the Intelligent Health Pavilion at HIMSS2019 in Orlando in just a few weeks.interactive patient engagement solutions for 40 years, transforms the way hospitals engage, educate and empower patients. Allen helps hospitals impact patient outcomes, improve patient satisfaction and achieve operational efficiencies.

The Intelligent Health Pavilion has been one of the most visited destinations within the HIMSS2019 conference for the past nine years.  Visiting healthcare professionals will be able to experience first-hand innovative technologies, software, apps, and voice applications in real-time, contextual clinical settings. Rooms within the Pavilion are created to mimic the actual hospital setting, with individuals demonstrating the use of the latest technologies that have successfully deployed in hospital rooms. 

Allen’s E3 solution will be showcased in the labor/delivery/recovery demonstration room, on both television and tablet. In addition, Allen staff will be on hand for personal demos in the Pavilion’s Kiosk #10. The Intelligent Health Pavilion is located at Hall E, booth 8559.  

“We are thrilled to have our E3 Patient Engagement Solution showcased at this year’s Intelligent Health Pavilion,” said Mark Lancaster, CEO. “Leveraging technology like ours to deliver a better patient experience and support more efficient patient care is a game changer for today’s hospitals. The E3 Solution transforms a traditional patient room into an interactive smart room, without the need for additional hardware in the room, putting interactive patient engagement within reach for virtually any hospital.”

Have a Happy and Healthy New Year!

And Let’s Help Set The Nation on Course For a Healthy 2030! We publish a great Post from the NEHI team (Network for Excellence inHealth Innovation) because it links innovation to achievable you and me health aims for the year. Based in Boston, USA- this is something we all can aspire gto. Great idea; this is what they say:

Every decade, the federal government’s Healthy People initiative develops a new set of science-based, 10-year national objectives with the goal of improving the health of all Americans.

The U.S. Department of Health and Human Services (HHS) is now soliciting written comments regarding the Healthy People 2030 objectives. The public comment period is now open through January 17, 2019.

Members of the public can comment on the proposed HP2030 objectives, and can also propose their own objectives. You can get more information on Healthy People 2030 and this public comment period by clicking here;

Previous public comments on the proposed Healthy People 2030 framework helped shape the vision, mission, foundational principles, plan of action, and overarching goals for Healthy People 2030. In this public comment period, HHS would like input on the proposed Core, Developmental, and Research objectives.

Please don’t miss this important chance to have input into this once-a-decade process to help shape the nation’s health goals!

In response to stakeholder input, Healthy People 2030 will be a streamlined set of national health objectives guiding the Nation in efforts to improve health. Heathy People 2030 will continue to represent critical public health priorities by addressing the leading causes of morbidity and mortality and driving action at the national, state, and local levels.

Again, Happy 2019!
The NEHI Team

Latvia becomes the 19th EU country to join eHealth cooperation for personalised healthcare

On 12 November Latvia signed the European Declaration on linking genomic databases across borders that aims to improve understanding and prevention of disease and allow for more personalised treatments, in particular for rare diseases, cancer and brain related diseases.

The Declaration is an agreement of cooperation between the countries that want to provide secure and authorised cross-border access to national and regional banks of genetic and other health data, in accordance with all EU data protection rules.The goal is also to keep the EU at the global forefront of personalised medicine, at the same time as fostering scientific output and industrial competitiveness. Latvia is the 19th signatory of the Declaration, which was originally launched on 10 April 2018 during the Digital Day. The other EU Member States that have signed it are Austria, Bulgaria, Croatia, the Czech Republic, Cyprus, Estonia, Finland, Greece, Italy, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Slovenia, Spain, Sweden and the UK. In April 2018, the Commission put forward an action plan to secure healthcare data while fostering European cooperation.

The interesting point is ironic; At a time of apparent Brexit confusion, the UK, with it’s Genomics England agency – is one of the leaders in genomics understanding and promotion. and three of the key protagonist countries in Europe – Belgium, Germany, France – are not on the list of signatories to the above declaration. 

Don’t you just love it?

Can We Celebrate 70 Years of the NHS?


As increasing numbers of ordinary people move away from this cherished institution – we ask the question – why do they do so?

This is not about private medicine and public services. The UK NHS and its principle guardian of healthcare – free to all – at the point of delivery – is the cornerstone of just about every UK and European belief that healthcare is a public right – not something that you only get if you can afford it.

Fair enough.

The problem is when you put that into practice for the ordinary lives of people like you and I. The principle might be ok but – well, if other places are offering something better, and its within our price range, we are going to choose whatever that something else is.

And so they do.

At the recent Employee Benefit Fair in London just a couple of weeks ago, of the 115 Exhibitors, some 30% were all offering private walk in Doctors facilities.  And the services they were offering were better, than their NHS counterparts, particularly in areas that can be monitored remotely by smart technology on the wrist of all of us. As the provision of healthcare moves away from hospitals into a more community based environment, if for just a few bucks a  month, say you can have your diabetes monitored every day, in real time – or your heart and blood pressure similarly managed – does it matter that you never get to see a real Nurse?  All you want is the Nurse to call you when things look wrong – and for you to be able to drop by as you pass thru the local train station en route to work.

So why do so few NHS Hospitals and CCGs want to adopt similar practices?

The problem is twofold; if we can  solve a specific problem, with  technology, using half the nurses – then we can schedule the remaining nurses somewhere else where there is a greater need. Except that clinical grass roots staff have a fear of change and a fear of losing their job. And Managers have a fear of losing their nurses – and their silo based budgets.  As long as they have lots of people coming through those hospital doors – the money will keep rolling in.

And second – we regularly get emails and responses from NHS senior Managers saying;  “Sure, come by for a conversation, but not for a conversation that means we have to do something”. There is this misplaced belief among so many NHS Managers that as things have always been done this way – then life will continue to be done this way.

Not any more.  

We are seeing already that the public is voting with its feet. Sure, its a small beginning – but its a beginning none the less. As a senior more enlightened NHS Director told me – “we cannot keep trying to squeeze 100 appointments into the time reserved for only 40”.

There will become a time, sooner rather than later, when the public itself will start to wonder why they are paying any money for public healthcare at all. By then of course, it will be too late.

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Charisma. Either you’ve got it. Or you haven’t.

We look at the growth of the Park Annual healthcare forum in Gothenburg and ask – why is it so successful?

It’s a question of how you measure success. There are talking shops, and there are talking shops. For Iris Ohrn, Investment Advisor at Business Region Goteborg, the emphasis is as much on the “shops” (ie the actual business quotient), as it is on the “talking”. She is eager to support all companies interested in the Gothenburg innovation system. Although she can have a chat with anybody she certainly prefers and enjoys discussing concrete business and investment opportunities in Gothenburg – based companies. The chat – is not the end, but the means to an end.

It is a subtle distinction that can easily be lost in the informality of the Park Annual event itself. There are many “Life Science”. Forums out there. The secret sauce of Park Annual is not focusing on trade, investments or scientific research as such. It focuses on gathering all groups ex. entrepreneurs, scientists, innovators, companies and investors in the heart of Göteborg and get them to network and be inspired in a very relax by effective way. Entrepreneurship and innovation are one of word that best describes the event and that could differentiate it from other also good events. Usually start-ups and innovators are the starts of the event.

What Iris says is; “It provides a great forum for debate. You leave the event with a very positive feeling. With that feeling that you are not alone and that is great fun to be part of the Innovation system.”

And it is indeed true – there are indeed similar events. The NJ Pharma Hub; and PACT in Philadelphia come to mind, where both of these have the advantage of zillion times larger population. But that may not be an advantage. Sweden is a small and export dependent country. It is home, so to say, to just 0.13 per cent of the global population. Which means that, in order to succeed, its companies need to be born global and more focussed.

Iris continues: “ Our products compete on the global market from day one as our internal market is very limited, despite our purchase power. We top most lists when we talk about innovation and competitiveness. We do not compete by market size but by the quality of our products. Our formula is collaboration, collaboration at all levels, small and large companies, public and private sector, universities, hospitals and patients. Most of our success relies on our capacity to collaborate. Now, more than ever, cross-sectorial collaboration is our focus. Digitalization and the rapid technological development are disrupting most industries.”

But probably the key missing ingredient is not just the mix of University supporting industry backed by Government It is more the qualification of what constitutes success that we mentioned above. And it is two fold – sure, there are commercial yardsticks, performance indicators. But underlying all of that is the understanding that Park Annual is a healthcare forum. The basic raison d’être is eradicating diseases. Park Annual has its heart in it.

Park Annual is on the 27th Sept 2018 at Sahlgrenska Science Park Sweden.