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

The Financial Market is Changing. Time for some New Thinking.

We look at the I-FIHN management consulting company in Paris and ask, has their time come, to seize the initiative in their core financial markets?

It’s a mistake easily made, that any conversation with a French company will be philosophical, psychological almost. It’s not like they haven’t had enough practice. I can’t think of any time since Voltaire, where the impression has not been one of internal ennui.

And consulting companies generally, either continue this trend and deliver reports but no deliverables; or they focus on the cart of technology, rather than the horse of actual business need.

“Hey, we are the best in the world at blockchain!”… Well, that’s wonderful.

Yet at a time when all financial and business leaders recognise that 2019 will demand considerable innovation in how we develop our businesses, not just pure tech competence – now is the time for new players to come to the front, with a new focus on a different mix of delivering what you and I know we need.

But that still leaves the question of “what” constitutes “original thinking”. The risk of compliance and legislated focus of financials, still requires adherence to a set of rules, and competence in what business is all about. Sure, technology is important – but that starting point remains the balance of where do we want to take our business matched by – the deep understanding of the financial business in which our service providers are involved.

And whilst London has always been, and continues to be seen as, the leader in financial innovation – so that has not stopped newcomers from taking the lead, from other areas. And yet these are not newcomers. It its just that they have been below the radar – until now. It is similar to the sudden superstar actress, who has been treading the provincial boards for so long, now landing the key movies role. Suddenly, with their own unique and business approach – their time has come.

The I-FIHN Consulting company based in Paris, typifies the new approach – sure, they talk about their expertise and their competences, all within a deep understanding of financial practice – but it not until page eight of their Brochure, that you finally understand that this is no technology company; this is advisory and innovation based on human face to face values, covering a wide variety of international experience.

The benefit of this approach is that it takes financial transformation into new areas of “what could be possible” – rather than play safe within the trusted hallowed of your own organisation.

It is an important differentiation.

I talked with Ladan Haghighi, Head of Advisory Practice at I-FIHN – she told me: “the multinational experience that we all have, is now coming into fruit, in the different ways each of our Team view a client situation”.

We expect to see more of this approach and this company in the future.

The I-Fihn company can be contacted at their Paris office on +33768481502.

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?

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.

AND NOW FOR THE RUSH OF PUBLIC SCRUTINY…

The recent Presentation from John Keyes at the DAMA event #LifeWithGDPR2018 – drew a lot of attention.

We are going to publish the key points in brief – but what is becoming crucial for companies, is to have a rapid and foolproof and automated way – to deal with the requests for private information that are going to flood to all of our corporates that deal with the public.

Recently  launched, is  a relevant solution called ALTADA – http://www.altada.com – which is an eloquent and seamless way to deal with this issue. Please see their website. But here are the key points…

And remember, we haven’t even gone two months yet since GDPR first came into play.

* 169% increase in Weekly “Breach Notifications” since May 25th. Up from Avg 54 per week in 2017, to 145 per week in 4 weeks from May 25th

* 54% increase in weekly “Complaints and Enquiries”

* Upcoming E-Privacy regulation – Direct Marketing will require “consent”. The current perception that some companies have that they may use “Legitimate Interest” as the legal basis for Direct Marketing is unfounded.

* Article 6: “Legal Basis”
The 1st question the DPC ask when a concern is raised: “What is/was the legal basis for processing”

* Article 12: Transparency.
“I havn’t seen a Data Privacy Notice that complies with Article 12 yet”

It will be interesting to see how these stats pan out over the year – It would be great if John and the DPC could publish them regularly on their website….

COCIR launch new Healthcare Roadmap in Brussels.

There is a great deal of benefit from being connected with our nearest neighbours and being aware of and part of their healthcare initiatives on a broader scale.  We are pleased to publish the latest announcement.

The Integrated Care Alliance (ICA), of which COCIR is a founding member, has launched today its ‘Multi-Stakeholder Digital Health Roadmap’ in support of Integrated Care. The Roadmap is being launched at the 18th International Conference on Integrated Care in Utrecht hosted by the International Foundation for Integrated Care (IFIC).

The Roadmap follows up on the ICA’s successful Call to Action ‘United Towards Integrated Care’ launched in the European Parliament in June 2016. The ICA partners have worked through the points identified in the Call, recommending measures in four key areas; health policy, new care models, skills and training as well the use of digital care technologies. It also identified the need to build capacity to execute these measures at all levels – European, national and regional. The partners are also inviting those other stakeholder organisations that play critical roles in the integrated care value chain to become part of the initiative.

The publication emphasises the vital role that integrated care will play in reorienting healthcare delivery, creating systems designed to meet the needs and demands posed by an ageing population. At a time when budgetary and human resources are becoming increasingly scarce, an integrated care approach directs resources to where they have the greatest impact. Using the principles of integrated care systems engages citizens, makes provisions for patient education and allows primary and secondary prevention along with early diagnosis and intervention. Digital technologies and services can help ensure appropriate care is readily accessible outside the hospital setting.

Nicole Denjoy, COCIR Secretary General, said; “This Alliance will be key to accelerating the successful transition and scaling-up towards an integrated care mode. The multi-stakeholder approach brings the variety of approaches and insights that we need. It also provides the partners with an ideal platform of communication to share best practice and adds to the existing momentum provided by the ICA’s 2016 Call to Action. As one of the founding members of the ICA, COCIR is committed to making the work of this Alliance successful.”

The ICA is committed to strengthening and expanding integrated, sustainable health and care services across the EU Member States. The Alliance is made up of multi-stakeholder experts dedicated to sharing their experience and expertise while providing direction, advice and guidance for establishing and consolidating integrated care schemes.

By 2021, the Alliance aims to make innovative and interoperable digital care technologies central to healthcare delivery and to harmonise sharing of data plans routine in daily practice. The Alliance’s future work is fully aligned with the objectives of the Digital Single Market and Digital Transformation of Health Care in Europe.

For more information, contact:

Nicole Denjoy
COCIR Secretary General
Tel: +32 (0)2 706 8961
Opens window for sending emaildenjoy@cocir.org

Is South America now worth going after?

When it comes to healthcare, it would certainly seem so. We have been monitoring where Israeli health vendors are now choosing to market their solutions.  Having seen a focus on cyber security in 2017 and 2018 at the HIMSS platform in the USA – their attention is now moving south.

This is interesting because it says what we have always suspected, that the lead time in getting traction in the UK and Europe, is just too long. Put it down to myopia or simple monotonous decision making times – other parts of the world are moving ahead of our own so called advanced healthcare, and South America is one of them, because of a faster uptake.

We publish a current editorial from Mobile and e-Health company G Medical Innovations Holdings Ltd (ASX: GMV), who have announced they will  be demonstrating its medical monitoring solutions for the first time in South America at Hospitalar 2018, commencing tomorrow in Brazil. Such a presence will enable the company to present its medical monitoring systems to a growing and dynamic region. What they say is this:

Hospitalar has been a leading trade fair in South America for the past 25 years, and is one of the most important shows in the healthcare sector for local and foreign markets.

The company will showcase the Prizma Medical Smartphone Case and Vital Sign Monitoring System with G Medical Patch (VSMS with GMP), including a demonstration of its Prizma’s User Portal and Doctor Portal and GMP’s nurse multiple and single patients view station. The Prizma has received approvals from regulatory authorities including the FDA, CE and TGA.

The Prizma enables consumers to easily transform their smartphone into a highly-reliable mobile medical device for independently managing their own health. Currently the Prizma measurements include a 1-lead ECG, heart rate, stress levels, temperature and oxygen saturation. Consumers can continuously measure, monitor and share these biometrics with caregivers and loved ones. In addition to providing immediate access to personal health indicators, the medical data can be sent to the consumers’ personal Portal where it is stored, and can be easily viewed and shared with those involved in their medical care.

 The Vital Sign Monitoring System with G Medical Patch   is a modular, easy-to-use, clinical grade solution for monitoring patients, the VSMS with GMP utilizes patented wireless technologies, proprietary information technology and service platforms. This innovative solution is ideal for monitoring patients in most healthcare settings including clinics, assisted living residences, hospitals and out-patient locations. It can be used to monitor patients at all stages of the healthcare lifecycle, and takes the burden off medical and healthcare personnel, while still enhancing patient care.

G Medical will be exhibiting at Hospitalar 2018 from May 22-25, 2018, held in Sao Paolo, Brazil, as part of the broader Israeli E-Commerce Group presence at the show. Attendees at Hospitalar 2018 are welcome to visit G Medical, located at Hall 15, Stand #178 in the International Pavilion.