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.”