Regulation, safety and sustainable development: three short important updates

Erik Vollebregt has just released a blog that should be read by anyone with a medical device or whose technology is likely to be classified as a medical device under the new Medical Devices Regulation (MDR – Regulation 2017/745/EU) which replaces the MDD in early 2020. It makes scary reading as to what will need doing to comply with the new regulations as approval under the MDD will no longer apply (no ‘grandfathering’). MedTech Europe has helpfully produced a flowchart describing the necessary steps. Advice from official sources given to this editor is that, as the MDR already applies in the EU, its continued application in the UK after Brexit is not in serious doubt, so UK companies should not delay.

The Digital Health & Care Alliance (disclosure; that this editor manages) and DigitalHealth.London are jointly running a digital health safety conference on 7th November. Key players in the UK are on the agenda (including the CQC, MHRA, HSIB, NHS Digital/England, Datix, Vitalpac etc.). This is a topic that requires the attention of all developers and providers of digital health, as new technology, being unfamiliar, is inherently risky. It is therefore really key for everyone involved to share experiences, understand the risks and carefully plan avoidance and mitigation.  The draft agenda and booking details are here (there is a small charge for lunch).

For those who have doubts about the benefits that mobile communications can bring at times, a read of the GSMA’s 2017 report on mobile’s contribution to the UN’s sustainable development goals will fill you full of optimism of what technology can do, for health and many other aspects of life. Beautifully presented and full of interesting facts: recommended! (If you’ve not enough time, the summary is here.) Hat tip to Prof Mike Short. 

Calling all digital health people in the North of the UK (and the South)

Sadly the DHACA Day in Leeds on 27th April had to be cancelled because of competing events on that day – readers are reminded of the next DHACA Day now in London on 21st June – agenda still to be set.

Elsewhere, Nesta has updated its European Digital City Index, showing the position at the end of 2016
of the top 50 cities in Europe for start-ups. Not digital health-specific though very interesting, nevertheless. TechCity have produced a more detailed website exploring why the UK is the Tech Nation of Europe, which is excellently animated. Though with little mention of digital health it is nevertheless an excellent read, and resource…and something to make those of us who are involved in the UK digital scene proud of our achievements. And if you are a supplier looking for opportunities to capitalise on the UK’s standing, what better than to attend Healthcare UK and NHS Digital’s International Digital Health Opportunities event in London on 25th April?

If you are still feeling international though less interested in exporting, perhaps you might like to attend (more…)

Applications invited for the DigitalHealth.London accelerator by 25th April

The DigitalHealth.London Accelerator, is part of DigitalHealth.London. It will work with 30 small digital health businesses each year over an initial three-­year period. It will provide help with engagement with clinicians and healthcare experts, so companies can refine their products. It will provide advice on topics such as such as navigating the intricacies of the NHS, understanding how to work with sensitive data, and opportunities to showcase new technologies in hospitals.

Life Sciences Minister George Freeman launched DigitalHealth.London at City Hall in February with the aim of speeding up the use of new digital health technologies by bringing together clinicians, healthcare providers, research institutes, entrepreneurs and industry to give companies a clearer route to market based on the needs of patients, the NHS and wider health sector.

Speaking at an Accelerator information day held recently, Dr Tony Newman-­Sanders, Consultant Radiologist and Chief Clinical Information Officer, Croydon Health Services NHS Trust, said (more…)