The FDA certified Apple Watch is still not a medical device

The new Apple Watch has been cleared by the FDA to sell as a low-grade health tracking device but is not producing medical grade data.

At the event where the new iPhones were launched, Apple also launched the 4th iteration Apple Watch. Though it was not the focus of the event, Apple deservedly prided itself for being the first smart watch to pass FDA test. One feature highlighted at the presentation is, by combining the readings from the gyroscope and the accelerometer the Watch can tell when a user has tripped or fallen. If the user stays static after the fall for more than a minute, the cellular equipped Watch can automatically call for help from emergency service or reach out to the family or friend. This can turn out very helpful for the aging population.

Another function of the Apple Watch being marketed is its capability to detect and alert the user irregular heartbeats which can be a symptom of a heart condition called atrial fibrillation, or AFib. This can also be a meaningful feature for a large user group: according to estimates by the US Centers for Disease Control, between 2.7 and 6.1 million people in the US have AFib, many of whom may not be even aware of it.

Apple has conducted an “Apple Heart Study” with Stanford University, the findings of which became the basis on which it gained the FDA clearance. However the total sample size was small (few than 600) and the match rate with professional medical devices was not extremely high. But the data was good enough to convince FDA that the solution worked and it was safe. Apple Watch was given a Class II risk device category, meaning it will not be life threatening even if it does not work. In contrast, if a pacemaker stops working the patient will die, therefore it is classified Class III.

In its approval file to Apple, the FDA demanded Apple to explicitly spell out the possibility of inaccurate reading as well as warn users that the is not a replacement for medical care, although the worst that can happen when the Watch reading is wrong is to cause scare for a healthy user.

Therefore, the new Apple Watch can do the job of a low to mid-range electrocardiogram reader, but it is not a medical device. In a typical professional situation, a patient will have 12 reading leads attached to different parts of the body, including the chest and the limbs, to provide accurate reading. What Apple Watch can give is equivalent to one of them, on the wrist.

No professional physicians will make judgement based on the reading on the Apple Watch. Any sensible users had better not either.

Will you grow an extra ear from too much Snapchatting?

This week Telecoms.com has 16 year-old Shannon O’Connor joining the team for work experience, and today she looks at the potential for damage of radio frequency radiation on society. Here are her thoughts.

Telecommunications has been evolving significantly in recent years. With an increased pressure for increased connectivity in major cities, many people in the suburbs and poverty stricken areas are at risk of being left behind. However, it can said that the major issue surrounding wifi, and wireless on the whole, progress is the lack of care being taken to support the healthcare of society’s vulnerable.

The US National Toxicology Program tested on lab rats and mice to find what affects radio frequency (RF) energy used in cell phones could have on individuals in the long term. The lab animals were exposed for approximately to 2G and 3G frequencies nine hours a day, starting before birth and continuing for up to two years on large groups of rats and mice.

A draft of the final results was published in February 2018. It showed that an increased risk of ‘malignant schwannomas’ (rare heart tumours) was found in the male rats open to RF radiation. Interestingly, the majority of exposed male rats lived longer than rats who were not open to RF radiation. While these are shocking results, the two conflicting statements call the validity of the research into question. What results like these could mean for people is questionable, but there clearly is an impact on the health of living organisms.

When speaking to Tiago Rodrigues, (General Manager) from the Wireless Broadband Alliance earlier this week, questions began to arise from the innovations suggested by the company in exposing a larger amount of people to wifi radiation signals. He began to explain the larger concept of the company’s work but failed to mention the safety checks carried out.

In response to questions regarding the impact of RF radiation on people, Rodrigues stated the organization had not done any specific research and was not on the charter of the Alliance. On a personal note, he suggested that the industry needed some common level of agreement on assessing the radiation impacts. A concise and collaborative approach needed to be taken as there were no consistency in the way results were actually developed.

It has become apparent through speaking to Rodrigues and taking up further research into this matter that someone needs to take the lead and a conclusive decision needs to be made in standardizing how to measure the health risks attached to radiation from our networking devices.

While there does seem to be some concerns regarding the health impact today, with 5G on the horizon, the number of cell towers is certainly going to increase. In Germany for example, Deutsche Telekom’s CFO Thomas Dannenfeldt has suggested the number of towers could increase to 50,000 from 28,000 today. And this is just DT’s towers, what about the other German companies?

There is an increased need for answers, perhaps something which the World Health Organisation, European Commission or the United Nations could kick start? These conclusive tests could finally provide an explanation as to how this may impact those in the future such as myself.

Nokia disposes of Withings and yet another Technologies President

Nokia has indicated that Gregory Lee’s main job was to get rid of Withings, so now that process is complete he’s moving on.

When Lee was poached from Samsung Electronics North America less than a year ago the messaging was that his consumer electronics expertise would take Nokia’s re-entry into the consumer space to the next level.

“Gregory’s passion for innovation and operational excellence, along with his proven ability to build and lead global consumer technology businesses, make him well suited to advance Nokia’s efforts in virtual reality, digital health and beyond,” said Nokia CEO Rajeev Suri at the time.

Withings, which had only been acquired the previous year, was clearly meant to be a cornerstone of this consumer tech effort, so imagine Lee’s dismay when, at the start of this year, Nokia announced it was ‘reviewing strategic alternatives’ for its digital health division. By the start of this month that process concluded flogging it back to the bloke they bought it from was the best strategic alternative, which kind of called Lee’s position into question.

“Gregory came to Nokia, made a clear-eyed assessment of our consumer business and incubation activities, and took the bold decision to refocus Nokia Technologies on licensing,” said Suri. “As part of that effort, he assessed strategic options for Digital Health, which led to the sale of that business. Given that, we have agreed that his work at Nokia is done. He leaves the company with my great appreciation and thanks.”

So the official line is that the guy they brought in to head up its consumer tech business quickly concluded Nokia shouldn’t be in the consumer tech business. OK, fair enough, but that’s a pretty strange narrative. A simpler explanation would be that, by the end of 2017, Nokia realised (once more) that it couldn’t hack it as a standalone devices player and that Lee just had the misfortune to be in the wrong place at the wrong time.

Nokia’s confusion about what to do with the devices IP it kept hold of when it flogged the handset division to Microsoft seems to have manifested itself in turmoil at the top of the Nokia Technology division. Ramzi Haidamus was brought in from Dolby in 2014, oversaw the brand licensing idea, but cleared off after two years, just after the acquisition of Withings, indicating he maybe disagreed with the move.

They then brought in Brad Rodrigues, but only ever named him as ‘Interim President’ of Nokia Technologies and he lasted a year or so before moving on not long after Lee came on board. Now, were told, current Nokia Chief Legal Officer Maria Varsellona has been handed this poisoned chalice, a move that makes sense if the division is reverting back to patent trolling, which seemed its most likely strategy from the start.

We all make mistakes. Nokia thought it could re-enter the devices market in a narrower, more targeted way through Withings and at the same time position itself to capitalise on consumer IoT when it starts to take off. It then had to be reminded the hard way that devices are no longer a core competence and Lee has been unfortunate to be at the helm during that process.

Clothes are getting smarter

In several of the MWC conference sessions, speakers talking about breakthrough 5G services inevitably referenced mobile health applications and even remote surgery. But while some talk, the 5TONIC co-creation laboratory in Madrid builds. Arturo Azcorra, the VP of the 5TONIC lab, explains how a 5G T-shirt could help save lives.

You wear it well

Imagine if that very smart T-shirt you were wearing was actually really smart.  As in connected smart. And imagine if it could read, hold and send data about you and your condition over a mobile network to a doctor or an emergency services team.

That’s the project that the 5TONIC co-creation team are working on alongside the medical technology experts of Madrid’s Emergency services operation.  The project is based on the fact that, in emergency situations, the sooner a critical patient gets appropriate medical attention, the far greater the chance of survival.

But in situations when someone collapses in the street, passers-by coming to their aid can only provide the barest of information to the emergency services.  They can make a call, they can speak to an operator, and explain where they are and what they have seen – but the crew arriving on site will have virtually no medical history for the patient.

Now imagine this.  You are a patient with a pre-existing, potentially, critical condition.  Maybe you suffer from very high blood pressure, a weak heart or acute diabetes.  The hospital equips you with a device you can wear all the time – in the laboratory the team are using a T-shirt but it could be a bracelet or something similar.

The shirt includes sensors that constantly monitor your condition – sensors that could notice a deterioration in your condition even before you become fully aware yourself.  The T-shirt also knows enough about your medical condition to spot danger signs and it constantly and precisely tracks your location.  It also knows the best hospitals to treat your specific condition, as well as those closest to your actual location at any given time.

Now, even before you collapse in the street, warning signals that you could be in trouble are relayed to the control centre.  Your health records, vital signs and an intelligent diagnosis are immediately available, as well as your current exact location.  As things take a turn for the worse, the data continues to flow, and the ambulance crew may be on their way to you even before you hit the floor.   And of course, when the crew arrive they know everything they need to know about you, can have been briefed by experts on actions to take at the scene, and are in constant contact with the right hospital to get you the right treatment.

This smart T-shirt can take vital minutes out of the response times and ensure that those arriving on the scene don’t lose further valuable time trying to assess what needs to be done. If you cut in half the time between incident and treatment, you exponentially increase the survival rates.

And if all that was not ‘smart’ enough for you – here’s another little trick this T-Shirt and a 5G network has at its disposal.  What if that collapse happens in a basement, or on a metro station platform with no network coverage or Wifi service?  In that instance, the T-Shirt would take advantage of the device-to-device capability of a 5G network and find its way to a signal.

Because even if your device has no coverage, and the device of another person near you has no coverage, they can still see each other and exchange data.  So, the T-shirt sends the vital data to another smartphone, and that one relays it to another, with these devices all the while looking for a handset that has internet access. Because as soon as the data hits a device with coverage, it hits the internet and goes straight to the emergency services so they can spring into action.

In fact, the qualities of a 5G network are vital for this type of service.  Network slicing means that the emergency services can have a dedicated priority slice of the network for emergency situations; the fact that 5G devices will be up to 90 per cent more energy efficient can make the battery small enough for such devices to be feasible; and the sheer capacity of a 5G network makes it possible to have all these additional connected devices.  A 5G network can even accommodate ‘closed user groups’ which means that using the device-to-device facility our T-Shirt might be able to locate a registered first-responder, say an off-duty doctor, who is on the same metro station platform as our patient and can be given the same access to patient data.

This scenario is not some far-off vision of the future.  As I said at the start, this smart T-Shirt is being developed, built and tested right now in the 5TONIC co-creation laboratory in Madrid in conjunction with the City’s emergency services experts.  It is just one of a number of visionary projects based on the capabilities of 5G networks that are being developed in the laboratory and test facility.

The opportunities and scope created by 5G are bigger than any one company can comprehend or deliver.  That’s why the 5TONIC laboratory brings together, in partnership, companies such as Telefonica, Imdea Networks, Intel, Ericsson, Commscope, and other members to work on projects alongside innovative collaborators and partners from vertical market sectors such as Madrid’s emergency services team.

The idea is simple – to help ideas grow into development projects, to turn development projects into potential products, and to build the business models that can support the delivery of those products across 5G networks.

It is a simple idea, but it needs a laboratory and a dedicated team to make it happen. And in the case of the emergency services in Madrid, 5TONIC is literally designing, building and wearing the life-saving 5G T-shirt.

 

Arturo EUCNCArturo Azcorra is the founder and Director of the international research institute, IMDEA Networks, and is also a Full Professor at the University Carlos III of Madrid (UC3M). Arturo has directed or contributed to 53 different research and technological developments including many centred on 5G technology. Since 2015 he has been the Vice President of the 5TONIC 5G Co-creation Laboratory in Madrid which IMDEA Networks founded in partnership with Telefonica.  The 5TONIC laboratory is focussed on the development and testing of 5G technologies and solutions in partnership with its member companies and collaborators from different vertical market sectors. He is an IEEE Senior Member, an ACM SIGCOMM Member and a member of the Partnership Board of the European 5G PPP.