Arto Holopainen's Blog

I have been involved with medical regulations and standardization work lately and stumbled into quite important issue related with mHealth, the Medical Device Directive.

What is Medicel Devices Directive? The Medical Devices Directive (MDD) is intended to harmonise the laws relating to medical devices within the European Union.[Wikipedia]

First some background to the subject (as defined by EC Medical Devices Expexts Group):

Various health care providers and actors are uncertain of which rules shall apply when it comes to information systems that are used in health care. Authorities get questions about whether various software, intended to be used in health care organisations, should be defined as medical devices and if so, how they shall be classified. Furthermore, an increasing number of incidents have been noted with the involvement of computerized information systems. On some occasions patients have suffered severe consequences. In most of these cases the Medical Device Directive has not been applied by manufacturers. This means that the assessment of safety issues has become unclear since the manufacturer’s responsibility is not clear.

Revised MDD (2007/47/EC) will come in effect March 21st, 2010. A general opinion is that, from a patient safety point of view, it is desirable that stand alone software and systems intended to influence diagnosis, health care and treatment of an individual patient or person shall be regulated under the Medical Device directives 

So why should you be interested all this regulatory talk?

One example

You might be developing mHealth applications that e.g. reads results from blood pressure meter or from glucose meter and transfers results to some health Portal. Quite normal mHealth application, what’s the catch?

If your physician is reading the results from health portal that your software has collected and he/she is doing treatment decisions based on that, wouldn’t your application influence diagnosis and hence should be handled under MDD according to above reasoning?

So what if your application is handled as medical device? Don't let the terminology "medical device" to fool you that this concerns only HW. In this context medical device can be also SW.

If your application is a "medical device", then it must be classified to proper medical device class and handled through proper regulations and validations. This might get quite unbearable for SMEs. So basically your application needs to have medical CE mark in Europe and FDA approval in US etc.

So, where do you find the criteria for classification that you can use to determine whether your software is medical device or not? You cannot. At least not yet. The MDEG group mentioned at the beginning is now creating guidelines for this, let just hope they will be ready soon as the directive will commence in 21st of March...

This for first impressions what is coming…

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Now that mobile phones with built-in GPS have become more common their usage possibilities for the eHealth has expanded accordingly.

When you think of elder people living independently with dementia or child wanderers that might just take a walk and forget where they are. This might generate quite a lot activity and unnecessary concern.

As I have previously presented the use of integrated accelerometer for fall detection, the built-in GPS can be used as well for wide range of applications.

So, basically the interest is to track people or to get notification when they leave defined area. For this, GPS can be used very effectively.

Ok, think of case where elderly person with dementia is living at home. You would be interested to know (or some emergency service) if the person leaves the house too far. In this case, we could define the allowed perimeter from house as geofence (location area defined by set of coordinates). If the person exceeds the geofence, the alarm would be fired. Following picture describes above.

Again simple and very effective way of using mobile phone technology for eHealth purposes.

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I have been participating to interesting FN Bantora system as Forum Nokia Developer Advisor Council member.

I thought to throw event to Bantora close to my heart (so to speak) that I’m also organizing: The 14th Finnish National Telemedicine and eHealth conference.

This event will cover almost everything I have been blogging so far from Finland national point of view. As you perhaps know, the use of Electronic Health Records (EPR) in Finland is very high (you could say 100% in all hospital districts). You can find related statistics from here.

So keeping this in mind and the fact that Finland is also very advanced in Mobile Technology, the conference will provide very interesting topics indeed.

Conference will cover themes from updating the knowledge about Finnish national eHealth situation and projects up to the latest advancements of business solutions. As well as attention will be paid to international standards and frameworks like HL7, IHE and Continua Health Alliance. Conference will also include site visits to Oulu University Hospital and other eHealth related top units in the region. Special international symposium as a part of the conference features guest speakers from European Space Agency and from Japanese University Hospital in Gifu prefecture.  Conference will be organized in collaboration with Northern Ostrobothnia Hospital District and Finnish Society of Telemedicine and eHealth. 

If you are still wondering why to participate such an event here’s few pointers:

• As health care professional: you just can’t miss the event if you like to catch up current developments
• As developer: excellent opportunity to “hear from user”. As there are lot of health care professionals present, you have outstanding opportunity to network and to gain unique knowledge of the needs and trends. I can just imagine how hard it would be to gain same information trying to contact all these health professionals individually.

Anyway, I will be there presenting pretty interesting mobile health solutions.

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Providing basic health care services is usually responsibility of the society. Nevertheless there still is plenty left to the patients and to their family and relatives. A few examples include monitoring of chronic diseases, control and adjustment of treatments, safety and wellbeing of elderly people leaving at home. This is particularly true when patients are small children or senior citizens requiring continuous monitoring and prompt reactions. These are demanding tasks for relatives both in terms of responsibility and in terms of time investment, which contribute to increase their concern and to limit their daily life.

For instance how to know if your child suffering of diabetes, who is having fun in a soccer camp, is following his correct nutrition program? And is he regularly measuring his glucose values? Is he taking his medication? And how does he feel right now? These questions are perhaps repeatedly asked the child, who might feel himself under an even bigger pressure. Usually teenagers don’t stand this obsessive care, do they? Even if they know these are important matters. On a similar way, adults may become anxious when thinking of their aged or seek parents living alone and far away.

The following real life example summarizes effectively how a family can use advances of mobile eHealth solutions in daily life. In this example, a father with a daughter suffering of severe epilepsy actively looked new technology to their problems during the sleeping time and found the following mobile technology helping their life.

The example presented is a wireless blood oxygen saturation monitoring system based on mobile phones. This straightforward e-Health solution continuously monitors overnight the SpO2 values of this young patient and automatically sends alerts to the parents’ mobile phone whenever it detects relevant changes.

I like to conclude this with a citation from the father in this case: "The mobile system gives our daughter more autonomy and the chance to be ‘alone’ while remaining under our discreet surveillance."

Again very effective yet simply use of mobile phones for health monitoring. 

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Pain is highly subjective to the individual experiencing it. A definition that is widely used in nursing was first given as early as 1968 by Margo McCaffery: "Pain is whatever the experiencing person says it is, existing whenever he says it does".[Wikipedia]

Pain is affecting everyone’s life time to time and it is very difficult to measure and diagnose.

However, some pain forms or should I say the prognosis of it can be estimated. For example pain due to lack of proper ergonomics in your work (especially if you are an office worker) can lead to low back pain as well as neck and shoulder area pain. One cause for the pain can be muscle stiffness.

One might ask the question: “Do you find yourself rubbing your neck and shoulders during or after work?” So you should pay attention to ergonomics and your working posture, that’s for sure.

How could technology (especially mobile) help with this?

Well, you could always use following setup.

N810: perfect bio-signal monitor?

Since the release of N810 I have been intrigued by the possibility to use the device for health monitoring purposes. Now I had finally opportunity to evaluate device for this. Especially I wanted to test N810 Adobe Flash 9 (that not even FlashLite 3 can cope) capabilities for online remote biosignal monitoring.

N810 has quite perfect characteristics for bio-signal monitoring: large screen, touch screen and wireless connectivity. However the device comes with Linux based MAEMO platform instead of S60 and it does not have mobile connectivity as mobile phones, instead it has Bluetooth and WLAN for browsing.

Using normal mobile phones the screen is limited in most phones to too small form factors. N810 brings nice addition for platforms for health professionals.

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Blaise Pascal warned us that “The heart has its reasons, which reason does not know.” But what if someone’s heart starts acting up, and for reasons which a cardiologist might know and be able to remedy?

As discussed in previous blog the fact is that coronary heart disease is by far the most common cause of death in many countries. Combining mobile heart monitoring and novel analyzing algorithms you get powerful t ool for your own health monitoring. Actually this ended up as a success story for Forum Nokia, please read it here.

The core of this system is the analyzing of the information collected from heart to mobile phone and to focus on the fine fluctuations of the R-R intervals, which are analyzed and processed by using a particular algorithm specially created for this purpose. The result is a single parameter called index µ, which expresses the variability of the heartbeats. Although a large number of studies have been made on HRV, the µ index is calculated in a completely new method, which allows sensitive detection of HRV in an innovative way.

For each measurement session the algorithm also generates an image in colors representing the individual characteristics of the heart. These computer-generated pictures greatly different from one subject to another and vary with the age of the patient and possible abnormal conditions of the heart.

 
For more comprehensive illustration about this heart visualization, please see the short video about real-life system here.

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Last year I wrote few thoughts from the Symbian Smartphone show 2006 and Medica 2006 regarding to mobile health care. Then I noticed that the industry as well as user attitudes are changing more acceptable for mobile device use in health management. This year at the same events it was clear from the beginning that the mobile health care solutions are here to stay.

I saw the same progress also at the Mobile Monday Global Summit at Helsinki in last September. There were executive panel that was discussing the current trends in mobile world. When one from the crowd asked from the panel members what might be the next big “thing” in mobile markets if you don’t count today’s hit-products like positioning, entertainment and social networks. Prof. Murakami from Sekei University, Japan (former KDDI Executive Director) pointed out that the health care and medicine will be the next big business area for mobile devices.

At the last years Smartphone Show mobile health applications were just a vague thought but this year’s Smartphone Show 2007 health related applications got more attention. I was there also personally presenting mobile health applications at the Forum Nokia’s Booth and I also had lecture at the one of the seminars there about mobile health applications. You can find my presentation from the event web: “HealthPhone – Use of modern smart phones to enhance remote self-care services”. During the presentation I used N95 + Bluetooth ECG sensor and WLAN to transfer the N95 screen to the presentation. So everyone could see how my heart was “bouncing” during the presentation...

And what about this year’s Medica 2007 fair (International Trade Fair with Congress World Forum for Medicine)? The fair was again enormous, 17 really large halls full of exhibitors. The interest for remote health monitoring solutions was higher than ever.  Also as my surprise I also met by accident some people that knew me by my blogs here. Nice isn’t it? Anyway, there were lot of companies that were presenting Bluetooth wireless medical measurement devices that can be also connected to mobile phones. Bluetooth SIG had even own booth there where they were promoting also upcoming Bluetooth medical profile.

As far as I see it, mobile world is moving fast also for health related applications. Stay tuned for more…

Find more related topics in my blogs here.

Have you ever imagined that when your mobile rings you could answer the call just by stretching you hand muscle or just by twinkling your eye? Well, this might not be so far in the future as you think. Actually it is already today’s (or should I say yesterday’s) technology.

I have been studying this bio-feedback technology with Symbian some time now and as I have found it provides excellent (and natural) control input for mobile device.  So, basically your whole body could be the interface for your mobile. Following picture will visualize the potential to you with Symbian Series60 phone.

The beauty of this is that you could control almost everything from your S60 phone using just a small “driver-like” application: keyboard, games, messaging, answer/hang-up phone, control 3rd party applications, control the music player, control web access.

Ok, by now you are wondering how to provide your “body groove” to the phone and to control it. For starters there are few my earlier blogs that cover gaming aspect of this:

Enter to the next level of mobile gaming experience
Symbian device control using muscle activity - a case study part 2
Symbian device control using muscle activity - a case study

What comes to required accessories, there is small Bluetooth enabled device (like Mega Electronics Ltd produces) collecting information from you (can be also integrated to your clothes) that provides the information to mobile phone.

What do you think? Have you ever though that device control could be something beyond normal and touch IUs?

I will have presentation at the Symbian Smartphone Show “Here & Now” seminar next October and I’m glad to expand the presentation to show you “hands-on” how this can be done if you like, just send me reply to this blog. 

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Coronary heart disease is by far the most common cause of death in many countries. For example, every few seconds someone in Europe is suffering of chest pain caused by an insufficient supply of blood to the heart.

While a short-term oxygen scarcity usually origins angina pectoris, a long-term severe lack of oxygen causes a myocardial infarction, which may eventually lead to a cardiac arrest. Therefore it is very important to identify a heart attack and immediately seek for medical attention. However heart attack victims can wait on average two hours or more after the beginning of symptoms before they seek medical help but sadly it might be already too late then.

The electrocardiogram (ECG) is certainly the most effective way to identify anomalies in the cardiac activity. “An electrocardiogram (ECG or EKG, abbreviated from the German Elektrokardiogramm) is a graphic produced by an electrocardiograph, which records the electrical activity of the heart over time - Wikipedia”

Symbian mobile phones provides excellent platform for home heart monitoring. The heart monitoring can be performed using wearable wireless ECG miniature sensor (e.g. Mega Electronics Wireless Bio-Amplifier, WBA), which continuously measures the heart activity and wirelessly transfers the data directly to the mobile phone using Bluetooth. The information then can be automatically transferred to the health care provider using mobile phone networks or even analyzed on the device.

However, several measurement sessions may need to be taken in different situations to assess the best information of the condition of the heart. So, this kind of mobile phone based ECG monitoring offers a valuable tool for easy measurement of ECG without interfering with everyday’s life.

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There has been some time from my last blog entry. I have been working with very interesting cases and they have consumed totally my time. Now I’m on my summer holiday and I finally have time to unwrap some of my thoughts.

I like to present you one exciting case with telemedicine and sports - The Ironman European Championship (www.ironman.de). It was quite amazing to be present at the Ironman event 1^st of July. Just imagine the view of over 2000 athletes to start the competition with swimming at the same time...

Anyway, the Ironman competition is acknowledged to be one of the most challenging sporting events in the world. Even athletes with diabetes compete in this event. Keeping their glucose at the optimum level is a challenge that must be thought very carefully.

So, for the 180km cycling section (in this case), athletes’ bicycles were equipped with special telemedicine kit (blood glucose meter, Bluetooth adapter, Nokia 5500 Sport with special application and headset). With this setup it was possible for their medical team to monitor glucose levels during the cycling section of the triathlon. The medical team, who are located in a special medical service centre during the triathlon are able to monitor glucose with minimal delay, and thus can inform each athlete when they should eat, and when they should inject insulin -  not just when they are at one of the medical support points, but during the entire section.

Following picture illustrates the system setup:

I was just amazed how easily these athletes could use this kind of telemedicine system even though they must totally concentrate to their performance. For blood glucose measurement, they must take small drop of their blood (from finger tip) and put it to the glucometer. This is normally trivial task but these guys did it during cycling in very tough competition. Nokia 5500 Sport was perfect choice for the mobile phone with its robust and water resistant enclosure.

And surely you can apply monitoring for other vital signs like heart beat and muscle activity as well. Again, this case shows the great potential of today’s mobile phones in health related applications. So be tuned for more...

There has been quite a lot of discussion related to exergaming (games that also provide exercise- Wikipedia). Especially Nintendo Wii with wireless accelometer based gesture controller has been in spotlight. I have been presenting another view to this subject with the idea of using muscles to control wirelessly mobile phone applications like games in my previous blog “Symbian device control using muscle activity - a case study”. 

I was very pleased when Forum Nokia made Developer Vibe success story about muscle controlling (see the story here). So, I thought that it would be good idea now to update the progress in this matter. 

Since the first case study, the muscle controlling has advanced quite far.Now the actual muscle controller is kind of wearable “sleeve” that is made of skin tight material like sport clothes. The “sleeve” has built in textile electrodes to measure EMG signal from muscles as well as integrated small Bluetooth enabled bio-amplifier to collect and to forward the information wirelessly. Following picture illustrates this:

You just wear the sleeve and start using it. MuscleControl application in mobile phone receives muscle activity and translates it to phone commands. Instead of creating own games that uses the “sleeve” in closed-box like fashion, the beauty of MuscleControl is to act more like a joystick driver that can be used to control other applications. So basically you can use and configure it to commands you like. Nice isn’t it? 

In addition to just for fun, the application can be harnessed for more serious use like muscle rehabilitation (games for health) and for help to disabled persons (to activate e.g. phone call with certain muscle activity). And of course one obvious usage is the sport exercises. Wouldn’t it be nice to monitor your muscle activity during your training and to get to report afterwards? There are some many applications for MuscleControl that I’m just wondering why this hasn’t been done before… 

But how about applying this to control PC? Since mobile devices are much more close to my heart than bulky PCs I have not intentionally applied this to PC, not until now. After the release of Nokia 5500 with built-in 3D accelometer I have been bouncing an idea to use it to control PC games in my head. Obviously others have had same kind of thinking going on. For example fellow Champion Paul Colton describes one approach in his blog “Using gesture as an interface for mobile applications”. But instead of developing own closed-box games I liked to do same thing as with mobile phone controller, use the Nokia 5500 as generic joystick driver. And of course I wanted to use the “sleeve” for the controlling as well. 

So I ended up with a case where the combination of MuscleControl "sleeve" and Nokia 5500 accelometer are used together to control PC games. Data from both are seen in PC as a normal joystick, so any existing PC games can be used that support joysticks. The analogue nature of muscle activity and accelometer information are perfect for steering, throttle and x/y-axis controlling. Following picture illustrates this case: 

Even though PC’s are quite bulky compared to slim mobile devices, it is quite nice to use wireless controller for games with big displays.  

Nokia 5500 does not only provide accelometer information for PC joystick but it can be used for joystick buttons and also to provide force feedback feel through phone’s vibra. Actually I found the combination of MuscleControl and Nokia 5500 really impressive. E.g. use muscles for power (throttle/brake) and 5500 for steering. Even more all this can be used to control mouse and keyboard as well!

Find more related topics in my blogs here.

It has been studied that falls are one of the leading causes of fatal and nonfatal injuries to older people. This leads to case where fear of falling forces many otherwise healthy persons to leave their own home to live in an assisted-care environment. The fear of falling has been studied by the researchers and they describe this as a cycle in which after a fall elderly become so afraid of falling again they limit their activities. This in turn decreases their fitness, mobility and balance and leads to decreased social interactions, reduced satisfaction with life and increased depression. Even more this fear cycle is a “driver” to increase the risk of another fall. This might sound quite unbelievable but it is the reality.

As we know the amount of elderly citizens is constantly rising in many countries and the need for more efficient and cost effective caring methods are needed. One aim is to provide elderly citizens the means to stay at home longer than previously. However, the fear of falling effectively drives elderly to seek even more care from the health care providers.

So how could this kind of situation helped? One effective approach is to provide tools (technology) for the elderly to guide and to give more secure feeling to cope in their daily life. Nokia 5500 provides excellent feature for this: the 3D accelometer.

Nokia 5500 has built-in 3D accelometer that can be used as fall sensor to detect falling automatically with suitable algorithms. Fall sensor again can be used to create applications that automatically provide fall monitoring and alerts dedicated caring personnel if the person does not recover from the fall in set time frame. You could think the application as an “emergency button” that is automatically activated when you have felled and you are not standing up in certain time frame. This gives persons more confidence since they get the knowledge they are not alone if something happened and medical help will be coming when needed.

 

This is again very simple and effective example how smart phones can be harnessed to enhance personal wellbeing and health.

As you know, there is a Sensor API plug-in to Series 60 3^rd edition SDK at the Forum Nokia. You just need to download the plug-in and install it over the existing Series 60 3^rd SDK and you are ready to start developing accelometer aware applications for Nokia 5500. I warmly recommend you to try!

For deeper insight to the algorithms needed for fall detection using accelometer I suggest you to read e.g. paper “An Optimum Accelerometer Configuration And Simple Algorithm For Accurately Detecting Falls”.

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Let’s imagine situation where there has been big accident or some natural disaster like hurricane. There could be many injured people around and paramedics/rescuing personnel trying to retrieve as much of information from injured vital sings as quickly as possible. Could smart phones be useful in this kind of scenario? Surely!

I can just imagine the scenario that there are no even landline communication possibilities in disaster site due to damaged cables but there might be mobile network working (and of course satellite communications). Paramedics/rescuing personnel could use their smart phones to rely first hand information to the health centre for further decisions and information.

Of course the first advantage that comes to mind is relying information by talking with the health centre. Second and more advanced usage is the imaging and positioning possibilities of the modern smart phones. But I like to go beyond of these obvious functionalities and present some ideas to extend smart phone usage in this kind of scenario. Following picture will compact my ideas together.

I must say that I think this is so simple technical setting compared to the help it might provide in the disaster site I wonder why it has not been around already. Basically for this scenario you need just a suitable smart phone “off-the-shelf” with add-on software and few small-sized Bluetooth enabled medical measurement devices.

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I attended the Medica 2006 fair (International Trade Fair with Congress World Forum for Medicine) on 15^th to 18^th November. It was so exhausting to see 17 really big exhibition halls full of different medical related “things” ranging from software to equipment that I cannot even explain.

Anyway it was very good experience in overall. I thought that mobile phone usability in medical applications, especially in mobile telemedicine solutions, would be questioned a lot. But actually the acceptance of mobile devices in personal wellbeing and professional healthcare related solutions was really good. I was so busy presenting all the possibilities smart phones could offer that I did not even notice the 8^th hours passing by each day.

I was really amazed to notice that also big medical device manufactures (producing small homecare devices) are coming to notice mobile telemedicine applications as an important business area. There were so many exciting Bluetooth equipped medical measuring devices presented that they got my mind mixed up with all the possibilities they present with smart phones.

But as every coin has its counter side, also this event. I met people from companies that were working closely with Symbian devices (at least in their opinion) and trying to establish something (I’m not really sure what) with healthcare. As I came to understand, they were there just to sneak out all the possibilities others have invented. They even promised almost everything between earth and sky to get working applications at will to their mobiles. This was very strange experience indeed.

But in overall this event exceeded all my expectations. It truly seems that medical industry is beginning to accept mobile devices like smart phones. Since mobile phones are so common, they are also perceived as natural way to communicate health related information to caring personnel. Just the way I like to think.

Find more related topics in my blogs here.