tag:theconversation.com,2011:/fr/topics/mobile-medical-devices-1066/articlesMobile medical devices – The Conversation2013-07-10T20:39:05Ztag:theconversation.com,2011:article/147062013-07-10T20:39:05Z2013-07-10T20:39:05ZWatch and learn: a new tool for measuring Parkinson’s disease<figure><img src="https://images.theconversation.com/files/27104/original/v5sjmhpv-1373325234.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The Parkinson's KinetiGraph provides a new way to objectively measure the movements of Parkinson's sufferers.</span> <span class="attribution"><span class="source">Malcolm Horne</span></span></figcaption></figure><p>For every medical condition, treatments are most effective when measurement guides the choice of therapy and its effects. Just think of diabetes, where blood glucose levels guide the choice of treatment then measure its effectiveness. </p>
<p>Until now there’s been no objective measure to guide therapy for <a href="https://theconversation.com/explainer-what-is-parkinsons-disease-698">Parkinson’s disease</a>, which affects more than six million people globally. But my colleagues and I at the <a href="http://www.florey.edu.au/">Florey Institute</a> think we’ve found an effective and inexpensive way to do it: the Parkinson’s KinetiGraph (PKG) uses advanced technology to measure and assess Parkinson’s sufferers’ treatment.</p>
<h2>Measuring up</h2>
<p>In a single day, people with Parkinson’s oscillate between the slowness and disability of undertreatment and the trying, involuntary movements of overtreatment. They struggle to accurately communicate this message to their doctors. If an experienced specialist takes time, much can be gleaned from the patient; although, even in this circumstance, admission to hospital for observation may be required. </p>
<p>Many patients, especially in regional areas, do not have access to doctors with the experience or time to address and analyse their symptoms, so what’s needed is an objective measure of the everyday movement abnormalities of people with Parkinson’s - and this measure also needs to take into account the consumption of medications.</p>
<p>In untreated Parkinson’s, movements are described as <a href="http://www.medterms.com/script/main/art.asp?articlekey=11215">bradykinetic</a>, a word with Greek origins, literally meaning “slow movement”. </p>
<p>In treated Parkinson’s, medications may produce excess troublesome movements called <a href="http://en.wikipedia.org/wiki/Dyskinesia">dyskinesia</a> (bad movements). </p>
<p>For a long time, these movements were considered to be fundamentally different to normal movements.</p>
<h2>Just like starting over</h2>
<p>Over a long period of time analysing the movements of Parkinson’s sufferers, our research team at the Florey Institute came to the conclusion these movements were not necessarily “abnormal”, but rather normal movements made in the wrong context. </p>
<p>Consider the process of learning to drive. Initially, the learner driver’s attention is directed at co-ordinating clutch, brakes and gears. Steering and movements at this stage are slow, uncoordinated and with too many pauses between them. As they become natural they become smoother and faster and no longer require intense attention. The driver can then focus on negotiating traffic and external happenings. </p>
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<img alt="" src="https://images.theconversation.com/files/27056/original/nstjjzw2-1373259968.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/27056/original/nstjjzw2-1373259968.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=432&fit=crop&dpr=1 600w, https://images.theconversation.com/files/27056/original/nstjjzw2-1373259968.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=432&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/27056/original/nstjjzw2-1373259968.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=432&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/27056/original/nstjjzw2-1373259968.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=542&fit=crop&dpr=1 754w, https://images.theconversation.com/files/27056/original/nstjjzw2-1373259968.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=542&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/27056/original/nstjjzw2-1373259968.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=542&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Parkinson’s affects the same part of the brain as used for learning new movements.</span>
<span class="attribution"><span class="source">Wikimedia Commons</span></span>
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<p>This process of making things natural and automatic is controlled by the part of the brain - <a href="http://biology.about.com/od/anatomy/p/Frontal-Lobes.htm">frontal lobes</a>, <a href="http://en.wikipedia.org/wiki/Basal_ganglia">basal ganglia</a>, <a href="http://en.wikipedia.org/wiki/Substantia_nigra">substantia nigra</a> - affected by Parkinson’s. For people with Parkinson’s disease, automatic movements are not easily accessed and are made as if they were being newly learned.</p>
<p>On the other hand, overtreatment of Parkinson’s may produce an excess of automatic movements, which are unnecessary, without purpose and have too little time between them.</p>
<p>Put another way, bradykinesia is the propensity to make slow movements with more and longer pauses between them; dyskinesia, comparatively, is the tendency to make an excess of automatic movements with too few gaps in between.</p>
<h2>Keeping watch</h2>
<p>Our team at the Florey placed sensors on the limbs of Parkinson’s sufferers to measure acceleration as a means for measuring movement. They then developed two algorithms: one to produce a bradykinesia score and the other to produce a dyskinesia score. The accelerometer output was recorded continuously over the day and night and the algorithms use the data to produce a score every two minutes.</p>
<p><a href="http://www.globalkineticscorporation.com.au/">Global Kinetics Corporation</a> was formed in Melbourne in 2007 to take the algorithms and develop them into a system that could be readily used in routine clinical practice for the management of Parkinson’s disease. Their system is known as the <a href="http://www.innovation.gov.au/Industry/PharmaceuticalsandHealthTechnologies/MedicalDevicesandTechnology/Pages/TheParkinsonsKinetiGraphSystemCaseStudy.aspx">Parkinson’s KinetiGraph (PKG)</a> and comes in the form of a small wrist-worn device. </p>
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<img alt="" src="https://images.theconversation.com/files/27154/original/y7zdh8yn-1373352430.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/27154/original/y7zdh8yn-1373352430.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=340&fit=crop&dpr=1 600w, https://images.theconversation.com/files/27154/original/y7zdh8yn-1373352430.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=340&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/27154/original/y7zdh8yn-1373352430.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=340&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/27154/original/y7zdh8yn-1373352430.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=427&fit=crop&dpr=1 754w, https://images.theconversation.com/files/27154/original/y7zdh8yn-1373352430.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=427&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/27154/original/y7zdh8yn-1373352430.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=427&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Keeping watch with the PKG.</span>
<span class="attribution"><span class="source">Global Kinetics Corporation</span></span>
</figcaption>
</figure>
<p>The device contains analysis systems that collect data and apply the algorithms to produce a report for the clinic. The device contains an accelerometer for measuring movements, sufficient memory to store the accelerometry data for more than 20 days, a reminder to patients to take their medications and a means for recording when the medicines were actually consumed. </p>
<p>The patient wears the device continuously, night and day, for ten days and then returns it to the clinic. The data is extracted, analysed and within ten minutes, put into a report that is emailed to the referring clinician.</p>
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<img alt="" src="https://images.theconversation.com/files/27151/original/rh4kdn9c-1373350264.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/27151/original/rh4kdn9c-1373350264.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=474&fit=crop&dpr=1 600w, https://images.theconversation.com/files/27151/original/rh4kdn9c-1373350264.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=474&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/27151/original/rh4kdn9c-1373350264.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=474&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/27151/original/rh4kdn9c-1373350264.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=596&fit=crop&dpr=1 754w, https://images.theconversation.com/files/27151/original/rh4kdn9c-1373350264.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=596&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/27151/original/rh4kdn9c-1373350264.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=596&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">An example of the data retrieved by the PKG.</span>
<span class="attribution"><span class="source">Global Kinetics Corporation</span></span>
</figcaption>
</figure>
<p>The report shows how bradykinesia and dyskinesia vary over the time of day and in relationship to the timing of medications. It also shows compliance in taking medications. As well, the research team has shown that when the PKG’s bradykinesia score is very high, then it is almost certain that the person is asleep. As daytime sleepiness and nighttime insomnolence is a major (but treatable) problem in Parkinson’s, the sleep data can be a major aid in better management. </p>
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<img alt="" src="https://images.theconversation.com/files/27150/original/4ynnqrc7-1373350134.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/27150/original/4ynnqrc7-1373350134.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=443&fit=crop&dpr=1 600w, https://images.theconversation.com/files/27150/original/4ynnqrc7-1373350134.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=443&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/27150/original/4ynnqrc7-1373350134.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=443&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/27150/original/4ynnqrc7-1373350134.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=557&fit=crop&dpr=1 754w, https://images.theconversation.com/files/27150/original/4ynnqrc7-1373350134.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=557&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/27150/original/4ynnqrc7-1373350134.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=557&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">The PKG works by detecting movement.</span>
<span class="attribution"><span class="source">Global Kinetics Corporation</span></span>
</figcaption>
</figure>
<p>A further and surprising development is the ability to detect impulse control behaviours which are common in Parkinson’s and cause serious damage to family relationships.</p>
<p>The PKG System is now used in routine clinical care in leading centres in Australia, Europe and the UK. In these clinics, patients wear the PKG prior to their consultation so that the report is available to the clinician at the time of consultation. </p>
<p>Feedback from clinicians suggests that for approximately 30% of patients using the PKG, the device provides information that would not otherwise have been known. This is important in managing dosage, side-effects and, importantly, the timing and management of surgery for insertion of deep brain electrodes.</p>
<p>The PKG provides the clinician with objective measurement that allows them to manage Parkinson’s with the same precision that they can manage disorders such as diabetes.</p>
<p>As mentioned at the outset, better measurement of medical conditions equals better treatment – and we believe we’ve come up with a workable solution on this front. </p><img src="https://counter.theconversation.com/content/14706/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Malcolm Horne consults with Global Kinetics Corporation (GKC) and owns shares in this company. He works for the Florey Institute for Neurosciences and Mental Health, which has also invested in GKC. This company has received funding from the Medical Research Council Fund, Comercialise Australia (Australian Federal Government) and the Small Technologies Industry Uptake Program (Victorian Government)</span></em></p>For every medical condition, treatments are most effective when measurement guides the choice of therapy and its effects. Just think of diabetes, where blood glucose levels guide the choice of treatment…Malcolm Horne, Honorary (Professorial Fellow) at the Centre for Neuroscience, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/27942011-08-11T21:21:26Z2011-08-11T21:21:26ZTattoo you: the stick-on medical revolution<figure><img src="https://images.theconversation.com/files/2855/original/kim3HR.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The epidermal electronic system can measure your vital signs in a completely unobtrusive way.</span> <span class="attribution"><span class="source">John A. Rogers</span></span></figcaption></figure><p>When you think of tattoos you probably imagine bikies, <a href="http://www.dailytelegraph.com.au/entertainment/movies/mike-tysons-tattoo-artist-is-suing-warner-bros-over-a-similar-looking-tattoo-used-in-the-hangover-part-ii-movie/story-e6frexli-1226060912410">celebrity tats</a> or that Japanese flourish on your left foot that means “Honour” (or so you think).</p>
<p>You probably don’t picture medical revolution … which is what tattoos may now represent. Well, temporary tattoos, at least. </p>
<p>Work <a href="http://www.sciencemag.org/content/333/6044/838.abstract">published today in Science</a> shows how a simple stick-on tattoo could be used in a medical context.</p>
<p>Think of a patient in hospital overnight with a heart complaint. With existing technology, the patient might be hooked up to an <a href="http://www.nlm.nih.gov/medlineplus/ency/article/003868.htm">electrocardiogram (ECG) device</a> in order to monitor their heart.</p>
<p>Those devices use <a href="http://www.gereonics.com/electrodes.html">skin electrodes</a> to pick up readings from the patient but unfortunately, there are significant drawbacks to using electrodes.</p>
<p>Worn for more than a few hours, they can start to leave marks, and on sensitive people (or when left on for longer than recommended) they can leave some impressive welts.</p>
<p>In the case of non-disposable electrodes, the application of conductive gel and cleaning (or even abrasion) of the skin is required.</p>
<p>The new development by Dae-Hyeong Kim and colleagues at the University of Illinois could put an end to the use of surface electrodes forever.</p>
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<p></p><figcaption>Wearable electrodes are virtually invisible. <span>Video courtesy of John A. Rogers</span></figcaption> <p></p>
<p>Using recent developments in nanotechnology, the team has developed a technique for printing electronic circuits on to water-soluble polymer sheets that can be applied like a “temporary tattoo”.</p>
<p>This development blurs the line between biology and electronics and offers nothing less than the possibility of completely unobtrusive, fully wearable, biological monitoring – with no electrodes in sight.</p>
<p>The researchers have dubbed it the “epidermal electronic system” (EES), and it has exciting possibilities in a range of disciplines:</p>
<p><strong>In <a href="http://en.wikipedia.org/wiki/Cardiac_electrophysiology">cardiac electrophysiology</a> (i.e ECG):</strong></p>
<p>Cardiology patients under observation over the course of a day typically wear a <a href="http://www.nlm.nih.gov/medlineplus/ency/imagepages/8810.htm">Holter heart monitor</a>. Such devices are usually attached for a minimum of 24 hours (and often substantially longer) to capture the behaviour of the heart.</p>
<p>By making equipment lighter and wearable, it might be possible to continuously monitor patients who have known cardiac illnesses which put them at risk of heart attack. </p>
<p>A wearable “skin” sensor with an integrated circuit to detect <a href="http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002091/">arrhythmias</a> – irregularities in the heart beat – could conceivably monitor individuals with a known cardiac problem or those who have a high-risk of developing such a condition – people with anorexia, for example.</p>
<p>In my field (heart rate variability), we extract measurements of the <a href="http://www.nlm.nih.gov/medlineplus/autonomicnervoussystemdisorders.html">autonomic nervous system</a> – the part of the nervous system that controls involuntary actions – from the beat-to-beat changes in the heart.</p>
<p>Comfortable, unobtrusive electrodes will allow us to monitor patients or experiment participants over very long periods of time, and investigate the very long-term changes in the variation of the heart. </p>
<p>Currently, we know almost nothing about what these changes represent.</p>
<p><strong>In exercise physiology:</strong></p>
<p>The firing rate and contraction force of the muscles are monitored by surface electrodes of an <a href="http://my.clevelandclinic.org/disorders/electromyograms/hic_electromyograms.aspx">electromyogram (EMG)</a>. </p>
<p>These devices <a href="http://www.cardiff.ac.uk/sohcs/rcck/facilities/physiology/index.html">are quite bulky</a>, and often prevent full, violent or natural movements to be studied while athletes are performing at their peak. (Try running at full speed while carrying an extra device and a dozen electrodes stuck to each leg!) </p>
<p>With a “skin” electrode it may be possible to monitor athletic performance completely without any noticeable difference from normal. </p>
<p>If the information can be accessed in real time, it may be possible to monitor the loss of force development over time during training itself and adjust accordingly – almost as if your muscles were “talking back to you” from under the skin.</p>
<p><strong>In neurology:</strong></p>
<p>One of the main problems with existing <a href="http://www.nlm.nih.gov/medlineplus/ency/article/003931.htm">electroencephalogram (EEG)</a> techniques – measuring the electrical activity of the brain using electrodes placed on the scalp – is the fact that participants are placed in artificial situations: stuck in a lab chair, barely able to move, watching stimuli on a screen.</p>
<p>But with the fully wearable, portable and invisible EES system Kim and colleagues have developed, we could monitor the same signals in real life, as they actually happen.</p>
<p>Moreover, in the case of conditions such as <a href="http://professionals.epilepsy.com/page/lateral_temporal_lobe_epilepsy.html">lateral temporal lobe epilepsy</a>, it may be possible to pick up patterns indicative of seizures, directly from electrodes layered across the surface of the scalp.</p>
<p>All of this is just the beginning.</p>
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<img alt="" src="https://images.theconversation.com/files/2857/original/kim7HR.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/2857/original/kim7HR.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/2857/original/kim7HR.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/2857/original/kim7HR.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/2857/original/kim7HR.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/2857/original/kim7HR.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/2857/original/kim7HR.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">The EES can be applied (and removed) as easily as a stick-on temporary tattoo.</span>
<span class="attribution"><span class="source">John A. Rogers</span></span>
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<p>Kim and colleagues have already tested a number of these possibilities. Soon, instead of merely being passive sensors, the EES might entail whole integrated printed circuits that are able to measure biosignals, correct and analyse those signals, and provide feedback from digital devices in real time, all the time.</p>
<p>Psychophysiological experiments are frequently concerned with “external validity” – whether or not what we measure in the lab sufficiently represents the phenomena we’re trying to model in the real world. </p>
<p>With this system, that concern may soon be a thing of the past, as we won’t even be able to see the equipment. </p>
<p>So how long until we see this technology in Australian hospitals?</p>
<p>Well, if EES systems are <a href="http://www.pharmout.com.au/downloads/white_paper_medical_device_registration_australia.pdf">classified as a medical device</a> – and considering their role, that’s entirely likely – there will be some years of testing before they can be successfully employed in treatment. </p>
<p>It’s very hard to say when any device will be brought to market, but in around two years our laboratory will be asking suppliers if the EES is available for purchase yet.</p>
<p><em>Read more about the EES at <a href="http://theconversation.com/game-changing-printed-tattoos-may-replace-hefty-medical-monitors-2811">our news story</a>.</em></p><img src="https://counter.theconversation.com/content/2794/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andrew Kemp receives research funding from the Australian Research Council and is currently a National Health and Medical Research Council Career Development Research Fellow.</span></em></p><p class="fine-print"><em><span>James Heathers does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>When you think of tattoos you probably imagine bikies, celebrity tats or that Japanese flourish on your left foot that means “Honour” (or so you think). You probably don’t picture medical revolution…James Heathers, PhD Candidate in Applied Physiology, University of SydneyAndrew H Kemp, Associate Professor, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/25062011-07-26T04:49:54Z2011-07-26T04:49:54ZOpen app and say aah: the perils of medical diagnosis on a mobile<figure><img src="https://images.theconversation.com/files/2489/original/Screen_shot_2011-07-26_at_2.45.10_PM.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The US FDA is moving to regulate medical mobile apps linked to instruments it currently oversees.</span> </figcaption></figure><p>The <a href="http://www.fda.gov/">US Food and Drug Administration (FDA)</a> is proposing to regulate some medical mobile applications, or apps, in an apparent bid to protect consumers from harming themselves or others. </p>
<p>At first sight, this may appear as over-the-top meddling. But in fact, the proposal doesn’t go far enough to warrant that charge.</p>
<h2>Oversight of medical apps</h2>
<p>Medical apps have grown in popularity, covering anything from monitoring fertility to making diagnoses based on clinical data. </p>
<p>The FDA would like oversight on two specific kinds of medical mobile apps: </p>
<ul>
<li><p>those where the device that runs the app is used to present data from a separate and active device (for example, it displays the results of an X-ray scan): the app “transforms a mobile platform into a regulated medical device”; and </p></li>
<li><p>those where the device is attached to passive sensors (such as a blood pressure sensor) and the app interprets and processes information: the app becomes “an accessory to a regulated medical device.”</p></li>
</ul>
<p>In both of these cases, the active or passive instruments that are to be connected to the device and linked to the app have already undergone FDA scrutiny. </p>
<p>The proposal is therefore relatively benign and a logical extension of what’s already in place. Implementation would also only affect a small percentage of apps available on popular apps markets. </p>
<p>This may well be a calculated move by the FDA. Were its proposals to go further – requiring oversight of all medical apps – they would likely cause an uproar. </p>
<p>And where to draw the line to separate health apps from lifestyle apps? There are many examples of these and some are quite popular. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/2488/original/screenshot1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/2488/original/screenshot1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=900&fit=crop&dpr=1 600w, https://images.theconversation.com/files/2488/original/screenshot1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=900&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/2488/original/screenshot1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=900&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/2488/original/screenshot1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1131&fit=crop&dpr=1 754w, https://images.theconversation.com/files/2488/original/screenshot1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1131&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/2488/original/screenshot1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1131&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Apps such as this occupy a fine line between health and lifestyle.</span>
</figcaption>
</figure>
<p>Consider, for example, apps that allow couples to track fertility (above), or keep track of medication intake, or even analyse sleeping patterns. </p>
<p>The FDA’s move raises questions about the necessity as well as desirability of similar future government moves, not just in the health sector. </p>
<p>After all, some well-intended apps may cause accidents or pose public safety concerns when used irresponsibly. These are of far more concern than has ever been the case with desktop software. </p>
<p>For example, it would be easy to create an app for sharing data about planking success and for users to rate the most successful or outrageous planks. </p>
<p>But one only has to think of the <a href="http://www.brisbanetimes.com.au/national/planking-death-man-plunges-from-balcony-20110515-1entn.html">recent death attributed to the planking craze</a> to see how this harmless idea can have a negative social impact. </p>
<p>However, for practical as well as philosophical reasons, it seems unlikely any government will attempt to actively regulate all apps on the market. </p>
<h2>Implications for Australia</h2>
<p>Most medical apps are sources of information so they fall outside the regulatory scope of the Therapeutic Goods Administration(TGA). </p>
<p>Those that make diagnoses based on clinical data could be investigated by the TGA if they received a complaint about the app. That’s because such apps may be classified as therapeutic goods. </p>
<p>As in the United States, apps considered medical device software would have to be submitted for approval just as other medical software.</p>
<p>A TGA spokesperson said the regulatory body would monitor advances in medical device technology, the Australian Doctor reported yesterday.</p>
<h2>Alternatives to regulation</h2>
<p>Thankfully, there are several alternatives to full government oversight. </p>
<p>First, governments could let the market (for instance through popularity ratings) along with the legal system separate the good from the bad. </p>
<p>This is roughly the current situtation and it works well enough at present. Unfortunately, this approach usually deals with tragedies after they happen.</p>
<p>Alternatively, the device manufacturer could control what apps become available. This is Apple’s business model and appears to handle public health and safety concerns quite well. </p>
<p>For instance, it’s conceivable for Apple to be sued if an app they approved could be shown to have caused real harm. This provides incentive for the company to apply a rigorous screening process for apps before releasing them into the market.</p>
<p>Finally, governments could create special categories in app markets and special interest groups and relevant government bodies could certify good apps. </p>
<p>In this instance, a developer would still be able to publish their app on the general market, but users would become more willing to put their trust in the app once it receives an official stamp of approval.</p><img src="https://counter.theconversation.com/content/2506/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Stijn Dekeyser does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The US Food and Drug Administration (FDA) is proposing to regulate some medical mobile applications, or apps, in an apparent bid to protect consumers from harming themselves or others. At first sight…Stijn Dekeyser, Associate Professor and Head of Department of Maths & Computing, University of Southern QueenslandLicensed as Creative Commons – attribution, no derivatives.