tag:blogger.com,1999:blog-33155474135471998102024-02-06T21:40:22.793-05:00The Mobile DocAs a hospitalist at Duke University who takes care of both children and adults, as well as the Director of Mobile Technology Strategy, I get to take care of patients both one at a time as well as a million at a time. Technology has never held so much promise for the improvement of medical care as it does right now. These are my thoughts on how we can make that happen.Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.comBlogger41125tag:blogger.com,1999:blog-3315547413547199810.post-31473128136200813522016-09-13T03:00:00.000-04:002016-09-13T03:00:15.776-04:00Today, C-CDA Goes Mainstream at Duke Health with HealthKit in iOS 10<div dir="ltr" style="text-align: left;" trbidi="on">
Back in June <a href="http://www.rickybloomfield.com/2016/06/cdaccd-coming-to-apples-healthkit.html">I broke the news</a> that support for HL7s C-CDA was coming to Apple's HealthKit, giving consumers more control over their health information. This is a major step forward for patient empowerment, and also - of particular interest to me - standards-based interoperability.<br />
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But this cool new feature is meaningless if patients can't get access to their health information!<br />
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So, I'm very happy to report that today, with the launch of <a href="http://www.apple.com/ios/ios-10/">Apple's iOS 10</a>, Duke Health is ready to allow patients to download their C-CDA from our <a href="https://www.dukemychart.org/home/">Duke MyChart</a> portal and import it into the Health app, ready for sharing with other compatible apps! This process currently requires accessing the Duke MyChart website, but we hope to add the same functionality to the MyChart iOS app in a future release.<br />
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To start, simply log into the Duke MyChart portal from the Safari browser on your iPhone or iPod touch (the iPad doesn't currently support HealthKit). Tap on the <b><i>My Medical Record</i></b> tab along the top, then on the <b><i>Download My Record</i></b> option. This will take you to a page fitting called <b><i>Download your Continuity of Care Document</i></b>. Simply tap the green <i style="font-weight: bold;">Download</i> button here (Note: if you choose the option to encrypt the document, you will not be able to open it in the Health app).<br />
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<div style="text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjiJlK9vo0B_3ZgHCgNYUBVJAfx0nThX3skLI5TWGnaWIvKA6rLg6MVuPleG-RX0HAQiWhdOUn33UOzj3roo0Vm2f0_SXyExEf_uUMSnxB7okrN_iF47Y52l4XPjctume0HvVa1qeS4nWo/s1600/IMG_4763.jpg" imageanchor="1"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjiJlK9vo0B_3ZgHCgNYUBVJAfx0nThX3skLI5TWGnaWIvKA6rLg6MVuPleG-RX0HAQiWhdOUn33UOzj3roo0Vm2f0_SXyExEf_uUMSnxB7okrN_iF47Y52l4XPjctume0HvVa1qeS4nWo/s400/IMG_4763.jpg" width="225" /></a></div>
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The document will then download, and you'll be presented with a screen asking you what you'd like to do with it. If it doesn't say "Open in Health," tap the "More..." button and then select "Add to Health" from the top list. It'll be the icon with the heart on a white background as shown below:<br />
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<div style="text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgbsI-ibxn1ZIfBSH6yON8LKSVNWUh6gk9jaW9kWc8_HbGIk0a2V-K0WD8QqTZ3isxJwChJOz_NNX8pGJd02eWtL9qPlVhiKVp9RhZkMLUI8G-io-3dPk4mJhf0Ef2-ipZicdfuc7eCKOU/s1600/IMG_4761.jpg" imageanchor="1"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgbsI-ibxn1ZIfBSH6yON8LKSVNWUh6gk9jaW9kWc8_HbGIk0a2V-K0WD8QqTZ3isxJwChJOz_NNX8pGJd02eWtL9qPlVhiKVp9RhZkMLUI8G-io-3dPk4mJhf0Ef2-ipZicdfuc7eCKOU/s400/IMG_4761.jpg" width="225" /> </a><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhwZncWX-qZs2XAFtlGq5FyvrTmLTbKtvH_8CfKXL-Licyc4uthOf43OsELabVhPSvWDKJRie5Pc37IbWTPHlieN8-bL2FwS4cwwFiB0taebW6yz-Eo2LMikXlpwW9ahtybpmZm1xd7TMQ/s1600/IMG_4766.jpg" imageanchor="1"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhwZncWX-qZs2XAFtlGq5FyvrTmLTbKtvH_8CfKXL-Licyc4uthOf43OsELabVhPSvWDKJRie5Pc37IbWTPHlieN8-bL2FwS4cwwFiB0taebW6yz-Eo2LMikXlpwW9ahtybpmZm1xd7TMQ/s400/IMG_4766.jpg" width="225" /></a></div>
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You'll then be shown a preview of the record:<br />
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<div style="text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjMhhc7tWtbBxQ-MprB2fg7zg4RrdNZYuvbe0jIadH4D0ozfSJjtNsdN6IB6eS55hCthbTqOYa-eJ1q5_6MTBgFL1q6tXzab82Xi7GaVRRm0ypYTwPnl8d2esaUF_HSuU0fnu5XWtpPbi4/s1600/IMG_4759.jpg" imageanchor="1"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjMhhc7tWtbBxQ-MprB2fg7zg4RrdNZYuvbe0jIadH4D0ozfSJjtNsdN6IB6eS55hCthbTqOYa-eJ1q5_6MTBgFL1q6tXzab82Xi7GaVRRm0ypYTwPnl8d2esaUF_HSuU0fnu5XWtpPbi4/s400/IMG_4759.jpg" width="225" /></a> <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjW8TBnEkQ9v0E_qirgs8J_HzKk4VVkkpNZ3ysOz7n_CEpg4gq7IunmUomG5eLYX8uOQ4jDvxGSsT8T8F9uMQGH-UEEW-YgC2xsLQd7ACeE81SZgXNnu7A4RwyXRwHaQtCae1h9nVXUYFA/s1600/IMG_4760.jpg" imageanchor="1"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjW8TBnEkQ9v0E_qirgs8J_HzKk4VVkkpNZ3ysOz7n_CEpg4gq7IunmUomG5eLYX8uOQ4jDvxGSsT8T8F9uMQGH-UEEW-YgC2xsLQd7ACeE81SZgXNnu7A4RwyXRwHaQtCae1h9nVXUYFA/s400/IMG_4760.jpg" width="225" /></a></div>
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Including a searchable view of the C-CDA itself (some information here redacted):<br />
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<div style="text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgBMEsEVSXkvkpFn0dPJR0_8Agqk2wGRtPWaHyvjZfPU2mAp54gUppF3ybgvlSOwG6_aP9RvPsWJKeUAjcwd0BQW1Mku7SIvR9F8Mf4ky13oc3bPzzmZHMWkA8rdzr0im3AOq2-yNKleI8/s1600/IMG_4767.jpg" imageanchor="1"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgBMEsEVSXkvkpFn0dPJR0_8Agqk2wGRtPWaHyvjZfPU2mAp54gUppF3ybgvlSOwG6_aP9RvPsWJKeUAjcwd0BQW1Mku7SIvR9F8Mf4ky13oc3bPzzmZHMWkA8rdzr0im3AOq2-yNKleI8/s400/IMG_4767.jpg" width="225" /></a></div>
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If you're happy with this information, simply tap "Save" (see left screenshot above), and the record will be imported into the Health app.<br />
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To view this record later, simply open the Health app and select Health Records, where you will be able to view all imported records:<br />
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<div style="text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiWFCXoK6ldB3m6HmrxQVIptRr3b3VV5oRUxCLkKZtpsic7BiSFUKtdDn6hFkCPt8_ESzlBirgnyJTx8dKrxDPKsfzEEber4gap48DdUhGX9Jx_zfn7C26ppvLnhV6h2nD4f3s0e5xwoA0/s1600/IMG_4764.jpg" imageanchor="1"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiWFCXoK6ldB3m6HmrxQVIptRr3b3VV5oRUxCLkKZtpsic7BiSFUKtdDn6hFkCPt8_ESzlBirgnyJTx8dKrxDPKsfzEEber4gap48DdUhGX9Jx_zfn7C26ppvLnhV6h2nD4f3s0e5xwoA0/s400/IMG_4764.jpg" width="225" /></a> <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7uvv52zPteI5ct15oYQhGYWFKp_3DZtjbUofeHqtf57t_uP5xkoRX5C8WLv9rtdyjGl8lDQeBrXNgwk9tm4I3XsyVzbgTNAAnmIINSX_LrsrDetAjdyu7rPSzKZ5ZFeMd5bKCj_5Pn6A/s1600/IMG_4765.jpg" imageanchor="1"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7uvv52zPteI5ct15oYQhGYWFKp_3DZtjbUofeHqtf57t_uP5xkoRX5C8WLv9rtdyjGl8lDQeBrXNgwk9tm4I3XsyVzbgTNAAnmIINSX_LrsrDetAjdyu7rPSzKZ5ZFeMd5bKCj_5Pn6A/s400/IMG_4765.jpg" width="225" /></a></div>
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If you tap on the individual record from here, you will be able to view it as well as share it with other apps that can accept C-CDAs.<br />
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Also note that you are not prevented from importing documents from other individuals. I was able to import my daughters' C-CDAs and view them all from the Health app.<br />
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<a href="http://www.rickybloomfield.com/2016/06/more-information-on-ccda-and-healthkit.html">As I've mentioned previously</a>, on import into the Health app there is very little parsing going on - just enough to identify the individual. If you share this document with another app, it will need to handle document parsing itself in order to make use of the structured content. Fortunately, there are already some open source tools popping up to handle such tasks, such as <a href="https://github.com/alexandern/ccdaviewer">this one</a> written by Alex Nolasco as part of HL7's <a href="http://www.hl7.org/events/toolingchallenge.cfm">C-CDA Rendering Tool Challenge</a>, which contains a C-CDA parser as well as an iOS viewer written in Objective-C.<br />
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This is a great step forward in our march towards greater patient empowerment and health system transparency. I can't wait to see where the next steps take us!<br />
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Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com2tag:blogger.com,1999:blog-3315547413547199810.post-33458972436264860382016-09-09T10:24:00.000-04:002016-09-09T10:26:48.919-04:00iPhone 7 and the Case of the Frustrated Consumer<div dir="ltr" style="text-align: left;" trbidi="on">
So you've probably heard by now that the <a href="http://www.apple.com/iphone-7/">iPhone 7 was announced on Wednesday</a>. According to most outlets (and Apple themselves), it's an evolutionary upgrade. Yet, there has been palpable disappointment from many corners of the internet that this version bump didn't follow the traditional "tick tock" cycle of "major upgrade" (i.e., when the version number changed) followed by "speed upgrade" (with the addition of the "S," a tradition harking back to the <a href="https://en.wikipedia.org/wiki/IPhone_3GS">iPhone 3GS introduced in 2009</a>).<br />
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Something has been bothering me about this disappointment, and not in an "Apple Fanboy (or girl)" kind of way. I usually get my best insights while monotonously swimming laps in the mornings, and today was no exception. I was struck by this obvious thought: <i>the majority of consumers (and the media, and Wall Street) - perhaps unconsciously - judge the novelty of new products primarily based on its aesthetic appearance.</i> Beauty is only skin deep. Perhaps there's a greater lesson there for society, but that's not the point of this post ...<br />
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But that's not all. The problem with that thought as it relates to the iPhone (and smartphones in general) has to do with Apple's general design philosophy of "<a href="https://en.wikipedia.org/wiki/Form_follows_function">form follows function.</a>" In other words, the product will be designed with the singular purpose of enabling it to function at the highest level for its intended use.<br />
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When it comes to the iPhone, this largely seems to be a solved problem. How much has the iPhone <u>design</u> <i>truly changed</i> since its introduction in 2007?<br />
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<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgqAyGhr68PXBR1-9ZSJbrc1Qk7sL4MuP7ccs8ErateOEOkJ9NfWmytuYM2VIbiSdk1WKM3KJsph7QnDPJ902MHgHVS9CowsAi4r18QsVeobZfA3ygKkqTOVodUvssEUAsWdQy1Z1mbzG8/s1600/iPhone.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"></a><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi052n_bJ9W-o7JJl4R9eiAw9jNb2PavpykC7p_qWWR0m4EpxMC5fvZUmAmW88daj07loUdy_fBPRyqgL16FXDbi2o2ae0fpHFFae3uD3Z1vycFmFVs5hyEnsTcYGRbZ38bGyb69W9eohI/s1600/iPhone.png" imageanchor="1"><img border="0" height="300" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi052n_bJ9W-o7JJl4R9eiAw9jNb2PavpykC7p_qWWR0m4EpxMC5fvZUmAmW88daj07loUdy_fBPRyqgL16FXDbi2o2ae0fpHFFae3uD3Z1vycFmFVs5hyEnsTcYGRbZ38bGyb69W9eohI/s400/iPhone.png" width="400" /></a></div>
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There's a screen, a home button, speaker(s), volume buttons, a power button, a mute switch. It's obvious that despite the marketing and the version numbers and the minor cosmetic tweaks, the most significant changes have <i>always</i> been related to internal components. Every time. Just take a look at the major advertised features of each release:<br />
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<ul style="text-align: left;">
<li>iPhone (first release, <a href="https://www.youtube.com/watch?v=vN4U5FqrOdQ">need I say more</a>?)</li>
<li>iPhone 3G: 3G, GPS</li>
<li>iPhone 3GS: speed, better camera with video recording</li>
<li>iPhone 4: Retina display, custom A4 chip, front-facing camera</li>
<li>iPhone 4s: Siri, custom A5 chip, 1080p video recording</li>
<li>iPhone 5: larger display, LTE, Lightning connector, custom A6 chip</li>
<li>iPhone 5s: TouchID, dual-LED flash, A7 (first 64-bit mobile chip with M7 motion coprocessor)</li>
<li>iPhone 6: larger (higher resolution) displays, Apple Pay, custom A8 chip</li>
<li>iPhone 6s: custom A9 chip, 3D Touch, LTE Advanced</li>
<li>iPhone 7: custom A10 Fusion chip (quad-core), dual-cameras, water resistance, stereo speakers (no audio jack!)</li>
</ul>
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<div>
Throughout all those upgrades, has the design <i>truly changed</i>? If you count moving from rounded edges to squared edges (then chamfered edges) to rounded edges again, yeah, a bit. I guess (if I squint).</div>
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So why hasn't there been the revolutionary design change the people are clamoring for (and constantly disappointed when it doesn't materialize)?</div>
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<b><i>Because it's not necessary.</i></b></div>
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The minor design updates have had no noticeable impact on how people use the phone. Changes in usage have <i>all</i> been driven by the internal upgrades noted above (I count the screen and buttons as internal - the design is the same).</div>
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The basic design is already nearly optimal for the device's intended usage. For more proof, look no further than the competition. Since the original iPhone was released in 2007, smartphone designs in general have converged on the standard Apple pioneered: a screen and a button.</div>
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So should Apple change the design of the iPhone simply for the sake of change? This seems to be what the public is expecting. Hence their disappointment.<br />
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Yet Apple, <a href="http://images.apple.com/media/us/iphone-7/2016/5937a0dc_edb0_4343_af1c_41ff71808fe5/films/materials/iphone7-materials-tft-cc-us-20160907_1536x640h.mp4">through Jony Ive's disembodied voice</a>, continues to make it clear that the design <i>evolution</i> (rather than <i>revolution</i>) is quite intentional:<br />
<blockquote class="tr_bq">
"We have created a product that is the most deliberate evolution of our original founding design." "Our obsession remains to continuously simplify and improve." "iPhone 7 is the most singular, the most evolved representation of this design."</blockquote>
Understanding this is the key to unlocking the future of the iPhone. Do I expect the next iPhone to be the big design revolution people are expecting? Of course not. Do I expect some pretty cool internal changes that might cause me to rethink how I use the device? Absolutely.<br />
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In the end, Apple's courage to challenge these consumer expectations is probably the most revolutionary thing of all.<br />
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<i><span style="font-size: x-small;">The views contained within this post are my own and do not reflect the views of my employer. Furthermore, I have no financial interest in Apple whatsoever.</span></i></div>
Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com1tag:blogger.com,1999:blog-3315547413547199810.post-81760726345980169212016-08-09T11:41:00.001-04:002016-08-09T11:42:43.316-04:00Is ResearchKit right for you?<div dir="ltr" style="text-align: left;" trbidi="on">
<div dir="ltr" style="line-height: 1.38; margin-bottom: 0pt; margin-top: 0pt; text-align: center;">
<span style="background-color: transparent; color: black; font-family: "arial"; font-size: 14.666666666666666px; font-style: normal; font-variant: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><img alt="" class="scaled_image no_zoom" height="260" src="https://slack-imgs.com/?c=1&url=https%3A%2F%2Fimages.unsplash.com%2Fphoto-1434123700504-d8cfba6a12c8%3Fixlib%3Drb-0.3.5%26q%3D80%26fm%3Djpg%26crop%3Dentropy%26w%3D1080%26fit%3Dmax%26s%3Db420397cdb17ae36eae557cf83d97ec7" width="400" /></span></div>
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<span style="background-color: transparent; color: black; font-family: "arial"; font-size: 14.666666666666666px; font-style: normal; font-variant: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><i style="color: #666666; font-family: 'Trebuchet MS', Trebuchet, Verdana, sans-serif; font-size: 13px; white-space: normal;"><span style="font-family: "arial";"><span style="white-space: pre-wrap;"><br /></span></span></i></span></div>
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<span style="background-color: transparent; color: black; font-family: "arial"; font-size: 14.666666666666666px; font-style: normal; font-variant: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><i style="color: #666666; font-family: 'Trebuchet MS', Trebuchet, Verdana, sans-serif; font-size: 13px; white-space: normal;"><span style="font-family: "arial";"><span style="white-space: pre-wrap;">Note: This is the second in a special series of posts jointly </span><span style="white-space: pre-wrap;">written by both <a href="https://www.linkedin.com/in/katie-donohue-mcmillan-mph-0ab5ab8" style="color: #2288bb; text-decoration: none;">Katie Donohue McMillan</a> and me. Katie recently joined Duke as our Innovation Portfolio Manger and brings with her a wealth of experience and a unique perspective from outside the stodgy halls of academia.</span></span></i></span></div>
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<span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;"><br /></span></div>
<div dir="ltr" style="line-height: 1.38; margin-bottom: 0pt; margin-top: 0pt;">
<span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;">In March of 2015, Apple announced <a href="http://researchkit.org/">ResearchKit</a>, and open-source framework intended to accelerate medical research on mobile platforms. For those of us in healthcare, this made our ears perk up. One of the largest companies in the world is taking an interest in medical research? And providing tools to </span><span style="font-family: "arial"; font-size: 14.666666666666666px; font-style: italic; vertical-align: baseline; white-space: pre-wrap;">help us</span><span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;"> with it? For those of you unfamiliar with the details of ResearchKit, it is a software framework to facilitate the collection of data from study participants via an iPhone app. The first apps announced at the event supported research around </span><a href="http://parkinsonmpower.org/" style="text-decoration: none;"><span style="color: #1155cc; font-family: "arial"; font-size: 14.666666666666666px; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">Parkinson’s</span><span style="color: black; font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;"> </span></a><span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;">, </span><a href="http://glucosuccess.org/" style="text-decoration: none;"><span style="color: #1155cc; font-family: "arial"; font-size: 14.666666666666666px; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">Diabetes</span></a><span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;">, and </span><a href="http://apps.icahn.mssm.edu/asthma/" style="text-decoration: none;"><span style="color: #1155cc; font-family: "arial"; font-size: 14.666666666666666px; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">Asthma</span></a><span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;"> (to name a few.) Later, apps were released for</span><a href="http://threadresearch.com/our-work/pride-study-research-app#LGEomYb7BbD6hgh4.97" style="text-decoration: none;"><span style="color: #1155cc; font-family: "arial"; font-size: 14.666666666666666px; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;"> LGBTQ health</span></a><span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;"> and </span><a href="https://autismandbeyond.researchkit.duke.edu/" style="text-decoration: none;"><span style="color: #1155cc; font-family: "arial"; font-size: 14.666666666666666px; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">Autism Screening.</span></a><span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;"> The possibilities are seemingly endless.</span></div>
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<span style="font-family: "arial"; font-size: 14.666666666666666px; font-weight: 700; white-space: pre-wrap;"><br /></span></div>
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<span style="font-family: "arial"; font-size: 14.666666666666666px; font-weight: 700; white-space: pre-wrap;">But how do you know if ResearchKit is right for you?</span></div>
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<span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;">Let’s say you have an idea to study people who have blue freckles. You want to know when people first noticed their blue freckles, how many they have, and if things like sunlight or moonlight increase the number of them. Maybe blueberries have something to do with it? No one really knows, because this blue freckle condition is rare and it’s hard to find more than 10 people in your area with them. You really just want to find more people with the condition and ask them a few questions at different intervals, over 12 months. In this case, Research Kit would be a good fit for you. It is </span><span style="font-family: "arial"; font-size: 14.666666666666666px; font-style: italic; vertical-align: baseline; white-space: pre-wrap;">great</span><span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;"> for surveys. Also, because the app can be downloaded from the Apple App Store, you can enroll patients all around the US and increase the sample size of your rare patient population to ensure that your evidence has statistical significance.</span></div>
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<span style="font-family: "arial"; font-size: 14.666666666666666px; white-space: pre-wrap;">Here are some example screens of survey questions:</span></div>
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<tr><td style="text-align: center;"><img alt="Screen Shot 2016-08-05 at 10.39.12 AM.png" height="223" src="https://lh4.googleusercontent.com/CAasNvhhyjhGGF5vmMltsPNvpDLhOTXn7NDWzIYmoJRVza6RoWcZv2RbMVjWh-4LwON2rzAIojlT7TLolyfu0_bQS8BFM49gQVMTq9qkQWXX4H1QRjt069XsrLBbxwZQ9IINy-MR" style="border: none; margin-left: auto; margin-right: auto; transform: rotate(0rad);" width="400" /></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><span style="color: #1155cc; font-family: "arial"; font-size: 14.666666666666666px; text-align: left; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;"><a href="http://researchkit.org/docs/docs/Survey/CreatingSurveys.html" style="text-align: left; text-decoration: none;">Image credit</a></span><span style="font-family: "arial"; font-size: 14.666666666666666px; text-align: left; white-space: pre-wrap;"></span><br />
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<span style="font-family: "arial"; font-size: 15px; white-space: pre-wrap;">In addition to surveys, ResearchKit has other standard capabilities, like a self-consent process (a crucial part of any study), active tasks and data visualizations.</span><br />
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<tr><td style="text-align: center;"><img alt="Screen Shot 2016-08-05 at 10.37.44 AM.png" height="456" src="https://lh4.googleusercontent.com/aQJvHobJ7E4xYGApfQAXiz30KGi49Gfs3ZSsuNAcfEc5DtNPl9yWyQNHgxOg8oYMw49JIK_5Asvm31WTw1fi48FBNz0Tr9NQqMwFqLpwcOtKECSydijaTQ52eToMcUDG2CS1INr9" style="border: none; margin-left: auto; margin-right: auto; transform: rotate(0rad);" width="624" /></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><a href="http://researchkit.org/docs/docs/ActiveTasks/ActiveTasks.html" style="text-align: left; text-decoration: none;"><span style="color: #1155cc; font-family: "arial"; font-size: 14.666666666666666px; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">Image credit</span></a></td></tr>
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<span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;">Studies that require use of the hardware found in an iPhone would also be ideal candidates for ResearchKit. For example, the Parkinson’s app makes use of the accelerometer and gyroscope to assess the gait and balance of participants. It also employs the touch screen to assess fine motor control through repetitive tapping activities. The </span><a href="https://med.stanford.edu/myheartcounts.html" style="text-decoration: none;"><span style="color: #1155cc; font-family: "arial"; font-size: 14.666666666666666px; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">MyHeart Counts</span></a><span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;"> app uses the pedometer in a walk test that is used to calculate heart risk.</span><br />
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<span style="font-family: "arial"; font-size: 14.666666666666666px; white-space: pre-wrap;">The Autism and Beyond app stretched beyond these standard capabilities to include facial recognition and recording video. If you have an idea that technology can support, ResearchKit’s open-source nature makes it amenable to exploration and experimentation.</span></div>
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<span style="font-family: "arial"; font-size: 14.666666666666666px; font-weight: 700; white-space: pre-wrap;">So, when wouldn’t you want to use ResearchKit?</span></div>
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<span style="font-family: "arial"; font-size: 14.666666666666666px; white-space: pre-wrap;">ResearchKit works best as an encapsulated study, meaning that everything the participant is required to do to participate occurs within the app. If you are interested in a study that includes both a survey and blood samples, a ResearchKit app could facilitate some of the data collection, but other aspects of the study would be more traditional, and study participants should be educated on the various aspects of their involvement.</span></div>
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<span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;">Likewise, if your survey questions take an hour to fill out, this also might not be the best choice. </span><a href="http://www.statista.com/statistics/202485/average-ipad-app-session-length-by-app-categories/" style="text-decoration: none;"><span style="color: #1155cc; font-family: "arial"; font-size: 14.666666666666666px; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">People spend an average of 2.6 - 7.5 minutes in a mobile app.</span></a><span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;"> If you want them to continually submit data over time, it needs to be quick and easy. </span></div>
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<span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;">Are you interested in collecting data unbiased by socioeconomic factors inherent in supporting only a single platform? While ResearchKit is iOS-only, </span><a href="http://researchstack.org/" style="text-decoration: none;"><span style="color: #1155cc; font-family: "arial"; font-size: 14.666666666666666px; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">ResearchStack</span></a><span style="font-family: "arial"; font-size: 14.666666666666666px; vertical-align: baseline; white-space: pre-wrap;">, a comparable toolkit, is available on Android. If you are interested in collecting data from people with either iPhone or Android devices, you’ll have to plan your budget accordingly to pay for the development of two apps. (Likely an additional 75% to 100% of the cost of the first app).</span></div>
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<span style="font-family: "arial"; font-size: 14.666666666666666px; white-space: pre-wrap;">Would you like to track people for more than a year? You may want to also make use of more traditional study methods. Just as we didn’t know about ResearchKit a year ago, who knows what new technology will arrive on the scene in the next year? The possibilities in healthcare tech are endless and rapidly changing and you may not want to tie a long term study to a new mobile technology.</span></div>
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<span style="font-family: "arial"; font-size: 14.666666666666666px; white-space: pre-wrap;">The tools ResearchKit provides to simplify research app creation have already demonstrated that there are ways to dramatically improve our ability to collect data at scale by tapping into the supercomputers that billions around the world have in their pockets. Research is no longer constrained to the ivory towers of academia. Understanding the strengths and limitations of the current version is important to ensure the success of your study. The beauty of ResearchKit and ResearchStack is that due to being open source, they will continue to evolve to meet the ever-growing needs of researchers around the world and improve our understanding of human health.</span></div>
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<span style="background-color: transparent; color: black; font-family: "arial"; font-size: 14.666666666666666px; font-style: normal; font-variant: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><br /></span></div>
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<span style="background-color: transparent; color: black; font-family: "arial"; font-size: 14.666666666666666px; font-style: normal; font-variant: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><span style="background-color: white; color: #666666; font-family: "arial"; font-size: 13px; font-style: italic;">About Us: Ricky Bloomfield, MD, is the Director of Mobile Strategy and practicing pediatrician at Duke Health. In his spare time he likes to develop software and play with emerging technologies. </span><a href="https://www.linkedin.com/in/katie-donohue-mcmillan-mph-0ab5ab8" style="color: #2288bb; font-family: arial; font-size: 13px; font-style: italic; text-decoration: none;">Katie Donohue McMillan</a><span style="background-color: white; color: #666666; font-family: "arial"; font-size: 13px; font-style: italic;"> is the Innovation Portfolio Manager at Duke Health. Together, they’re attempting to accelerate the entrepreneurial spirit within Duke and amplify great solutions that improve healthcare.</span></span></div>
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Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-37766269160850083972016-06-22T11:32:00.000-04:002016-06-22T14:19:46.959-04:00More information on CCDA and HealthKit<div dir="ltr" style="text-align: left;" trbidi="on">
<a href="http://www.rickybloomfield.com/2016/06/cdaccd-coming-to-apples-healthkit.html">Last week I reported</a> that Apple is bringing support for CCDA to HealthKit, enabling users to download their medical records from any Meaningful Use Stage 2-compliant electronic health record system. At the time there wasn't much additional information available. Since that time, Apple has publicly posted the WWDC session on the topic, <a href="https://developer.apple.com/videos/play/wwdc2016/209/">which can be viewed here</a>. The portion on Health Records starts at the 17:20 mark.<div>
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From the presentation it is clear that Apple allows users to download and view their documents:</div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj7bTLIN0_g4R_J9GhducS7UnwFg0dBm9yWMIDVfrx6Y63-ISPCVH0dP1OyBkTl4ctjp8_gBQ3-nhEotbCA1Yj2Mizj_Mz7_eaKIzax7MRO5w0u3EUIkgzA0zGpZQSt2zhCqQsJIU4JUuU/s1600/Screen+Shot+2016-06-21+at+9.54.25+PM.png" imageanchor="1"><img border="0" height="250" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj7bTLIN0_g4R_J9GhducS7UnwFg0dBm9yWMIDVfrx6Y63-ISPCVH0dP1OyBkTl4ctjp8_gBQ3-nhEotbCA1Yj2Mizj_Mz7_eaKIzax7MRO5w0u3EUIkgzA0zGpZQSt2zhCqQsJIU4JUuU/s400/Screen+Shot+2016-06-21+at+9.54.25+PM.png" width="400"></a></div>
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One question I've received, however, is what HealthKit does with the document once it has been downloaded, i.e., is it "parsed" in such a way that makes the discreet data elements available for use by other applications, or visible in HealthKit? For example, would blood pressure, weight, or glucose values be added automatically to the appropriate fields in HealthKit?</div>
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Currently, the answer appears to be "no." According to the limited <a href="https://developer.apple.com/reference/healthkit/hkcdadocument">documentation of the HKCDADocument Class</a>, the class has 5 instance properties, one of which is the document data as a blob. The other 4 instance properties are parsed from the XML, and include: <a href="https://developer.apple.com/reference/healthkit/hkcdadocument/1779381-authorname">authorName</a>, <a href="https://developer.apple.com/reference/healthkit/hkcdadocument/1779390-custodianname">custodianName</a>, <a href="https://developer.apple.com/reference/healthkit/hkcdadocument/1779384-patientname">patientName</a>, and <a href="https://developer.apple.com/reference/healthkit/hkcdadocument/1779387-title">title</a>. These 4 data elements appear to have been chosen to allow the consumer of the data to identify the document and compare with other health documents that might be saved to HealthKit.</div>
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At this point it's important to note that each CCDA document saved to HealthKit becomes a distinct entity, and that any de-duplication of data would need to be done by the consumer of the data. For example, if a user downloads a CCDA from their patient portal, then re-downloads the document a month later, those are saved as two, separate documents, and the second document would contain all the information from the first document, plus any additions from the past month.</div>
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So, if the user gives your shiny new health app access to these documents, you (as the developer) will need to decide whether you pull only the most recent document or whether you pull all of the documents and harmonize the data yourself (a good bit of work).</div>
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In speaking with some of my colleagues, it might also be helpful in a future version of this implementation to have access to additional HKCDADocument properties to facilitate positive patient identification, such as date of birth or phone number (which is increasingly becoming part of our identities!). This will be important because HealthKit does not limit a user to only import his or her own health records. Work on a national patient identifier would definitely be helpful here!</div>
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Despite these limitations, the importance of giving patients access to their own data in this way cannot be overstated. This is a watershed moment. Yes, it allows hospitals and users to fulfill the intent of the MU2 requirements, but more importantly, it empowers patients to be stewards of their own data, and to decide when and how it will be used to improve their health.</div>
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Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-44770117902145313902016-06-13T16:23:00.001-04:002016-06-17T21:08:27.682-04:00CDA/CCD Coming to Apple's HealthKit!<div dir="ltr" style="text-align: left;" trbidi="on">
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<tr><td class="tr-caption" style="text-align: center;">HK and HL7, together at last!</td></tr>
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Today I was fortunate to be able to attend the keynote presentation for Apple's annual Worldwide Developers Conference, or WWDC (aka, "dub dub"). The presentation itself focused on Apple's four primary OSs: watchOS, tvOS, macOS (bye "Mac OS X"!), and iOS. Personally, the most exciting keynote announcement (besides emojis that are 3x the size!!!) was a new apps called <a href="http://www.apple.com/swift/playgrounds/">Swift Playgrounds</a>, intended to help teach children to code. My 10 year-old daughters will love it (heck, <b><i>I</i></b> will love it)!<br />
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But for me, the most exciting announcement did not come as part of the keynote. The most exciting announcement is that for iOS 10, Apple will add support for HL7's <a href="http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7">Clinical Document Architecture</a> (CDA) and the <a href="http://www.hl7.org/implement/standards/product_brief.cfm?product_id=6">Continuity of Care Document</a> (CCD) directly to HealthKit. For those unfamiliar with CDA/CCD, it's basically a standard way (using XML) to describe an individual's health history in a single, structured data format.<br />
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This means that any app (such an EHR patient portal app) will be able to share a CCD with the user in order to save it to HealthKit, and that any app can then get permission to read the CCD from HealthKit.<br />
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<b><i>In other words, this gives a user more control over his/her medical information than ever before.</i></b><br />
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This is huge. I've spoken previously about paternalism in medicine and how patients are often the least empowered of <i>their own care team</i>. This needs to change fast, and Apple's inclusion of CCD as a first class citizen in HealthKit will usher in a new breed of health apps that empower patients and give them more choice in what they can do with their health information. The is one of the precise goals of the NIH and ONC's <a href="https://www.healthit.gov/buzz-blog/health-innovation/nih-and-onc-launch-the-sync-for-science-pilot/">Sync for Science</a> project: to allow individuals to 1) access and 2) donate their data to science.<br />
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The contents of the CCD are also informing the work on <a href="http://smarthealthit.org/">SMART and FHIR</a> related to the <a href="https://github.com/argonautproject/implementation-program/wiki">Argonaut Implementation Program</a>, which aims to standardize the way we implement FHIR on various systems, focusing on use cases that represent what the CCD can do.<br />
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Ultimately, the more we can put users in control of their own health, the better of they will be. I welcome this significant step in that direction.<br />
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<b>Update:</b> The developer documentation isn't yet available, but the placeholders for <a href="https://developer.apple.com/reference/healthkit/hkcdadocument">HKCDADocument</a> and <a href="https://developer.apple.com/reference/healthkit/hkcdadocumentsample">HKCDADocumentSample</a> are on the web.</div>
Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com5tag:blogger.com,1999:blog-3315547413547199810.post-30189883526782854432016-06-02T12:05:00.002-04:002016-06-02T12:10:30.454-04:00What is Health Technology Innovation?<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="background-color: transparent; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; vertical-align: baseline;"><i><span style="font-family: "arial";"><span style="white-space: pre-wrap;">Note: This is the first in a special series of posts jointly </span><span style="white-space: pre-wrap;">written by both <a href="https://www.linkedin.com/in/katie-donohue-mcmillan-mph-0ab5ab8">Katie Donohue McMillan</a> and me. Katie recently joined Duke as our Innovation Portfolio Manger and brings with her a wealth of experience and a unique perspective from outside the stodgy halls of academia.</span></span></i></span><br />
<span style="background-color: transparent; font-variant-alternates: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; vertical-align: baseline;"><i><span style="font-family: "arial";"><span style="white-space: pre-wrap;"><br /></span></span></i></span></div>
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<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">A new app? A new device? An old device used in a new way? And old interface put to a new use? None of the above?</span><br />
<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><br /></span></div>
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<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">We bet many of you share our frustration with the term innovation. Overused, cliché, and now practically blasé, the word has clearly lost its way, the meaning diluted through inclusion in overzealous marketing phrases and conference taglines. If we had a dime for every time someone around here used the word innovation, we’d probably have enough funding to build several </span><a href="http://researchkit.org/" style="text-decoration: none;"><span style="background-color: transparent; color: #1155cc; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">ResearchKit</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">/</span><a href="http://researchstack.org/" style="text-decoration: none;"><span style="background-color: transparent; color: #1155cc; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">ResearchStack</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"> apps that incorporated the </span><a href="https://www.microsoft.com/microsoft-hololens/en-us" style="text-decoration: none;"><span style="background-color: transparent; color: #1155cc; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">HoloLens</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"> </span><a href="https://www.microsoft.com/microsoft-hololens/en-us" style="text-decoration: none;"><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">and </span></a><a href="https://www.scanadu.com/scout" style="text-decoration: none;"><span style="background-color: transparent; color: #1155cc; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">Scanadu Scout</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">. We’d get all our transplant patients a </span><a href="https://en.wikipedia.org/wiki/Organ_printing" style="text-decoration: none;"><span style="background-color: transparent; color: #1155cc; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">3D-printed organ (or two)</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">. We’d be able to buy all of Duke Health patients their own Apple Watch. </span><br />
<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><br /></span></div>
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<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">Yet, with all the overuse and confusion around the term, it still </span><span style="background-color: transparent; color: black; font-family: "arial"; font-style: italic; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">means</span><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"> something to people that is not represented more clearly through use of another word. For us, it’s the belief that we can find new ways to improve health for all humankind. So we’re not advocating that you jettison “innovation</span><span style="background-color: transparent; color: black; font-family: "arial"; font-style: italic; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">”</span><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"> from your vocabulary. At least not yet.</span><br />
<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><br /></span></div>
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<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">Merriam-Webster defines innovation as “</span><a href="http://www.merriam-webster.com/dictionary/innovation" style="text-decoration: none;"><span style="background-color: transparent; color: #1155cc; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">a new idea, device, or method.</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">” Yet in healthcare, we see “new” things all the time that subjectively don’t rise to the level of innovation. Does a </span><a href="http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm" style="text-decoration: none;"><span style="background-color: transparent; color: #1155cc; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">new generic drug</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">,</span><a href="http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm" style="text-decoration: none;"><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"> </span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">another </span><a href="http://www.medfusion.com/" style="text-decoration: none;"><span style="background-color: transparent; color: #1155cc; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">patient portal app</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">, </span><a href="http://searchhealthit.techtarget.com/feature/Analytics-drives-healthcare-data-storage-in-the-cloud" style="text-decoration: none;"><span style="background-color: transparent; color: #1155cc; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">moving data to the cloud</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">, </span><a href="http://www.healthcareitnews.com/news/ehrs-now-nearly-ubiquitous-hospitals-onc-annual-meeting-gets-under-way" style="text-decoration: none;"><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">or the implementation of an electronic health record</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"> really fit the bill?</span><br />
<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><br /></span></div>
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<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">Some would argue, though, that something doesn’t have to be </span><span style="background-color: transparent; color: black; font-family: "arial"; font-style: italic; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">groundbreaking</span><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"> to be innovative. Maybe integrating an existing </span><a href="http://emr.bilitool.net/" style="text-decoration: none;"><span style="background-color: transparent; color: #1155cc; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">clinical risk calculator into an EHR</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"> </span><a href="http://emr.bilitool.net/" style="text-decoration: none;"><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">could be considered innovative - it could save time and improve care.</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"> Allowing patients to </span><a href="http://www.opennotes.org/" style="text-decoration: none;"><span style="background-color: transparent; color: #1155cc; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">view their doctors’ notes</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"> is breaking down the centuries-old paradigm of paternalism in health care. Giving patients a way to </span><a href="http://www.rickybloomfield.com/2015/03/researchkit-and-future-of-healthcare.html" style="text-decoration: none;"><span style="background-color: transparent; color: #1155cc; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">electronically consent for a study</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"> with tools</span><a href="http://www.rickybloomfield.com/2015/03/researchkit-and-future-of-healthcare.html" style="text-decoration: none;"><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"> like Research Kit </span></a><a href="http://www.fastcompany.com/3058125/in-its-first-year-has-apples-researchkit-revolutionized-medical-research" style="text-decoration: none;"><span style="background-color: transparent; color: #1155cc; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: underline; vertical-align: baseline; white-space: pre-wrap;">can increase study enrollment by orders of magnitude</span></a><span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">.</span><br />
<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><br /></span></div>
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<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">Perhaps we’re simply demanding too much of the poor word and the people who use it? Or we’re spoiled by the constant miracles technology has wrought to the extent that the miraculous has become mundane. That one entrepreneur’s great idea has simply become another executive’s IT expenditure. </span><br />
<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><br /></span></div>
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<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">We will be exploring the concept of innovation over the next year. What is innovation? What does innovation mean? How do you cultivate it within a healthcare system? How do you support innovations and entrepreneurs?</span><br />
<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;"><br /></span></div>
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<span style="background-color: transparent; color: black; font-family: "arial"; font-style: normal; font-variant-alternates: normal; font-variant-caps: normal; font-variant-east-asian: normal; font-variant-ligatures: normal; font-variant-numeric: normal; font-variant-position: normal; font-weight: 400; text-decoration: none; vertical-align: baseline; white-space: pre-wrap;">This question may be unanswerable, or there may be a thousand right answers. What do you think? What does innovation mean to you? </span><br />
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<span style="font-family: "arial"; font-style: italic; vertical-align: baseline; white-space: pre-wrap;">About Us: Ricky Bloomfield, MD, is the Director of Mobile Strategy and practicing pediatrician at Duke Health. In his spare time he likes to develop software and play with emerging technologies. <a href="https://www.linkedin.com/in/katie-donohue-mcmillan-mph-0ab5ab8">Katie Donohue McMillan</a> is the Innovation Portfolio Manager at Duke Health. Together, they’re attempting to accelerate the entrepreneurial spirit within Duke and amplify great solutions that improve healthcare.</span></div>
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Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-71904982717114441992016-05-31T07:00:00.000-04:002016-05-31T07:00:13.087-04:00Work Can Wait!<div dir="ltr" style="text-align: left;" trbidi="on">
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiQuiYtETDITHmZfpX-YZPHYBhGPf2fpLMx7WpyjiITYAUPfyXaS1wuzpm9P3q6UB6G2vQ7NVPG8a7qg9geDMkCJg4xlIZ_uRMkhZRMxCwtfPMmkVHRCsmYCK5-l1jDrKu2lCXuVJT270k/s1600/disable-annoying-red-badge-alerts-for-apps-your-iphones-home-screen.w654.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="120" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiQuiYtETDITHmZfpX-YZPHYBhGPf2fpLMx7WpyjiITYAUPfyXaS1wuzpm9P3q6UB6G2vQ7NVPG8a7qg9geDMkCJg4xlIZ_uRMkhZRMxCwtfPMmkVHRCsmYCK5-l1jDrKu2lCXuVJT270k/s400/disable-annoying-red-badge-alerts-for-apps-your-iphones-home-screen.w654.jpg" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;"><span style="font-size: large;">That's at least a weeks' worth of email!</span><br />
Image credit: http://ios.wonderhowto.com/</td></tr>
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Work-life balance has always been a topic about which I've been passionate. It's important to <a href="http://news.unchealthcare.org/news/2012/september/real-doctors-real-people-richard-bloomfield">enjoy life</a> <a href="http://www.usms.org/comp/meets/indresults.php?SwimmerID=08BF0">outside work</a>! Achieving - and maintaining - such balance is not only good for our interpersonal relationships and mental health, but I believe allows us to bring more energy and creativity to our work.<br />
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Now, the medical profession isn't known for being conducive to work-life balance. Medical residents work up to 80 hours per week (and it used to be more!) and many physicians end up working even more than that post-residency, when there are no duty hour restrictions.</div>
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As you all know, I'm passionate about the power of technology to transform our lives, and I have no doubt that we are beginning to see real change in healthcare because of it. Arguably the greatest technological advance in the last century has been the Internet, with the greatest benefit being the ease with which we now communicate. Messages that used to take weeks or months to arrive now take milliseconds. In place of quill and ink we now have Skype and FaceTime. Collaboration can now take place in real time with multiple users around the world editing the same document simultaneously.</div>
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But with the obliteration of our communication barriers has also come the obliteration of critical boundaries between work and our personal lives. Since it only takes seconds to send a text or email (or millions of them, for that matter ...), we do it without a second thought. And while we may not <i>intend</i> for the person on the receiving end to feel obligated to immediately respond, they often do, <i>especially</i> if the email is sent from someone higher in the chain of command.</div>
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I understand that in healthcare there are times when it's important to respond immediately to a request. People don't just get sick M-F, 8-5pm (<i>that</i> would be innovation!), but that's not what I'm talking about here. Most of my time is spent in healthcare IT, and while there <i>are</i> healthcare IT emergencies (we want our EHR running 24/7, after all), those are fortunately very rare. Most of what I do - and most of what typical office workers do - can wait. That's right. <i><b>Work can wait.</b></i></div>
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And not only <i>can</i> it wait, but it <i>should</i> wait. The following dialog has been uttered many times in our household when my (10-year old) daughters have been overcome with emotion related to needing something <i>immediately</i>: "Are there meteors raining down upon us? Are there volcanoes erupting in central North Carolina threatening to submerge us in boiling lava? Are there earthquakes rending the earth and attempting to swallow us whole? No? Ok, then we can probably take a breath and deal with this a little later." In work terms, "a little later" is usually the next business day.</div>
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For many, this is easier said than done. One of the most common reasons I hear for after-hours email is: "That's the only time I have to do it! I have meetings all day!" Okay, well, that's a problem for another day. The most common malady I encounter at Duke is not bronchitis, but <i>meetingitis</i>. There are ways to improve that, too, like scheduling a personal, recurring meeting every day - <i>with yourself</i> - <i><b>to do your email</b></i>. I also understand that there are also times when it's just more convenient to respond to an email after hours, or perhaps you just want to get that email out of your inbox (I <i>do</i> like a clean inbox!).<br />
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But how can you handle that email without making the recipient feel obligated to immediately respond? One way is to set an expectation with your coworkers that they are not obligated to respond to after-hours correspondence (which I do), but another way is to compose the email, but schedule it to go out on the next business day. I actually use a Mac Mail plug in called <a href="https://www.feingeist.io/mailbutler/">SendLater</a> (although now called MailButler) that does this exact thing. Microsoft Outlook <a href="https://support.office.com/en-us/article/Delay-or-schedule-sending-email-messages-253dbfd7-0db7-4f41-bcc5-9e8e68ae29bf">has a similar feature built in</a>. This way I can tend to the email when convenient for me, yet not burden others unnecessarily. Of course, my first priority is to get the email done during the work day, but this works for me as a backup when needed. So for those of you who may have noticed flurries of emails from me at 7:00am sharp on weekdays, now you know why!<br />
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This is something I've been thinking about for a long time, but I have to admit that my post was in response to reading David Hansson's (the creator of Ruby on Rails) <a href="https://m.signalvnoise.com/worker-protections-for-office-workers-77d3425f2639#.mlezznsu9">comments found here</a>. That's also where I borrowed #WorkCanWait. So kudos to David!<br />
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I also recently read John Halamka's <a href="http://geekdoctor.blogspot.com/2016/05/a-zero-tolerance-policy-for-business.html">post on business spam</a> - BIDMC has instituted a "Zero Tolerance" policy and has set up a blacklist on their network using a commercially available appliance. That's another approach to simplifying our work lives, and one I'd love to try out!<br />
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So let's all roll up our sleeves and get to work ... enjoying our newfound free time! I've been meaning to teach myself how to play the guitar ...</div>
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Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-8494758629952799372016-02-13T16:52:00.000-05:002016-02-13T16:52:00.415-05:00Does HIPAA Apply to Your App?<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-family: inherit;">There has been lots of confusion in the marketplace regarding when the Health Insurance Portability and Accountability Act, or HIPAA (one 'p' and two 'a's), should apply to mobile apps. You can <a href="http://www.hhs.gov/hipaa/index.html">read more about HIPAA here</a>.</span></div>
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<span style="font-family: inherit;"><br /></span></div>
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<span style="font-family: inherit;">Typically, confusion <span style="background-color: rgba(255, 255, 255, 0.529412);">≠ innovation.</span></span></div>
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<span style="font-family: inherit;"><span style="background-color: rgba(255, 255, 255, 0.529412);"><br /></span></span></div>
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<span style="background-color: rgba(255, 255, 255, 0.529412);"><span style="font-family: inherit;">Recently the Department of Health and Human Services released </span><a href="http://hipaaqsportal.hhs.gov/" style="font-family: inherit;">a new website targeted at mobile health app developers</a><span style="font-family: inherit;"> via the Office of Civil Rights. This site was intended to open a dialog regarding issues relevant to mHealth developers, and one of the issues likely raised by many was the applicability of HIPAA. In response to this, they recently updated the site with additional guidance, <a href="http://hipaaqsportal.hhs.gov/community-library/accounts/92/925889/OCR-health-app-developer-scenarios-2-2016.pdf">found here</a>.</span></span></div>
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<span style="background-color: rgba(255, 255, 255, 0.529412);"><span style="font-family: inherit;"><br /></span></span></div>
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<span style="background-color: rgba(255, 255, 255, 0.529412);"><span style="font-family: inherit;">This document, only a few pages long, helps to clarify a number of issues through relevant examples. The questions it attempts to address are:</span></span></div>
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<ol style="text-align: left;">
<li><span style="font-family: inherit;">How does HIPAA apply to health information that a patient creates, manages or organizes through the use of a health app?</span></li>
<li><span style="font-family: inherit;">When might an app developer need to comply with the HIPAA rules?</span></li>
</ol>
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<span style="background-color: rgba(255, 255, 255, 0.529412);"><span style="font-family: inherit;">Please refer to the document for all the detail (and it makes clear that a slight change in the facts of a situation may change the applicability), but here are some highlights:</span></span></div>
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<span style="background-color: rgba(255, 255, 255, 0.529412);"><span style="font-family: inherit;"><br /></span></span></div>
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<span style="background-color: rgba(255, 255, 255, 0.529412);"><span style="font-family: inherit;">"A consumer downloads a health app to her smartphone. She populates it with her own information."</span></span></div>
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<b style="font-family: inherit;">Developer is NOT a HIPAA Business Associate.</b></div>
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<b style="font-family: inherit;"><br /></b></div>
<div style="text-align: left;">
<span style="font-family: inherit;">"Consumer downloads a health app to her smartphone that is designed to help her manage a chronic condition. She downloads data from her doctor's EHR through a patient portal, onto her computer and then uploads it into the app. She also adds her own information to the app."</span></div>
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<b>Developer<span style="font-family: inherit;"> is NOT a HIPAA Business Associate.</span></b></div>
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<b><span style="font-family: inherit;"><br /></span></b></div>
<div style="text-align: left;">
<span style="font-family: inherit;">"Doctor counsels patient that his BMI is too high, and recommends a particular app that tracks diet, exercise, and weight. Consumer downloads app to his smartphone and uses it to send a summary report to his doctor before his next appointment."</span></div>
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<span style="font-family: inherit;"><b>Developer is NOT a HIPAA Business Associate.</b></span></div>
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<span style="background-color: rgba(255, 255, 255, 0.529412);"><span style="font-family: inherit;"><br /></span></span></div>
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<span style="font-family: inherit;">"Consumer downloads a health app to her smartphone
that is designed to help her manage a chronic condition.
Health care provider and app developer have entered
into an interoperability arrangement at the consumer’s
request that facilitates secure exchange of consumer
information between the provider EHR and the app. The
consumer populates information on the app and directs
the app to transmit the information to the provider’s
EHR. The consumer is able to access test results from the
provider through the app.</span><span style="font-family: Calibri; font-size: 11pt; font-weight: 700;"> "</span><br />
<b style="font-family: inherit;">Developer is NOT a HIPAA Business Associate.</b><br />
<b style="font-family: inherit;"><br /></b>
<span style="font-family: inherit;">In all of these cases, the developer is <b><i>not</i></b> a HIPAA Business Associate because the developer is not creating, receiving, maintaining or transmitting protected health information (PHI) <i>on behalf of a covered entity or another business associate.</i> </span><span style="font-family: inherit;">That last piece is the key. The consumer made the choice to take these actions, and the consumer has the right to do what she wants with this information.</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">This last example is also what would likely apply when a consumer chooses to make use of </span><a href="http://www.rickybloomfield.com/2014/09/apple-healthkit-flexible-platform-for.html" style="font-family: inherit;">Apple's HealthKit</a><span style="font-family: inherit;">, which we have been using for over a year here at Duke. The way it's set up here, even when a physician makes a recommendation to have a consumer share his/her information in order to facilitate care, the consumer can choose to do so manually via MyChart or via HealthKit. HealthKit is never required - it's the consumer's choice.</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">There are two additional examples in the document regarding cases when the developer <i>would</i> be a business associate. Those include the following:</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">"At direction of her provider, patient downloads a health
app to her smart phone. Provider has contracted with
app developer for patient management services,
including remote patient health counseling, monitoring
of patients’ food and exercise, patient messaging, EHR
integration and application interfaces. Information the
patient inputs is automatically incorporated into provider
EHR.</span><span style="font-family: inherit;">"</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">"Consumer downloads to her smart phone a mobile PHR
app offered by her health plan that offers users in its
network the ability to request, download and store
health plan records and check the status of claims and
coverage decisions. The app also contains the plan’s
wellness tools for members, so they can track their
progress in improving their health. Health plan analyzes
health information and data about app usage to
understand effectiveness of its health and wellness
offerings. App developer also offers a separate, direct-
to-consumer version of the app that consumers can use
to store, manage, and organize their health records, to
improve their health habits and to send health
information to providers."</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">Hopefully this helps provide a little clarity regarding when HIPAA is relevant. If you have additional questions, I suggest <a href="http://hipaaqsportal.hhs.gov/a/ideas/top/campaign-filter/active">submitting them</a> to the <a href="http://hipaaqsportal.hhs.gov/">mHealth HIPAA site referenced above</a>.</span><br />
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Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-70639513827116939462015-10-15T08:30:00.000-04:002015-10-15T08:47:40.866-04:00ResearchKit is Official at Duke: Autism & Beyond<div dir="ltr" style="text-align: left;" trbidi="on">
Over the past 6 months there's been something brewing at Duke ... something that we're now incredibly excited to share with the world.<br />
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But first, a bit of background:<br />
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<ul style="text-align: left;">
<li>1 in 68 children will be diagnosed with Autism</li>
<li>Autism can be diagnosed as young as 18 months old</li>
<li>The average age of Autism diagnosis in the US is over 5 years old</li>
<li>A child's brain will grow at a rate of 700 synapses/sec in the first years of life</li>
<li>70 counties in NC have no access to a childhood mental health specialist</li>
<li>In Africa, where there are approximately 500 million children, there are only about 50 childhood mental health specialists</li>
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Do you detect a need?</div>
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We do, too.</div>
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Thus, <a href="https://autismandbeyond.researchkit.duke.edu/">Autism & Beyond</a> was born. Autism & Beyond is an incredible new <a href="http://www.rickybloomfield.com/2015/04/researchkit-is-upon-us.html">ResearchKit</a> study that builds upon the groundbreaking work of Geri Dawson, Helen Egger and Guillermo Sapiro, who over the past several years have been working to refine novel video algorithms that can analyze and detect a child's emotion in real-time. They've been conducting studies at Duke clinics using an iPad prototype app for almost 2 years.</div>
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In early 2014 I had the pleasure of working with Kathleen Campbell, a wonderful 2nd-year medical student on her inpatient Pediatrics clerkship. I was her attending physician at the time. Shortly thereafter, and knowing I had an interest in mobile technology, she gave me a demo of an app that the aforementioned team had put together. The idea and technology were amazing. I thought it was great work, although I really had nothing to add at the time. I looked forward to seeing the results of that research.</div>
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Fast forward to March 2015, and the announcement of <a href="http://www.apple.com/researchkit/">ResearchKit</a>. It was clear that we needed to put this technology to the test, and quickly. We cast a wide net looking for "shovel-ready" projects, and of course, the autism app Kathleen showed me bubbled to the top. The project was already underway (with an iOS app no less!), and had a great team that had already made significant strides in this area. It was an natural fit.</div>
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It was also a remarkable coincidence that at this exact time within <a href="http://www.dihi.org/">the Duke Institute for Health Innovation (DIHI)</a> we had just hired two talented mobile developers, Mike Revoir and Jamie Daniel, who were (are) passionate about mobile technology, health, and research. They were so excited about the project that they were eager to dive in even <i>before</i> their first official day of work! As the scope of the project grew, so did the number of individuals and teams involved. In the end, it was a peerless example of cross-institutional collaboration across Duke University and the Health System. This project <i>couldn't have happened </i>without any of them.</div>
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<h3 style="text-align: left;">
<b>Autism & Beyond</b></h3>
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So what about the actual app? I could explain it in detail here, but seeing is believing, so <a href="https://itunes.apple.com/us/app/autism-beyond/id1025327516?ls=1&mt=8">go download it</a> now! And if you want more info, <a href="https://autismandbeyond.researchkit.duke.edu/">check out the website</a>. Even if you don't meet the eligibility criteria, we've made it simple to get a taste of the cool technology that's gone into it without ever signing up.</div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjFyyfxCfhC2HC7cWUOTPr7cEoByNqeYUb7nL_46x8Vd8KZoPYf1SeeFWjwIjsDo3yls3fqtnKV4nKeZEh7ZA_5vA_ccgQws-8yX8-FfGmM4uuw9dbxPnAIsSrRPiLAR9nYgn5wQPR1Gs0/s1600/1.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjFyyfxCfhC2HC7cWUOTPr7cEoByNqeYUb7nL_46x8Vd8KZoPYf1SeeFWjwIjsDo3yls3fqtnKV4nKeZEh7ZA_5vA_ccgQws-8yX8-FfGmM4uuw9dbxPnAIsSrRPiLAR9nYgn5wQPR1Gs0/s400/1.png" width="225" /></a> <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhEO_0JrrX6JV22fy3X6U889yBZb8rKCgT8PlYr6skAZZL0Dfxf_u5Jv5fTJhVjmVjYGX9dUkyIqWY4pgxcL4iF3f5Mz0QNiv0AlS7HWg7cjmasq-KwdLbDSuKwbZ8QRcc3RI2FYjWYGTI/s1600/4.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhEO_0JrrX6JV22fy3X6U889yBZb8rKCgT8PlYr6skAZZL0Dfxf_u5Jv5fTJhVjmVjYGX9dUkyIqWY4pgxcL4iF3f5Mz0QNiv0AlS7HWg7cjmasq-KwdLbDSuKwbZ8QRcc3RI2FYjWYGTI/s400/4.png" width="223" /></a></div>
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The app basically comes down to our need to know one thing: could we one day use a mobile phone to automate screening for conditions such as autism or anxiety? To start, we first need to know if it's even feasible to analyze facial expressions on such a small device. That's what this study is intended to determine: <b>feasibility</b>.</div>
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As you can see from the screenshot above, the software algorithms developed by Guillermo and his team not only detect facial features, but also expressions, and can do so in real time. The data from this study will help to refine those algorithms.</div>
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In addition to the facial recognition pieces, we've also included several critical questionnaires with the help of Helen and Geri. For example, we ask about temper tantrums and provide feedback to users regarding where their child falls compared to his/her peers.</div>
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Additionally, study participants will be able to see how many other families have enrolled as well as a few additional aggregate data points:</div>
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<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEijy1JNOXkfxDJ4OaQGrEBxbD85pBGFD0RXBuVQzdLCt_2NcMXVcZqVAtOvPsaSOZFS3UBlHxURLnxrnjxu_nt6vJwEZIcoa6xaMv8DGSn2C_Mpzxmine5C93e933HLTV7lk0gnzYKunBE/s1600/2.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEijy1JNOXkfxDJ4OaQGrEBxbD85pBGFD0RXBuVQzdLCt_2NcMXVcZqVAtOvPsaSOZFS3UBlHxURLnxrnjxu_nt6vJwEZIcoa6xaMv8DGSn2C_Mpzxmine5C93e933HLTV7lk0gnzYKunBE/s400/2.png" width="223" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Check out the number of enrolled <br />
participants in near real-time!</td></tr>
</tbody></table>
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While the release of the app marks the end of one chapter (and a whole lotta work by our incredible team!), it's clearly just the beginning. We hope that the app will have an impact in the US, but also plan to roll it out in China and South Africa soon. The more children we can reach, the more we can help. While ResearchKit allows us to reach millions, we still need to take care of one child at a time, and ensure that <i>those children</i> have access to the resources they'll ultimately need for full diagnosis and treatment. That's going to take even more teamwork!</div>
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Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-77276064212814341592015-10-13T16:31:00.001-04:002015-10-13T16:31:28.595-04:00Duke's on FHIR (for real this time)!<div dir="ltr" style="text-align: left;" trbidi="on">
<div dir="ltr" style="text-align: left;" trbidi="on">
<a href="http://www.rickybloomfield.com/2015/06/dukes-on-fhir-but-its-ok.html">In June I described</a> our work to date on integrating the <a href="http://smarthealthit.org/">SMART</a> and <a href="https://www.hl7.org/fhir/">FHIR</a> APIs into our Epic-based EHR.<br />
<br />
As a recap, we started this process in 2014 with a custom Android app that pulled patient problems, medications and demographics directly from the EHR via simple REST-based APIs. As we became more familiar with SMART and FHIR, we realized the value in joining forces with a common standard. It was never our intention to create something that would only be useful to us, and it was clear that the momentum around FHIR was building.<br />
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Fast-forward to January 2015, when we had our first SMART apps running in our proof-of-concept environment. It could be done! We followed this with integration of several additional apps and a demo at HIMSS in Chicago. You've seen this before:<br />
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<iframe allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/fN_z92Twlec" width="560"></iframe></div>
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This was all fine and dandy, but it was still all in our proof-of-concept system with "fake" patient data.<br />
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Since that time our amazing development team, led by Felipe Polo-Wood, has been diligently working to move this infrastructure into our production environment, an important milestone in order to show that SMART and FHIR can do more than just play in the sandbox.<br />
<br />
I'm happy to report that as of August 26, 2015, the infrastructure has been live for some Duke-specific internal use-cases. In fact, Felipe was so excited to share that I had a screenshot waiting in my inbox that morning, demonstrating that the systems were, indeed, calling the FHIR APIs, and that the transition was seamless from the outdated infrastructure FHIR was intended to replace:<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgF1QTKzEJ7qyoENTIue1TkXwncytaXwyXSTf3yWxs0HKriHJN28TwYMwLFjJ9cigvp_MrCX0Y5FNauPM8TZPVcHB7z6D8mZn84QB_X7p9E6tnk-NScQ7OPQWPdO0Ofsh6W2EeRo68K6HQ/s1600/FHIR+Activity.png" imageanchor="1"><img border="0" height="306" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgF1QTKzEJ7qyoENTIue1TkXwncytaXwyXSTf3yWxs0HKriHJN28TwYMwLFjJ9cigvp_MrCX0Y5FNauPM8TZPVcHB7z6D8mZn84QB_X7p9E6tnk-NScQ7OPQWPdO0Ofsh6W2EeRo68K6HQ/s400/FHIR+Activity.png" width="400" /></a></div>
<br />
<br />
Duke was officially on FHIR!<br />
<br />
But not ones to rest on their laurels, the team immediately got to work to enable a more visible example of what FHIR can do: a true SMART-compatible app, <a href="http://smarthealthit.org/smart-app-gallery/pediatric-growth-chart/">Pediatric Growth Chart</a>.<br />
<br />
<b>Drumroll ...</b><br />
<br />
On October 9, 2015 I successfully logged into our production system for the first time to view <i>real patient data</i> in a FHIR app! I'd love to share screenshots with you, but they contain <i>real patient data</i>, so I can't! Let me say that again: <i>real patient data</i>, via FHIR, within Maestro Care, our Epic-based EHR.<br />
<br />
And, of course, the best is yet to come!<br />
<br />
Kudos to Felipe and the rest of the incredible CATS development team for making this happen. It has truly been a team effort, and I know they share the same enthusiasm for this project as I do, because they're always smiling!<br />
<br />
The incredible CATS team:<br />
<ul style="text-align: left;">
<li>Felipe Polo-Wood (<b><i>Señor</i></b> Manager)</li>
<li>Vince Guaglione</li>
<li>Lusia Li</li>
<li>Luiz Omori</li>
<li>Carrie Porterfield</li>
</ul>
</div>
Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-90698875891745188122015-07-08T15:45:00.000-04:002015-07-09T09:49:01.061-04:00White House Champions of Change in Precision Medicine: Duke's Commitment<div dir="ltr" style="text-align: left;" trbidi="on">
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<span id="goog_1444202121"></span><span id="goog_1444202122"></span>Today I had an opportunity today to attend <a href="https://www.whitehouse.gov/the-press-office/2015/07/08/fact-sheet-new-patient-focused-commitments-advance-president%E2%80%99s-precision">a White House event</a> highlighting work in the field of precision medicine. I was joined by my colleague Geoff Ginsburg who directs the <a href="http://dukepersonalizedmedicine.org/">Duke Center for Personalized and Precision Medicine</a> (video replay <a href="https://www.whitehouse.gov/live/white-house-champions-change-%E2%80%93-precision-medicine">here</a>, with Geoff's comments at 2:08:30). As part of the event, Duke was highlighted for our commitment to precision medicine. This was for two reasons:<br />
<br />
<ul style="text-align: left;">
<li>The innovative <a href="http://dukepersonalizedmedicine.org/disease-risk-and-diagnosis/risk-assessments/family-history/metree">MeTree platform</a> created by Geoff, Lori Orlando and the rest of the MeTree team. This platform provides a way for patients to work together with their doctors to improve the recording of their detailed family health history - information that is critical to the success of precision medicine.</li>
<li>The fact that the MeTree platform will be integrated into our Epic-based EHR using <a href="http://smarthealthit.org/">SMART on FHIR</a>. Duke is an "Implementer" of the <a href="https://hl7-fhir.github.io/argonauts.html">Argonaut Project</a>, and <a href="http://www.rickybloomfield.com/2015/06/dukes-on-fhir-but-its-ok.html">was the first health system</a> with an Epic-based EHR to run unmodified SMART apps directly (see our <a href="http://www.youtube.com/watch?v=fN_z92Twlec">HIMSS demonstration video</a> here).</li>
</ul>
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<br />
As I've said elsewhere, we're on the verge of a renaissance in healthcare technology modularity and interoperability, led by open and familiar standards. The same principles that have led to the successful mobile app ecosystem are being applied to healthcare, with the result that many more innovators will have access to tools that allow them to build EHR-compatible apps. The problems in healthcare are enormous, and the more brilliant minds we have focused on these problems, the more likely it is that we'll find compelling solutions, and soon.</div>
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<br /></div>
<div>
Geoff shared a few comments with the group at the event today, which I've shared here with his permission:</div>
</div>
<blockquote>
Good afternoon. My name is Geoff Ginsburg and I direct the Duke University Center for Applied Genomics and Precision Medicine. </blockquote>
<blockquote>
It is an honor for our work to be recognized at this Champions for Change for Precision Medicine event. I want to acknowledge up front the support of the Duke Health System, of my colleague Ricky Bloomfield (Director of Mobile Technology Strategy and hospitalist at Duke) who is in the audience and of Lori Orlando (a health services researcher and internist at Duke) who could not be here today but who has been key to the development of this idea and making it real. </blockquote>
<blockquote>
Today we are announcing the development of a platform that will make it easier for the patient to provide information about their family history to their provider and for providers to access family history and risk information to better care for their patients<br />
-- information that is critical to precision medicine. </blockquote>
<blockquote>
Several years ago we recognized that family history is fundamental to optimizing effective clinical approaches to personalized and precision medicine. However, our research showed that seldom, if at all, was a patient’s family history captured and adequately documented by providers. Furthermore, when histories were taken, there were challenges in interpreting the risk information in a multigenerational family history.<br />
<br />
How many of you in the audience have had a truly detailed family history taken by your doctor and learned something from the results?<br />
<br />
To address this challenge we created a patient facing, web-based, evidence based software platform to capture family health history – called MeTree. Patients talk to their families and loved ones about what illnesses family members have had and their age of onset and enter the information via the web into our software platform. The information is used to calculate risks for developing disease and the results are reported back both to the provider and to the patient creating an effective provider-patient interaction about their hereditary health risks and what to do about them. </blockquote>
<blockquote>
Two years ago we were fortunate to be funded by National Human Genome Research Institute to expand the reach of this platform to five different health systems across the country representing a variety of care environments and demographic groups. </blockquote>
<blockquote>
Now thousands of patients are learning about their family history of disease and using that information with their providers to get appropriate screening, genetic counseling and testing and taking actions to enhance disease prevention. </blockquote>
<blockquote>
Duke is pioneering the use of open, vendor-neutral standards espoused by the Argonaut Project. These standards will be in place by year’s end to enable this platform to be integrated into multiple patient portals and EHRs, which will allow will near universal accessibility of family history information to patients and providers seamlessly -- improving shared decision making related to prevention of inherited disease. </blockquote>
<div>
With commitment comes responsibility. We will now get to work to honor this commitment to the President and to our patients. It is our hope that this work will help facilitate many more innovations from health systems and technology companies in the future so that we can realize our shared goal of higher quality and more cost-effective healthcare in our country.</div>
</div>Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-34888786586578950742015-06-24T21:41:00.001-04:002015-06-24T21:42:13.573-04:00Duke's on FHIR (but it's ok)!<div dir="ltr" style="text-align: left;" trbidi="on">
Current EHRs are among the most complex pieces of software
ever written. They serve a critical role to help standardize clinical workflow,
facilitate billing, and integrate simplistic forms of clinical decision
support, yet tremendous effort is required to customize EHRs to meet
the needs of diverse hospital systems.<br />
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We felt there had to be a better way.<o:p></o:p></div>
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Starting in 2012 we started investigating ways to create a
framework built on top of our Epic-based EHR that would allow us to access the
EHR in a standard way from any device or platform. By the summer of 2013 we had
a functional proof of concept that allowed us to access patient demographics,
problem lists, medications and more from a simple Android app. Duke Apps
Supporting Healthcare, referred to internally as DASH, was born!<o:p></o:p></div>
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Around this same time, we started learning more about a
similar effort underway at Boston Children’s Hospital called <a href="http://smarthealthit.org/">SMART</a> (Substitutable Medical Apps and
Reusable Technologist) that incorporated a new REST-based open API called <a href="http://www.hl7.org/fhir/">FHIR</a> (Fast Healthcare Interoperability
Resources, supported by <a href="http://www.hl7.org/">HL7</a>). Since our goal
was general ease of use and interoperability, it made sense to join this
effort, originally funded by the <a href="http://www.healthit.gov/newsroom/about-onc">ONC</a> via the SHARP program.
There were already several proof-of-concept apps written to be SMART on FHIR compliant, so from a practical standpoint, this made sense.<br />
<br />
We updated our code to be compliant with both SMART and FHIR and as of January 2015 we became the first Epic-based hospital system to run unmodified SMART apps within our EHR (in our proof of concept environment).</div>
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We were thrilled to present this work at the HIMSS 2015 national conference, and you can view a sample the demonstration here (UI bits blurred at Epic's request):<br />
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<iframe allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/fN_z92Twlec" width="560"></iframe></div>
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In order to have a compelling demo, we wanted to show several types of apps running in multiple environments. We chose:<br />
<br />
<ul style="text-align: left;">
<li><a href="https://gallery.smarthealthit.org/apps/3">Growth Chart</a>, an open-source pediatric growth chart app with an award-winning interface</li>
<li><a href="https://gallery.smarthealthit.org/apps/7">Meducation RS</a>, a closed-source app by <a href="http://www.pgsi.com/">Polyglot</a> that presents a patient's medication list in simple language translated into 21 languages</li>
<li><a href="https://gallery.smarthealthit.org/apps/14">Duke PillBox</a>, a skill-based interactive learning tool to help patients teach themselves how to take their medications as part of the discharge process. This was developed by <a href="http://www.medapptech.com/">MedAppTech</a> for a Duke research initiative.</li>
</ul>
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<br /></div>
<div>
We demonstrated each of these apps running in both the Epic desktop environment as well as the Epic mobile apps for iOS. Once the infrastructure was in place, it took <i>less than 5 minutes</i> to add these SMART apps to our mobile EHR. Playing with FHIR has never been so fun (or easy)!</div>
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<br /></div>
<div>
Finally, we also demonstrated a native iOS app, <a href="https://gallery.smarthealthit.org/apps/19">Pediatric Growth Charts</a>, that we launched with the patient context from the Epic iOS app.</div>
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<br /></div>
<div>
So, we demonstrated an open source app, a closed source app, and an internally-developed app all functional within desktop and mobile EHR environments, plus a native iOS app to boot. And we're just getting warmed up!</div>
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Probably the most frequent question I get is: <i>How did you do it?</i></div>
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Answer: <i>Very carefully.</i></div>
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<br /></div>
<div>
Ok, so the real answer is that this was a development effort in the truest sense of the phrase. Prior to our switch to Epic, Duke had a home-growth EHR, which means we have some seriously talented developers here who know how to write production-grade EHR code. In this case, we were able to use many of the web services already provided by Epic and simply add a FHIR wrapper. Some data elements required a bit more work. To tie it all together, we wrote a rate-limiting and authorization server in <a href="http://node.js/">Node.js</a> and installed <a href="https://github.com/mitreid-connect/">MITREid Connect</a> to handle authentication.</div>
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<div>
Is this the path we'd recommend for everyone? No, probably not. Fortunately, most hospital systems won't have to write their own SMART on FHIR implementations. Through the <a href="https://hl7-fhir.github.io/argonauts.html">Argonaut Project</a>, many major EHR vendors and academic medical centers have committed to FHIR as well as the OAuth profiles needed to make it all work. This includes Epic. So hang tight, and your EHR vendor of choice will likely soon provide you the tools you need to kindle the flame.</div>
<div>
<br /></div>
<div>
Duke is involved in Argonaut as an "Implementer," which means we have real-world experience implementing apps that use the standard, and have provided feedback to improve both SMART and FHIR.</div>
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<br /></div>
<div>
As I've said before, there probably hasn't been a more exciting time to work in healthcare technology. Between novel patient engagement tools such as <a href="http://www.rickybloomfield.com/2014/09/apple-healthkit-flexible-platform-for.html">HealthKit</a> and Google Fit, cutting-edge research platforms such as <a href="http://www.rickybloomfield.com/2015/04/researchkit-is-upon-us.html">ResearchKit</a>, and now truly modern APIs that will usher in a new generation of substitutable EHR apps, there's plenty to keep us busy, and most importantly, to help patients take better care of themselves and providers take better care of patients.</div>
<div>
<br /></div>
<div>
And the best part? Things are just starting to heat up ...</div>
</div>
Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com2tag:blogger.com,1999:blog-3315547413547199810.post-38270164559703627932015-05-25T23:06:00.000-04:002015-05-26T08:11:14.236-04:00The Apple Watch: Counting Calories Counts<div dir="ltr" style="text-align: left;" trbidi="on">
I've now spent a few weeks with Apple Watch, and while there's a lot to talk about, one feature in particular has "<a href="http://www.entertainment.com/cms/customer-retention/why-surprise-and-delight-marketing-really-works/">surprised and delighted</a>" me, and it's not the one I was expecting.<br />
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I exercise regularly, but I wasn't expecting Apple Watch to help me much with respect to my routine. That's not because I didn't think it would be accurate or easy to use, but simply because Apple Watch wasn't made for me: I'm a swimmer.<br />
<br />
Granted, it's been shown that Apple Watch <a href="http://www.dcrainmaker.com/2015/05/apple-watch-waterproofing.html">can withstand a good swim</a>, but it's still not designed to track swimming (I use my <a href="http://www.swim.com/workout/148639">Pebble with the swim.com app for that</a>), and Apple specifically discourages it.<br />
<br />
So rather than lament Apple Watch's neglect of swimmers the world over, I went for a walk. A few of them, actually (dog needs exercise, too). And what I saw surprised me. Check out the following two workouts that Apple Watch saved to the Health app. Notice anything interesting?<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEga_h4WTudOqaLjtDpvthyiwd4oWViLf3uk_aoosqUGcN04sywEWKuTooPkdODsHzyk_VNLylNQ6zyaaHsDPR-3Co5KAjJcJK5rq9VQ7W5MkxuaFUl0XdM4fOBDqo9BD-uVrHeY9WNL8Cc/s1600/IMG_3124.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEga_h4WTudOqaLjtDpvthyiwd4oWViLf3uk_aoosqUGcN04sywEWKuTooPkdODsHzyk_VNLylNQ6zyaaHsDPR-3Co5KAjJcJK5rq9VQ7W5MkxuaFUl0XdM4fOBDqo9BD-uVrHeY9WNL8Cc/s400/IMG_3124.jpg" width="225" /></a><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhF0l7wlWEcqaLCCKWCaf6dF8eyZIjF_maMIbkkg3Hve41o11jECOtC9uhlGO3JQIa6eTyg_AeXSqeth6cpL2C59pVlYGE5KABTHdPS_MIupvOOpZIvQkBVtFuHrbmPtCkeb3GisjdYk30/s1600/IMG_3125.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhF0l7wlWEcqaLCCKWCaf6dF8eyZIjF_maMIbkkg3Hve41o11jECOtC9uhlGO3JQIa6eTyg_AeXSqeth6cpL2C59pVlYGE5KABTHdPS_MIupvOOpZIvQkBVtFuHrbmPtCkeb3GisjdYk30/s400/IMG_3125.jpg" width="225" /></a></div>
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I did a double-take when I saw these results, but then it dawned on me what was going on, and it's super cool. If you noticed, the first workout was a 0.93 mile walk that lasted 17 minutes, during which I burned 66 calories. The second workout was only 0.91 miles, lasted only 14 minutes, yet <i>I burned 72 calories</i>!</div>
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So how could a shorter walk (both in distance and duration) lead to more calories burned? While you mull that over, take a few minutes to head over to <a href="http://abcnews.go.com/Technology/inside-apples-top-secret-health-fitness-lab-apple/story?id=29765653">ABC News to view a 5-minute video about Apple's secret fitness lab</a>. I'll wait.</div>
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Wasn't that cool? Apple is amassing what is probably the world's largest and most complete set of physiologic data during exercise (over 18,000 hours and counting), all while volunteers wear Apple Watch. This testing takes multiple factors into account, including activity level (accelerometer), heart rate, temperature, and probably also factors in height and weight when available, although I don't have access to their algorithms to know for sure. The volunteers in the fitness lab also wear specialized (and very expensive) gear designed to accurately measure caloric expenditure. These data can then be used to create accurate data models to fit almost every profile, leading to an extremely accurate estimate of calories burned.</div>
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In other words, Apple is <i>validating the watch</i> to be the most accurate consumer-oriented calorie-counting machine ever created.</div>
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Of course, this explains the "discrepancy" in my workout numbers. In the second workout, I had to walk much quicker in order to cover 0.91 miles three minutes faster than the 0.93 miles I walked the day before. Apple Watch <i>knew</i> I was working harder because it was tracking my heart rate every 5 seconds for the duration of the workout, and my heart rate reflected the increased activity.</div>
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Lesson: to burn calories, nothing can replace good old-fashioned, heart-pumpin' aerobic exercise!</div>
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Want to know the coolest part? Measuring heart rate is just the beginning! As <a href="http://www.rickybloomfield.com/2014/09/watch-relevant-to-healthcare.html">I've mentioned before</a>, now that we have a computer in constant contact with our skin, the market for transcutaneous sensors is going to explode, and the more data we collect, the more accurate these measurements will be.</div>
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Just hurry it up with the swim tracking, ok, Apple?</div>
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Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-18095526288598239852015-04-14T13:02:00.004-04:002015-05-25T23:07:04.814-04:00ResearchKit is upon us!<div dir="ltr" style="text-align: left;" trbidi="on">
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Today, Apple has <a href="http://www.apple.com/pr/library/2015/04/14Apple-Announces-ResearchKit-Available-Today-to-Medical-Researchers.html">unveiled the open source code to their ResearchKit framework</a>. You can find it here:<br />
<br />
http://researchkit.github.io/<br />
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I was pleased to see the code hosted on <a href="https://github.com/">GitHub</a>, which I've found to be exceedingly user-friendly and which we already use here at <a href="https://github.com/dukemedicine">Duke Medicine</a>.<br />
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Also, not only has Apple released the code for ResearchKit itself, but they've also released the code for <a href="http://researchkit.github.io/">all 5 of the ResearchKit apps</a> developed to date, as well as <a href="https://github.com/researchkit/AppCore">the back end code</a> used for those apps, called <a href="https://github.com/researchkit/AppCore">AppCore</a>. That's the power of open source, folks!<br />
<br />
We've been discussing ResearchKit internally since it was announced in March. Anyone waiting for the code to be released before starting on their ResearchKit apps is already behind. Why? I'd estimate that over 90% of the effort required to create a ResearchKit app comes before a single line of code is written. The code itself is simple and straightforward, making it easy to create a <a href="http://researchkit.github.io/docs/docs/InformedConsent/InformedConsent.html">consent workflow</a> and make use of <a href="http://researchkit.github.io/docs/docs/ActiveTasks/ActiveTasks.html">active tasks</a>.<br />
<br />
But the real work comes in designing the study itself. What do you want to study? Why? What is your target population? Who gets access to the data? How many versions of the consent do you need? Do you want it localized? US? International? Has it been approved by the IRB? The list goes on.<br />
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In my opinion, this is the future of research for a certain category of studies that require access to large numbers of individuals for more refined data, or that need access to a very specific and hard-to-reach patient population, such as one with a rare disease.<br />
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I've already spent too long on this blog post. Our developers are jumping into the framework as we speak, ready to begin our study implementation. Time to dig in!</div>
Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-59130935941102055222015-03-21T23:33:00.001-04:002015-03-24T07:52:39.021-04:00Meaningful Use of Patient-Generated Health Data<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgAjTDfj_wBaPtnzrrtQjiKgQNsIZJpCeRymf2qWcCfAg1_PZi4leV4gw6dDyzjaf-U1hpXSghnlIRNDGukhAFLQS0_E7YFxMC5j2NuTbB3eG_rpnb040EOoRxEYvJn_VdCD8qA8BDS8tY/s1600/cms-log-blue.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgAjTDfj_wBaPtnzrrtQjiKgQNsIZJpCeRymf2qWcCfAg1_PZi4leV4gw6dDyzjaf-U1hpXSghnlIRNDGukhAFLQS0_E7YFxMC5j2NuTbB3eG_rpnb040EOoRxEYvJn_VdCD8qA8BDS8tY/s1600/cms-log-blue.jpg" height="147" width="400" /></a></div>
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<span style="font-family: inherit;">This week the NPRM for Meaningful Use 3 <a href="https://www.federalregister.gov/articles/2015/03/30/2015-06685/medicare-and-medicaid-programs-electronic-health-record-incentive-program-stage-3">was made available</a> in "unpublished" form on the Federal Register site. It seems that one of of the primary aims for MU 3 is to streamline the set of objectives applicable to eligible providers (EPs), eligible hospitals (EHs) and critical access hospitals (CAHs).</span><br />
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<span style="font-family: inherit;">The new item most interesting to me is <b>Objective 6: Coordination of Care through Patient Engagement </b>(starts on page 103 of the linked document).</span><br />
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<span style="font-family: inherit;">This proposed objective aims to "Use communications functions of certified EHR technology to
engage with patients or their authorized representatives about the patient's care" and employs three measures:</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;"><b>Measure 1:</b> >25% of all unique patients "actively engage with the electronic
health record made accessible by the provider" either by 1) viewing, downloading or transmitting to a third party their health information; or 2) "access[ing] their
health information through the use of an ONC-certified API that can be used by
third-party applications or devices."</span><br />
<span style="font-family: inherit;"><br />
I've previously discussed <a href="http://www.rickybloomfield.com/2015/02/the-argonaut-project-kickoff.html">the Argonaut Project Implementation Program</a> and its relation to the <a href="http://www.smartplatforms.org/">SMART on FHIR</a> project. The FHIR APIs and added functionality of the SMART project (OAuth, OpenID) will dramatically lower the barrier for third-parties to easily add functionality and significant value to current EHRs. While these APIs are already enjoying broad support even before they are complete, seeing this emphasized in the MU 3 NPRM is a testament to their importance.</span><br />
<span style="font-family: inherit;"><br />
<b>Measure 2</b>: For >35% of all unique patients, a secure message should be sent using electronic messaging function of CEHRT to the patient, or in response to a secure message sent by the patient.</span><br />
<span style="font-family: inherit;"><br />
It's critically important that we encourage direct engagement and interaction between patients and providers, and this measure intends to do just that.</span><br />
<span style="font-family: inherit;"><br />
<b>Measure 3</b>: "Patient-generated health data or data from a non-clinical
setting is incorporated into the certified EHR technology for more than 15 percent of all
unique patients."</span><br />
<span style="font-family: inherit;"><br />
This is exciting. While patient-generated data can come in many forms, including manual entry by patients, this measure will only be achievable if we employ technologies that reduce or remove such barriers. <a href="http://www.rickybloomfield.com/2014/09/apple-healthkit-flexible-platform-for.html">Apple's HealthKit</a> is by far the easiest-to-deploy tool to facilitate this data handoff currently, and it's available right now. We're hopeful an Android-equivalent will be available soon for patients with those devices (Google Fit doesn't yet ... <i>fit</i> that purpose).</span><br />
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Neither SMART on FHIR nor HealthKit are yet widely deployed or adopted, but these technologies will undoubtedly be critical to ushering in the learning health system, and it's great to see APIs and patient-generated data being emphasized in the latest NPRM.</span><br />
<span style="font-family: inherit;"><br />
MU 3, welcome to the 21st century!</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">2015-03-24 UPDATE: Just to make sure this is clear, MU 3 is still draft at this stage, and the content is subject to change. Also, attestation for objective 6 will require meeting only 2 of 3 of the measures listed above.</span></div>
Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-60162506970952317312015-03-09T16:27:00.003-04:002015-03-09T16:27:48.699-04:00ResearchKit - More Details<div dir="ltr" style="text-align: left;" trbidi="on">
ResearchKit is exciting, as I've <a href="http://www.rickybloomfield.com/2015/03/researchkit-and-future-of-healthcare.html">already noted</a>. Apple has posted some additional information in the form of a <a href="https://developer.apple.com/researchkit/researchkit-technical-overview.pdf">Technical Overview document</a>. This document publicly sheds a little more light on what ResearchKit will enable.<br />
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Apple describes three "modules" available within ResearchKit, including <b>Surveys</b>, <b>Informed Consent</b> and <b>Active Tasks</b>.<br />
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<b>Surveys</b><br />
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ResearchKit provides a standardized interface to quickly build surveys. These modules are already localized. This would work for the majority of current research use cases.<br />
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<b>Informed Consent</b><br />
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One of the most significant inclusions is native informed consent capability, as you may have seen in the keynote:<br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjm9Qd0fgOCxy7d3eQJ0uq-OPGsYbi1oAvt-_8wC_pfYV58tg2SI8dITkSst66D_GC521blXK5oNoL1U7exarIOomKRkWVQN67hfpRAkGcY0NGte38NEG46gcocDW6Rgy0un2DtRvg-uyI/s1600/Screen+Shot+2015-03-09+at+4.07.35+PM.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjm9Qd0fgOCxy7d3eQJ0uq-OPGsYbi1oAvt-_8wC_pfYV58tg2SI8dITkSst66D_GC521blXK5oNoL1U7exarIOomKRkWVQN67hfpRAkGcY0NGte38NEG46gcocDW6Rgy0un2DtRvg-uyI/s1600/Screen+Shot+2015-03-09+at+4.07.35+PM.png" height="640" width="320" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Credit: Apple</td></tr>
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This is something many researchers have been scrambling to buy, create or produce since it's not currently a common feature of modern EHRs. The fact that this is now available out of the box and in open source form is compelling. The informed consent mechanism is flexible and takes into account the use of waivers, use of institution-specific ethics language, and also provides the ability to insert comprehension tests ensure the patient has capacity to sign. The consent framework then generates a PDF for upload or email.<div>
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<b>Active Tasks</b></div>
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As demonstrated in the video today during the keynote, ResearchKit provides the ability to capture patient interactions which Apple calls "Active Tasks." The Active Task modules currently available in ResearchKit include:</div>
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<ul style="text-align: left;">
<li>Motor Activities</li>
<ul>
<li>Gait, tapping</li>
</ul>
<li>Fitness</li>
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<li>6-minute walk</li>
</ul>
<li>Cognition</li>
<ul>
<li>Spatial memory</li>
</ul>
<li>Voice</li>
<ul>
<li>Phonation</li>
</ul>
</ul>
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All of these are accomplished using hardware built-in to the phone itself.</div>
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<b>Open Source</b></div>
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Probably the most significant innovation here, however, is the fact that this is all (or will be soon) open source. For this to succeed and expand, it's vitally important that academic medical centers keep this in mind when developing their apps, and that they choose to share the source of their own apps so other researchers can build on their foundation. This collaboration will be the key to accelerating the transition to a Learning Health System.</div>
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Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-32947264159237743792015-03-09T13:47:00.005-04:002015-03-09T13:47:39.698-04:00ResearchKit and the Future of Healthcare<div dir="ltr" style="text-align: left;" trbidi="on">
Apple landed a pretty big bombshell today with the announcement of ResearchKit. And probably the biggest part of the announcement was this:<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh3Hr6lLHt7p1P8DfogAsn5rqqd-2nuNCemY1meaHAK8u8MrTqmMcdJTRx2obkbo7Zg3F6vdaJJ7vN3MfputumfVr8oRb_eD2k6GFJIqwEZB-_VTx3qYVrpl4V_N4vcINP8hLSmFTmPjy8/s1600/Open+Source.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh3Hr6lLHt7p1P8DfogAsn5rqqd-2nuNCemY1meaHAK8u8MrTqmMcdJTRx2obkbo7Zg3F6vdaJJ7vN3MfputumfVr8oRb_eD2k6GFJIqwEZB-_VTx3qYVrpl4V_N4vcINP8hLSmFTmPjy8/s1600/Open+Source.png" height="276" width="400" /></a></div>
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Yes, ResearchKit is fully open source. Why is that important? Because it means that this technology will eventually be available on any platform. Yup, including Android. And Windows. And whatever else comes in the future.</div>
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And it also means that integration between ResearchKit and other emerging healthcare technologies will be possible, including the SMART on FHIR platform, which is leading the way to modernize healthcare interoperability.</div>
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Given Apple's <a href="https://www.apple.com/privacy/">commitment to privacy</a>, I have no doubt that the healthcare industry will quickly adopt this new platform, as evidenced by the high-quality institutions already participating.</div>
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As I've mentioned previously, the <a href="http://www.rickybloomfield.com/2015/02/the-death-of-meaningful-use-oncs.html">Learning Health System</a> represents the vision of a world in which we are constantly learning from a stream of high-quality data, using that data to quickly make even better decisions, even at the point of care. ResearchKit will help us reach that goal even more quickly, possibly even before the 10-year goal as set forth by the ONC.</div>
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Let's get started!</div>
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Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-85260954469541661652015-03-09T12:50:00.000-04:002015-03-09T12:50:02.573-04:00The Why of Wearables<div dir="ltr" style="text-align: left;" trbidi="on">
Ten years from now, 2015 may well go down as the Year of the Wearable. Activity trackers are <a href="http://jama.jamanetwork.com/article.aspx?articleid=2108876">plentiful and accurate</a> (including those built-in to your phone), Android Wear devices are now becoming <a href="http://consumer.huawei.com/minisite/worldwide/huawei-watch/">more refined</a>, the Pebble will see its <a href="https://www.kickstarter.com/projects/597507018/pebble-time-awesome-smartwatch-no-compromises">first substantial upgrade</a> (including 10-day battery life), and, of course, the Watch will launch next month after additional details are revealed later today.<br />
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So why have these technologies recently become interesting and relevant? Did some Silicon Valley innovator simply decide that we needed more technology on our wrists (and *POOF*! VC funding suddenly made it happen)?<br />
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Of course not. The truth is actually far more interesting, and, when properly understood, is the lens through which we can peer into the future.<br />
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Time for a history lesson ...<br />
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My grandfather worked on the UNIVAC computer during his time in the Army at Ft. Meade, MD in the 1950s. It was large (and the battery life was <i>really</i> bad...). This is an example of a UNIVAC system that was used by the Navy:<br />
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiccz7jx4f-5L8mfQlu-z0pdMvieWjqJ53j81CzMZo3WiDAMYxEEm5tFJRxlyCWTPquOaYfRjl2Izrt07wZKO5MtZErgDIhpDyHpfhVgydUvOFfynWawRGiM-p2D_X49pZOaskHhOxPP-o/s1600/Univac-I-Navy-Electronics-Supply-Office-BRL61-0992.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiccz7jx4f-5L8mfQlu-z0pdMvieWjqJ53j81CzMZo3WiDAMYxEEm5tFJRxlyCWTPquOaYfRjl2Izrt07wZKO5MtZErgDIhpDyHpfhVgydUvOFfynWawRGiM-p2D_X49pZOaskHhOxPP-o/s1600/Univac-I-Navy-Electronics-Supply-Office-BRL61-0992.jpg" height="310" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Credit: <a href="http://commons.wikimedia.org/wiki/File:Univac-I-Navy-Electronics-Supply-Office-BRL61-0992.jpg">Wikipedia</a></td></tr>
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At this nascent point in computing history, could anyone have envisioned a device that's orders of magnitude more powerful, yet small enough to fit on your wrist? <a href="http://www.listsofnote.com/2011/12/heinleins-predictions.html">Perhaps (see #11)</a>. But truth is stranger than (science) fiction, and the reality is that in the realm of personal computing we've easily surpassed even the most fantastic futuristic visions of the 1950s.<div>
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The invention and subsequent miniaturization of the transistor have accounted for this success, which has followed a trajectory known as <a href="http://en.wikipedia.org/wiki/Moore%27s_law">Moore's Law</a>, which I won't rehash here. Some have warned that Moore's Law <a href="http://www.wired.com/2014/06/supercomputer_race/">is coming to an end</a>, <i>at least via silicon</i>. I wouldn't be so quick to throw in the towel. The progress is staggering (note a version of the UNIVAC at the bottom):</div>
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<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhCkGbex9VaGkh9el_7E6su6UbWwnRM98tWAjtJjd9O3mrxFT1PHq4nRfzl5685KLiR6VbJL-A35zuNMbIcjPA8KJJ_286V_ntJxDvWDSAQbAaBN4nKGLgPKhZbpQX230bD1pMWrTNEDnQ/s1600/supercomputer_performance.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhCkGbex9VaGkh9el_7E6su6UbWwnRM98tWAjtJjd9O3mrxFT1PHq4nRfzl5685KLiR6VbJL-A35zuNMbIcjPA8KJJ_286V_ntJxDvWDSAQbAaBN4nKGLgPKhZbpQX230bD1pMWrTNEDnQ/s1600/supercomputer_performance.jpg" height="377" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Credit: AMD via <a href="http://www.technologyreview.com/view/427891/moores-law-over-supercomputing-in-triage-says-expert/">Technology Review</a></td></tr>
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<div>
This dramatic miniaturization allowed my family to purchase its first desktop computer in the early 1990s - a Packard Bell with a 66MHz AMD chip inside. I have such fond memories playing <a href="http://en.wikipedia.org/wiki/Myst">Myst</a> with my dad. I had a desktop in college as well (this time a Dell with a <a href="http://www.intel.com/design/pentiumii/prodbref/">450MHz Pentium II</a>), and it wasn't until I started medical school in 2004 that I owned my first laptop, a sturdy <a href="http://en.wikipedia.org/wiki/ThinkPad">IBM Thinkpad</a>.</div>
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This miniaturization continued and I bought my first iPod touch in 2009 to use as a test device while I was teaching myself to write iOS apps in residency. This was followed by an iPad in 2010 (the day they were released, although I should note that the iPad was most certainly not the first tablet computer on the market), and then pretty much every iPhone since then (I now use an iPhone 6 Plus - the first iPhone that actually fits my hands). My first "smart watch" came in the form of the Pebble in 2013, and I've since used a plethora of other gizmos and gadgets that would fall in the "wearables" category.</div>
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Notice a trend here?</div>
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Computers have continued to progress towards smaller and faster devices, and as they've done so, new applications for that technology have inevitably been the result. "Wearables" are simply the next step in that logical progression.</div>
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEios_S__Wx1wqBx7Tv0q9k8o0IEtjSWLXugphQ45VBeVyrI64haGePW3MmtCiFzZgFxUKDR_woCJYdqbpZBH982HFfWJcdPhkQH3hbn1dQAQILE-AWA6YUGZC89JBfA2GscirkNtZxFYKc/s1600/1-21356099+Small.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEios_S__Wx1wqBx7Tv0q9k8o0IEtjSWLXugphQ45VBeVyrI64haGePW3MmtCiFzZgFxUKDR_woCJYdqbpZBH982HFfWJcdPhkQH3hbn1dQAQILE-AWA6YUGZC89JBfA2GscirkNtZxFYKc/s1600/1-21356099+Small.png" height="193" width="640" /></a></div>
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So don't be surprised as these devices start to pop up in ever smaller and more discrete places, such as the buttons on your shirt, woven into your socks (you gotta know how much your feet are sweating!), mixed with your food, in your medicine ...</div>
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If we've learned anything from the past, it's that this progression is inevitable, and that it will <i>only exceed our expectations and our wildest futurist fantasies</i>.</div>
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With respect to his latest creation, Jony Ive <a href="http://preview.howtospendit.ft.com/technology/77791-the-man-behind-the-apple-watch">seems to agree</a>: "It’s technology worn on the wrist. I sensed there was an inevitability to it."</div>
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Despite this predicable inevitability, the future will still hold plenty of surprises. And I suppose that's the best prediction of them all.</div>
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Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com1tag:blogger.com,1999:blog-3315547413547199810.post-37418256617981908602015-02-25T12:47:00.000-05:002015-02-25T12:47:03.842-05:00The Argonaut Project Kickoff<div dir="ltr" style="text-align: left;" trbidi="on">
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj7fm5LthsS_ZJ02Hy6-ojUdy_eXiJnVYoiEQg-LIM3t86CvNLNaxEA2LNCsb56nqA3ZvznMiA_3rkav_13TdSVkwFAQkEYUgSYQK4ZZLVeKH8JNq0ehu020Hg0G9PCED3WY-vxHFhqhVE/s1600/Jason_Pelias_Louvre_K127.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj7fm5LthsS_ZJ02Hy6-ojUdy_eXiJnVYoiEQg-LIM3t86CvNLNaxEA2LNCsb56nqA3ZvznMiA_3rkav_13TdSVkwFAQkEYUgSYQK4ZZLVeKH8JNq0ehu020Hg0G9PCED3WY-vxHFhqhVE/s1600/Jason_Pelias_Louvre_K127.jpg" height="320" width="230" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Jason returning with the Golden Fleece</td></tr>
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I just got off a kickoff call for the Argonaut Project Implementation Program.<br />
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This is, simply stated (and to paraphrase <a href="http://geekdoctor.blogspot.com/2014/12/the-argonaut-project-charter.html">John Halamka</a> on the call today), the most promising path towards meaningful healthcare interoperability we've ever known. Finally, we have modern protocols such as REST, OAuth and OpenID that are being applied to healthcare in a scalable way.<br />
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The <a href="http://www.smartplatforms.org/">SMART on FHIR</a> platform epitomizes the work done to date in this effort, and the Argonaut Project is intended as a sprint to get the <a href="http://hl7.org/implement/standards/FHIR-Develop/">FHIR DSTU 2</a> deliverables in time for a May ballot. To be clear, this is still an alpha/beta product and not quite ready for public consumption, but the promise is already quite evident.<br />
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When I arrived at Duke in the summer of 2013 (and before the SMART project had been converted to work with FHIR), I had a goal to create a standardized platform for interoperability for web and native mobile apps that would work with our Epic implementation.<br />
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Starting in 2014, while we already had a functional implementation of our own framework, we realized that we shouldn't recreate the wheel, and that the SMART on FHIR project was being developed the accomplish the same goals. With that in mind we realigned our efforts to push forward with integration of the SMART platform into our Epic EHR.<br />
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As of January 2015 we have a functional implementation of the SMART platform here at Duke in our proof-of-concept environment. We currently have an iOS app and a SMART-enabled web app working against this environment with plans for several more current and future app integrations, including apps developed here at Duke.<br />
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We're looking forward to be involved in this Pilot Implementation process (see graphic below) and look forward to sharing more in the coming months, including at HIMSS in April where we will demo these integrations.<br />
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Never before have we had such a golden opportunity for robust healthcare interoperability!<br />
<br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh5lchkrANH08-WZYIcx_nJtNHXKMo5lrE7W63A-fSHSY9oQRcCv6JVCC1StocwSlJrXLX-jipPq8fXtPKlu_dTdXiGmi30vXQ0lFPoktLsIKYVKT7y4TAgQPuokLz9FG1pIQcDXrq6RyM/s1600/Screen+Shot+2015-02-25+at+12.05.45+PM.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh5lchkrANH08-WZYIcx_nJtNHXKMo5lrE7W63A-fSHSY9oQRcCv6JVCC1StocwSlJrXLX-jipPq8fXtPKlu_dTdXiGmi30vXQ0lFPoktLsIKYVKT7y4TAgQPuokLz9FG1pIQcDXrq6RyM/s1600/Screen+Shot+2015-02-25+at+12.05.45+PM.png" height="255" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Anyone can get involved in this open process.</td></tr>
</tbody></table>
<br /></div>
Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-44630113358975861932015-02-12T21:34:00.001-05:002015-02-12T21:36:14.918-05:00FDA Updates & Finalizes Mobile App & Device Guidance<div dir="ltr" style="text-align: left;" trbidi="on">
<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgs9BeHBqJUiT88XyeOb1NKc4S8zdxQGd6dhU5mvTPVxBwLp5kfjDZDmhI9ruZp2O6GCfb9oEa4df8OgigrijIK3U2U0KdJaITLLzA8TaK8bfnkT3wlZpxBHMJAf3SLTjNyF2X4887l_xY/s1600/1000px-Food_and_Drug_Administration_logo.svg.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgs9BeHBqJUiT88XyeOb1NKc4S8zdxQGd6dhU5mvTPVxBwLp5kfjDZDmhI9ruZp2O6GCfb9oEa4df8OgigrijIK3U2U0KdJaITLLzA8TaK8bfnkT3wlZpxBHMJAf3SLTjNyF2X4887l_xY/s1600/1000px-Food_and_Drug_Administration_logo.svg.png" height="171" width="400" /></a></div>
<br />
This week the FDA released the final version of their guidance on <a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM401996.pdf">Medical Device Data Systems</a> (MDDS - original draft was released on June 20, 2014) as well as an update to their guidance on <a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf">Mobile Medical Applications</a> (last updated on September 25, 2013) to make it consistent with the MDDS document.<br />
<br />
I've <a href="http://www.rickybloomfield.com/2014/08/fda-mobile-app-guidance-for-dummies-or.html">shared</a> <a href="http://www.rickybloomfield.com/2014/08/fda-mobile-app-guidance-path-forward.html">my</a> <a href="http://www.rickybloomfield.com/2014/08/fda-further-eases-restrictions-on.html">thoughts</a> on this guidance previously.<br />
<br />
For those who aren't familiar with this guidance, the FDA divides mobile medical applications into three categories, only the first of which will be regulated:<br />
<br />
<b><u>Apps that are medical devices</u></b><br />
<br />
These apps <i>will be regulated</i>, and fall into one of two categories, including those that are either intended:<br />
<ol>
<li>to be used as an accessory to a regulated medical device; or</li>
<li>to transform a mobile platform into a regulated medical device.</li>
</ol>
<div>
The updated Mobile Medical Applications document provides a number of helpful examples of hypothetical apps as well as a list of approved applications that have gone through the 510(k) process. Most of these fall into one of the following categories:</div>
<div>
<ul style="text-align: left;">
<li>Apps that use an integrated or attached sensor to obtain data used in medical decision making</li>
<li>Apps that use the camera to analyze images and present data used in medical decision making</li>
<li>Apps that connect to and alter the behavior of other medical devices (physical connection or remote)</li>
<li>Apps used to calibrate medical devices</li>
</ul>
</div>
<b><u>Apps for which FDA intends to exercise enforcement discretion</u></b><br />
<br />
These are apps that MAY meet the definition of medical device but likely pose lower risk to the public, therefore <i>they will not be regulated unless decides the app poses a significant patient safety risk</i>.<br />
<br />
This is a <i>big deal</i> because all clinical decision support apps will fall into this category. Clinical decision support apps represent one of the most promising categories of medical software, including those that can be integrated into a provider's workflow through integration into the EHR via technologies such as the <a href="http://www.smartplatforms.org/">SMART of FHIR</a> framework.<br />
<br />
The FDA realizes that the volume of these apps will likely exceed their capacity to regulate them, but the bottom line is that purchasers and consumers of these applications need to be ever vigilant that what they are using is safe, and immediately <a href="http://www.fda.gov/Safety/ReportaProblem/">report any concerns to the FDA</a>.<br />
<br />
<u><b>Apps that are not medical devices</b></u><br />
<br />
These are apps the FDA has decided it <i>will not regulate</i>. Types of apps include:<br />
<ul style="text-align: left;">
<li>Apps that provide medical reference material</li>
<li>Apps used as educational tools for medical training</li>
<li>Apps used for patient education</li>
<li>Apps that automate office operations in a health care setting</li>
<li>Apps that are generic aids or general purpose products (e.g., apps that magnify images, record audio, facilitate communication, provide turn-by-turn directions)</li>
</ul>
For further examples of any of these categories of apps, <i>especially if you're planning to develop a medical app</i>, be sure to check out <a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf">the full document</a>.<br />
<br />
Once again I applaud the FDA for helping clear up some of the confusion regarding regulation of mobile medical applications. It will be expected, though, that these guidelines will continue to evolve as technology matures.</div>
Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-53585322128594525162015-02-01T23:03:00.001-05:002015-02-01T23:03:44.487-05:00The Death of Meaningful Use: ONC's Interoperability Roadmap<div dir="ltr" style="text-align: left;" trbidi="on">
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi9J3wCYq5XdNaTFi2aaxo2YpM7h8MdhGvlYX_1TslEB8FZi1QQRCsidqbNOUju2oirMteIKC5-VfOmGuLjIatX2g23VNxdlBiTUb7JoM0ni_Yh0uv2jFObO5duthJVvBcjoPhWH64CC4I/s1600/Health+IT+as+LHS.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi9J3wCYq5XdNaTFi2aaxo2YpM7h8MdhGvlYX_1TslEB8FZi1QQRCsidqbNOUju2oirMteIKC5-VfOmGuLjIatX2g23VNxdlBiTUb7JoM0ni_Yh0uv2jFObO5duthJVvBcjoPhWH64CC4I/s1600/Health+IT+as+LHS.png" height="182" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">ONC's vision of the health IT ecosystem as a Learning Health System</td></tr>
</tbody></table>
<br />
This past week the ONC released it's vision for health IT interoperability in a draft 1.0 document entitled "<a href="http://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version-1.0.pdf">A Shared Nationwide Interoperability Roadmap.</a>" There were a few items that caught my attention in the 166-page document, most notably the following words, nestled deep in the middle of page 50:<br />
<blockquote class="tr_bq">
"This Roadmap shifts the nation’s focus from <b><u>meaningfully using</u></b> specific technologies with specific features to <b><u>working together</u></b> as a nation to achieve the outcomes desired from interoperability and a learning health system."</blockquote>
Granted, this is a draft document, but that sure sounds like an official death knell to meaningful use (MU) as we know it.<br />
<br />
From my perspective, MU has done quite a bit of good to raise awareness of the importance of health IT to help us speak the same language so we can get the right information to the right person at the right time to make the right decision (<a href="http://www.rickybloomfield.com/2015/01/obamas-precision-medicine-initiative.html">sound familiar?</a>).<br />
<br />
However, the accompanying MU certification process has bogged-down health systems and stifled innovation through timed incentives and disincentives that has resulted in hospitals scurrying to claim their entitlements at the expense of thoughtful and measured health IT progress.<br />
<br />
So it's with great excitement that I read the ONC's draft document that focuses this effort on public-private collaboration to start solving the thorniest issues we've faced, including policies and technologies to promote streamlined and robust interoperability.<br />
<br />
The document also touched on a subject near and dear to my heart (p. 10):<br />
<blockquote class="tr_bq">
"Given the increasing volume of mobile technology usage among consumers and across the care delivery system, approaches to enable "send, receive, find and use" in the near-term <i>must support the flow of electronic health information across both institutional and mobile-based technologies.</i> This means traditional approaches to health IT interoperability will need to become more agile and leverage the experience of modular consumer applications, such as those created by Facebook, Amazon and Apple. <i>These secure, but simple architectures have enabled an ecosystem of applications that allow users to engage with electronic health information across a variety of different platforms and devices and open opportunities for entrepreneurial third parties to thrive.</i>"</blockquote>
Through the <a href="http://smartplatforms.org/">SMART on FHIR</a> framework, this will soon be a reality in health care. I'm excited to be leading the initiative at Duke to be the first Epic-based hospital with a functional implementation of SMART.<br />
<br />
Furthermore, the document highlights the importance of facilitating the incorporation of patient-generated health data into our EHRs (p. 46):<br />
<blockquote class="tr_bq">
"There needs to be a greater focus on incorporating patient-generated health data and ensuring the availability of tools for individuals to use this information to manage their health and make more informed health-related decisions."</blockquote>
Our experience with <a href="http://www.rickybloomfield.com/2014/09/apple-healthkit-flexible-platform-for.html">Apple's HealthKit here at Duke</a> has shown us that this idea is a reality, today. It's never been easier to get high-quality patient data integrated directly into our clinical systems so that providers can quickly act to improve patient outcomes.<br />
<br />
This type of technology is the essence of a Learning Health System, which is emphasis of the ONC's draft document. 2015 is going to be an exciting year for healthcare technology and interoperability.<br />
<br />
RIP, Meaningful Use.</div>
Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-50378194591431606742015-01-20T21:57:00.001-05:002015-01-21T09:42:34.618-05:00Obama's Precision Medicine Initiative<div dir="ltr" style="text-align: left;" trbidi="on">
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgnwi61KAYFixns8nnMct_2rXgFGHAuR0MEuNWyJkHBAzcAYndRJCgJrWYiIeTAJjO2qxRQQxfZHa5kEn36j39uY3JJXlwE_xNS5OyirJPK-cSwYQAUW-_Nkmluyl__NFYPCg0kGgDcGRc/s1600/1-USIIGtkypiwhO6W4o8cwIw.jpeg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgnwi61KAYFixns8nnMct_2rXgFGHAuR0MEuNWyJkHBAzcAYndRJCgJrWYiIeTAJjO2qxRQQxfZHa5kEn36j39uY3JJXlwE_xNS5OyirJPK-cSwYQAUW-_Nkmluyl__NFYPCg0kGgDcGRc/s1600/1-USIIGtkypiwhO6W4o8cwIw.jpeg" height="265" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">go.wh.gov/SOTUMedium</td></tr>
</tbody></table>
<br />
Despite the fact that President Obama spent the last week spilling the beans on the content of his State of the Union address, he had one little surprising tidbit for those of us who are passionate about Health IT: a Precision Medicine Initiative! In <a href="https://medium.com/@WhiteHouse/president-obamas-state-of-the-union-address-remarks-as-prepared-for-delivery-55f9825449b2">his own words</a>:<br />
<div>
<blockquote class="tr_bq">
"21st century businesses will rely on American science, technology, research and development. I want the country that eliminated polio and mapped the human genome to lead a new era of medicine — one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable. Tonight, I’m launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes — and to give all of us access to the personalized information we need to keep ourselves and our families healthier."</blockquote>
</div>
<div>
All I can say is, "Amen to that!"</div>
<div>
<br /></div>
<div>
We're currently at a critical juncture of the need for personalized and precision medicine and the availability of technology to support exactly that. Patients can - <i>right now</i> - share their own health information in real time with their physicians via novel technologies such as <a href="http://www.rickybloomfield.com/2014/09/apple-healthkit-flexible-platform-for.html">Apple's HealthKit</a>, which we've implemented here at Duke.</div>
<div>
<br /></div>
<div>
Plus, technologies such as the <a href="http://smartplatforms.org/">SMART Platform</a> (about which I'll have much more to say very soon ...) will enable a new generation of standardized medical apps that can scale to every EHR and every hospital in the country ... and eventually the world.</div>
<div>
<br /></div>
<div>
I couldn't be more excited to be surrounded by such talented and creative folks here at Duke working to make all of these things (and more!) a reality. Apparently for the past year we've been working to make the President's vision a reality ... we just didn't know it!</div>
</div>
Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-65457647523285485942015-01-20T21:37:00.002-05:002015-01-20T21:38:32.303-05:00FDA Draft Guidance for General Wellness Devices<div dir="ltr" style="text-align: left;" trbidi="on">
Today the FDA released <a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429674.pdf">draft guidance</a> on regulation of low-risk "general wellness" devices. Draft guidance is nonbinding and subject to change, but it does provide a window into the FDA's thinking on a topic of increasing relevance. This guidance will be part of a compliance policy of the Center for Devices and Radiological Health (CDRH).<br />
<br />
This draft guidance continues the FDA's recent trend to state explicitly what they <i>will not</i> be regulating. In September 2013 the FDA <a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf">issued final guidance</a> on mobile medical applications where they stated that "The agency intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers. The FDA intend to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended." My thoughts on that report can be found <a href="http://www.rickybloomfield.com/2014/08/fda-mobile-app-guidance-for-dummies-or.html">here</a>.<br />
<br />
Then, in August 2014 the FDA issued a <a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM407292.pdf">draft document</a> detailing their "Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements" - my thoughts are <a href="http://www.rickybloomfield.com/2014/08/fda-further-eases-restrictions-on.html">here</a>.<br />
<br />
So it comes as no surprise that this latest draft proposes that "CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act."<br />
<br />
The document goes on to define "<b>general wellness products</b> as products that:<br />
<ol style="text-align: left;">
<li>are intended for <u>only</u> general wellness use, as defined in this guidance, and</li>
<li>present a very low risk to users' safety."</li>
</ol>
<div>
Examples of device categories covered by this guidance include:</div>
<div>
<ul style="text-align: left;">
<li>weight measurement</li>
<li>physical fitness, including products intended for recreational use</li>
<li>relaxation or stress management</li>
<li>mental acuity</li>
<li>self-esteem (e.g., devices with a cosmetic function that make claims related only to self-esteem)</li>
<li>sleep management</li>
<li>sexual function</li>
</ul>
<div>
However, any devices falling into the above categories that are not low risk would not be covered by this guidance. The risk is determined by whether or not the product:</div>
<div>
<ol style="text-align: left;">
<li>is invasive</li>
<li>involves an intervention or technology that may pose a risk to a user's safety if device controls are not applied, such as risks from lasers, radiation exposure, or implants</li>
<li>raises novel questions of usability</li>
<li>raises questions of biocompatibility</li>
</ol>
<div>
Finally, to be very clear, the document gives several examples of low risk products, such as a mobile app that plays soothing music to manage stress; a mobile app that monitors daily energy expenditure to increase self-awareness to maintain good cardiovascular health; a mobile app that records food consumption help the user manage dietary activity; a device that monitors pulse during exercise or hiking; and a product that mechanically exfoliates the skin (to increase self-esteem).</div>
</div>
</div>
<div>
<br /></div>
<div>
I continue to applaud the FDA for giving clear guidelines for mobile apps and devices to help foster an environment ripe for innovation while keeping patients safe.</div>
</div>
Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0tag:blogger.com,1999:blog-3315547413547199810.post-65283363240460440672014-12-11T15:52:00.000-05:002015-01-20T21:37:57.918-05:00HealthKit: Can you bill for it?<div dir="ltr" style="text-align: left;" trbidi="on">
I had the opportunity to answer questions at the standing-room-only HealthKit 'Open Mic' session at the <a href="http://www.mhealthsummit.org/">mHealth Summit 2014</a> this week in Washington DC (read some of my comments <a href="http://mobihealthnews.com/38891/eight-things-we-learned-about-healthkit-from-duke-oschner/">here</a> and another reaction <a href="https://twitter.com/ashleyrgold/status/543046726278742016">here</a>), and one of the most frequent comments I've received since the session relates to CPT codes used for remote monitoring.<br />
<br />
Apparently, most people don't know about CPT codes 99490, 99090 and 99091. I didn't even know about them until recently.<br />
<br />
But first, a disclaimer: I'm not a coding expert, and the application and reimbursement of these codes can vary by state, so please consult with your healthcare institution for details regarding how these might be used at your facility.<br />
<br />
To review, there are two codes currently available that allow for collecting and reviewing patient data: <b>99090</b> for analysis of clinical data stored in computers and <b>99091</b> for collection and interpretation of physiologic data, with a monthly unadjusted, non-facility fee of $56.92. The catch is that CMS has required that these codes be used in conjunction with a standard E&M service code (99201-99499), which up until now has meant an in-person office visit.<br />
<br />
The <b><i>big deal</i></b> announced last month was code <b>99490</b>, which is new as part of the CMS Final Rule for 2015, and will be available starting in January 2015. This is an E&M code that can be used for remote chronic care management with a monthly unadjusted non-facility fee of $42.60. Unlike the other E&M codes, this code <b><i>does not</i></b> require the patient to be present. Thus, for the first time, this code could potentially be combined with codes 99090 or 99091 for total monthly unadjusted non-facility fee of $99.52.<br />
<br />
While promising, no one has actually billed for this combination, yet, so it's to be determined how it will work in practice and whether other payors will get on board. Ultimately, from my perspective as a clinician, it has the potential to allow us to care for patients with chronic disease without the inconvenience, higher-cost, or infection risk of a standard clinic visit. That's the future, folks.<br />
<br />
So to answer the titular question, we're getting <i>very close</i> to the point where we'll be able to bill for patient-generated data collected via technologies like Apple's HealthKit. The proof is in the pudding, so to speak, and the pudding may be ready as soon as next month.<br />
<br />
Is it any wonder <a href="http://www.rickybloomfield.com/2014/09/apple-healthkit-flexible-platform-for.html">why I feel technologies like Apple's HealthKit are taking us back to the future</a>?<br />
<br />
Additional reading:<br />
<a href="http://www.americantelemed.org/news-landing/2014/11/07/update-on-cms-payment-decisions---two-steps-forward-one-back">http://www.americantelemed.org/news-landing/2014/11/07/update-on-cms-payment-decisions---two-steps-forward-one-back</a><br />
<a href="http://www.mhealthnews.com/news/cms-boosts-telehealth-2015-physician-pay-schedule">http://www.mhealthnews.com/news/cms-boosts-telehealth-2015-physician-pay-schedule</a><br />
<a href="http://www.techhealthperspectives.com/2014/11/05/cms-expands-telehealth-reimbursement-in-new-rule/">http://www.techhealthperspectives.com/2014/11/05/cms-expands-telehealth-reimbursement-in-new-rule/</a></div>
Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com1tag:blogger.com,1999:blog-3315547413547199810.post-65899023813199779862014-11-05T14:37:00.001-05:002014-11-05T14:37:10.924-05:00The Calf-Path<div dir="ltr" style="text-align: left;" trbidi="on">
When attempting to solve the world's problems, whether mHealth or otherwise, sometimes it helps to take a step back and reevaluate your strategy. Following in the footsteps of others may seem effective and efficient, but often it's necessary to blaze your own trail.<br />
<br />
In case it's new to you, enjoy the following poem:<br />
<br />
<h4 style="text-align: left;">
The Calf-Path (1895)</h4>
Sam Foss<br />
<br />
I.<br />
<br />
One day through the primeval wood<br />
A calf walked home as good calves should;<br />
<br />
But made a trail all bent askew,<br />
A crooked trail as all calves do.<br />
<br />
Since then three hundred years have fled,<br />
And I infer the calf is dead.<br />
<br />
<br />
II.<br />
<br />
But still he left behind his trail,<br />
And thereby hangs my moral tale.<br />
<br />
The trail was taken up next day,<br />
By a lone dog that passed that way;<br />
<br />
And then a wise bell-wether sheep<br />
Pursued the trail o’er vale and steep,<br />
<br />
And drew the flock behind him, too,<br />
As good bell-wethers always do.<br />
<br />
And from that day, o’er hill and glade.<br />
Through those old woods a path was made.<br />
<br />
<br />
III.<br />
<br />
And many men wound in and out,<br />
And dodged, and turned, and bent about,<br />
<br />
And uttered words of righteous wrath,<br />
Because ‘twas such a crooked path;<br />
<br />
But still they followed—do not laugh—<br />
The first migrations of that calf,<br />
<br />
And through this winding wood-way stalked<br />
Because he wobbled when he walked.<br />
<br />
<br />
IV.<br />
<br />
This forest path became a lane,<br />
that bent and turned and turned again;<br />
<br />
This crooked lane became a road,<br />
Where many a poor horse with his load<br />
<br />
Toiled on beneath the burning sun,<br />
And traveled some three miles in one.<br />
<br />
And thus a century and a half<br />
They trod the footsteps of that calf.<br />
<br />
<br />
V.<br />
<br />
The years passed on in swiftness fleet,<br />
The road became a village street;<br />
<br />
And this, before men were aware,<br />
A city’s crowded thoroughfare.<br />
<br />
And soon the central street was this<br />
Of a renowned metropolis;<br />
<br />
And men two centuries and a half,<br />
Trod in the footsteps of that calf.<br />
<br />
<br />
VI.<br />
<br />
Each day a hundred thousand rout<br />
Followed the zigzag calf about<br />
<br />
And o’er his crooked journey went<br />
The traffic of a continent.<br />
<br />
A Hundred thousand men were led,<br />
By one calf near three centuries dead.<br />
<br />
They followed still his crooked way,<br />
And lost one hundred years a day;<br />
<br />
For thus such reverence is lent,<br />
To well established precedent.<br />
<br />
<br />
VII.<br />
<br />
A moral lesson this might teach<br />
Were I ordained and called to preach;<br />
<br />
For men are prone to go it blind<br />
Along the calf-paths of the mind,<br />
<br />
And work away from sun to sun,<br />
To do what other men have done.<br />
<br />
They follow in the beaten track,<br />
And out and in, and forth and back,<br />
<br />
And still their devious course pursue,<br />
To keep the path that others do.<br />
<br />
They keep the path a sacred groove,<br />
Along which all their lives they move.<br />
<br />
But how the wise old wood gods laugh,<br />
Who saw the first primeval calf.<br />
<br />
Ah, many things this tale might teach—<br />
But I am not ordained to preach.</div>
Rickyhttp://www.blogger.com/profile/08300848256292484991noreply@blogger.com0