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Types of medical apps the FDA will regulate

Types of medical apps the FDA will regulate
By: Brian Dolan | Jul 19, 2011 

The following examples represent mobile apps FDA considers “mobile medical apps” under the narrow definition it outlined in the draft regulatory guidelines it published this morning. The FDA is seeking comments and feedback from the public. Here are the types of apps the FDA plans to regulate:

Mobile apps that are an extension of one or more medical device(s) by connecting17 to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data. Examples of displays of patient- specific medical device data include remote display of data from bedside monitors, display of previously stored EEG waveforms, and display of medical images directly from a Picture Archiving and Communication System (PACS) server, or similar display functions that meet the definition of an MDDS. Examples of mobile apps that control medical devices include apps that provide the ability to control inflation and deflation of a blood pressure cuff through a mobile platform and mobile apps that control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform.

Mobile apps that transform the mobile platform into a medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Examples include a mobile app that uses a mobile platform for medical device functions, such as attachment of a transducer to a mobile platform to function as a stethoscope, attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter, or attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals; or, a mobile app that uses the built-in accelerometer on a mobile platform to collect motion information for monitoring sleep apnea.

Other mobile medical apps that use a hardware attachment or interface to a monitoring system that have been cleared include an automatic electronic blood pressure monitor (21 CFR 870.1130) and a perinatal monitoring system (21 CFR 884.2740).

Mobile medical apps that are extensions of regulated medical device for purposes of controlling the medical device or for the purpose of displaying, storing, analyzing, or transmitting patient- specific medical device data:

Apps that allow the user to view medical images on a mobile platform and perform an analysis or process for diagnosis;

Apps that connect to DICOM medical image servers and provide processing functions such as pan, zoom, measurement, auto contrasting, automatic detection of features, and other similar functionality;

Apps that analyze, assess, or interpret electrocardiogram or electroencephalogram data;

Apps that connect the mobile platform to vital signs monitors, bedside monitors, cardiac monitors, or other similar devices to:

Be used as a central viewing station for display;

Remotely access vital sign measurements of patients at home;

Be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners;

Record arterial oxygen saturation and pulse rate of adult and pediatric patients inside hospitals and activate an alarm based on changes in levels;

Remotely review other standard or critical real-time numeric data from labor and delivery; o Perform remote Holter monitoring;

Connect to medical imaging devices for displaying, processing or storing medical images;

Wirelessly connect to medical devices and can relay or generate alarms;

Perform remote control, setting changes, or readout via wireless links such as programming or controlling a hearing aid system or implantable or body worn medical device.

Apps that are used as patient screening tools for blood transfusion (extension of Blood Establishment Computer Software (BECS)) or other biologics;

Apps that connect to a home use diagnostic medical device such as a blood pressure meter, body composition analyzer, or blood glucose meter to collect historical data or to receive, transmit, store, analyze, and display measurements from connected devices;

Apps that control a blood-pressure cuff connected to a mobile platform to inflate the cuff and measure a person’s blood pressure; or

Apps that act as wireless remote controls or synchronization devices for MRI or X-Ray machines.

Mobile medical apps that transform or make the mobile platform into a regulated medical device by using attachments or sensors or similar medical device functions:

Apps that attach EKG/ECG leads to a mobile platform to collect/analyze/monitor EKG/ECG signals;

Apps that connect wirelessly to a blood glucose tester to display, calculate, trend, convert, or download results to a PDA;

Apps that generate sine signals from 125Hz to 8kHz (8 steps) to check the user’s hearing; • Apps that act as a blood glucose meter by using an attachment to a mobile platform; • Apps that act as an electronic stethoscope by connecting (either via wire or wirelessly) to an external sensor to record, manipulate, or measure sound waves; • Apps that use the mobile platform with or without a sound transducer (microphone) to act as an electronic stethoscope to amplify heart, lung, blood vessel, enteral, and other body sounds;

Apps that use the built-in accelerometer or other similar sensors in a mobile platform to monitor the user’s movement to determine conditions such as sleep apnea, sleep phase, fall detection, or detect motion related to other conditions or diseases or to measure heart rate;

Apps that use the light source from a mobile platform to cure and treat specific conditions, such as acne;

Apps that attach sensors to a mobile platform to measure blood glucose, electrocardiograph, or other similar functions;

Apps that use a mobile platform’s built in features such as light, vibrations, camera, or other similar sources to perform medical functions;

Apps that use a mobile platform to upload electroencephalograph (EEG) recordings and automatically detect seizures;

Apps that use a mobile platform to record response time and accuracy of patients completing a cognitive task and/or automatically score or interpret cognitive testing results;

Apps that use pictures and sound to diagnose conditions by comparing to previously determined diagnoses of images, symptoms, sounds, or other physiological measurements; or

Apps that use a mobile platform in determining blood donor eligibility prior to collection of blood or blood components.

Mobile medical apps that allow the user to input patient-specific information and – using formulae or a processing algorithm – output a patient-specific result, diagnosis, or treatment recommendation that is used in clinical practice or to assist in making clinical decisions:

Apps that perform calculations intended to be used by clinicians for automating tasks, such as:

eGFR with CKD-Epi, Cockcroft-Gault, and MDRD; o A-a gradient, etc.

Apps that act as calculators or utilize algorithms to produce an index, score, scale, or other similar calculations (e.g., Glasgow Coma Scale, pain index, Apgar score, NIH stroke scale, etc.);

Apps that calculate parameters associated with the use of radioisotopes; • Apps that calculate the amount of chemotherapy needed based on the patient’s Body Surface Area;

Apps that assist with patient-specific dosing, e.g., radiation planning; • Apps that calculate Warfarin Loading and Warfarin Maintenance doses for different anti- coagulation therapies based on nomograms; • Apps that act as calculators to determine the maximum dosage of local anesthesia base on a patient’s weight and age; or

Apps that calculate Osteoporosis Risk Assessment by Composite Linear Estimate (ORACLE score).

Apps that collect blood glucose readings and caloric intake to help manage diabetes by calculating pre-meal insulin dose (Bolus) or Basal adjustments; or

Apps that act as a dosing calculators for a treatment regimen intended for a specific patient population (pediatrics);

Apps that define disease stage or progression, and provide a prognosis of a medical condition or predict a patient’s response to treatment based on a analysis of physiological, laboratory, and other data; or

Apps that provide differential diagnosis tools for a clinician to systematically compare and contrast clinical findings (symptoms/ results, etc.) to arrive at possible diagnosis for a patient.

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IMPACT OF MOBILIZATION

Mobile Education:QualityEdReform OR Gadgets?

Can Mobile Learning Improve
Teaching, Learning, Workforce?

Current Studies: TBR & Nation
Research Study Spring 2011:
Faculty & Student Usage of Mobile Devices & Apps

Blog: How To Use Mobile Devices in Education 
TN PreK-20 Live Binder of Mobile Apps

Tennessee P–20 Mobile Devices and APPs

All Areas & Subjects
including research studies regarding the impact
in teaching, learning, and workforce development. 

 


The Tennessee Board of Regents (forty-seven campuses comprised of technical centers, community college, universities, workforce development, and PreK-12 and Business Partnerships) developed standards of quality for the use of mobile apps in education.

TBR Quality Standards for Using Mobile Apps 
Based on TBReLearning Faculty/ MERLOT Quality Indicators/
Sloan-C Five Pillars of Quality/Emantras Inc./

 

 

 

Education & Workforce MOBILE APPs RESOURCE BANK

App of the Month: FUTABA Collaborative Games-K-5

Futaba Collaborative Games App
This app contains a number of great learning sets, including Dolch Sight Vocabulary Words, Subtraction, Multiplication, Telling the Time, Currency, Countries and Flags and more. 


http://itunes.apple.com/au/app/futaba-classroom-games-for/id487979995?mt=8
*Seeking Elementary Educators to Evaluate App
No cost for app upon agreement to complete mobile learning assessment.
 

Found A Good App?Submit to TBR & MERLOT Peer Reviewers

      
Click Here to Submit APPs
TBReLearning and MERLOT
have launched a Discipline Peer
Quality Review Team to asses
mobile apps in the Discipline Community

*Monthly iTune Card Drawing
 

APPLE iBook2/iTunes U/ Digital Content

Overview of iBooks 2 with iPad


 


How To Create An iBook


Authoring Tools on iPad

Book Creator for the iPad from Red Jumper Studio on Vimeo.


/
Using Widgets in iBooks



How to Publish iBook

 

  • http://itunes.apple.com/us/app/ibooks-author/id490152466?ls=1&mt=12
  • http://www.apple.com/education/#video-textbooks
  • http://www.apple.com/education/itunes-u/
  • http://www.apple.com/ibooks-author/
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TEACHING Using Mobile: Why? How? WATCH

Teaching with Mobile Devices and Apps
Best practices techniques for teaching and learning with mobile devices and mobile apps. 


Mobile phones can be used effectively for learning.
*Photograph: Manu Fernandez

 Using Mobile Devices with
Teaching & Learning powerpt

Walters State Community College 
Natural Sciences Division
Teaching with Mobilization Model

http://library.ws.edu/mnaturalscience
 


iPads at Burley
Follow along as a public elementary school in Chicago integrates the iPad into its first through fifth grade classrooms.
http://ipadsatburley.blogspot.com/

 

 

 

 

APPLE Mobile: New iPad/iPad1-2/iPods/iPhones

            

Apple Mobile Learning Solutions

THE NEW iPad

Features and Comparison with iPad2
 


  • How to Use iPad
  • *How to Use iPad2
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  • iPad/iPod Troubleshooting

 


 

20 Apps in 20 Minutes Ipad Edition from TJ Houston on Vimeo.

In this webinar @tjhouston and @llacrosse will overview 20 apps in 20 minutes. These are the apps that were used in the classroom and found to be effective supplements to the curriculum. 


 

How To Use iPhone 4S 

 

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iOS 5 includes more than 200 new features for your iPad, iPhone, or iPod touch.

 

How To Use SIRI | iPhone 4S User Guide

Article from TC Greeks: RIHAN: October 30, 2011
Here’s the easy way on how to use SIRI to understand what you want it/she/he to do for you. It’s highly customize able but it does take a little bit of time to use it. I found a few tricks and tips that might help you figure out how to use SIRI.

SIRI is the new built in personal assistant voice command software in all Apple’s iPhone 4S. It’s not exactly software or an application like you can download and install. It doesn’t even have an icon, plus it’s only accessible oniPhone 4S. Some other sites say you can port it (copy it) to older iPhone but you can’t. SIRI can’t work unless it has an iPhone 4S or higher.

Setting Up How To Use SIRI

How To Use SIRIThe first thing you have to do with SIRI is add your name, if you want it to address you by name, and the language you want to speak, or rather listen to. Go toSettings>General>SIRI>My Info

Choose your name from the contact list and SIRI will address you by name. Choose the language you want to use and you’re all set. You can make other changes in the area too. They are very self-explanatory, so you won’t need step-by-step directions.

Some Tips for How To Use SIRI

How To Use SIRIFrom far, far away — You can use SIRI by two different ways. If it’s across the room, on the dashboard of your car, or sitting on the table at home, press the home button. Hold it until there are two quick beeps. A microphone should appear on the screen. Start talking. That’s it! Pretty easy, huh? Just check to see if the microphone is on the screen and SIRI is ready for you to start talking and giving orders. You don’t even need to yell or hold it close to your mouth.

From up, up close — Just pick it up and use is normally. You’ll still hear the two beeps that tell you SIRI is ready for your commands.

Remember, any voice recognition program has to be “programmed” before it will work properly.

It’s best if you talk in a normal voice but SIRI still needs you to enunciate (slowly say) many words before it will understand your voice. When you speak slowly and clearly it gets use to the way you speak and will deliver your commands better.

Always Have a Strong Connection – SIRI uses a remote server to process your words, so having a good connection will transmit your commands better.

Be Precise – In what you want SIRI to do. Instead of saying, “play iTunes” say, “Play my playlist number 5”. It’s easier for SIRI to understand specific command rather than general commands.

No Stuttering – Try not to stop in the middle of a command. Try not to use `ummmm’ or change the command in the middle of giving one. Use the whole command in one sentence or one go. SIRI can handle several commands but only if it/he/she has them all at once.

Speak Names Clearly – Say names clearly. When adding a contact you might have to repeat it several times before SIRI understands. Just say the name again and SIRI will give you an option box for the name. Accents need to be programmed into SIRI before it/he/she will understand the way your pronounce words.

Choose Relationship – When adding contacts, choose a relationship such as wife, son, daughter so you can say, “Call my wife” or “Call my daughter” and SIRI will dial it right away.

SIRI is only available on iPhone 4S at this time but there are a few other voice recognition programs you can use for other phones that do the same thing as SIRI. There’s Dragon Go! andVlingo for iPhones. They are both free and can be downloaded from Apple’s app store. They offer the same functions as SIRI does but they don’t have as many features. How to use SIRI is very easy to try.

iCloud for Education

What is iCloud? How can it help Education?

Students and teachers will be able to access their documents, their projects, their videos anywhere, whether they’ve created them at home or in the computer lab or on their mobile phones.Schools are increasingly recognizing the cost savings and efficiencies associated with cloud services (no need for maintaining district servers, for example).

But the major problem with iCloud is that it works only with Apple products. If you use a Mac at school but have an Android mobile phone, or if you use an iPhone but have a Windows computer at school and a Mac at home, then syncing isn’t so seamless. iCloud doesn’t really fulfill the promise of “access anywhere.”  Google Docs andDropbox, for example, have both seen widespread adoption in schools because of the ability to do just this — collaborate and share — without a restriction on device or operating system.

ANDROIDS APPs & Devices


         Android Mobile Devices     


Android Market

How To Use Android Market – Navigating Market

To make finding your way around Market easy, the apps are split into a number of areas; Featured (some of the favourites at that particular time), Top Paid, Top Free, Top Grossing, Top New Paid, Top Old Paid, Trending and Best Selling. Alternatively, if you know the name of the app you want you can put it into the search bar.

How To Use Android MarketThe apps themselves are split into 22 categories: (Comics, Communications, Finance, Health & Fitness, Medical, Lifestyle, Media & Video, Media & Audio, Photography, News & Magazines, Weather, Productivity, Business, Books & Reference, Education, Shopping, Social, Sports, Personalisation, Tools, Travel & Local and Libraries & Demo), while games are split into five (Arcade & Action, Brain & Puzzles, Cards & Casino, Casual and Sports). To simplify things, we’ve separated our reviews into five areas: Fun, Create, Connect, Knowledge and Office and we’ve put the sub-category at the top of the page, too.  ANDROIDS APPS

 

 

GOOGLE Apps for PreK-20 Education



 

  • Google Educational Apps
  • Integrating Google Tools 4 Teachers Workshop



WEB Based Mobile APPS

block4

Future of Mobilization & BLOG

BLOG: What do you think about the future of mobilization?
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MOBL21: Faculty Mobile Apps Development (no coding)

Create Free & Easy Website SHORTCUT APPs

Can't afford Apps? Create Your Own!
The
Safari Browser allows you to create 
website shortcuts Apps to your iPad Home Screen
 



Need Content for creating your mobile app?
Create Your Own Teaching & Learning Apps using
MERLOT Learning Objects and the Safari Browser Shortcut Website App Maker.
 
1. On you iPad open up Safari Browser
2. Go to URL: www.MERLOT.org
3. T
ype in the name of learning object
4. Create 'website shortcut app' 
5. The App will appear on your iPad 

 

ISTL Mobile Learning

Mobile Learning SIG
The goal of the SIG is to foster a community of stakeholders in order to support the use of mobile learning and promote best practices in the area of mobile and wireless computing integration in education. SIGML is the ISTE special interest group that is an advocate for mobile learning worldwide, and promotes meaningful integration of mobile devices in teaching and learning in formal and informal learning environments.

Members of SIGML include teachers, administrators, technology coordinators, university faculty and researchers, and representatives from profit and non-profit entities, including government. We hope you will get involved and join us. http://sigml.iste.wikispaces.net/Main

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