Mobile Medical Apps- Which Ones are Regulated?

The emergence of smartphones has changed the world. They have put a great impact on our lifestyle. One can do almost anything and everything using smartphone Apps ranging from playing games to shopping, paying bills etc. This digital technology has started approaching healthcare systems as well. The app designers are targeting the Healthcare industry in two ways: 1. directly targeting patients so that they can manage their health and wellness using simple apps like e.g.: BP monitoring etc. or 2. Targeting healthcare providers manage the health and wellness of their patients using apps like radiation apps.

According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications (

Undoubtedly, these Apps have improved the quality and convenience of healthcare, but there is a concern for the regulation of these devices as some of them may pose a risk to health.

On September 25, 2013, The FDA issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff, which explains the agency’s oversight of mobile medical apps as devices. In this Guidance, the agency has clearly stated that the regulation is only applicable to “mobile medical apps” — that present “a greater risk to patients if they do not work as intended.”

These mobile apps fall into the following categories:

  1. Mobile platform such as a smartphone transformed into a device already requiring FDA approval: e.g. iPhone into an electrocardiography (ECG) machine.
  2. Apps used as an accessory to a regulated device
  3. Mobile medical apps that perform patient-specific analysis and then provide a diagnosis, or treatment recommendations, such as a dosage plan for radiation therapy

These apps are regulated under the application process of 510(K), same process that is been followed for medical devices. No regulations are required for mobile apps other than those mentioned above.

In this space, we provide a comprehensive list of Mobile apps that are approved by FDA or other Health regulatory agencies(MHRA, Health Canada) with their features like cost, devices being used with these apps*

(Device if any)
Developer Approval/
Software Platform Cost
Category: Radiological Diagnostics
Mobile MIM MIM Software FDA iOS Free
Features/Functions: Radiology images can be compressed and then sent to the appropriate portable wireless device via Mobile MIM. It allows the physician to measure distance, image intensity values, display measurement lines, annotations and regions of interest.
Resolution MD Calgary Scientific FDA, Health Canada and CE Mark
iOS, Android
Features/Functions: It is a medical imaging product, enabling instant access to diagnostic-grade images and reports conveniently from web browsers and mobile devices. It allows physicians to see and manipulate 3D images of a patient’s brain on a smartphone as the stroke is happening.
MobiUs (Probe) Mobisante FDA iOS, Android
App is free. Probe costs $7495 – $7900 (GIZMODO Tech
Features/Functions: Transforming medical images by making safe, simple, non-invasive, and affordable ultrasound technology available to a broad range of clinicians. This allows them to move imaging closer to the point of patient care, which has been shown to improve clinical outcomes and efficiency in healthcare delivery.
MobileCT- Medical Image Viewer Nephosity FDA iOS $ 9.99
Features/Functions: MobileCT Viewer’s many features include image manipulation such as window and level, pan and zoom; full resolution images, ensuring that no detail is lost; HIPAA (Health Insurance Portability and Accountability Act of 1996) compliance, with SSL (secure sockets layer) encryption for all information in-transit and 256-bit AES (Advanced Encryption Standard) encryption for all patient data at rest; measurement of distances, display measurements and annotations; and lastly, Verify Lighting Check, which guides the user to determine whether the environmental lighting conditions can accommodate a diagnosis.
Centricity Radiology Mobile Access GE Healthcare FDA, CE Mark
iOS, Android
Features/Functions: It gives clinicians true anytime, anywhere access to images and reports from Centricity PACS through the AccessNOW application for qualified Apple and Android mobile devices. Immediate access to images and reports from Centricity PACS; Zero-footprint, native client to iOS or Android OS; AccessNOW application provides 2D, 3D, and MIP/MPR capabilities along with the ability to scroll, set W/L, zoom, And pan.
Osirix HD Pixmeo FDA iOS
App costs $29.99
Features/Functions: OsiriX has been specifically designed for navigation and visualization of multimodality and multidimensional images: 2D Viewer, 3D Viewer, 4D Viewer and 5D Viewer (3D series with temporal and functional dimensions, for example: Cardiac-PET-CT). The 3D Viewer offers all modern rendering modes: Multiplanar reconstruction (MPR), Surface Rendering, Volume Rendering and Maximum intensity projection (MIP). All these modes support 4D data and are able to produce image fusion between two different series (for example: PET-CT).
Osirix Pro Aycan FDA, CE Mark iOS N/A
Features/Functions: OsiriX PRO’s unique design for navigation and visualization of multi-modality and multi-dimensional images makes post-processing and primary diagnosis easy. The 3D Viewer allows for all current rendering modes (including MPR and MIP), and the 4 and 5D image manipulation and modeling capability allow temporal and functional dimensions to be added. aycan OsiriX PRO also enables image fusion between two different series.
Category: Cardiovascular Diagnostics
AliveECG (AliveCor heart Monitor) AliveCor FDA iOS, Android App is free and AliveCor Heart Monitor is $199
Features/Functions: Press the device against the skin found near the heart which make senses and initiate the ECG recording and Heart rate. Set your app to take 30 second, and up to continuous, rhythm strips. While the ECG records it will also display heart rate. ECGs over 10 seconds are automatically saved in the app for review and can be annotated with details.
Withings Health Mate Blood Pressure Monitor (Cuff, Connector) WiThings, S.A.S. FDA, CE Mark, Canada and Australia iOS App is free. Blood Pressure monitor costs £119
Features/Functions: Patient has to wrap the Blood Pressure Monitor around arm and plug it into your iOS device. Choose between one single measurement and a mean average (based on your doctor’s advice) and get instant visibility of systolic, diastolic BP and heart rate. Results are saved automatically on your iOS device. No need to worry about manually updating data.
Category: Opthmological Diagnostics
iEXAMINER™ (PanOptic™ Ophthalmoscope) (Examiner Adapter) Welch Allyn FDA iOS App is free Ophthalmoscope is $500 and $60 (From Steeles Online Shopping)
Features/Functions: PanOptic Ophthalmoscope view and take pictures of the eye. The adapter aligns the optical access of the PanOptic Ophthalmoscope to the visual axis of software. The iExaminer App then allows you to store the pictures to a patient file or email and print them. And, because the PanOptic Ophthalmoscope provides a 5x larger view of the fundus than a standard Welch Allyn ophthalmoscope and 25° field-of-view without having to dilate the pupil, the fundus imaging can happen anytime, anywhere.
MyVisionTrack Vital Art & Sciences Inc FDA iOS For Clinical Trial and Small Deployments It would available commercially till 4Q 2013
Features/Functions: The app will display three circles, one of which has wavy edges. The user will tap the circle that is different from the others. It allows patients with degenerative eye disease such as diabetic retinopathy (DR) and Age Related Macular Degeneration (AMD) to quickly and accurately test their own visual function at home.
Category: Endocrinological Diagnostics
BlueStar WellDoc FDA iOS $300/month (AIS Health Channel)
Features/Functions: A pharmacy gets the prescription, adjudicates the claim, and then forwards it to WellDoc. The company dispatches a trainer who helps the patient download BlueStar. BlueStar calculates insulin dose depending on blood sugar level and sends reports to physician.
Glooko IR Adapter, Glooko MeterSync Cable
Glooko FDA iOS, Android App is free but Glucometer, Adapter and Cable needs to be purchased
Features/Functions: N/A
iBG Star Sanofi-Aventis FDA, CE Marks iOS App is free and Meter costs $64.99
Features/Functions: With the iBGStarTM connected to your iPhone or iPod Touch, insert a test strip with the contact bars facing up. Use the lancing device to obtain a blood drop* then touch the end of the test strip to your blood drop. A beep on your iPhone or iPod Touch confirms a correct reading and that your data has been synced.* The iBGStarTM also works as a stand-alone meter, and when synced with your Apple iOS 3.0 device or higher, will also display the date and time. The meter can store up to 300 readings.
MySugr Companion MySugr FDA, CE Marks iOS $19.99 per anum
Features/Functions: The app has a similar purpose as a diabetes logbook. It provides immediate feedback and helps you stay motivated. You win points for every entry made which help tame your diabetes monster. The goal is to tame your monster every day. Challenges are available to help you set and attain personal goals.
MyGlucoHealth (Glucose meter) Entra Health System FDA, CE Marks and Canada Health Approval Android Free
Features/Functions: The app has a similar purpose as a diabetes logbook. It provides immediate feedback and helps you stay motivated. You win points for every entry made which help tame your diabetes monster. The goal is to tame your monster every day. Challenges are available to help you set and attain personal goals.
Category: Immunological
Propeller Mobile App (Propeller) AsthmaPolis/ Propeller Health FDA iOS, Android N/A
Features/Functions: The Asthmapolis sensor wirelessly syncs with your smart phone using your phone’s built in Bluetooth technology. Pairing the sensor with your phone is an easy, one-time step. Once your sensor is paired, your phone will automatically capture the data from your sensor whenever it is nearby. It allows you to view the data your sensor captures and give you personalized feedback and education on ways to improve your asthma control.
Category: Hematology
Gauss Pixel App Gauss Surgical FDA iOS $100 (RT News Channel)
Features/Functions: Both the Pixel App and the predicate device utilize visual assessment of sponges to count the number of surgical sponges used in a surgical procedure. The Pixel App and the predicate device are intended to be used together so that either method of visual assessment may be used during the surgical procedure and a final sponge count may be made by the user.
Category: General Medical Practice
AirStrip ONE™ OB AirStrip Technologies FDA, CE Mark
iOS, Android Free
Features/Functions: Monitor labor and delivery patients around the clock, from anywhere. With AirStrip ONE™ OB, clinicians have a window into the health status of each mother and baby from anywhere, anytime. AirStrip OB has supported physicians with more than 1.5 million deliveries and counting.
AirStrip ONE™
Patient Monitoring
AirStrip Technologies FDA, CE Mark
iOS, Android Free
Features/Functions: Provide clinicians on-the-go access to detailed, high-resolution waveform data and other vital signs for their monitored patients. With AirStrip ONE™ Patient Monitoring, medical professionals can scroll through 24 hours of waveform data right on their smartphone or tablet.
AirStrip ONE™ EMR AirStrip Technologies FDA, CE Mark
iOS, Android Free
Features/Functions: Erase the geographic and technological boundaries that separate clinicians from the patient electronic medical records (EMRs) they need to make informed care decisions. AirStrip ONE EMR provides relevant clinical decision support information via a single mobile interface.
(Wireless Thermometer)
Raiing Medical Company FDA, CE Mark
iOS App costs $4.99 and Device costs $79.99
Features/Functions: The device, which is worn under the armpit, uses Bluetooth to transmit data in real time to the iPhone. The thermometer can also store up to 72 hours’ worth of readings. According to the FDA filing, the device is battery-operated, reusable, and intended for use by ages 2 and up.
Express Script Medco Health Solutions FDA iOS, Blackberry, Android Free
Features/Functions: It offers eligible members the ease and convenience of managing their prescriptions and pharmacy care anytime, anywhere like, order prescription refills and renewals, check order status, locate a pharmacy, view medications and set reminders for yourself or other household members. look up lower-cost medication alternatives with the My Rx Choices® prescription savings program, learn more about the medications you may take, easily register right from the app, view alerts about your medication use and get important information to review with your doctors, use a virtual prescription ID card wherever you use your paper one today
Mersey Burns Medicapps CE Mark, MHRA Approval iOS, Android, HTML5 Free
Features/Functions: Mersey Burns is a free clinical tool for calculating burn area percentages, prescribing fluids using Parkland, background fluids and recording patients’ details. It was developed by specialist and consultant plastic surgeons and experts in burns management.
Teddy The Guardian iDERMA CE Mark iOS App costs €169
Features/Functions: Teddy the Guardian is a plush bear with embedded certified medical sensors that measure child’s heart rate, oxygen saturation, and body temperature seamlessly during the play, capture and send the data using wireless technologies to pediatrician’s app. Every time a child takes Teddy The Guardian by the hand or puts Teddy’s paw on his forehead sensors detect the values, capture them and transmit in real time to a mobile app where data is analyzed, visualized, managed and downloaded by the medical staff and parents.
Proteus Software Proteus Digital Health FDA, CE Mark iOS N/A
Features/Functions: The IEM sensor, which can be embedded into a pill, is activated by stomach fluid, and then transmits a signal through the body to the skin patch, indicating that a patient has ingested medication. The patch also measures patient vitals and body position, and wirelessly sends all of the data to a Proteus smartphone app.
Category: Dentistry Diagnosis
Beam App (Beam Brush) Beam Technologies FDA, CE Mark and FCC Approval iOS, Android App is free and Brush costs $24.99
Features/Functions: The Beam Brush is a toothbrush to remove plaque and debris from its user’s teeth and aide in the prevention of tooth decay. The Beam Brush collects brushing usage data and wirelessly transmits the data to a software application (Beam App) that runs on the users own mobile device.

Note: Cost for most of app has been taken from iTunes site, Google play site or company website sources else source has been mentioned.
*The table will be updated from time to time.

Regulation of mobile apps marks another step of FDA towards concern for safety of patients. The FDA’s so called risk based priorities makes sense, to apply the expensive and burdensome regulatory system only to mobile apps that pose a significant risk to patients. The regulatory procedure would also help maintain the standards and quality of the Apps thereby posing minimum risks to patients and ensuring that healthcare providers are benefited from the apps.

The regulations may be cause of worry for the app developers. The developers are uncertain about the time taken by the agency to approve an App. The new regulations might limit the new and small businesses to enter into this field. The cumbersome regulating procedures may drive up the cost of the product; delay the launch of these products into the market. For example, MIM Software introduced an app that displays diagnostic images on the iPhone in 2008 but was forced by the FDA to pull it from the market. After more than two years, including studies of the app’s performance under different lighting conditions, the company was finally granted approval. But the FDA stipulated that the app should be used “only when there is no access to a workstation. (BMJ 2013; 347:f5211)

So we can say that there are about 17000 medical apps available in the market and it is impossible to regulate all of them. FDA’s tailored policy of protecting patients while encouraging innovation favors patient safety, but may prevent innovation to enter into the market. A bypass route can be adopted by the authority by working in close relation with app developers, physicians and healthcare givers promote high standards. FDA can rightly work as a “watchdog”, where in it can keep a vigil and interfere only when required.

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Article contributed by Value Edge.

Value Edge

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