When is an app classed as a medical device?

Recently we’ve seen a number of apps with dosage calculator functions, some award winning, released to app stores but surprisingly these don’t seem to carry the CE mark to show that they have been registered with the MHRA as class I medical devices. There are currently over 11,000 medical apps in UK App stores aimed at HCPs which cover a huge number of disciplines from reference guides to dosage calculators. Everyday more and more are being added but how are HCPs supposed to know if the tools they are downloading have been thoroughly tested and are safe to use?

In the UK there is no official requirement to register smartphone or tablet apps either as software or devices with the MHRA and the guidelines that are available are just that, so it depends on what the app does and the level of patient risk associated with it as to whether it should be classified as a device or not.

MHRA Risk Indication

The European Medical Device Directive MDD 93/42/EEC says:

‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

The inclusion of the word ‘software’ means that potentially all healthcare apps could fall under the medical device banner. However the meeting minutes from the Medical Device Technology Forum in 2010 show that the MHRA will apply further criteria to understand if ‘software’ needs to be categorised as a medical device.

  • Electronic Health Records (EHR) – while views apparently differ across Europe, the MHRA believes that if software is purely a record archiving and retrieval system it is unlikely to be considered a medical device. However if it includes a module that interprets data or performs a calculation, then it is likely that this module (or system) may be considered a medical device, depending on the claims of the manufacturer. 
  • Decision Support software will generally not be considered a medical device if it exists to provide already existing information to enable a healthcare professional to make a clinical decision. However, if it performs a calculation or the software interprets or interpolates data and the healthcare professional does not review the raw data, then this software may be considered a medical device.

Now, common sense must prevail but for example, an app that calculates BMI is highly unlikely to fall within their definition of a medical device, but a dosage calculator which produces a recommended dose based on a patients details, would.

Based on the information available and to ensure patients are not being put at risk, if you are thinking of developing an app that will use patient data to either contribute to, or make a clinical decision then you should submit a registration for the app as a class I device with the MHRA.

Notifying the MHRA

If you want your app to carry the CE mark as proof that it conforms to the Medical Device Directive, you will need to notify the MHRA as soon as it is applied to the device. This process involves producing a declaration of conformity which includes a detailed technical document that proves that the design conforms to the directive. As part of the technical documentation you will also need to have undertaken a controlled test and risk assessment to demonstrate that the app supports and improves upon any existing process used to present the same information. Once all the documentation is in place you can submit your registration with the MHRA and your fee for the registration which currently stands at £70.00.

Ultimately there is no definitive answer as to whether an app should be registered as a device and until such a time as regulation dictates that all apps are registered as medical devices, it’s down to the nature of the app and what it does, applied with common sense that will dictate if an app should carry the CE mark.

What would be interesting however is to understand that if apps carry the CE mark, would they be more likely to be seen as a trusted source by HCPs for use within their professional day?

References: d4.org.uk, mhra.gov.uk

NHS Health Apps Library

In March this year The NHS Commissiong Board launched its Health Apps Library with the main aim of  making it easier for people to find health and medical apps that they can trust and which adhere to NHS safety standards in health IT.

With over 40,000 healthcare related apps available globally, a key focus for the NHS is on ensuring that the apps listed in the Library are all clinically safe and suitable for people who are living in the UK.  Dr Maureen Baker, Clinical Director for Patient Safety, and her team  developed a review process that applies, for the first time, safety standards in health technology to health apps.

At the time of writing this post I was able to discover around 70 apps listed on the site, so it is by no means a comprehensive source of information yet. The main focus is on apps aimed at patients but I would imagine that it would also be a useful place to list apps that are aimed specifically for use by healthcare professionals. As we know, many HCPs are using apps in their day to day roles to help perform medical calculations and diagnose patients etc, so adding a list of apps that have been tested and approved for use by HCPs would no doubt be of great value to them.

How to install, use and build Sencha Touch 2.1 apps on Windows

Sencha Touch is a Javascript Framework used for building high performance cross platform mobile apps. My experience with installing Sencha Touch was horrible. The docs are severely lacking with outdated and conflicting information. With much experimentation, web searching and thanks to some help on the Sencha forum I managed, finally to get it installed. This post deals with installing Sencha Touch, generating your first app and ‘building’ it so it’s ready for production web use. It doesn’t cover coding a Touch app or packaging your app for iOS and Android which I expect to cover in another post.

This was a piecemeal process and very much a learning experience. There may be errors in my recommendations or assumptions but the end result works for me. If I were to do it again I’d most likely choose a more ordered folder structure for the various installations just for the sake of good housekeeping.

Briefly, if like me you struggled to cut through the marketing hype, these are the core Sencha Products and what they do:

  • Ext JS – Javascript framework for developing desktop apps.
  • Touch – Javascript framework for developing mobile apps.
  • Architect – Standalone product for developing Ext JS or Touch apps using a GUI (as oppose to hand coding)

For the record, I am only concerned with Touch. I tried Architect but found the documentation so lacking that I gave up and decided to just use Touch instead. Unless you are an OEM, Touch is free to use. Architect is a paid product.

Installing and using Sencha Touch 2.1

What you need – I provide specific download links in the instructions below:

1. Apache

First up, if you don’t have a local webserver installed, do it now. Because I’ve used it before, I chose Uniform Server, a WAMP server (Windows Apache MySQL PHP). Uniform Server downloads as an exe (Coral_8_7_2.exe in my case). Run the exe and point it to the folder you want to work from. I chose:

C:\Users\Gareth\Documents\Sencha

So the path to my web root is:

C:\Users\Gareth\Documents\Sencha\UniServer\www

Next we need to allow other devices on your network to access the new Apache installation. This assumes the IP address used by your network is 192.168.1.X. If it’s different, you will need to change the input below accordingly. In the above folder there should be an .htaccess file. Open it in a text editor and change line 9 from:

Allow from 127.0.0.1

To

Allow from 127.0.0.1 192.168.1.0/24

192.168.1.0/24 allows any device using an IP in 192.168.1.X range to access your server.

Click Start_as_program.exe form C:\Users\Gareth\Documents\Sencha\UniServer folder. Don’t worry about passwords if prompted. From the interface click ‘Start Apache’ and it should open a browser window with the Uniform Server homepage.

To access your server from another device (i.e. your mobile or tablet) you need to enter the IP address of the machine you installed Uniform Server on in the web browser. To find your IP Address, open a command prompt (start > type ‘cmd’in the search box and press enter) and type ipconfig. In the first few entries you will see a line that says IPv4 address. Make a note and type this in your mobile browser address bar and you should see the Uniform Server homepage.

Note: Your IP Address could change every time you restart your machine so you will need to know it to be able to see it from your mobile or tablet.

2. JRE

Next install JRE – Java Runtime Environment. Download from:

http://www.oracle.com/technetwork/java/javase/downloads/jre7-downloads-1880261.html

I chose Windows x64 ( jre-7u10-windows-x64.exe at the time), you should choose the correct version for your system. I left the default install options which made the install path:

C:\Program Files\Java

3. Ant

Install Ant. Download from:

http://ant.apache.org/bindownload.cgi

Ant is a library used by other tools when building applications. Download, unzip and move the files to the folder of your choice. I chose c:\ant because that what’s mentioned in the install guide. Assuming you used c:\ant, you should have the folders C:\ant\bin, C:\ant\etc and so on.

Now, open a command prompt. At the prompt type:

set ANT_HOME=c:\ant
set PATH=%PATH%;%ANT_HOME%\bin

Close the command prompt window.

4. Ruby

Install Ruby. Download from:
http://rubyinstaller.org/downloads/

I used the defaults which installed to C:\Ruby193 and checked all 3 options:

Once Ruby is installed, open a command prompt. Type:

ruby -v

This should display a line which looks similar to:

Ruby 1.9.3p362 (2012-12-25) [i386-mingw32]

5. Compass and SASS

Assuming the above works, in the same command prompt or a new one, enter the following 4 commands, waiting for each to complete before typing the next. These commands install items, including Compass and SASS which Sencha relies on when building apps:

  1. gem install haml
  2. gem install haml-edge
  3. gem install compass
  4. gem install sass

6. Sencha Touch

Install Sencha Touch. Download from:

http://www.sencha.com/products/touch/download/

At certain points in their documentation, Sencha refer to this is the Sencha Touch SDK (not to be confused with the obsolete Sencha Touch SDK Tools). I downloaded the GPL version sencha-touch-2.1.0-gpl.zip and extracted the contents to:

C:\Users\Gareth\Documents\Sencha\UniServer\www\sencha-touch-2.1.0-gpl

So I have the following example folders:

C:\Users\Gareth\Documents\Sencha\UniServer\www\sencha-touch-2.1.0-gpl\builds

C:\Users\Gareth\Documents\Sencha\UniServer\www\sencha-touch-2.1.0-gpl\cmd

C:\Users\Gareth\Documents\Sencha\UniServer\www\sencha-touch-2.1.0-gpl\docs

Etc

7. Sencha Command

Install Sencha Command. Download from:

http://www.sencha.com/products/sencha-cmd/download

(SenchaCmd-3.0.0.250-windows.exe.zip for me). I used the default install directory which was C:\Users\Gareth\bin so ended up with the following example directories:

C:\Users\Gareth\bin\Sencha\Cmd\3.0.0.250\ant

C:\Users\Gareth\bin\Sencha\Cmd\3.0.0.250\lib

C:\Users\Gareth\bin\Sencha\Cmd\3.0.0.250\phantomjs

Etc

That should be it. Close all command prompts and then open a new one and type the following. You will need to change the paths to the correct ones. The first path is the path to where you installed Sencha Touch, the second is where you want your app folder:

sencha –sdk C:\Users\Gareth\Documents\Sencha\UniServer\www\sencha-touch-2.1.0-gpl generate app FirstTest C:\Users\Gareth\Documents\Sencha\UniServer\www\FirstTest

This will create a folder in the www directory called FirstTest which contains all the files for a basic Sencha Touch app. If you visit http://localhost/FirstTest (using Chrome) you should see the app:

My local IP Address is 192.168.1.96 so if I visit http://192.168.1.96/FirstTest on my iPhone I see:

Finally, to ‘build’ your app, that is, to export it in a format optimised for a particular environment, open a command prompt, change directory to the one we created for your FirstTest, and type:

sencha app build production

Your output should look like the screen shot below and your FirstTest folder should contain a new folder tree of ‘build/FirstTest/production’. Now, if you navigate to the address below you will be viewing the optimised, production ready version of your app:

http://192.168.1.96/FirstTest/build/FirstTes/production

That’s it. You should be up and running. The following resources where used by me and might help you if you get stuck:

http://www.ladysign-apps.com/developer/sass/installing-sass-compass-for-windows-os-x/ installing compass and sass on windows.

http://ant.apache.org/manual/install.html#windows – installing ant on windows

http://www.sencha.com/forum/showthread.php?252680-Docs-appalling-how-to-actually-get-started – my forum thread where Brice Mason provided a concise list of requirements.

 Other Useful App Development Resources

Mobile Medical Apps: A Great Way of Reaching HCPs?

Damon Lightley featued in Clinical Business ExcellenceDamon Lightley, Marketing Director at Genetic Digital was approached by one of the editors from Clinical Business Excellence to write an article about medical apps.

The article has now been published and appears on page 8 of the August 2012 issue of Clinical Business Excellence. It is titled: “Mobile Medical Applications: A Great Way of Reaching HCPs?” A PDF version is also available.

Mobile Medical Apps: A Great Way of Reaching HCPs?

Using Medical Apps for Diagnosing Patients

Using Medical Apps for Virtual DiagnosisIn May of this year Isabel Healthcare announced their new mobile application (app). The app is based on Isabel’s checklist system for diagnosis. The App allows doctors and nurses and other health care providers access to the app via iPhone, iPad or iPod touch mobiles.  Diagnosis can be established with the resulting possibility of treatment for patients being delivered faster.  And this innovative tool in the physician’s armoury has claimed a coveted top app rating in Apple’s Medical App category.  Where Isabel has gone many will follow and medical apps are beginning to make their presence felt in the medical community. Taking the Isabel App as an example it has been offered for download from Apple’s App Store with three subscription choices.  Customers can sign up for weekly, monthly or annual options, with the first level, the weekly option, pitched at just under £2.00 to attract the infrequent user.

Medical apps of the type offered by Isabel typically contain many thousand disease diagnostic markers both paediatric and adult and allow doctors instant access to the technologies that will help them make vital diagnoses.  Using a mobile diagnostic app a doctor does not even need to be in his hospital or clinic to diagnose a stroke in a patient and begin lifesaving treatment.  Using brain scan images that can be accessed via a smartphone and with an accuracy proven to be almost as reliable as the results of an ‘actual’ scan viewing, diagnosis can be made instantly.  This time saving ability is vital in the treatment of stroke victims.

Medical Apps – ‘Virtual’ Diagnosis?

Not everyone has welcomed this latest innovation in virtual diagnostics. There have been reservations concerning viewing detailed and complex anatomical images on a small 3.5-inch screen, from where critical emergency diagnoses will be made. However advances in image compression, microprocessors and wireless-data bandwidth, are likely to make this 21st century advance an essential diagnostic tool for doctors. For example, a CT scan image could be sent to a ‘cloud’ of the type that is commonly used as a storage device by PC users.  Downloaded to a mobile app or tablet, doctors could then zoom in to view images in more detail.  The use of this compression method to support any medical app is critical, in particular with the sending of high-resolution brain imagery.  Digital images are very large files to download and in a time sensitive situation such image files would take an hour to download using 3G or Wi-Fi.  Compression of the file overcomes this potential problem.

In countries where patients live in remote locations, this instant access diagnostic tool could prove invaluable.  In local or rural hospitals where medical staffing is limited, the instant access to patient’s results offered via this diagnostic tool, could also prove a lifesaver.

There is no doubt that this new application of technology will make a significant impact on the way in which doctors practice medicine both in and out of a hospital setting.   Gone will be the iconic picture of the consultant, clipboard in hand, with his entourage, visiting the wards.  In its place will be armies of medics with iPads and Android tablets that they can take home with them so that they always have a ‘virtual’ presence in their hospitals.

To learn more about our healthcare & medical app development services or to request a copy of our app design case studies, please contact us.

Mobile health apps need new regulatory framework

Last month, a mobile phone app became the first of its kind to be registered by the Medicines and Healthcare products Regulatory Agency (MHRA) as a medical device.

The app was developed by the team at the Mersey Regional Burns and Plastic Surgery Unit and is designed to help medical staff assess burn damages. This neat bit of kit is listed by the MHRA as a class 1 medical device and is available for free in the Apple app store.

According to research, 81% of healthcare professionals own a smartphone and as a result the Mersey Burns app will no doubt be useful by sharing the specialist knowledge from the burns unit with their medical colleagues. However, the licensing of the app has raised all kinds of questions on the future registration of mobile phone apps for use in the healthcare professions.

On the face of it, registration is eminently desirable; in healthcare accuracy is everything, so it is important that diagnostic, treatment and monitoring apps are rigorously tested to ensure their suitability for public release. Unregulated mobile health apps have the potential to put the public at risk.

However there is concern, particularly in the US, that excessive regulation of mobile apps will vastly increase the costs of app development and slow market availability down to such an extent that the technology could be out of date by the time it hits the market.

As a result, on both sides of the Atlantic, web and app developers and healthcare and pharmaceutical companies are calling for a new regulatory framework which will allow the testing and processing of relevant mobile apps at speeds equal to the pace of rapid technological change.

Mobile apps on the rise in pharma

Pharmaceutical and other life science companies are becoming increasingly aware of mobile applications’ potential to boost the effectiveness of their communication.

According to Cutting Edge Information, a US company that provides management analysis reports, support services and consulting to pharmaceutical biotechnology companies globally, apps also hold the key to pharma digital marketing in the future.

Casey Ferrell, research analyst at Cutting Edge, said: “Apps for physicians hold the potential to revolutionise the way in which healthcare is administered.

“There are digital imaging apps for ECGs and radiological procedures; there are apps that improve emergency room efficiency; and there are apps designed to improve patient-physician interaction, including some that facilitate remote consultations.”

Other research from Cutting Edge Information study shows many early implementers of apps and mobile technology are now finding that the pre-launch commercialisation period presents the best phase for successfully utilising mobile pharma technology.

Ferrell said: “”I would argue there is an opportunity for the industry to shift its focus and look for innovative ways to use mobile technology to improve clinical development.

“From streamlining trial data collection and analysis, to connecting potential trial patients to investigators, the clinical development space is an opportunity for pharma companies to differentiate themselves from the pack.”

Internet and smartphone-based nursing can help diabetic patients

Nursing via the internet and smartphones can be an effective way to help patients with uncontrolled diabetes to manage their care.

According to a new study conducted by McGill University, Canada for the Public Health Agency of Canada, tele-monitoring is also increasingly seen as a workable way of delivering care to patients with chronic conditions who live in remote places, or who require monitoring on a long-term basis.

During the pilot project, diabetic patients in four regions of Quebec submitted their blood sugar readings to a nurse every day using a secure website.

Patients also answered a series of questions online about their exercise, diet and food care.

Their nurses then monitored their responses, providing appropriate advice as and when required. If a patient’s readings were a cause for concern, then they appeared in red text and triggered an alarm.

Nurses also emailed their patients educational material to help them manage their conditions.

Antonia Arnaert, professor of nursing at McGill University, said: “Patients with chronic diseases like diabetes, or who have gone through surgery, often have lots of questions and the doctors and nurses don’t always have the time to answer them.

“With tele-nursing, whether using video-conferencing or text-messaging, patients say they feel they get lots of attention from their nurses, because they know that they have their full attention for an hour.”

“They said that tele-monitoring provided them with a sense of confidence in their ability to manage their diabetic condition themselves.”

Ad-funded drug apps on the rise

The popularity of smartphone technology within the pharmaceutical industry is growing, and while some prefer to pay to receive services ad-free, an increasing number of US medical professionals are opting for a different business model.

Epocrates, the app that provides information on drug dosage, side effects and interactions, has seen a rise in the uptake of its free ad-funded version.

According to reports, plans for its development include a virtual sales rep for pharmaceutical companies to showcase their new products.

Pharmaceutical giants such as Pfizer have already recognised the importance of putting their products literally ‘in the hand’ of the medical professionals within smart devices. Not only is this a more direct and measurable form of sales, but it can also create a better return on investment long term.

While the marketing messages offered in the free version of Epocrates will need to be refined to become more relevant to the user (as they currently have to be filtered  to get to the information requested), the launch of this type of app  introduces a new business model into the increasing mix of medical apps available.

Medical portal InPharm recently counted a total of 39 apps produced by the 11 largest pharmaceutical companies, across various markets and target groups.

Like Epocrates, the key to the success of smartphone apps will be the extent to which developers meet the needs of the specific medical groups by providing relevant content and timely propositions, so that an ad-funded business model doesn’t hinder their ability to access information they need to help their patients.

FDA to create new guidelines for mobile medical apps

The US Food and Drug Administration (FDA) is set to propose new regulations for smartphone apps.

The regulations affect a small number of medical apps in the States and provide a clue as to how regulation might develop in the UK.

Around 150 medical apps have been produced to date. These include patient diary apps and calculators for those working in the health sector.

The FDA has now launched a three month consultation in order to devise how it will oversee what it calls “mobile medical apps”. It is focusing on the apps that could present a risk to patients if they fail to work as planned.

These types of apps include those which enable doctors to see medical images on an iPad with a view to making a diagnosis from them.

Other apps that could come under the regulations include those which allow doctors to use their smartphone as an electrocardiography (ECG) machine, apps that calculate the maximum dosage of local anaesthesia based on a patient’s weight and age and apps that collect blood glucose readings to help manage diabetes.

The FDA has already approved a small number of apps for use. These include a smartphone-based ultrasound device and a medical iPhone/iPad app that lets doctors view medical images and X-rays.

Bakul Patel, FDA policy advisor, said: “There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks.”