Medical Device Regulation (MDR) is postponed until 2021

The new European Union regulations for medical devices will now come into full force on May 26th 2021. Which will be music to the hears for many medical device manufacturers considering a lot of Notified Bodies were struggling to cope with the increase in demand to help companies transition to the new regulations, which were due to come into full effect in May 2020. In fact, some of them were no longer accepting new applications for ISO 13485 certification, as they did not have the resources available.

Transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) has kept the med tech and pharma sectors extremely busy over the last couple of years. The MDR introduces some significant changes to the way in which medical devices, especially medical device software and apps can be legally marketed within Europe and this has created some considerable challenges for some of the smaller, more entrepreneurial driven companies.

So why the delay? Basically COVID-19 is behind it all. The EU wanted to ensure that there would be no delays in getting new devices like respirators onto the market to help prevent shortages of life-saving equipment in hospitals that are treating patients with Coronavirus.

What are the key changes?

The new Medical Device Regulation (MDR) and the related In-Vitro Diagnostics Regulation (IVDR) was introduced in 2017 and organisations were allowed this 3-year period to be able to transition and comply with these new regulations. The MDR replaces the previous MDD and one of main areas it has impacted is in the development of medical apps and eHealth software.

As a results of the new rules and criteria that have been incorporated into the MDR many medical app developers will now be facing a situation whereby their app is not compliant. We’ve seen rapid growth in the number of health and medical apps that have been developed and launched on the app stores over the last 5 years. Unfortunately, the Competent Authorities in each country (like the MHRA in the UK) who are responsible for ensuring that any medical device that is placed on the market is safe to use were late to catch-up with the boom that has taken place in the medical app development sector. This has meant that many of these health and medical apps that have been placed on the app stores prior to the launch of the MDR will now be classed as medical device software (MDSW) and the developers will now need to obtain the proper certification in order to keep marketing those products legally to customers.

Article 19 of the MDR states:

It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software’s location or the type of interconnection between the software and a device.

 Furthermore, those manufacturers that have their devices already CE Marked (under the MDD) may find that the classification of their device has changed under the MDR. Many Class I devices will now be upgraded to a Class IIa device and this change will significantly impact many smaller manufacturers and mHealth start-ups. This is because if your device is Class I then in most cases you won’t need to have a conformity assessment carried out by a Notified Body, you can do a self-assessment. As the legal manufacturer of the medical device software / app  it is your responsibility to demonstrate that the medical device meets the requirements in the MDR or IVDR by carrying out a conformity assessment. The assessment route depends on the classification of the device, so that is the first thing you will need to do.

To summarise the top-line process for bringing a medical device software or app to market would typically be as follows:

  1. Classify your device (i.e. Class I, Class IIa, Class IIb, Class III etc)
  2. Pass a conformity assessment
    (Self-assessment for Class I medical devices and Notified Body approval is required for Class IIa upwards)
  3. Draw up a declaration of conformity (Annex IV of the MDR and IVDR)
  4. Place a CE mark on the device
  5. Assign a Basic UDI-DI and provide it to the UDI database.
  6. Submit key information about the manufacturer, and authorised representative and importer if applicable, to the electronic system (Eudamed).
  7. Place your CE marked device anywhere in Europe or put your device into service

Closing thoughts

As I have pointed out the changes that are going to be introduced in May 2021 will impact some manufacturers more than others, mainly smaller mHealth start-ups and mobile app developers. This is because adherence to the various harmonised quality and data protection standards are going to dictate that those businesses re-design their software development, risk and quality management processes in order to comply with the MDR. This will not only take time to implement but will also incur additional costs through obtaining the correct certifications and involving Notified Bodies as part of the conformity process. Finding the right app or software developer and compliance experts to work alongside you to help you to create all the appropriate documentation is going to be key but be warned these specialist businesses are already stretched and their high demand has driven up the price of their services so it may be more economical for you to invest in and develop these skills in-house.  Our medical & health app developer directory could act as a useful starting point to help you find suitably skilled app developers and compliance experts that you can bring on board as part of your medical device software development team.

Avoiding app store rejection – the importance of using a medical app development specialist

There are many risks associated with using an app development agency that doesn’t specialise in developing medical apps but the most common one is app store rejection. Read on.

Over the past few years the gApps team have heard stories of a number of eHealth entrepreneurs and healthcare companies that have embarked on an app development project with a generalist digital agency only to find out that at the end of the development process they’ve have been unable to get their newly developed medical app published onto the app store.

This is because more often than not the main reason why their app has been rejected is because it does not conform to the regulatory guidelines that have been set for publishing medical apps. If you’re developing an app that is going to be classed as a medical device, then Apple will need to see evidence that you’ve compiled the appropriate paperwork required for launching an app of that nature onto the market. This will often include a genuine copy of the CE Mark certificate that only gets issued to the manufacturer of the device once all the required paperwork has been submitted to the appropriate competent authority within your country, like the MHRA in the UK.

Apple released their expanded section focused on safety requirements for health and medical apps back in 2016, so we get a little surprised when we get requests for help from companies who have had their app rejected due to regulatory issues.

Under the “Physical Harm” section, the guidelines provide several examples of user risk issues that may lead to rejection of an app.

  • For instance, medical apps intended for diagnosis or treatment or that run the risk of generating inaccurate health data “may” undergo more vigorous review by Apple; apps that have received regulatory clearance should provide links to appropriate documentation, as well
  • If your medical app has received regulatory clearance, please submit a link to that documentation with your app.
  • Drug dosage calculators must come from the drug manufacturer, a hospital, university, health insurance company, pharmacy or other approved entity, or receive approval by the FDA or one of its international counterparts. Given the potential harm to patients, we need to be sure that the app will be supported and updated over the long term.

If you’re looking to develop a medical device app then it’s vital that you do the required regulatory research and due-diligence on the app development companies that are being considered for your project. Ask them to show you apps that they have developed which carry the CE Mark (all apps that are classed as medical devices need to have a page within the app itself where the CE Mark is displayed).

You’ll need to consider the classification of your device as the guidelines differ for the various regulatory classes as well as the software safety class, while making sure your organisation can meet all of those guidelines. Also don’t forget that as of May 2021 your app all will need to conform to the Medical Device Regulation MDR.

At the end of the day the guidelines are there to protect patients and healthcare professionals that will be using your app and if you or your chosen app developer doesn’t have the required expertise to not only code these types of apps but to also produce the appropriate compliance paperwork for submission, then you will end up facing the same scenario above, which could prove very costly.

If your app meets the definition of a medical device then you could also face a significant fine for a regulatory violation, from the competent authority responsible for the registration of medical devices. Developing mobile applications that function as medical devices is complex. Choosing the right partner is more than just about assessing their technical capability. Medical device app developers also need to understand the regulatory and data security requirements, so make sure you do the right research before choosing your app development partner.

Useful resources

We have created a number of useful resources which will help you to better understand what additional aspects of app development you’ll need to consider if you’re developing an app that will be classed as a medical device:

How the Internet of Things (IoT) is transforming healthcare

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It is predicted that by 2024, mobile technology and the Internet of Things (IoT) will have transformed medical provision and healthcare management, all over the globe, beyond recognition.

Imagine a shirt that detects variations in blood sugar levels, contact lenses that can monitor changes in the retina or a toilet that can record hydration levels or vitamin intakes in the user. As Sci-Fi as this sounds, all these could be part of every day life in 10 years time.

Medical care provider Bupa have said that all kinds of ‘connected’ apps from those in household appliances to ones in furniture will all be supporting our daily health in ten years time. The mHealth app of tomorrow will monitor health and alert the user to any danger and may also incentivise healthy life style choices by offering rewards through ‘gamification.’ It is thought this would be done in much the same way as games like Foursquare, or Angry Birds unlock badges as rewards. Such an approach and the use of IoT technology and mobile health apps in this way is predicted to have a major role to play in preventing disease and dramatically reducing the onset of ever increasing complaints like diabetes.

Dr Paul Zollinger-Read, Chief Medical Officer at Bupa was reported as saying that mobile technology and advancements in the connected home (thanks to the Internet of Things) “gave us a glimpse into the future and allows us to imagine a time where people can become guardians of their own health,” he said, adding that “being aware of their likelihood of disease and possible risk factors, coupled with constant monitoring through intelligent technology means that they will be able to spot the symptoms of illness from a very early stage, or simply prevent them altogether.”

Some of the innovations that Bupa have suggested that might become part of our everyday life include ‘smart nappies’ that allow parents to monitor a range of things from hydration to kidney infection in babies. Moving away from the device accessed mHealth app, the fabric of clothes may become a monitor of pulse and heart rate while sensors in shoes will monitor periods of inactivity and prompt the wearer to exercise. One of the first forays into the world of tomorrow is perhaps the recently developed smart contact lens that can detect glucose levels in patients with diabetes through monitoring their tears. And in 2016 human trials of a miniature artificial pancreas will began.

There is no doubt that the advent of IoT technologies and connected mHealth apps are the spring board to a future where we will be able to monitor our health on a minute to minute basis and only visit the doctor when the apps monitoring our health tell us that we need to.

Developing an effective promotion strategy for your health app

The mobile health app environment has seen explosive growth as consumers flock to the Apple and Google Play App Stores. Usage of health and fitness apps on Apple’s iPhone and iPad is booming, according to mobile analytics firm Flurry. Flurry tracks more than 6,800 apps in the health and fitness category, and claims that usage – measured by the number of times people open and use the apps – has grown by 62% in 2014 compared to 33% for apps in general.

Flurry says that this compares to 49% usage growth for health and fitness apps in 2013, versus 115% for apps overall that year. So there’s plenty of money flying around the app economy and the health app marketplace is clearly becoming highly competitive, even Apple launched their dedicated health app called HealthKit to track people’s health data, and it can also integrate with apps from other health app developers.

However many companies and app publishers invest in health apps only to see them end up in the “app graveyard” — not easy to discover, and giving themselves very little chance of generating a positive return on investment.
From a searcher’s perspective, app markets are clumsy and awkward to navigate. App search is still relatively unsophisticated and in its infancy – it’s a bit like the early day web search engines, remember AltaVista! The reality is that the app stores are still evolving their search technologies so that they become better at connecting app seekers with relevant apps.

So what’s the best way to promote your app?

There is no “best” way. You must employ multiple tactics to crack the success code. Simply relying on word of mouth is not enough – you need to ensure that you are using multiple channels to reach your different audiences and typically this will involve using a combination of some of the mobile & digital marketing tactics below.

Native App Store Marketing

Since its inception, the native app storefronts have been the most powerful merchandising and promotional vehicle for app discovery. With the app stores being so influential, it is incredibly important to understand how to use them to your advantage. Success starts with setting up a proper product page that uses effective keywords and is categorised appropriately. Pay attention to the comments you get from reviews and ratings. This feedback, whether good or bad, can give you an idea of what is working and what you’ll need to change.

Your product page is a marketing opportunity
Be sure to put some thought into the elements that make up your product page in the app store. Don’t treat this as a just a mandatory step in the submission process, but rather an important marketing opportunity. Remember, all parts of this page need to be geared towards one goal – download. Your name, icon, description and screenshots are tools you have to convince the user to download your application. Make sure you use all options available to their full potential.

Some quick tips:

  • If you are not an already established brand, then choose an app name that is relevant to your app’s purpose.
  • Your app icon is your logo so make sure it is creative, high quality and represents what your app is all about.
  • Upload as many screenshots as possible, prioritising those that showcase your features and content.
  • Don’t waste screenshots on loading screens or standard device processes like calling, texting or shutting down – focus on your app.
  • Include an app explainer video as many app stores now allow you to include them, a well done demo of your application goes a long way to converting the audience to a user.

Don’t forget your keywords

The app stores search algorithms and their use of metadata is still somewhat a mystery. What we do know is that optimising your description and utilising keywords does make a difference. Some app stores like to provide fields to input keywords of up to 100 characters. If this is available, use it!

When selecting your keywords:

  • Start first with keywords you may already have from your search engine optimisation efforts.
  • You don’t need to include your app name.
  • Many developers believe that you only need commas to separate, not spaces, which should free up some characters.
  • Select keywords that will maximise results – avoid general terms and use words relevant to your app’s niche and purpose.
  • Additionally, write your app description including all of your keywords. List your features, your content and even go as far as include the types of users or scenarios you feel your audience may use to search for an app.

Choose your category strategically

When it comes to choosing a category for your app within the store, do your homework. Perform searches to see where your competitors show up. Look in the categories you feel you would most fit to see what apps are featured.
You will want to choose a category that is a logical choice for your audience to find you. But be on the lookout for opportunities that will allow you to stand out. Categories with fewer total apps or that have little to no other apps with your offering may be better suited to provide you the visibility you need.

Reviews & ratings can be the key to climbing the charts

When a user enters the app store they make most of their download decisions in the list view. Here they are given only a couple of things to help them make their decision: app name, icon, price and the rating and number of reviews. Ratings and reviews aren’t just great vehicles to collect feedback on yours, they also help your app standout in the list. Apps with more activity (ratings and reviews) are more likely to be tapped on than those that have no star ratings or comments.

Additionally, app stores have started to factor in activity (ratings and reviews) as part of the criteria used to build the merchandising areas – like the top chart. Actively encourage feedback from users. Include a call to action in your app, your webpage and social networks to request reviews and ratings.

Create an area in your “About” or “Info” area of your app that has a link to review and rate your app. Consider a timed pop-up to appear in the app while the user is interacting with it to remind them to give feedback. Make getting feedback from your users a core part of your on-going marketing efforts for your app.

There are also specific healthcare and medical app review sites like iMedicalApps and Medical App Journal that you should submit your app to for a review.

Web Search Engines

Search engines are highly effective channels to reach out to both patients and HCPs and make them aware of your app and website. 80% of Internet users look online for health related information. Health related searches on Google are up 47% from last year. And searches aren’t just using their desktops either. A survey carried out Manhattan Research (Taking the Pulse Europe 2011) showed that 75% of European HCPs use a smartphone. Of that group 74% use their smartphones to search the web and 52% use them to download apps. So making sure that your website is ‘mobile friendly’ is also important.

Developing a comprehensive app marketing strategy is key to making sure that your target audience can find your app. Think about the types of keywords they will type into search engines like Google that relate to what your app does. You can use app marketing techniques such as pay per click (PPC) and search engine optimisation (SEO) techniques to help give you a presence on the front page of search results.

A number of app search engines have also arisen to confront the so-called “app discovery problem.” Among them are Quixey and AppCurl.com; and one can also search Google Play for apps of course.

Search engine optimisation for mobile

As app owners, the best place for users to find your product is on their smartphone. This will increase the chance to download, which is your main goal. As your product is mobile, it is definitely important to make sure that you optimise for mobile search.

The biggest step in mobile SEO is to make sure that you have a mobile optimised marketing page. A fully optimised mobile page will rank higher in the mobile search results than that of a desktop page, so it is in your best interest to have this created when you are developing your online marketing presence. In addition, this page will be of better use to the users who click on it, as they won’t have to work (pinch, zoom, etc.) to use it.

Google recently made some major changes to its algorithm and it has started to favour websites that have been optimised for mobile devices. By some estimates, more than 60% of all Google searches are now performed on mobile devices, so it makes sense that Google wants to capitalise on this traffic and ensure the best possible experience for its users. Responsive designs are the most popular way forward, but you can also have a separate hosted mobile version of your site. Google doesn’t have a preference, as long as mobile users’ experience isn’t interrupted.

10 Tips for Launching a Health App

The buzz surrounding health apps is quickly becoming a deafening roar and that first comer window of opportunity is closing fast. While there is no doubt that health apps are the way of the future, as an avalanche of them become available, here are ten tips to help make your mHealth strategy and mobile app a success.

1. Originality – Present your app as offering something original that actually makes a useful contribution. Or if your app is in a category that already exists present your app in a unique new and attention getting way.

2. Strategy – Nothing is likely to be much of a success without the right amount of planning. Plan your strategy in a systematic way. Look at the app from the customer’s point of view. If you were they, would you buy it? Check that you are within compliance requirements and whether or not your app needs to be registered as a class 1 device.

3. Website – First A great website is half the battle of marketing your app. Make sure that yours is professional looking and up and running, without glitches, before you launch. Tell people how your mHealth app will benefit them and make your website a great marketing tool. Also don’t forget to optimise it for relevant key phrases so that people can find it on search engines like Google.

4. Social Media – Your mHealth app will stand the best chance if it is fully supported by social media. Twitter is an excellent platform that will supply you with endless attention free of charge. However with a 140-character limit make sure you choose your words wisely! Other social media platforms like LinkedIn and Facebook are also key networks that will give you a channel to get people talking about your app. Also don’t forget the much smaller, niche social networks that also exist within your sector, sometimes you will find that these can be more effective in terms of engaging and interacting with your target audience.

5. Sales Pitch – Make sure that you have honed your sales pitch to the best that it can be before you do anything else. Your sales pitch needs to convince people to take the next step. Creating app promo videos are often a great way to show people the key features and benefits of your app.

6. Blogs – are very popular and setting up a good one can be a great step towards your having a successful mHealth app. They are very much joined at the hip with social media and if you can get Tech sites or other relevant sites to feature you, then that will also be an invaluable l marketing tool. Also reach out to other influential bloggers and ask if they’d be interested in writing a post about it.

7. The Friendly Approach – Make your tweets, posts and blogs casual, and not too formal, but still professional. People respond better to a more friendly approach.

8. Tease! – Start the hype early and keep the customer guessing as you build up to the launch. Make the eventual reveal an event that people want to know about.

9. Media Hype – Creating a buzz or media hype around your mHealth app will certainly help it launch. Offer free downloadable press releases of your app with high-resolution images for potential users. Ask reputable, category specific blogs to feature any promos.

10. The Big Launch – All the hype and the work you have done towards launching your mHealth app will be wasted if your launch ends up as something of a damp squib. Ensuring that you have maximum app store visibility is key so you amy also want to consider an app store optimisation (ASO) campaign. Make sure that you send out newsletters and press invitations – do everything you can to make the launch go with a bang.

If you are considering developing a health or medical app then check out our resources section or use our directory to find a suitable medical and health app developer.

Tips for designing a medical app – is connectivity on your list?

One of of the gApps team came across an interesting discussion on LinkedIn titled: “One tip for designing a medical device.”
Members of one of the medical device groups were being asked to share their views on what advice they would give someone when it came to designing a medical device?

The post as you can imagine got a great deal of response (the group currently has over 320,000 members). I read through the responses with interest and although all the responses were well considered. Some of the advice shared was:

“I would recommend co-development of the product with the customer. This provides clear understanding by both parties of what the design requirements are, what testing is required, expected costs, lead times, design for manufacturability issues, and mostly, you have the most important thing, at least one customer.”
“In my past we were successful by starting a voice of customer assessment and convert that into a list of customer requirements. Then have R&D translate that into functional spec of what they could provide and on top of that what other features or capabilities that customers are not aware of. Then a negotiation occurs where there are mismatches and confirmed with customers. In parallel how will it be verified and validated, sample availability, collaborations needed? Then and only then do we start development.
“Ask the customer exactly what they need and why, what are the features they could not do without? Would this new product get then to move away from what they already use, and why, why not? ensure they get just that… and quickly. Then ensure their experience is backed up with service.”

“Most of the time customers, don’t really know very clearly what their needs are, especially physicians. But patients, caregivers probably understand better way what can help them and what they are willing to pay for it. Latin America still needs help in rural medicine: handle chronic disease, early diagnosis especially in oncology. I agree about co-development.

As you can expect with any conversation around new product development there is this recurring theme of start with the end-user. And this is all sound advice and as a marketer this notion that the customers’ needs drive the NPD process is etched into my brain. But it also got me thinking that when it comes to medical devices we should also be considering how we can take advantage of new technological advances taking place and look for opportunities to future-proof any device that we are looking to design. This will help to increase the product’s shelf-life as well as improve the product’s chances of generating a healthy return on investment. But as we know technology is moving faster than ever so this becomes and an even greater challenge for medical device manufacturers.

One area that can sometimes get missed during the initial concept and business analysis phases is “connectivity” – so assessing the capacity for the interconnection of platforms, systems, and applications. We would most certainly be bringing connectivity to the table early on in the process and exploring how mobile technologies could help to improve the user experience and also the cost effectiveness of developing such a device.

Here are some examples of companies that have benefited from developing medical device apps and apps that connect with existing hardware devices:

Improving end-user experience

  1. Control interfaces: OvuSense streamlines the user experience taking advantage of high res screens with more real estate to graphically monitor temperatures and get fertility predictions compared the original black and white LCD screen on the original hardware product http://www.ovusense.com/uk/
  2. Portability and access: Rosemont Pharma changed a very large ring bound folder which references their entire product range and has consolidated all the information into an online database which is updated to an app every time the app is opened and fits in the pocket. The app also included a dosage calculator (CE Marked) to make it easy for HCPs to calculate the dosage requirements based on key factors: https://www.rosemontpharma.com/prg/
  3. On Demand: Dr Now / Push Doctor, these types of on demand apps are the future of medical services. Real time access to medical professionals when required with minimum disruption to your own schedule. http://www.drnow.com/ http://www.pushdoctor.co.uk/
  4. Data sharing and analysis: Diabetes apps like enable patients to accurately monitor their blood sugar levels and at the same time automatically share this data with healthcare professionals who can monitor their patients remotely and intervene if necessary. http://www.mystarsanofi.com/web/products/glucometers/ibgstar

Cost of development

  1. Less investment in hardware: Fertility Focus have moved away from the physical production of a hardware reader to an app that utilises the hardware within a device. This massively reduces the investment in manufacturing and enable a constant evolution of the product features http://www.ovusense.com/uk/
  2. Concept testing / rapid prototyping: The Instant Weight For Height calculator was prototyped and tested by healthcare professionals to make sure it was easy to use and complex calculations would be simple to interpret before going to the coding stage. This allowed for a much quicker development cycle having ironed out any design issues before hand
  3. Updating firmware: Fitbit is a good example of where the product software or firmware is constantly evolving to incorporate customer feedback and improve user experience. Distribution is over the air via an app update which in turn updates the firmware on the wrist band. http://www.fitbit.com
  4. Distribution: The distribution and update of apps has become a seamless process with both Apple and Android devices performing automatic updates for the apps running on their devices. This massively improves reliability of the apps, the devices and is a simple push to an app store that then distributes the apps to millions of devices. http://www.apple.com http://www.android.com

10 Things your boss should know about mHealth

mHealth is the step forward that gives the patient a better opportunity to access healthcare at their fingertips. It gives the ability to monitor, educate and facilitate management of medical conditions from home and through devices that we are all familiar with using. Going to see an actual doctor is often inconvenient and is something that an employee might not want to have to explain or to ask for time off for. Far better that patients take responsibility for some of the management of a medical condition themselves with a back-up of medical care.

So here are ten things that your boss needs to know about mHealth and why it is unquestionably the way ahead.

  1. mHealth, while commonly used as an interactive app, in its broadest application, can attach to a pocket, to a wrist, to clothing, to underwear or directly onto the skin to monitor health.
  2. mHealth can offer a future where there is individual self-determination providing a positive impact on the user’s individual health and the health of the public at large.
  3. mHealth can offer a future that will motivate employers, policymakers, and other professionals to create guidelines and situations that both support and promote healthy behaviour.
  4. mHealth will allow for a freer flow of information, within and outside any health care system.
  5. mHealth will contribute to a future that encourages health care providers to put real value on patients and on their data.
  6. mHealth will create a future that builds respect and trust between patients and their health care providers as well as competence in technology-supported self-and shared management of all aspects of health care.
  7. mHealth will make use of social media for greater and more effective communication.
  8. mHealth will allow for the combination of supporting health and delivering health care information for individuals and for the wider community. That information will be accessed from diverse sources, and can also include non-clinical information.
  9. mHealth will promote technology that can map and show trends in health status, and will highlight any deviations from the norm for any given person in any given scenario.
  10. mHealth will promote user friendly technologies that assimilate health activities and treatment into the rest of a patient’s life.

Finally in February 10, 2014, the Apple iStore contained almost 30,000 health & fitness apps, and over 23,000 medical apps. Many are free, some cost a few pence and others cost a substantial amount. They perform many different functions, but there is one thing all mHealth apps have in common: they all collect information about us and impart vital information to us as users and to medical professionals as they assess health and monitor treatment.

There is no doubt that mHealth solutions are already part of the future for our health and well-being but there are still many organisations involved int he healthcare sector that have yet to develop an effective mHealth strategy to help them capitalise on the opportunities that this exciting area of digital can offer .

Can Text Messaging Improve Patient Engagement Outcomes?

Text messagesMedication non adherence is a significant problem, it always has been and it will continue to be so with an estimated cost to the NHS of £600m* a year! So what can be done to improve patient outcomes? Changing patient behaviour is key to this and there have been a number of clinically led studies conducted that demonstrate that apps can help to improve compliance.  But, when looking at patient engagement, perhaps there is another solution where a person-centric approach is more likely to improve the odds of success. A successful engagement programme needs healthcare providers to be able to reach their patients in familiar and effective ways and by doing this, patients are encouraged to take an active role in their treatment which will in turn lead to better healthcare outcomes.

This is where I think text messaging could be the answer.

It’s a cost effective way of providing a more personalised experience with a greater reach than just smartphone users. Last year over 145 billion* text messages were sent and despite the rise of instant messaging platforms among younger users, text messages remain device agnostic and one of the easiest ways reach anyone with a mobile phone.

The Personal Touch

Your health is a private matter and the more personalised the experience, the more likely patients are to respond and take an active role in managing their own treatment. Medication reminders, exercise reminders, appointment booking, pre-op instructions, post op advise can all be communicated ‘one-on-one’ and doing this on a personal level, knowing that a real person is supporting them, can be a real motivator to empowering them to make the necessary changes.

A GSMA study in 2012 showed that 54% of consumers wanted to improve their healthcare using their mobiles in more personalised ways, taking more control in their treatment.

Patient Preferences

Reach

In order for any patient engagement programme to be successful the number of patients you are able to reach is very important. Patients comes from a variety of backgrounds and demographics with a range of communication preferences. Combined with the fact that it’s not always possible to be connected to the internet, text messaging offers the lowest common denominator and most reliable way of contacting patients. Text messaging also is the quickest way to reach the most people. The average text message is read within the first 90 seconds, whereas the average email is opened within the first 90 minutes*.

Security

Clearly security and compliance are also considerations for any healthcare system that communicates patient information. The text messages can be stored securely inline with HIPAA compliance but because security depends on the cooperation of all parties involved in the transmission process there are bound to be challenges. However if the tool is used correctly, with guidelines in place to support patients with their treatment plans and not for discussing medical issues, many of these security concerns are negated.

Conclusion

There is no doubt that apps and smartphones will make communication easier, reduce costs and improve efficiencies throughout the NHS. But let’s not just assume that apps are the answer before considering all the technologies available to us and the way in which patients use them. Familiarity, reach and simplicity can play a big role in the success of an initiative like this and, used in the correct way, could see tangible benefits in terms of outcomes and cost savings.

*http://europe.newsweek.com/health-apps-created-surgeons-put-patients-control-313531
*http://www.hsj.co.uk/resource-centre/best-practice/qipp-resources/how-improved-medication-adherence-can-prevent-costly-medicine-waste/5041067.article#.VVXLXJNVhBc
*http://www.theguardian.com/technology/2014/jan/13/number-text-messages-sent-britain-falls-first-time
*http://www.pewinternet.org/2012/11/30/the-best-and-worst-of-mobile-connectivity/
Image credit: Amancay Maahs (https://www.flickr.com/photos/amanky/3211478871/)

Connecting your medical app or website to the NHS : The N3 Network

Many ideas for apps and websites we deal with are based around some interaction with the NHS but integrating with NHS services and facilities isn’t always straight forward. One of the barriers to entry is the NHS N3 network. N3 is the broadband network for the NHS which connects all NHS locations and over a million employees. It connects hospitals, GP surgeries, pharmacies and many other service providers to securely facilitate sharing of healthcare data including sensitive patient records.

If your app, website or service needs to interact with NHS data then you may well need to be connected to the N3 network. As specialist providers of health related apps and websites, Genetic Digital’s customers often fall in to this category with web services we develop (which are often the backend of an app) requiring access. However, just to muddy the waters somewhat, N3 connectivity isn’t always mandatory (which can be true for non Patient Identifiable Data only); some NHS trusts have a more relaxed approach than others depending on their internal IT policies and configuration.

So who needs an N3 connection? There are no hard and fast rules but, broadly speaking, if you want to exchange data with an NHS trust (or trusts), especially sensitive data such as patient records, then you’ll need to be on N3. Even if it’s not a requirement if you are offering an on-premise solution, it’s often a commercial advantage if you can offer it. Given two competing services, an NHS trust could well choose one that offers services via N3 over one that doesn’t.

One point worth noting is only traffic from England can flow over the N3 connection so you can’t manage the service from an Indian call centre for example or push or pull patient data from Scotland, Wales or any other country. Knowing where your data resides is vital in applying for your accreditation to connect to N3.

How do you go about connecting to the N3 network? It’s a multi-step process with the first being deciding who you will contact to request access. For this, there are two options, one is to deal with the HSCIC direct (the N3 service provider) and the other is to deal with an N3 commercial aggregator. Dealing direct the process tends to take longer and commercial aggregators are organisations who have been granted power by the HSCIC to vet, assess and grant end user access requests to N3. This latter route is often much quicker and enables you to work with experienced staff who can offer direct support to help complete the required documentation.

Once a request is made there are then two parts of a pre-assessment questionnaire that need completing:

  • The HIGCAP – an eight question form asking about the nature of the connection, name of the company making the request, contact details, ISO certification status etc.
  • You then need to get a sponsor to complete their portion of the form – a sponsor is a responsible individual within an NHS organisation who will vouch for your connection application, for example, a senior manager with knowledge of your project.

After the above two are completed they are assessed for pre-approval. Once pre-approved you move on to:

  • The LCA – Local Connection Architecture questionnaire – this is a comprehensive break down of why the N3 is required – what the connection is for, the type of data etc.

If using a commercial aggregator, a meeting or conference call is usually had to discuss the LCA and help complete it. Once completed to the satisfaction of the provider, N3 approval is granted and a connection is setup.

Once an N3 connection is setup, the end user (our client for example) is obliged to complete the IG Toolkit. This is a process similar to ISO27001 certification which ensures procedures and policies are in place to prevent misuse or negligence of the N3 connection and associated service. They have until the end of March to complete it, so, if access is granted on the 30th March they have 1 day to complete it, if access is granted on 1st April they have a full year. Yes, this is odd. Because of this, completion is not strictly enforced and can (and does) take longer to complete. However, ultimately it needs to be done annually.

What type of connection would I need? For our customers, the need is most often for hosting a server which can connect to N3. Commercial aggregators such as Redcentric own their own data centres with a direct connection to the N3 backbone.  Once approved, our clients can host their servers, either physical or virtual cloud based, in the data centre and their app or web visitor traffic flows in over the public internet and out over the N3. To ensure integrity of the N3 service, you are obliged to utilise a managed firewall that monitors and filters all traffic that crosses over the N3 boundary.

If your service is connected outside of a data centre, in a pharmacy for example, then, in addition to the N3 connection and firewall, you would need to purchase a broadband connection from the commercial aggregator at rates comparable to standard DSL providers.

What about the costs? There are no direct costs associated with obtaining an N3 connection but, like all network connections, there are ongoing costs for using it. There is a minimum 3 year contract and costs increase depending on the speed required. Connections are sold in increments of 1Mb/s which, despite sounding slow (a domestic high speed broadband connection is upwards of 50Mb/s), when dealing with low traffic levels and small packets of text data often used in apps, the basic 1Mb/s can sometimes suffice. Additionally, there are costs for the firewall, hosting in the data centre if necessary and costs for an external DSL connection if required. In all likelihood there would also be consultancy costs associated with completing the IG Toolkit.

In summary, there are commercial benefits to having an N3 connection available to your service and in many instances it will be a necessity. But it comes at a price, both financial and administrative so the decision to apply shouldn’t be taken lightly and should be based on your specific needs, requirements and business opportunities.

Thanks to Redcentric for their expert N3 knowledge that helped shape this article.

What is mHealth?

What do we mean when we use the term mHealth and what is a ‘mHealth app’?

Many of you will have started to hear the term mHealth being used more frequently, the EU even recently published a Green Paper on mHealth, but as with most jargon unless you are directly involved in the sector responsible for dreaming up these new buzzwords, chances are could find yourself sat in a meeting thinking what on earth is that person talking about when you hear the phrase:

“You need to develop an integrated mHealth strategy and build a suite of native mHealth apps for both iOS and Android platforms”

Here is the Wikipedia definition:

mHealth (also written as m-health) is an abbreviation for mobile health, a term used for the practice of medicine and public health supported by mobile devices. The term is most commonly used in reference to using mobile communication devices, such as mobile phones, tablet computers and PDAs, for health services and information, but also to affect emotional states. The mHealth field has emerged as a sub-segment of eHealth, the use of information and communication technology (ICT), such as computers, mobile phones, communications satellite, patient monitors, etc., for health services and information. mHealth applications include the use of mobile devices in collecting community and clinical health data, delivery of healthcare information to practitioners, researchers, and patients, real-time monitoring of patient vital signs, and direct provision of care (via mobile telemedicine).

In the EU Green Paper they define mHealth as:

Mobile health (mHealth) covers “medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs) and other devise. It also includes applications (apps) such as lifestyle and wellbeing apps that may connect to medical devices or sensors (e.g. bracelets or watches) as well as personal guidance systems, health information and medication reminders provided by SMS and telemedicine provided wirelessly.

Useful mHealth/health app resources

Apart from our own resources collating mHealth statistics, events and news stories, there are some great blogs and websites that cover the topics of mHealth.

Here are our top five:

  1. iMedical apps – http://www.imedicalapps.com/
  2. mHealth professional – http://paper.li/mhealthpro
  3. Mobile Health News – http://mobihealthnews.com/
  4. mHealth Alliance – http://mhealthalliance.org/media-a-resources
  5. mHealth News – http://www.mhealthnews.com/

You can also search for and read tweets that have been posted to the following hashtags: #mHealth; #healthcareapps; #HCApps