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

I recently 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 and medical device regulatory affairs are moving faster than ever so this becomes and an even greater challenge for medical app developers.

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. I 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. Let me share some of the benefits that we’ve witnessed through our involvement in developing connected medical devices and designing CE Marked mobile applications for the healthcare sector.

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 https://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. 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. https://www.drnow.com/ https://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. https://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 https://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. https://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. https://www.apple.com https://www.android.com

Want to learn more about medical app compliance?

Read our free guide “A Quick Guide To Regulation of Medical Apps

Medical app compliance eBook

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/)

Top 5 Medical Apps for Clinicians

With the explosion in medical apps available on the app stores, it’s not surprising that there are more ‘digital tools’ available to help healthcare professionals carry out everyday tasks. As with medical apps for patients there are thousands out there which aim to create efficiencies and improve access to resources on the go and we’ve selected our top 5 currently available (in no particular order).

Figure 1

This app has earned itself a lot of press recently and is a great way of allowing medical and nursing professionals to share and discuss patient treatment options by sharing medical images in a safe and secure environment. It takes a serious approach to privacy and medical app compliance with the app running on a HIPPA compliant infrastructure and algorithms like automatic face blocking built into the app to protect patient details. This is a clever app and fills a void where healthcare professionals are increasingly using unsecured or generic apps like ‘What’s App’ to share and discuss patient cases.

http://www.gponline.com/app-review-figure-1-medical-images/article/1309858
http://www.imedicalapps.com/2013/07/figure-1-app-review-instagram-physicians/
https://itunes.apple.com/gb/app/figure-1-medical-cases-for/id645948529?mt=8
https://figure1.com/

iOS & Android

Figure 1 Figure 1

 

Doximity

Doximity is the largest US network dedicated to healthcare professionals with over 50% of doctors signed up. It’s been going since 2012 and provides HIPAA-secure communication & electronic faxing, tailored medical news and career management. One of the biggest attractions is ability to earn CME credits as it’s been made very simple to do, but the most popular part of the app, is the ability to send secure HIPPA compliant faxes with each medical professional registered to the app being assigned their own dedicated fax number, free, for life. Interestingly the co-founder of LinkedIn, Konstantin Guericke, sits on Doximity’s Advisory Board so that might give an indication of where Doximity sees it’s future.

http://33charts.com/2013/08/12-things-about-doximity.html
https://itunes.apple.com/us/app/doximity/id393642611?mt=8
https://www.doximity.com/

iOS & Android

Doximity Doximity

Prognosis (For Junior Doctors)

This is an interesting app aimed at healthcare professionals, junior doctors, medical students and nurses. By simulating a number of different clinical cases it allows you to test your diagnostic ability. With new cases added to its library each week you are presented with a short detailed review of the diagnostic process which is supported by up-to-date discussions around that condition.

http://www.prognosisapp.com/
http://www.juniordr.com/index.php/technology/best-medical-smartphone-mobile-and-ipad-apps.htmlhttp://www.imedicalapps.com/2010/11/prognosis-your-diagnosis-app-simulation-clinical-cases-iphone-free-medical-app-review/
https://itunes.apple.com/us/app/prognosis-your-diagnosis/id392489854?mt=8

iOS & Android

Prognosis Prognosis

 Vital Signs (NHS Workers)

This app is something a little different and has been designed specifically for the wellbeing of NHS employees. It’s purpose is to help keep NHS health professionals fit and healthy but also to provide a support infrastructure for help with alcohol misuse, healthy eating & mental wellbeing at work. There are also a range of work tools available within the app like hospital maps, local transport information and the latest health & safety guidance.

http://www.vitalsigns.nhs.uk/
http://www.ahsc.org.uk/ahsc-healthcare-apps/
https://itunes.apple.com/gb/app/vitalsigns/id585262640?mt=8

iOS & Android

Vital SIgns Vital Signs

NICE BNF

The NICE BNF app kind of encapsulates the digital transition in the medical profession. Going from what used to be hard copy buried deep within a hospital ward, the information is now available in your pocket. Once the initial download has taken place the app works off line without the need for an internet connection and its recent re-design makes it a pleasant and easy to use system allowing you to set bookmarks combined with a really good search facility. It is a free app but in order to login you will need a free Athens account that’s available to all NHS clinical staff.

http://www.nice.org.uk/about/what-we-do/nice-apps-for-smartphones-and-tablets
http://www.imedicalapps.com/2012/09/british-physicians-bnf-app-nhs-clinical-staff-free/
http://review2013-2014.nice.org.uk/support/British_National_Formulary_BNF/

iOS & Android

BNF BNF

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

N3 logo

Many ideas for medical pp development and healthcare web design projects 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.

To find out more about how Genetic Digital’s expertise in developing healthcare and pharmaceutical websites and health apps could benefit your project contact us now.

World’s first prescription only app

welldoclogoTake Two Pills Twice a Day – and An App

Without our mobile phones we would be lost, appointments would be missed, and our lives would fall apart. We rely on smartphones to get us up and get us through the day but are we ready to rely on them for medical advice? An innovative new app is due to launch later this year, as BlueStar’s prescription only app for smartphone becomes a trailblazer in its field.

Could this potentially be the start of something momentous, and poses the question – just how far away are we from being prescribed apps with our medication?

Do we even want to go down that route? What are the pitfalls and the benefits? Is introducing this remoteness and prescription by app to be welcomed or feared? Will GP’s be comfortable prescribing an app with medication and how will a prescription only app be paid for? Furthermore, what restrictions will be placed on marketers with regards to promoting the app, will it fall under the ABPI code of practice as do prescription only medicines (POMs)? So, are we likely to see the buzzword POA (prescription only apps) being added to the pharma jargon dictionary?

WellDoc – a prescription only app

The Blue Star app can be downloaded to tablet, computer or smartphone in the normal way but will only become interactive with a special prescription code issued by a pharmacy. This is the first healthcare app that needs a doctor’s prescription to work and it is being trialled in a small area of the US where it is already causing quite a stir, as several large US corporations have announced plans to incorporate the app into the health cover that they offer their employees. The precise cost of the app is not yet known but speculation is that it is very likely to be some way over $100 per month.

This medical app has been put through its paces by the FDA in the USA and was approved for use in 2010. The app has been designed as an aid for people with type 2 diabetes. It prompts them to check blood sugar levels and gives them useful information about controlling fluctuations in glucose levels along with other advice to help them manage their condition. The prescription only app will offer encouragement and praise for regular blood sugar checking and might also issue helpful reminders to take medication with food, for instance.

Following in the wake of Nike’s FuelBand, an app that is designed to record health related performance, Blue Star’s app does not monitor a patient directly but rather provides a platform for them to use to record the information needed to best manage their condition. The question is how will doctors receive this innovation? Not having immediate control of their patient may not sit well, but BlueStar plan to calm any qualms by sending patients statistics to doctors who can then use the data to make adjustments to treatment. Another potential stumbling block may be the perceived intrusion that might be resented by patients if no immediate improvement or benefit is seen. Only time will tell if the prescription only app is going to become mainstream.

Genetic Apps Launches

genetic_appsThe last 6 months has been an exciting time in Genetic Digital’s growth and we’ve established ourselves as one of the UK’s leading experts in the area of health and medical mobile app development.

We’ve built some highly innovative apps for the likes of the NHS and pharmaceutical brands and we recently completed the development of our first MHRA approved app which we believe to be only the second app in the UK (the first one being Mersey Burns App) to carry the CE mark as a class 1 medical device.

As a result of this specialism we’ve launched a dedicated website called Genetic Apps which will contain specific content relating to our health and medical app development services. Over the coming months we’ll be adding more new resources and insightful blog posts to help you keep up to speed on this fast evolving and innovative area of digital and mHealth.

We’re exhibiting at MedTech Innovation Expo

MedTech ExpoGenetic Digital are going to be exhibiting at this year’s MedTech Innovation Expo at the Ricoh Arena, Coventry on the 20th & 21st April.

As specialists in developing web and mobile solutions for the healthcare, pharma and medical device sectors this will give attendees a great opportunity to come and talk to us and learn more about the mobile apps we have built for our clients.

We’ve developed apps that interface with medical devices; taken apps through CE Marking and built sophisticated online ordering systems.

Win an Apple WatchWe will also be giving you the opportunity to test our demo app which connects to a medical device and by doing so you’ll also be entered into our prize draw to win an Apple Watch.

Terms & Conditions Apply

Visit us on stand #27 or arrange a meeting with us in advance.

Turning your clinical pathway into a mobile app

It has been reported that health and wellbeing applications are estimated to make up approximately 40% of new smartphone apps currently being developed. Health and medical related apps have the potential to be adapted and used by healthcare professionals, helping to revolutionise the sector and reflect the digital age we live in.

There has also been a lot of discussion around providing HCPs with greater access to clinical pathways and care maps so that they can easily check medical guidelines on the go to help ensure that they are implementing a specific task in-line with best practice.

So, does it make sense for healthcare organisations to create handy mobile apps that HCPs can quickly and easily access on their smartphone so that they can check to make sure that they’re following the correct procedure?

Here are 5 key areas for you to consider that will help you to make an informed decision.

1. Does the pathway already exist already?
Because clinical pathways exist to promote efficient patient care based on evidence based practice they are more often than not available in a paper format but trying to track them down can be difficult. If the pathway already exists in paper based format then it’s more than likely that the pathway can be re-produced to work as an app, providing that there is a clear process that can be followed.

2. Can the pathway be used in its current format or does it need modifying?
Generally clinical pathways refer to medical guidelines. However a single pathway may refer to guidelines on several topics in a well specified context, for example both paediatric and adult pathways for a single indication, so it’s important to imagine the user and the point at which they may need to engage with the pathway. If the pathway is overly complex covering a number of topics, can it be reproduced in a number of different flavours making it easier for the end user to access the correct pathway more quickly?

3. Additional help information and any other relevant reference points.
Using the devices functionality a user will be guided through the process by answering relevant questions about the patient and their symptoms. In some cases the answer may not be entirely clear but developing the pathway as an app allows you to include additional information in the form of text, images and video to help clarify points and questions. In addition to this if there are other reference points that are relevant to the pathway, links can be built into these to help provide further explanation.

4. Test the app with local teams to check its effectiveness, sign off and launch the app and tell everyone about it.
As with any new tool, it’s important that you test it thoroughly before launching it for use by the whole of the department/organisation. Testing should involve making sure that each end-user can fully complete each specific task on the app that you set them. If they are unable to do so then you will be able to identify whether the app has a technical glitch or if the user journey is not clear and thus making it confusing for the end-user to complete the task. It’s also important to make sure that if the app is designed for use on multiple devices and operating systems, i.e. iPhone, Android, iPad, Blackberry, Microsoft etc, then make sure that you have users in your testing group that will be trialling the app on each of the devices and platforms that you will want the app to work on.

5. Track usage and improve the app where necessary
Even when the app is ‘live’ and in use it’s still important to capture data on its usage and give end-users the opportunity to submit feedback to highlight any glitches or possible areas for improvement. Your end-users can provide you with some useful insights into additional features and functionality that could help make the app even more useful and this can help to encourage more people to download it.

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.