Apple healthbook mock-up

Apple’s Healthbook app could make it easier for you to manage your own health

In line with the current trend towards health apps and wearables, Apple is due to launch their own app, Healthbook.  The release of the app is likely to be timed to coincide with the release of iOS 8.  It will collect and then organise specific information as well as data points that relate to the health of the app user.  Included in the app’s offerings is the chance to access statistics on fitness, delivered from the new M7 processor in the iPhone 5.  Other data will be collected from a new wearable device (the iWatch – rumoured to be a ‘smartwatch’ that acts as a small wearable computer worn on the wrist and synced with the iPhone.) The app will be preinstalled and will be capable of tracking data points such as information on things like blood pressure, heart rate, hydration levels, and has the potential to monitor other significant data for conditions like diabetes with measurement of blood glucose levels. Another feature could be the capability to remind the user of times at which they should take their medication.

Taking multiple user interface cues from the Passbook app, also produced by Apple, the Healthbook app has been developed to store such things as coupons and loyalty cards as ‘virtual cards’ removing the need for the actual item to be carried in a physical purse or wallet.

Apple's Healthbook Screen Mockup

Essentially the interface of the new Healthbook application is a virtual store of cards that can be swiped with ease. Each of the stored cards signifies a different data point for a health or fitness parameter. The logo for the Healthbook app bears a striking resemblance to the Apple Passbook icon.  The design of the Healthbook app, however, is decorated with graphics that depict vital signs.  Along with this new app, Apple are rumoured to be working on the design of their iOS 8 with the iWatch very much in mind.  Sources also suggest that both the iWatch and iPhone will be dependent on each other to a great extent to enable the health-tracking features.  It is thought that the iWatch will be able, in the same way as the Healthbook does, to measure health parameters that include vital signs such as heart rate etc.

An Apple App a Day Will Keep The Doctor Away

Although as yet the speculation as the launch date of the app is just that, sources do suggest that Apple have managed to combine several of the health sensors into just one chipset to keep the size as small as possible.

Recently, Apple has also even requested a few patents. According to one document filed with the U.S. Patent and Trademark Office, the company is developing technology that could possibly unlock a device like an iPhone by identifying the owner’s unique electrical signals from the heart. And last year, Apple hired several health, medical, and fitness experts to work on these hardware and software projects.

None of the above comes as a surprise to me as Apple are looking at a number of new areas to diversify into to help re-ignite its growth and with the healthcare app development market set to grow to over $20 billion by 2017, I guess Apple want a slice of that tasty pie and with lashings of cream on top!

Medical app compliance

World’s first prescription only app

Take 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

WellDoc - World's first prescription only appThe 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.

Medical app compliance

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