App Store Rejection

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 we’ve been approached by a few companies that have embarked on an app development project with a different 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.

They’ve approached us for help, 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.

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 medial 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 security requirements, so make sure you do the right research before choosing your app development partner.

To learn more about our expertise and experience in developing medical device apps, check out our portfolio and our medical device app development section on our website. Alternatively get in touch.

Rosemont Pharmaceuticals dosage calculator app

What we learnt from taking an app through compliance & CE Marking

We launched an app that carries the CE Mark and conforms to the EU Medical Device Directive 2007/47 EC for Rosemont Pharmaceuticals who are now registered as a Class 1 device manufacturer. The MHRA have recently released guidance on what constitutes a medical device for apps but this guidance was unavailable when we took this client through the process and this is what we learned.

Understanding the directive

I can’t remember the number of times I read this document picking out key details that were relevant to the development of standalone software. Although there was nothing directly relating to apps there are clear references to how software combined with, or independent of a device should be classified and therefore the level of compliance that needs to be achieved.

Understanding if your app would fall into the category of a medical device

The MHRA recently released their guidance on medical device stand-alone software (including apps)7  and it helps to clarify which types of apps should be classified as medical devices. It still requires developers to understand the implications of the EU Medical Device Directive but helps to identify through the use of words and phrases which apps could be classed as medical devices.

“Decision support or decision making software that applies some form of automated reasoning, such as a simple calculation, a decision support algorithm or a more complex series of calculations, eg dose calculations, symptom tracking, clinicians guides. These are the types of software most likely to fall within the scope of the medical devices directives.”

Testing and risk assessment

Registering your app as a medical device

A rule of thumb for understanding if your app needs to be compliant is if the results produced by using the app could potentially harm a patient e.g. a dosage calculator then it should undergo the necessary compliance procedures to ensure it complies with the EU Medical Device Directive. Part of this process is to thoroughly test the app across different devices, platforms,  audiences and specific functionality built in to it to demonstrate that it works as it should, producing expected results. This will form part of the risk analysis necessary for completing the document of conformity.

The registration

Once this process has been completed the application can be made to the MHRA which requires an accompanying payment of £70.00 (as of the date of writing this 15/04/2014). The application should take between 14 and 21 day to process at which point the company will receive their registration number and only after that point can the app carry the ‘CE’ mark to prove that it has full regulatory backing and will demonstrate that the app reaches all the necessary standards laid out by the EU.

App store submissions

To ensure you get submissions approved quickly, it’s really important to submit the app to iTunes Connect under the correct developer account ensuring all your meta data is completed as fully as possible and providing any references that you feel reviewers will benefit from seeing. Tripping the ‘reject’ status can lead to weeks of delays and once that’s happened it appears that Apple will scrutinise each further submission with a fine tooth comb. Google Play is far simpler by comparison and will take far less time to submit and approve before publishing.

Supporting Documents

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

NHS Health Apps Library

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 / compliance 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.