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.

Communicating with Physicians on the Internet, What Healthcare Companies Need to Know.

There is no doubt that more and more doctors are coming around to the use of the digital world – according to Simon Grime Managing Director of Communications for Doctor.net.uk the UK’s largest and most active network of medical professionals.  Over 40,000 doctors engage with Doctors.net.uk each day – that’s over 25% of all UK doctors using the same website in a single day.

But, Grime warns, to make the most of the huge potential to engage with doctors online, pharma and healthcare companies must first make it their business to understand doctors’ needs and digital behaviour, so that they can be sure that they are providing the right content in the right format.

Grime points out that when contemplating any approach ‘en masse’ to medical professionals, the first thing to bear in mind is that they are not all the same.  Indeed, according to his experience Grime has observed that doctors online information and communication needs vary significantly according to such factors as their specialty, the age of the doctor and their nationality.

Work that Doctors.net.uk have done has shown, for instance, that:

    • Oncologists are more likely to download medical apps when compared to haematologists. (71% vs 51%)
    • Haematologists use the Internet much more frequently to read clinical papers than psychiatrists. (40% vs 8% use the Internet at least twice a day to read a clinical paper)
    • Rheumatologists are half as likely to visit pharma-operated websites in a typical month compared to Haematologists. (14% vs 30%)

Doctors.net.uk has also gathered information from other sources specifically data from their partners in the Networks in Health Alliance of Physician networks – which covers more than two million physicians worldwide through its online community networks.  They have found from this that there is considerable variation in physician attitudes and on-line behaviour across Europe.

Some interesting statistics that they have posted show that pharmaceutical representatives are most likely to be trusted by doctors in Spain and least likely to be trusted by them in the UK, Sweden and Germany.  Interestingly it is in the latter group where the use of the Internet and membership of independent online communities is more advanced and important to physicians that the greatest caution is observed.   Surprisingly, the work that Doctors.net.uk has done shows that the use of the Internet by doctors in France is significantly lower than doctors in other major European countries, although this picture, they report, is changing.

There is no doubt that making contact with online professional communities can provide the most effective method of making meaningful long-term relationships with any medical orientated audience.  They offer a wide array of prospects and exclusive understanding of the on-line physicians’ thinking and behaviour.

In a world where so much information is available, doctors, when they use the Internet are naturally seeking to ensure that they have the security of an authenticated and legitimate online sources within the medical and pharmaceutical community. These communities, therefore, are becoming the communications channel of choice for pharmaceutical companies who wish to reach medical professionals.

It follows therefore that those wishing to communicate with physicians and other medical professionals need first to do their research into the group they want to target with their message.  Then they need to understand those groups on line behaviour, if they want theirs to be the message that is received, understood and acted upon.