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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

How to Use QR Codes to Engage Your Audience

A QR Code – Quick Response Code – looks like this. QR CodeThey are becoming increasingly more popular as an easy way of storing different types of information like URL links, contact information and text that can be read and stored by a smart phone.

Why is this important?

When used in conjunction with more traditional forms of off line media they provide an extremely effective way of communicating specific information to your target audience and, at the moment, a relatively novel way of engaging your audience as part of your digital marketing strategy.

A study released on May 4th by Manhattan Research revealed 81% of HCPs are using smart phones between 1-2 hours a day to access the internet and this figure is growing rapidly. This means the smart phone is fast becoming the tool of choice for HCPs across the world making QR codes an increasingly effective way to interact with this audience.

By ‘reading’ QR Codes with a smartphone a number of different predetermined actions can take place. If the information contained within the code is a web address, you will automatically be directed to that website or if it is contact details, you will be prompted to add them to your address book.

Download free QR Readers for iPhone and Android phones.

iPhone logo   android logo

One of the most important benefits of integrating QR codes with a campaign is how, through increased audience engagement, they become an effective means of driving HCPs and/or patients to the next step in the marketing funnel where they can be provided with additional detail or sign up options.

How can you use QR codes

Here are 5 good examples of how you could use QR codes as part of your marketing strategy:

Product labels
One of these codes printed either directly on the product packaging or to the label attached to the product could direct users to a dedicated page on your website which contains all the product specific information.

eDetailing
By including a QR code as part of you eDetailing, you can save doctors time, directing them to information they need about a particular product on your website they can then reference at any point in the future.

Direct mail
You could add one of these codes to the end of each mailing which directs people back to a page on your website with more information. You could then encourage them to opt in to email rather than postal communications.

Leave piece
A QR code printed on any product literature will make it easy to direct individuals to the right area on your website without having to navigate menus to find information. Once there, you could encourage them to perform another action like sign up for product updates.

Conferences
Introduce a QR code as part of your stand design allowing interested individuals to store your contact details directly to their smart phone, engaging them and making it easy to contact you in the future. Future event appearances can also be stored direct to their calendar.

QR Codes are already being used by many Medical, Healthcare and Pharma companies to provide quick and easy access to their latest information. If you’re not using them, it’s time to consider it!

Mobile technology to foil counterfeit drugs

An American technology company is utilising mobile phone technology in an attempt to combat the $75 billion-a-year counterfeit drugs market. Copies of proprietary brand drugs not only eat into the margins of pharmaceutical companies, who invest hundreds of millions of dollars in developing medicines every year, but also threaten the health and safety of those that take medicines not subject to stringent industry testing.

Drug counterfeiting is a global problem and is endemic in certain parts of the developing world where up to 30% of all medicines are counterfeit. To combat the increasing availability of fake drugs, PharmaSecure has developed a system that creates a direct link between manufacturers and the end user. This provides consumers with a guarantee that the medicines they are taking were produced by the licensed and regulated company.

PharmaSecure’s track and trace authentication system provides a unique ID code on product packaging, which can be used to track every stage of the drug’s journey through the supply chain right into the hands of the end customer. The customer can then use a simple SMS messaging system to verify authenticity. The system ensures the customer is protected from the dangers of counterfeit medicine and the company protects its trademark as well as maintaining the integrity of its products and brand identity.

Due to the simplicity of the system and the relatively low cost of implementation, PharmaSecure track and trace programme has the ability to be scaled on a global level and deal a severe blow to the counterfeiters.

Internet and smartphone-based nursing can help diabetic patients

Nursing via the internet and smartphones can be an effective way to help patients with uncontrolled diabetes to manage their care.

According to a new study conducted by McGill University, Canada for the Public Health Agency of Canada, tele-monitoring is also increasingly seen as a workable way of delivering care to patients with chronic conditions who live in remote places, or who require monitoring on a long-term basis.

During the pilot project, diabetic patients in four regions of Quebec submitted their blood sugar readings to a nurse every day using a secure website.

Patients also answered a series of questions online about their exercise, diet and food care.

Their nurses then monitored their responses, providing appropriate advice as and when required. If a patient’s readings were a cause for concern, then they appeared in red text and triggered an alarm.

Nurses also emailed their patients educational material to help them manage their conditions.

Antonia Arnaert, professor of nursing at McGill University, said: “Patients with chronic diseases like diabetes, or who have gone through surgery, often have lots of questions and the doctors and nurses don’t always have the time to answer them.

“With tele-nursing, whether using video-conferencing or text-messaging, patients say they feel they get lots of attention from their nurses, because they know that they have their full attention for an hour.”

“They said that tele-monitoring provided them with a sense of confidence in their ability to manage their diabetic condition themselves.”

Mobile platform to ease prescription communication for US doctors

Smartphone for medical useA healthcare communications network in the USA has revealed a new mobile platform for managing prescription plans.

NaviNet, a web-based provider of health messaging systems, will be using a system called Mobile Connect for PBMs (Pharmacy Benefit Managers) to allow pharmaceutical companies to communicate with doctors and insurance providers.

Mobile Connect for PBMs lets doctors check their patients’ insurance plans during check-ups to see which drugs they can and cannot administer according to their plan.

Doctors will also be able to receive information on whether patients are sticking to their medication schedules based on refill data from the pharmaceutical and insurance companies.

This will help them to improve their levels of care for each patient. It also enables them to access this vital information quickly and easily, saving them time on research and administration that can be better devoted to clinical practice.

Although the medical system is slightly different in the USA than it is in the UK, Mobile Connect for PBMs shows how smartphones can be used to improve communication between pharmaceutical companies and their end users and stakeholders in order to improve both sales and service.

Around 80% of doctors in America use smartphones, a figure that is expected to be replicated in the UK within the next couple of years. It’s clear that healthcare companies’ IT and marketing strategies need to embrace the smartphone and all it has to offer.