In our digital focus month, James Whitehouse explores the mobile health apps market and takes a look at the European and American regulations that provide guidance on how healthcare apps can be classed as medical devices.
Market context for mobile devices and healthcare apps
Since the launch of the Apple iPhone in 2007, the mobile application market has seen a meteoric rise. The inclusion of other competitor application markets (like Google’s android market and Microsoft’s Windows application market) has also helped to increase the number of people using mobile applications.
In the UK, it is believed that the number of smartphone users is expected to reach 41.9 million people (or 65.1% of the population)¹.
Figure 1: The estimated growth of UK mobile smartphone users¹
Since the beginning of this “mobile generation”, the number of healthcare professionals making use of mobile technology has also increased. In a survey conducted in the UK, 99% of registered health professionals use a mobile phone, with 81% of these being a smartphone².
The healthcare profession’s increasing use of mobile devices has created a new way for healthcare and technology to interact. With this has come an increasing number of mobile health “applications” - apps.
"...in October 2012, more than 6000 apps were classified as “health”, “healthcare” or “medical”."
In August 2012, it was estimated that 40% of the apps in development had some form of healthcare context3 and in October 2012, more than 6000 apps were classified as “health”, “healthcare” or “medical”4. They are said to have huge potential in training and professional development, as well as helping to truly bring the digital age to the healthcare profession3.
As well as their potential for training and professional development, healthcare apps can be broadly classified into three different types, Encyclopaedia apps, that often contain data or knowledge that can be found in books, health lifestyle apps which are made for people who are not clinicians and contain information about life, hygiene and general health condition, and finally, medical device applications that are subject to regulatory scrutiny. Through draft guidance released in 2011, the FDA defined a small subset of mobile medical apps that may impact on the performance or functionality of currently regulated medical devices and as such, will require FDA oversight. In Europe, we are already seeing apps obtain a CE Mark under the EU’s Medical Device Directive’s4.
But what makes an app a medical device?
The regulatory framework for healthcare applications: are apps a medical device?
The European Commission’s latest guidance from January 2012, defines a medical device as:
“…any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and / or therapeutic purposes and 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
"Broadly speaking, software is a medical device when it has a controlling function..."
• 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”5
Broadly speaking, software is a medical device when it has a controlling function, such as drug delivery, x-ray intensity, defibrillation current and gas mixture administration. Software that is considered standalone or independent from other devices may also be considered a medical device when it is performing an action on data different from storage, archiving, lossless compression, communication or simple searching6.
If an application, regardless of platform, is deemed to perform any of the functions detailed above then the software needs to be registered as a medical device.
There are now a great number of examples of apps that have a medical device status. In January 2012, the Mersey Burns app was the first app to be registered as a medical device in the UK. The app, developed at the Mersey Regional Burns and Plastic Surgery unit, helps healthcare professionals calculate burns area, fluid prescriptions and background fluids, as well as recording patients’ details7.
"Before long, it could be the norm for doctors to prescribe applications to help treat disease..."
More recently, OncoAssist has become the latest app to gain a CE mark. The app is designed to save the oncologist time by providing quick and easy access to prognostic tools that can help with decisions surrounding risk stratification and suitability for inclusion into clinical trials. The app is free to download, but has a monthly subscription fee dependent on the number of tools the user adds into the software8.
Considerations for the pharmaceutical industry
It is important for any industry to keep up to date and evolve, especially the pharmaceutical and healthcare industry. Before long, it could be the norm for doctors to prescribe applications to help treat disease as well as using applications in diagnosis and patient management.
Along with the tremendous opportunity mobile applications present, the pharmaceutical industry needs to be aware of the strict regulations surrounding medical devices when developing applications that meet the criteria as described above. It will be important to seek legal advice and liaise with the regulatory authorities when developing an application that could be considered to be a medical device.
1. eMarketer. In the UK, Will Mobile Payments Go Mainstream? www.emarketer.com. [Online] 31 January 2013. [Cited: 01 March 2013.] http://www.emarketer.com/Article/UK-Will-Mobile-Payments-Go-Mainstream/1009641.
2. d4. A survey of mobile phone usage by health professionals in the UK. www.d4.org.uk. [Online] 2010. [Cited: 01 March 2013.] http://www.d4.org.uk/research/survey-mobile-phone-use-health-professionals-UK.pdf
3. Guardian, The. The benefit of healthcare apps. www.guardian.co.uk. [Online] The Guardian, August 2012. http://www.guardian.co.uk/healthcare-network/2012/aug/21/apps-healthcare-tablets-mobile-smartphones.
4. Michaud, Cyrille. The boom of software medical device apps. www.md101consulting.com. [Online] October 2012. http://www.md101consulting.com/articles/item/113-the-boom-of-software-medical-device-apps.
5. Commission, European. GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES. ec.europa.eu. [Online] January 2012. http://ec.europa.eu/health/medical-devices/files/meddev/2_1_6_ol_en.pdf.
6. Pinfold, Malcolm. Regulatory framework for healthcare apps. www.medilinkem.com. [Online] October 2012. http://www.medilinkem.com/docs/default-document-library/malcolm-pinfold-version-for-web.pdf.
7. Tyer, Dominic. Are pharma apps medical devices . www.pmlive.com. [Online] January 2012. http://www.pmlive.com/blogs/digital_intelligence/archive/2012/jan_2012/are_pharma_apps_medical_devices.
8. —. OncoAssist becomes latest app to be classified as a medical device. www.pmlive.com. [Online] February 2013. http://www.pmlive.com/blogs/digital_intelligence/archive/2013/february/oncoassist_becomes_latest_app_to_be_classified_as_a_medical_device.
About the author:
James Whitehouse, BA (Hons), is an analyst at GfK Bridgehead.
James studied at Lancaster University Management School attaining a BA (Hons) degree in Economics and Politics. He completed his final year project on the factors effecting gross domestic product in the UK and was awarded a first class for this. After completing his undergraduate degree,
James moved to work for the NHS, working for University Hospitals Birmingham NHS Foundation Trust. Here he worked in the Trust’s contract department, building and developing the hospital’s legally binding acute contracts with Commissioners. James developed detailed knowledge of the NHS operating framework as well as the inner workings of the payment by results system, the National Institute for Health and Clinical Excellence (NICE) and reimbursement in the NHS.
James started an MSc in Health Economics whilst working for the NHS and will continue his studies. It was during these studies that he developed a keen interest in the economics of healthcare as well as reimbursement, market access and the commercial side of the industry.
Tel: +44 1664 503700
Can mobile health apps be classed as medical devices?