Hands up who remembers being sent around wards to do ‘obs”?! The practice of going from bed to bed with an array of tools has been derided as ‘task orientated’ – and while few argue with this, I personally feel it had one benefit, in that it was a structured way of ensuring that all patients (even the quiet ones!) had at least a basic assessment and a few minutes of chat regularly each day.
Did you ever imagine, as you wheeled that squeaky sphyg (or carried it awkwardly in the crook of your arm) that there would be a day when patients would show you their own recordings of their ‘obs’ on their phone, taken at various times during their day, at home in their own environment?
If you haven’t already had a patient show you a graph of their blood pressure readings on their phone yet, it’s only a matter of time. In many ways it’s patients around the world who are driving the move to mobile health. People are seeking better insights into their own health and there are plenty of app developers willing and able to provide the necessary technology, free or at a very small cost. There are predictions that in the not too distant future, patients will be prescribed health promotion apps along with medication and exercise programmes.
What exactly is an App?
A mobile app is application software, i.e. a computer program, that’s designed to run on smartphones, tablet computers and other mobile devices. Apps became widely available to smartphone users in 2008. The term Application Software was shortened to App in popular culture and became so widely used that in 2010 it was voted Word the Year by the American Dialect Society. (For fun, or to score points at table quizzes, check out their website to see when the terms ‘tweet’, ‘bailout’, ‘hashtag’ and ‘mother of all – ‘ were each voted Word of the Year).
There are over 1 billion apps on the market across all platforms – IOS, Android, Blackberry, Windows, etc. It’s believed that there are now 100,000 health related apps available. Some collect data that’s entered by the user. Others encourage positive changes in health behaviours through encouragement and motivation, e.g. smoking cessation apps that calculate how much money has been saved and how many measurable improvements have been made to quality of life since quitting. The really fascinating (and scary!) apps are the ones that are designed to have a diagnostic function, e.g. scanning skin for lesions, x-raying fractured limbs or reading cardiac arrhythmias.
Health related Apps – a rich opportunity – but for whom?
There are 11 million professional software developers globally1 and many see healthcare as a niche that’s rich in opportunity (and income) because demand far exceeds supply simply because healthcare systems and structures are so far behind what patients are demanding in terms of e-Health. The mobile health market in general is estimated to be worth $9billion this year2 and expected to rise to $20billion by 20183. While this is good news for those in the I.T. sector, there is concern about the quality and effectiveness of apps, and the fact that they are largely unregulated. For example, relatively few lifestyle apps incorporate the processes necessary for behaviour change and an alarming number provide information that has no scientific basis4. The FDA in the US has only cleared about 100 mobile medical apps to date through its regulatory process.
A recent study of iTunes found almost 43,700 health related apps, but only 54% were ‘genuine’ healthcare apps and 69% of these were aimed at patients. 159 of these captured data – the rest were mostly educational in nature. Fewer than 50 related to management of specific conditions or included tools and calculators5.
A leading advisor on health technology in Canada has said that some apps on the market amount to “virtual quackery, of, if you prefer, digital snake oil,”6 Experts and commentators refer to current times as “the Wild West of the app phase”, citing inadequate regulation and privacy issues when apps collect more information than necessary, such as geographical location of the user.
However, the future is also ripe with opportunity for improving healthcare and health literacy if app technology can be harnessed and managed properly.
A study of smartphone users in the US revealed that 38% used their device to find health information.5 By 2018, half of the world’s 3.4billion smartphone users will have downloaded a health app5. Obviously this will represent a significant shortcut for healthcare providers to tap into each person’s ‘trigger’ at that crucial teachable moment when motivation is high – but the change management will only be successful if app developers and health experts have worked together to ensure the app systematically takes the user through all the steps to change and to incorporate a feedback mechanism for the healthcare provider to monitor progress. To date, this sort of collaboration appears to be the exception. Separate studies in Ohio and the UK revealed that more often than not, apps had little or no input from health experts during their development.4
Regulation is another area that needs to keep up with what is happening ‘on the ground’. As often happens in our fast moving world, governance of this demand-led technology has really only gained traction in the last couple of years. Some of the challenges for regulators are the sheer number of healthcare apps, the speed with which apps come and go from the market and the pace of technological advances.
United States: In the US, mobile medical apps (MMAs) are defined by the FDA as apps that are intended to “diagnose, cure, mitigate, treat, or prevent a disease or other condition; or affect the structure or any function of the human body”. 7 The FDA published guidance on MMAs in September 2013, but this guidance was the subject of some debate at Congress because some legislators do not believe software can or should be classed as a medical device. Also, the guidance did not include the area of clinical decision making software. This will be addressed separately by Congress and the FDA is currently undergoing a consultation process with stakeholders.8
An updated guidance document was published by the FDA on 9th February 2015, which “Further narrows apps defined as MMA …Mobile apps that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or for use in active patient monitoring or displaying, storing, analyzing, or
transmitting patient-specific medical device data.” Here is a link to the slides from a webinar the FDA held to explain the updates.
Europe: In Europe, the EU’s Medical Devices Directive was introduced in 1993 to harmonise laws relating to medical devices within the European Union9. Devices that comply with the Directive must have a CE mark applied. CE (Conformité Européenne), is a key mark of a product’s compliance with relevant EU legislation.10 As of October 2013, there were only 3 medical apps in Europe that have a CE mark (and one of them was developed by an Irish software company!)11.
Software was added to the EU definition of medical devices in 200712 and apps that perform specific interpretive or diagnostic functions are likely to be classified as medical devices and therefore subject to the same regulatory requirements as physical devices.13 Here in Ireland, medical devices are classified by the Health Products Regulatory Authority (HPRA) – formerly the Irish Medicines Board – based on their intended function, the method of collecting data (e.g. if invasive to the body), and whether they represent a low, medium or high risk to health. It is the responsibility of manufacturers to classify any medical device they intend to put on the market.
International Standards: The HPRA is now a member of the European Commission to the International Medical Device Regulators Forum (IMDRF) which aims to ‘harmonise regulatory systems as much as possible’ and whose remit will also include software as a medical device.14
In summary, apps that simply store information or summarise it in graphs or pie-charts are not classed as medical devices. Apps that have an interpretive or diagnostic function are termed “software as a medical device” for regulation purposes and are subject to the current laws governing regulation.
So, if an App doesn’t have a CE mark, how can you decide if it’s credible?
- Look for controlled clinical research that supports the app.
- Check if the developer has linked up with a medical school faculty that can test their product or at the very least has had advice from a named healthcare professional.
- Look for citations to journal articles and medical literature or a peer-review process for content and recommendations.
- Look for apps supported or endorsed by a reputable group or government agency.
- com is a private US based company that recently launched App Certification based on standards agreed with the American Medical Association and other stakeholders. Physicians can pay a fee to access curated apps.
- Avoid any that have advertisements for products dancing around the screen.
- Avoid apps that ask for unnecessary or excessive personal information.
- Download apps from reputable app stores, such as iTunes or Google PlayStore.
- Check how many times that app has been downloaded. Several thousand or more usually indicates an app that works and is liked by other users.
Nurses are ideally placed to assist and encourage patients who are motivated and engaged in their own health. Even if your workplace is not quite in the digital age yet, if you keep an open mind to the benefits of mobile technology while watching out for the pitfalls, you won’t be ‘left behind’ when your patients move with the times. While we all await the rollout of e-Health you could even be the one healthcare professional who empowers them now, today.
Edited from an article originally published in ‘Nursing in General Practice‘ July/August 2014 issue.
1 International Data Corporation www.idc.com
2 “mHealth revenue to reach $9 billion in 2014” – https://www.asdreports.com/news.asp?pr_id=1942
3 “The Explosion in Health Apps, And How They’re Disrupting the Gigantic, Lethargic Health Care Industry”
4 “What’s missing from many health apps — medical expertise” – www.amednews.com
5 “The Numbers on Mobile Healthcare Apps” – http://www.healthcarepg.com/uncategorized/a-few-statistics-on-the-mobile-healthcare-market/
6 “PwC: Formularies for health apps needed”, September 2013, www.MobileHealthNews.com
7 “A Developer’s Guide to Privacy and FDA Regulation of Mobile Medical Apps” – http://www.imshealth.com/deployedfiles/imshealth/Global/Content/Technology/mHealth/DevelopersGuide.pdf
8 “FDASIA Health IT Report – Proposed Strategy and Recommendations for a Risk-Based Framework” – http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhreports/ucm390588.htm
9 Irish Medicines Board – Medical Devices Newsletter, October 2012. http://www.hpra.ie/docs/default-source/publications-forms/newsletters/medical-devices-newsletter-issue-no-35-octomber-2012.pdf?Status=Master&sfvrsn=2
10 European Commission. Enterprise and Industry: CE marking
11 “Irish app certified by CE as a medical device” – http://www.siliconrepublic.com/innovation/item/31753-medtech
12 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 September 2007 – http://ec.europa.eu/health/medical-devices/files/revision_docs/2007-47-en_en.pdf
13 “Guide to Classification of a Medical Device” Health Products Regulatory Authority (formerly Irish Medicines Board) – http://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/adv-g0004-guide-to-classification-of-a-medical-device-v2.pdf?sfvrsn=4
14 Irish Medicines Board – Medical Devices Newsletter, May 2014 – https://www.hpra.ie/docs/default-source/publications-forms/newsletters/medical-devices-newsletter-issue-no-39-may-2014.pdf?sfvrsn=6