Craven and colleagues discuss the potential and the problems associated
with using apps to support patients and carry out healthcare research.
importance of human factors in healthcare app design was highlighted by
the Food and Drug Administration in the USA, which has developed
regulations for apps that are closely tied to those existing for medical
devices. Likewise in the UK, the Medicines and Healthcare Products
Regulatory Agency (MHRA) has, in the past year and half, begun to
regulate some healthcare apps as medical devices.
researchers at the University of Nottingham have developed a number of
healthcare apps in recent years, the majority of these being co-designed
with clinical researchers. These apps are intended to support a number
of different studies with volunteers who are, for example, undergoing
treatment for sickle cell anaemia to monitor their experience of pain or
for sufferers of mild asthma where physiological signals are captured
in parallel with self-assessed wellness scores.
particularly interested in the kind of ‘ecological’ assessment that is
offered by patients having continuous access to smartphones. This access
means that the timing of data collection can be controlled and
monitored more easily than with paper-based methods. Phones can be used
either as diaries or collection tools for measurements from medical
devices, some of which are able to communicate directly via Bluetooth.
Furthermore, phone features such as in-built accelerometer readings can
be used to detect movement, while cameras can be used to monitor light
Our initial experiences of co-design with researchers have
shown us that once the possibility of regular ambulatory monitoring or
self-monitoring is made possible using smartphone Apps, a number of
issues will arise. If researchers are asking participants to collect
personal data it should obviously be collected and stored in a secure
manner, and this is of prime concern in gaining ethical approval.
security is a key consideration in the new regulatory regimes, which
means it may not be acceptable to use insecure methods such as SMS
texting or emailing to prompt data collection. Furthermore, the burden
on the patient cannot be overlooked from an ethical perspective. How
often is it acceptable to ask for data collection, such as through an
app that uses the alarm clock feature of the smartphone?
illness or stress be exacerbated by a requirement to self-monitor and,
if so, what degree of user involvement should be specified in the data
collection process? It may be better to passively monitor rather than
ask someone to self-monitor too often.
As with apps in general,
users’ cognitive ability, prior experience of using computer systems and
the internet and preferences for modes of communication will all have
an impact on results. This fact suggests that a user survey or phone
audit would ideally be conducted before commencing a design.
other real-world user issues have arisen in our pilot studies.
Healthcare app users, like all phone users, do not always keep them
turned on or charged up. For a research study this could be inconvenient
or result in loss of data. A research instrument may also, in time,
become a product and if an App is being used to monitor care these
aspects of reliability will need to be assessed.
The authors are
currently working towards a protocol for healthcare App design that will
include the above considerations and others. It will be useful to share
experiences with others who are applying human factors to healthcare
By Michael Craven, Jennifer Martin & Kirusnapillai Selvarajah
This article first appeared in The Ergonomist, No 518 August 2013