mHealth – diagnosis via your smartphone sounds great but if something goes wrong who is at fault?
We have recently been reading with interest EU and UK development in the field of medical apps (mHealth) to help with patient care and monitoring. The emergence of this technology is advancing rapidly and there are currently 97,000 apps available on the market. Testing, regulating and approving these apps is a major task as anyone can download anything they choose if they feel it will help improve their situation.
Our interest as clinical negligence lawyers in this changing playing field is where these apps fall regarding medical negligence issues. We can see how they can benefit patients and medical practitioners and there are potentially a huge number of advantages from using clever technologies but when something goes wrong, for example an incorrect diagnosis is given that the user is healthy when they are not, who is to blame? Is it the doctor, the app developer or the patient?
The following is a précis of a Green Paper on mobile health by the European Commission released in 2014 and makes very interesting reading. The full report can be downloaded here.
mHealth is an emerging and rapidly developing field which has the potential to play a part in the transformation of healthcare and increase its quality and efficiency. mHealth solutions cover various technological solutions, that among others measure vital signs such as heart rate, blood glucose level, blood pressure, body temperature and brain activities. Prominent examples of apps are communication, information and motivation tools, such as medication reminders or tools offering fitness and dietary recommendations.
mHealth could also support the delivery of high-quality healthcare, and enable more accurate diagnosis and treatment. It can support healthcare professionals in treating patients more efficiently as mobile apps can encourage adherence to a healthy lifestyle, resulting in more personalised medication and treatment.
It can contribute to the empowerment of patients as they could manage their health more actively, living more independent lives in their own home environment thanks to self-assessment or remote monitoring solutions and monitoring of environmental factors such as changes in air quality that might influence medical conditions.
In this respect, mHealth is not intended to replace healthcare professionals who remain central to providing healthcare but rather is considered to be a supportive tool for the management and provision of healthcare.
mHealth has the potential to play a key role in transforming our lives for the better . Yet it is imperative to ensure that technology is safe and secure for use by citizens.
mHealth solutions support the changing role of patients from a rather passive, to a more participative role while enhancing their responsibility over their own health through sensors that detect and report vital signs, and mobile apps that encourage them to adhere to diet and medication.
It is also foreseen that by 2017 3.4 billion people worldwide will own a smartphone and half of them will be using mHealth apps.
Consumers might be concerned about the risks posed to their health information, such as unwanted sharing with third parties (e.g. employers or insurers). Indeed, 45% of consumers say they are concerned about the unwanted use of their data when using mobile devices for health-related activities. There are also legitimate concerns about the security of individuals’ health data when using mobile health technologies as their personal data could be accidentally exposed or easily leaked to unauthorised parties.
The eHealth Action Plan 2012-2020 indicated that the rise of mHealth is blurring the distinction between the traditional provision of clinical care and self-administration of care and wellbeing; and that different actors were seeking clarity on their roles and responsibilities in the value chain of mobile health28.
There may be a need to assess the legal issues arising from the use of lifestyle and wellbeing apps, in view of the potential safety risks they may pose to citizens’ lives.
Over 97,000 mHealth apps are currently available across multiple platforms on the global market. Despite interest in apps and enthusiasm for their use, they have yet to enter mainstream of healthcare provision, and in many respects are still viewed as a novelty.
The safety of mHealth solutions and lifestyle and wellbeing apps may be cause for concern, explaining the potential lack of trust. Reports underline that some solutions do not function as expected, may not have been properly tested or in some cases may even endanger people’s safety. In addition, the information these solutions provide can sometimes be insufficient as to who developed them and whether they have undergone appropriate reviews or followed established medical guidelines or clinical tests
Finally, safety concerns arise when citizens can use the results of an mHealth solution or app to take decisions on their own which can potentially endanger their health or when the mHealth solution erroneously states the person is healthy.
mHealth solutions are not meant to replace doctors. They may help people stay healthy and/or support patients in managing their health conditions. In some cases, it may be necessary that doctors accompany patients in their use of these solutions.
The issue of identifying potential liability arising from the use of an mHealth solution may be complex, because of the numerous actors involved: the manufacturer of the mHealth solution, a healthcare professional, any other care professional involved in the treatment or the electronic communications provider providing the internet.
The damage to patient health can come from various sources: a defective device; a wrong diagnosis by the healthcare professional based on inaccurate data; an error by an IT specialist; the patient did not use the device correctly or sent the wrong data to his doctor. This list is not exhaustive and cannot envisage all the possibilities of risks but they certainly highlight a cause of concern.
So if you have used or are planning to use a mHealth app make sure it is has the CE mark, explained in this Royal College of Physicians factsheet:
And should something go wrong with your treatment or diagnosis we would suggest seeking legal advice to ascertain where the fault lies.