mHealth, or mobile health, is the use of digital health apps with mobile technology, such as phones, tablets, smart watches and other wearables.
As well as everyday wellness and fitness monitoring, mHealth is increasingly used in patient care, including apps that:
mHealth apps are also used for public health and healthcare management purposes, such as:1
The global mHealth market is currently estimated to be worth over USD 50 billion and is projected to increase in value to more than USD 800 billion by 2030.2
“With their wide availability, mobile technologies have huge potential to support healthcare in developing countries with limited resources and infrastructure.”
Kirsten Beasley | Willis Towers Watson
With their wide availability, mobile technologies have huge potential to support healthcare in developing countries with limited resources and infrastructure.
Regulation varies between jurisdictions: not all countries have regulation and not all apps are regulated.
Regulation largely depends on what an app claims to do.
Apps that meet the definition of a medical device – typically, those that diagnose, treat or mitigate disease or health conditions – are always likely to be subject to regulatory scrutiny.
Areas of regulation can include:
Current regulatory frameworks in major markets include:
The regulatory environment is struggling to keep up with the speed of change.
One example of this is the UK NHS Health Apps library, which was launched in 2013 to guide patients and providers to safe and effective mHealth applications.
The library was plagued by criticisms about the NHS’s ability to screen mHealth apps, particularly on safety and efficacy.
It was shut down after two years and only relaunched in 2017 once rigorous testing and screening had been put in place.
Claims to date have focused on apps not performing as promised, especially where they have made inaccurate claims about their capabilities, such as advertising to protect against cognitive impairments, or claiming to detect symptoms of certain types of cancer.
Where an mHealth application is used as part of an intervention, it’s possible that it could result in bodily injury or physical harm to a patient.
“Where an mHealth application is used as part of an intervention, it’s possible that it could result in bodily injury or physical harm to a patient.”
Kirsten Beasley | Willis Towers Watson
This raises the possibility of liability for medical malpractice.
There is also the potential for product liability exposures as the boundaries between digital and physical healthcare blur and apps become redefined as products.
App-related exposures are currently typically covered by an errors and omissions policy designed to pick up the economic losses resulting from the failure of a technological service or product.
However, as discussed above, app providers need to consider that they may also be open to claims for medical malpractice and product liability claims as the technology evolves.
Some product liability policies already accept tech in their product definitions.
Fully understanding the evolving coverage needs for mHealth apps requires several different areas of underwriting expertise.
Since underwriters tend to specialise in one area, app providers need to consider brokers and insurers that can combine the different sets of knowledge required.
1 Labrique et al, Global Health: Science and Practice August 2013, 1(2):160-171; https://doi.org/10.9745/GHSP-D-13-00031
2 Global Market Insights, 2021
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| Can an mHealth app be liable for malpractice? | .4 MB |
