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November 20th 2015

Medical Negligence

Should health and wellbeing apps receive heavier regulations?

Should health and wellbeing apps receive heavier regulations?

The increase of a health conscious nation has led to a significant boom in medical health and wellbeing apps, with over 500 million users in the UK. The convenience of an instant diagnosis can be appealing, but some health apps offer inconsistent or inaccurate data. Without sufficient regulation, consumers could be at risk of misdiagnosis and avoid seeking appropriate medical advice.

UntitledThe increase of a health conscious nation has led to a significant boom in medical health and wellbeing apps, with over 500 million users in the UK. The convenience of an instant diagnosis can be appealing, but some health apps offer inconsistent or inaccurate data. Without sufficient regulation, consumers could be at risk of misdiagnosis and avoid seeking appropriate medical advice.

British Life Science minister, George Freeman, stressed the importance and benefits of health apps by stating that: “We need to continue to encourage patients and citizens to use new technologies to better manage their health, care and treatment. And they need to feel confident in doing so.”

What is a health app?

At the start of the decade, mobile phones featured simple pedometers and exercise apps. Today’s Internet-of-Things-culture has meant that we can access standalone software from a number of devices at any time.

Wearable technology is on the rise, with brands like Apple implementing their HealthKit suite across their range of devices. This significant shift by Apple highlights the mainstream ability to provide cost-effective care, particularly for users in the US. The popularity of mobile health apps has led to the industry being abbreviated to “mHealth”.

A study by Deloitte, Investigating the rise in digital technology throughout the healthcare industry, found that by 2018, Europe will be the largest mHealth market. Worth $7.1 billion, it has a projected a year-on-year growth of 61.6%. According to the study, over 75% of the UK population go online for health information or a rudimentary diagnosis. This can have significant benefits in promoting patient independence and minimising the use of services.

The study concludes that four types of health apps are most prevalent:

  • Single use – A smartphone app generally used to focus on wellness, diet and exercise e.g. general tips on fitness, sleep, calories and diet
  • Social – A gamification app which encourages users to complete goals e.g. Nike+ Running app
  • Integrated – An app used in hospitals and the healthcare industry to monitor patients
  • Complex – A professional app to manage diseases and analyse complex data

The relationship between pharmaceutical companies and software developers is quickly changing the face of global healthcare. Mhealth technology is even leading the way for professional health care workers throughout the developing world. Healthcare companies such as MobiSante have developed a smartphone-based ultrasound device that allows healthcare workers to perform tests almost anywhere via a secure Wi-Fi connection. These developments in technology present opportunities for the health and medical industry to seek new ways of treating patients or promoting a health-conscious nation.

What’s the worry?

The term ‘health app’ now has a certain degree of ambiguity as it no longer as easy to categorise software. An app could be used by a doctor to support their decisions, yet another app could support the decision of consumers who may be ill at home.

The last two years has seen a number of high-profile cases in which start-up companies providing health apps were fined due to deceptive claims that they could diagnose potential cancerous moles without legitimate scientific evidence. Similarly in 2011, Pfizer had to recall a rheumatology calculator app due to incorrect data values, which had the potential to put consumers at risk.

How is the industry being monitored?

The mHealth industry is still very much in its infancy. Whilst Apple have taken the lead in financial investment, there are blurred lines between recognising whether an app should be used for novelty or for serious healthcare diagnosis.

Despite growth in the demand for mHealth apps, UK regulatory requirements remain a grey area of discussion.

The UK regulator MHRA uses the definition of a medical device as a starting point. This defines a medical device as an “instrument, apparatus or appliance intended for the purposes of diagnosis, prevention, monitoring, treatment or alleviation of disease”. The UK guidelines also suggest that software developers should review the existing EU guidelines on standalone software used in healthcare.

The guidelines also state that apps could be classified by function and ‘decision support software’, which calculates, interprets, converts or measures. As a result, these could be classed as a medical device. For example, if the app told you what time to take your next medication or if it calculated your heart rhythm, then this would support the app being a medical tool.

If the user hasn’t followed the correct steps and the app is seen as a medical device then it is harder to argue any defence on product liability.

If I am misdiagnosed from an app could I seek legal advice?

The popularity of the mHealth market has led to a significant increase in using an app that may be unregulated, which could lead to fatal consequences. This could be a potential reason to seek legal advice; however this can depend on a case-by-case basis.

The influence that mHealth apps will hold remains to be seen, but there is no doubt that this technology has a bright future in changing global healthcare.

However, it is imperative that consumers seek professional advice for health and wellbeing issues. Until the UK and EU regulatory bodies make formal guideline changes, this technology will be available with a degree of risk.

If you have been misdiagnosed by a professional it is recommended that you speak to a specialist solicitor who can guide you through the necessary steps.

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