01482 778 463
Client Focussed
No Win No Fee
Specialist Legal Teams
Hudgell Solicitors™ | Latest News | Should health and wellbeing apps receive heavier regulations?

Should health and wellbeing apps receive heavier regulations?

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.

No Comments

Leave a Reply

*Required

Request a callback

Request A Callback

I am an existing client.










Or call us FREE on:

01482 778 463


trust pilottrustpilot startrustpilot startrustpilot startrustpilot startrustpilot star

The data you submit will only be used by Hudgell Solicitors and only for the purpose of dealing with your enquiry.
See full privacy policy.

Looking to see if you're eligible?

Get in touch for free legal advice

0808 159 7699

Call today to speak to an expert

OR
Start your claim

What Our Clients Think

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Caroline was great in handling my case

"Caroline was great in handling my case, very informative and always kept me up to… "

Mr Richard Brook

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Dispute with EasyJet

"Although Hudgell offices were not local to us, there was no need for concern, as… "

Glyn

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Always on the ball

"Always on the ball! Great at what they do, very professional and fast with a… "

CHRISTOPHER CURTIS

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Excellent service

"Excellent service. Very happy with result. Thank you."

Miss Erika Panakova

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Was an easy process and the caseworker…

"Was an easy process and the caseworker was very informative and very knowledgeable on my… "

Rachel Fee

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Lovely business to deal with

"Lovely business to deal with. Would recommend to anyone."

Mrs Kelly Byrnes

trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Great communication

"Great communication! My solicitor was lovely to deal with, open and listened to me."

Sue Ockendon

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Very happy with how they managed my…

"Very happy with how they managed my claim. I would recommend them."

Mr Steve Roberts

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Very helpful and truly understanding in…

"Very helpful and truly understanding in a very sensitive case would highly recommend to anyone"

Miss Sarah Morris

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Friendly

"Friendly, supportive and professional, couldn't ask for more."

Mr Adrian Fisher

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

A first class service with a heart too

"I never had claimed before and was quite apprehensive about dealing with claims solicitors as… "

M Sheikh

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

They made me feel that I wouldn’t be on…

"They made me feel that I wouldn’t be on my own after my experience. They… "

Mrs Melinda Diane Tovey

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

The service was excellent and Lauren…

"The service was excellent and Lauren Cartwright kept me well informed and gave good advice… "

Mr Roger Harrison

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Recommended company

"Excellent service, fully recommended. Efficient communication and reliable."

Mr R Taylor

trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Hudgell took over my road traffic case…

"Hudgell took over my road traffic case from a different solicitors and successfully negotiated a… "

Mr JSW

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Hudgell Solicitors made my personal…

"Hudgell Solicitors made my personal injury claim so easy, they got me the treatment i… "

Mr Nick Todd

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

I have never used solicitors before

"I have never used solicitors before, my dealings with Hudgell have been excellent I have… "

David Varley

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Very helpful

"Very helpful"

Ethan Ferguson

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

First Class service

"Hudgell Solicitors are currently working on my case and I must say so far the… "

Emma Jeeves

trustpilot-star trustpilot-star trustpilot-star trustpilot-star trustpilot-star

Always kept me up to date on all…

"Always kept me up to date on all correspondence concerning the case and acknowledged any… "

Mrs Anne Marie Wells

Rated 9.4 out of 10 based on 454 reviews

Powered by Trustpilot

Our offices

London

55 Fleet Street
EC4Y 1JU

VIEW DETAILS

Hull

No 2 @ The Dock
46 Humber Street
HU1 1TU

VIEW DETAILS

Leeds

10 Park Place
Leeds
LS1 2RU

VIEW DETAILS

© 2018 Hudgell Solicitors®. All Rights Reserved.

Hudgell Solicitors is a trading name of Neil Hudgell Limited | Director Dr. Neil Hudgell MA LLB (Hons) LLD | Registered in England No. 7078429 | Authorised and Regulated by the Solicitors Regulation Authority | SRA No. 521372 | VAT Registration No. 254 7802 90