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Published On: 29 May 2015
The nature of technology is to develop and advance constantly. Today, that includes the rapid growth of mobile applications (apps) on smartphones, tablets and laptops – including many medical apps, which are currently not generally regulated. These apps advise on how to have a healthy life, provide instant access to useful information (and even treatment of a sort) and offer users the chance to manage their own health and fitness.
In February, the US Federal Trade Commission (FTC) settled lawsuits with two companies that had marketed what claimed to be melanoma detection apps. According to the FTC complaints, each of the apps instructed users to photograph a mole with a smartphone camera and input information about it. The apps then claimed to calculate the mole’s melanoma risk. However, the FTC said there was inadequate evidence to support such claims and both companies are now prohibited from making health claims about these apps, unless they can be supported by “reliable scientific evidence”.
In another case, a former Houston-based company that was once the maker of what claimed to be acne-fighting medical apps, AcneApp and Acne Pwner, settled a complaint, filed by the FTC, alleging that the company had marketed the apps on the basis of health claims that were not substantiated by competent and reliable scientific evidence. The FTC stopped sale of the apps and forced the firm to forfeit all profits.
“Truth in advertising laws applies in the mobile marketplace. Developers and marketers must have scientific evidence to support any health or disease claims they make for their apps.” Jessica Rich, Director of the FTC’s Bureau of Consumer Protection
In a recent white paper, PricewaterhouseCoopers listed do-it-yourself healthcare and the proliferation of digital health products as two of its top ten health industry issues for 2015. The paper said that this year the Food and Drug Administration (FDA) in the United States is set to review a record number of mobile health apps. It has been regulating such apps for several years, and so far has approved only about 100 products, but the market is growing fast.
In February, the FDA produced Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff, which states that if an app is intended to transform a mobile platform into a medical device, or is an accessory to a medical device, it will regulate that kind of technology.
Rather than resisting the trend of the growing use of apps, the NHS appears to be embracing it, and NHS Choices has an operational Health Apps Library with more than 200 apps that are reviewed by the NHS (doctors, nurses and safety specialists) to make sure they are clinically safe. All apps submitted to the library are checked to make sure that they are relevant to people living in England, comply with data protection laws and comply with trusted sources of information, says NHS Choices. Before apps are added to the library, they are checked to see if they could potentially cause harm to a person’s health, or condition by using information from a non-trusted source or by misuse.
"The problem will be the quality of information that’s provided. It’s about creating sources of information that are reliable and trustworthy," says Dr Gerry Morrow.
In November of last year, the Department of Health and NHS England announced a strategy in which they planned to have an ‘NHS app store’ made up of approved apps that would be kitemarked by the health service and that might be provided free to patients trying to improve their health. The plan, being carried out by the government’s National Information Board (NIB), is to give the public access to a set of health and care digital apps endorsed by the NHS.
The NIB will publish proposals by June and kitemarking of apps will begin by the end of 2015. Kitemarked services will be able to use the NHS brand and be accessible through NHS Choices.
In the UK, some medical apps show real promise in offering benefits to patients. The Babylon app for GP consultations, launched last year, claims to be the first service of its kind to be registered with regulator the Care Quality Commission. For a monthly fee, the app offers users virtual GP consultations with professional doctors (which are recorded), as well as monitoring symptoms, issuing prescriptions, making referrals to specialists, and offering a means of booking blood tests, X-rays or scans at a nearby partner facility. The app is also working in partnership with the NHS, whereby it can provide patients of specific GP practices with consultations via their smartphone.
However, there are potentially serious pitfalls from apps, as Tim Sewart, partner and Head of DAC Beachcroft's technology sector, says: “If people use them and they are providing inaccurate information, they could get seriously ill or die. But I don’t think it’s credible to try and regulate all of them, or to try and prevent the use of them. The pitfalls are something we have to accept as part of the information age we are living in and be aware of them.
“Obviously, providing all of this information to patients may cause them to make the wrong diagnosis or to treat themselves inappropriately, but equally it may provide them with an indication of when they need to seek qualified medical care.”
The medical profession is acutely aware of the potential risks and benefits of apps, stresses Dr Gerry Morrow, Medical Director for Clarity Informatics, a health technology business. “The worst thing that could happen is that a person goes off on a tangent and does the wrong thing or omits to take a medication that they have been prescribed,” he says. “Beyond that, there is a financial impact. People could lose money by being persuaded to buy disreputable products. Also, if it becomes obvious that there is poor-quality information out there, sometimes it has a reputational attrition.”
The profession has mixed views about the growth of medical apps. As Morrow says: “The enlightened majority will probably be of the view that it’s useful that patients are more engaged with their health and more involved in their clinical decision-making. But the problem will be the quality of information that’s provided. It’s about creating sources of information that are reliable and trustworthy, and making that clear.