Can smartphones become health counsellors for patients or diagnostic tools for doctors? The answer is yes, at least technically. However, health apps that comply with valid medical device regulations are still rather rare in Germany. Many health insurance companies are reluctant to pay for the use of these modern tools because the legal framework is inadequate and doctors are not yet fully capable of using them. Nevertheless, the use of such tools on the private healthcare market is on the increase, and there are already a few applications that are covered by the statutory health insurance companies.
If you tap the keyword 'health' into your smartphone's app store, it will come up with a fair few hits, mostly wellness, nutrition and sports apps that count calories and steps, give advice on healthy diets or suggest different workouts. Cardio and blood pressure apps are also popular, although this raises the question as to how a smartphone can measure blood pressure. It obviously cannot do so on its own; accessories are required. This makes the range of healthcare options that smartphones are able to offer without professional support rather limited.
The applications mentioned in this article are what are called health and fitness apps and can help people achieve a healthy lifestyle. There are also some very useful medical smartphone applications for physicians, clinics and patients on the market that are not yet widely known or used. At the Connecting Healthcare IT (conhiT) trade fair in Berlin in April 2015, young companies presented ideas for apps involving the interaction of medical doctors, care personnel and patients. An international competition to find the best healthcare app was won by the Mimi Hearing Test, a smartphone-based tool developed by the Berlin-based company Mimi Hearing Technologies. People with hearing deficiencies can use the smartphone-based Mimi Hearing Amplifier, a so-called personal sound amplification product (PSAP), to improve their hearing capacities.
These mobile medical applications or apps have huge potential as a support tool for physicians in everyday clinical practice as well as for patients with chronic diseases. This includes blood pressure and blood glucose monitoring devices that can be connected to iPhones. Data from measurements are archived and can also be sent to other people. Nevertheless, there are several security and data protection issues that users need to be aware of. Prof. Dr. Karl Broich, president of the Federal Institute for Drugs and Medical Devices (BfArM), spoke at the symposium "BfArM in dialogue – medical apps", and warned of the potential risks of mobile medical applications.
With health-related apps, it is often impossible for users to tell where the wellness function ends and the medical application begins. "Patients and users have to know that medical apps are clearly regulated and reliably tested," said Broich. This means that they need to be formally treated as medical devices: they must comply with the same regulatory requirements as other medical devices. When software that serves a medical purpose is used as stand-alone software, it is also considered to be a medical device (Medical Devices: Guidance document - Qualification and Classification of Stand-alone Software, MEDDEV 2.1/6, European Commission, January 2012).
The Italian company Health Path Srl has developed a medical app for assessing wounds and tissue (MOWA – Mobile Wound Analyser) that has been cleared as a class I medical device for application in people suffering from pressure sores (decubitus). Medical apps could therefore become an integral part of traditional healthcare. So it comes as no surprise that the statutory health insurance fund Barmer GEK and the medical insurer AXA reimburse the cost of a smartphone app prescribed by physicians for the internet-based therapy of children with functional amblyopia, a vision development disorder in which normal visual acuity cannot be achieved (Caterna Vision Therapy). The Techniker Krankenkasse healthcare insurance company announced that, under certain conditions, it will cover the cost of an annual licence for Tinnitracks, a smartphone-based therapeutic app developed by Hamburg-based Sonormed GmbH that has been cleared as a medical device. The app enables users to set up their own music to treat tinnitus. Ear, nose and throat (ENT) specialists from Hamburg are also involved in the project. Subjective tinnitus, a hearing problem where people can hear sounds when no external sound is present, is the result of abnormal nerve cell hyperactivity. As the hyperactivity correlates with the perceived volume of the tinnitus sound, tinnitus therapy starts by determining frequency of the tinnitus. The app then filters the music and removes the frequencies that cause the tinnitus. As a result, only nerve cells that respond to frequencies above and below the ones that cause the tinnitus are activated; the activity of neighbouring nerve cells is inhibited and the tinnitus treated.
In February 2015, the American Food and Drug Administration (FDA) issued guidelines for developers of mobile medical applications that clearly define when a medical app falls under medical device regulations, namely, apps used as accessories or extensions to a regulated medical device. This applies, for example, to a blood pressure measurement unit connected to and operated via a smartphone. The app also records data and can analyse medical images or patient data. An app is also considered a medical device when it can be used to calculate drug doses on the basis of patient data.
The FDA does not classify apps in the fields of medical education or hospital management as medical devices. There is a grey area where the FDA does not insist on compliance with medical device requirements. This includes apps that help patients manage their medicines, or apps that patients use to enter their medical data. The issue arises as to whether a patient's treating doctor can use the data recorded by the patient. Of course, data of this kind is always subject to a certain degree of uncertainty and should not be used to decide on a certain therapy. However, when certified medical devices transfer measured data to an app, treating physicians can rely on this information and use it to make therapy recommendations. Certification will probably therefore be a crucial issue for physicians. The Association of Internet Medicine moved towards this with the creation, in September 2015, of a quality seal for medical apps.
Europe does not yet have such binding rules. According to the BfArM, experts agree that legal requirements need to be revised in order to better respond to the challenges of new technologies. However, the applicability of existing legislation to apps has not yet been clarified. The new eHealth Act will not contain any binding rules for user data and data protection security on mobile devices. Users, physicians and patients, will therefore have to decide for themselves whether it is to their advantage to use medical apps or not.
Experts advise people to use apps provided by health insurance companies or apps whose costs are reimbursed rather than ones distributed free of charge by manufacturers that are not yet known on the market. The data protection issue is highly relevant, and a study by the consulting company ePrivacy in April 2015 found that the lack of privacy guidelines is just one of the many problems associated with medical apps. The company tested approximately 730 apps from various categories, including banking, eHealth and travel on data security and data protection and the results were alarming. The study was based on information provided by the German state of Bavaria's local privacy regulator (BayLAD) for 2014. None of the medical apps tested was equipped with protection against so-called man-in-the-middle attacks (MITM) where attackers relay and possibly alter data communicated between two parties. The safety of medical apps is a cause for concern, and applications that do not function as expected may even put people's health at risk, for example diabetic patients who use diabetes apps and blood glucose monitors to determine drug dose. False information could have fatal consequences. Communication of sensitive data has to be made secure, but there is still a long way to go.
Despite current shortcomings, medical apps can be used to support physicians in their work and promote patients' wellbeing. A study carried out by Philips in 2015 found that 24 percent of those surveyed believe that smartphone or tablet apps help them take more notice of their health. Private health expenditure in Germany has risen steadily since 1995 and amounted to 42.9 billion euros in 2013, which represents 13.6 percent of total healthcare expenditure in Germany. Once medical apps become more trustworthy, this percentage will increase even more in the future, and it can be safely assumed that medical apps will end up playing an interesting role in our healthcare system.