06.09.2018 mHealth – what opportunities are there for mobile apps in the healthcare system?

Digital change is having a profound impact on our everyday life. The smartphone is further accelerating this process. It is a constant and ubiquitous presence, and is being increasingly used in prevention and health promotion (to measure fitness and health data) as well as in everyday medical practice (measurement of vital data, coordination and disease management). Compared with other economic sectors, however, the use of apps in the medical field has some catching up to do, not least because of the more stringent requirements regarding security and protection of health-specific data. We have sought to provide you below with an insight into the possible uses of mobile health and the challenges it faces.

mHealth applications are used along the entire chain of care.

Pictures mHealth – what opportunities are there for mobile apps in the healthcare system?

TODO CHRISTIAN

mHealth applications are used along the entire chain of care.

Source: Study by A.T. Kearney, see in: eHealth Suisse: mobile Health. mHealth, Empfehlungen I, dated 16.3.2017, p. 5

In the framework of the "Swiss eHealth Strategy 2.0", eHealth Suisse – the coordination body of the Federal Government and cantons – was mandated with the task of supporting the introduction of the electronic patient dossier (EPD) (1). In 2017 it issued initial recommendations on the use of mHealth apps.(2) One vision of the "eHealth Strategy 2.0" is that the population of Switzerland is digitally literate and makes optimum use of the potential of new technologies for its health. A further vision is that healthcare facilities and health professionals are digitally networked to such an extent that they can exchange information electronically along the entire chain of care and make repeated use of recorded data (3).

This means that patients in future can not only access their EPD but can also add data and documents to it, including any that stem from mHealth applications (apps). This would enable diagnoses to be made more rapidly and/or treatment to be supported by appropriate apps. For example, at the Inselspital Bern (Berne University Hospital) a bariatric app is used to support follow-up treatment after gastric bypass surgery. In general, however, there is still a lack of binding standards governing the exchangeability of information between mHealth apps (in the example cited here, between patient and service provider). 

mHealth as part of eHealth

mHealth (mobile health) is a component of eHealth (4). Based on the WHO definition, mHealth is designated as "medical procedures and measures of private and public healthcare that are supported by mobile devices such as mobile phones, patient monitoring devices, personal digital assistants (PDA) and other wireless devices".(5)

New technical options are no substitute for medical treatment

Besides the above example, mHealth apps are used in routine medical practice to measure vital parameters such as pulse, blood sugar, blood pressure, body temperature or cerebral activity or to remind patients to take their medicines or that they have an imminent doctor's appointment. mHealth apps can also be used to communicate fitness and dietary recommendations. The fact that more and more people own a smartphone means that mHealth is opening up a whole new range of healthcare functionalities to service providers. However, mobile healthcare apps are never a substitute for treatment by a doctor or for patient-doctor communication, though they can facilitate both of these. 

Mobile healthcare apps are never a substitute for treatment by a doctor or for patient-doctor communication, though they can facilitate both of these. 

The practical examples discussed in this issue are designed to provide an insight into current developments and the possible benefits for users, patients and health professionals. It remains to be seen whether mHealth can also help reduce costs.(6) Evidence and therefore sound results that enable mHealth to be recommended and used without reservations are still also lacking in many areas.  Particular consideration is called for when it comes to using mHealth apps in "digital immigrants", i.e. older people or other disadvantaged groups. They, too, should be able to use digital technologies, and therefore they must be given an opportunity to acquire the necessary skills. 

"Health 2020" and digital technologies

The Federal Government's "Health 2020" strategy calls for the use of digital technologies which will support the treatment process and help improve primary healthcare for the Swiss population. Besides launching the EPD, the Federal Government envisages measures to support developers of mHealth apps and achieve greater transparency for users with regard to data protection and data security of such apps. The stated aims of the strategy are to improve the quality and efficiency of healthcare and to ensure a better exchange of information and more efficient healthcare processes. 

Mobile healthcare apps are never a substitute for treatment by a doctor or for patient-doctor communication, though they can facilitate both of these.

mHealth as a medical device

In Switzerland, whether or not an mHealth application qualifies as a medical device (i.e. as 'medical device stand-alone software' or as a 'mobile medical application'/app) is determined by the Medical Devices Ordinance (MedDO, SR 812.213), which is derived from the European Medical Devices Directive (93/42/ EEC), and from EU guidance document MEDDEV 2.1/6. Swissmedic has published an information sheet on Stand-alone Medical Device Software containing further details.  In order to be marketed in Switzerland, the EEA states and Turkey, medical devices do not have to be officially authorised as is the case for medicinal products; instead they must have successfully completed the relevant conformity assessment procedure (certificate and/or EC conformity declaration). Medical devices placed on the market must also bear the CE marking.  Data accuracy is an important aspect of the use of health-specific data. If the data are not reliable, they are more likely to jeopardise the health of users than to promote it. Research, too, is dependent on reliable data. A welcome development would therefore be the introduction of a form of certification or of quality labels, also for health and fitness apps, that would increase confidence in them among medical professionals as well as among users. 

Personal security for users of mHealth

mHealth app users should already be observing minimum security precautions with regard to their apps. They should, for instance, never use their Twitter or Facebook user data to register with (mHealth) apps. In turn, app producers should state which data they store, and where, and should offer transparent opt-in and opt-out choices that enable the actual users to decide which data they wish to release. In this connection, the providers' general terms & conditions prevent users from determining for themselves what they want done with their data. The terms & conditions are usually so long that nobody actually reads them. Users nevertheless have to agree to them if they want access to the app. 

Digital technologies will play an increasingly important role in healthcare. Their success in the medium to long term will, on the one hand, largely depend on the achievement of a degree of expertise and hence a healthy critical relationship with mHealth apps on the part of users and healthcare providers. On the other, it will need developers, producers, experts and specialists to join forces and resolve the challenges in respect of data security, protection and reliability while taking ethical standards into account. If these minimum requirements are met, there will be no need for strict regulations that could be challenged as being a "brake on innovation".

(1) eHealth Suisse: Strategie eHealth Schweiz 2.0 2018–2022, dated 1.3.2018. 
(2) eHealth Suisse: mobile Health. mHealth, Empfehlungen I, dated 16.3.2017.
(3) Strategie eHealth Schweiz 2.0 2018-2022, 1.3.2018, p. 4.
(4) "eHealth (or electronic healthcare services) is understood as the integrated use of information and communication technology to design, support and network all processes and stakeholders in the healthcare system". www.e-health-suisse.ch, [status: 13.4.2018].
(5) From the study by the University of Applied Sciences, St. Gallen: mHealth im Kontext des elektr. Patientendossiers, Eine Studie im Auftrag von eHealth Suisse, p. VIII; WHO World Health Organization, in: mHealth. New Horizons for Health Through Mobile Technologies, Geneva, 2011, p. 6.
(6) A study by A. T. Kearney from 2013 assumes "an improvement in patient treatment and safety" and "sustained cost reductions for the healthcare system from using the available technical infrastructure such as smartphones", in: A. T. Kearney (2013): Mobile Health: Fata Morgana oder Wachstumstreiber?, p. 4.

Contact

Stefan Spycher, Health Policy Directorate, stefan.spycher@bag.admin.ch 

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