Medical apps: functionality and safety is key

Successful communication is most important in medicine. The most modern channels have been utilized in this area for quite some time now. Medical apps need to meet several requirements at once. For their use to pay off, they need to be beneficial for prevention or therapy. And to ensure a safe application, they also need to be both technically and medically flawless.

05/02/2014

Photo: Screenshot from a medical app; Copyright: PLRI MedApp Lab

English gesture for "Coulkd you repeat that, please?" from the "iSignIT" app; ©PLRI MedApp Lab

The "iSignIT" app for instance can help if a deaf patient needs help and no interpreter is available. The app is a "digital collection of 800 sentences and terms that are regularly being used in daily medical practice," explains Dr. Urs-Vito Albrecht. "These sentences were translated by sign language experts into German Sign Language (German: Deutsche Gebärdensprache, DGS), Austrian Sign Language (ÖGS) and British Sign Language (BSL) and provided as videos." Albrecht is the Assistant Director of the P.L Reichertz Institute for Medical Informatics at the Technical University Braunschweig, Hannover facility, and the Hannover Medical School (MHH), which is responsible for the development of "iSignIT". At the live AppCircus at MEDICA 2013, "iSignIT" was crowned the "best mHealth app".

It provides patients with basic sentences such as "I have pre-existing conditions or allergies" or "I take medicine" in text and video format. Medical staff on the other hand chooses statements like "I am going to take your temperature" or "I am going to take blood from you". The users can communicate via the replayed videos, but only in a limited fashion: the app is not a substitute for an interpreter. However, it is able to support and speed up the treatment of a deaf patient in emergencies.

Albrecht is an expert on the development of medical apps and also works on other applications besides "iSignIT", which support health professionals, for instance in the areas of eLearning or hygiene compliance. However, experts only make up a portion of the potential audience for health apps, as Albrecht explains: "Especially apps for patients that help them in managing their illness, that being digital patient diaries, medication reminder apps and schedule management, are in high demand." What is more, fitness apps and social media apps with a health aspect that support self-help groups for instance are becoming more and more popular. Just like with the general app market, idea and functionality is also key here.
Photo: Screenshot from a medical app; Copyright: PLRI MedApp Lab

History of statements selected in the "iSignIT" app; ©PLRI MedApp Lab

Safe programming

However, all medical apps require more than this. Developers need to primarily pay attention to safety. On the one hand, the app needs to work safely, which pertains to the used algorithms and the medical information that form the basis for the app. They need to come from a reliable and provable source. On the other hand, solid data protection is also essential, since very personal data is gathered and submitted in the medical field. In Germany, this is regulated by the Data Protection law, the Telecommunications Act and the Telemedia Act. Other countries have different regulations, with the result that "universal safety standards and regulations are unfortunately scarce commodities", regrets Albrecht.

Aside from data protection measures that developers are able to implement with current encryption technology for instance, other factors also influence the safety of patient data. This can be the operating system of the end device, apps from other providers or the safety of network connections for instance. According to Albrecht, for apps that support the communication between patients and health professionals and that store data not just locally, but on a server to do this, "the user must be educated on the kind of captured and processed data. They should always maintain full control over their data and be able to cancel an already granted consent to processing and storage, respectively."
Photo: Screenshot from a medical app; Copyright: PLRI MedApp Lab

Choice of categories in the "iSignIT" app; ©PLRI MedApp Lab

Safe application

Good data protection alone does not make apps safe for medical use - patient safety is also relevant. This is also something the "iSignIT" development team shows with a clear indication on the website: "The iSignIT app can and does not aim to replace a professional translator. An interpreter is required for complex conversations, particularly in situations that represent danger for health, body and life." In doing so, the app particularly addresses staff’s judgment and sense of responsibility when it comes to the question of safety.

However, the manufacturer can assign a specific purpose as defined by the Medical Devices Act for the apps as Albrecht explains: "These apps can only be put on the market, when the manufacturer proves in a conformity assessment procedure that the product conforms to current EU regulations and standards. The CE marking can then be attached and rendered." That said it is up to the manufacturers whether they actually officially devise a specific function. The cost and complexity of the procedure deter most of them, if the application has a higher risk potential for the patient. This is why "of the 100,000 health-related apps on the market, only a handful of them have this label," Albrecht summarizes.

This represents a big challenge for the mHealth field: suitable end devices have long since become the norm and apps are an obvious way to support users with medical issues. However, patients are sometimes not able to identify and judge the risks involved with an app. As long as medical apps are still not subject to uniform legal provisions or at least quality guidelines beyond country borders, they should not be used in a non-critical manner - even if their basic idea is good and innovative and the implementation is practical.
Foto: Timo Roth; Copyright: B. Frommann

© B. Frommann

The articla was written by Timo Roth and translated from German by Elena O'Meara.
MEDICA-tradefair.com