Wearables, Apps & Co: Digital tools of a new medicine

The heart beats fast and irregularly, the throat becomes tight, the shortness of breath?is accompanied by fear, trembling and cold sweat all over the body - anyone who has ever had a panic attack wants to never feel exposed to this situation again. And he appreciates that there are now medically approved apps that can help him in this distress, and with which he can learn to get his panic attacks under control. Also helpful is the behavioral therapy-based app for tinnitus patients, which is available by prescription. With it, the patient learns to cope with his tinnitus better. Such apps are small digital helpers that cannot replace therapy, but they are always and everywhere with you, and that is exactly what makes them so valuable for sufferers.??

?Electronic Health and Mobile Health?

Electronic Health (eHealth) and Mobile Health (mHealth) are?healthcare megatrends that have been catapulted into the fast lane by Corona. Whether medically approved apps for depression and anxiety disorders, such as those offered by the Berlin-based company Selfapy, or freely available apps to combat migraines, sleep problems or even for individual preventive care - they are being used by more and more people. And for once, Germany is a pioneer here, as it is the first country in the world where digital health applications, so-called DiGAs, can be prescribed on prescription since October 2020. Already every fourth doctor wants to prescribe DiGAs in the future (?rzteblatt 6/2021).?

In the course of the digitalization of medicine, there is no way around mHealth. But what is the difference between medical apps and wearables and the freely available consumer wearables??

?Consumer wearables?

(Non-medical) consumer or leisure wearables, such as fitness trackers, are small computer systems that are worn on the body. Using sensors and electrodes, these devices record?vital signs such as heart rate, steps, speed and duration of an activity. The market for this type of wearables has been growing for years. Around 1.5 million fitness trackers are purchased annually in Germany alone; worldwide sales of wearables are estimated at around 445 million units in 2020. Smartwatches, which are intended to motivate their wearers to lead a healthier lifestyle, are particularly popular. However, this measured data is not reliable for medical use because it is not precise enough. Commercially available fitness wearables can in no way replace a doctor's consultation. And unfortunately, consumer wearables also offer potential for data misuse. According to a study by the German government's consumer portal Marktw?chter Digitale Welt, all of the fitness apps tested require a network connection, and the providers are vigorously collecting data. The awareness that this personal data is of considerable commercial value is still far too little developed among consumers. Data protection regulations and independent quality control would also be desirable for leisure wearables and apps in order to give users security and orientation.?

Medical wearables and apps?

Unlike consumer offerings, medical apps and wearables, as medical devices in Europe, are?subject to the strict regulatory requirements of the new Medical Device Regulation (MDR for short), which came into force on 26 May 2021.??

Medical wearables are applications such as wristbands, smart patches, event recorders or textiles that measure body temperature, blood pressure, blood oxygen or blood sugar. Other wearables can use actuators to deliver medication, such as insulin for diabetes. Miniaturization and advancing precision in sensor technologies are constantly creating new potential applications. In chronic diseases, such as asthma, monitoring the patient's breathing parameters should signal dangerous deviations from the norm. In the case of acute danger, such as nocturnal apnea, medical wearables could trigger an alarm.?

?Wearables and apps as part of telemedicine?

Medical wearables and apps are an essential part of telemedicine, which has received a boost in Germany, particularly as a result of the Corona pandemic. Telemedicine covers the areas of diagnostics, treatment and aftercare. Among other?things, video consultation, e-mail, messenger, but also wearables and apps for monitoring vital values are used. With the Digital Health Care Act (DVG), the legislator has created the legal framework to open the way for DiGAs (digital health applications)?in general health care. A medical device is called a DiGA if its central functions are based on digital technology. To find out which DiGAs are currently approved, visit the website of the Federal Institute for Drugs and Medical Devices:?www.diga.bfarm.de?

According to an online survey conducted by the company Capterra in April 2021, 17 percent of the patients surveyed in Germany have already used a telemedicine consultation, three quarters of them during the Corona pandemic. More than 90 percent of respondents want to continue using telemedicine in the future. This is understandable, also from the point of view of doctors and health insurers. After all, telemedicine offers numerous advantages: fewer visits to the doctor, less time spent by patients, faster diagnosis and treatment, reliable monitoring and better access to medical care even in structurally weak areas. Added to this are the simpler, faster specialist consultations between doctors via teleconsulting. Together with home testing technologies and AI-based decision support systems, these innovations offer an ideal complement to medical diagnosis and patient care beyond the traditional visit to the doctor's office.?

Prof. Dr. Gernot Marx, Director of Intensive Care Medicine at Aachen University Hospital and Chairman of the Board of the German Society for Telemedicine, demanded at the NRW Telemedicine Congress at the end of June 2021: "It's time for comprehensive and cross-sector telemedicine care in?Germany." It can be assumed that the trend towards telemedicine with its sub-disciplines will continue at an accelerated pace.??

?Telemonitoring and consulting?

Medically approved wearables and apps will play a central role?for telemonitoring in the context of telemedicine in the future. For example, the readings from medical wearables can be used to provide the attending physician with vital data over a longer period of time. Using AI-based "decision support systems", the doctor can then make the diagnosis faster and more reliably based on the large amount of data. Changes in the state of health are detected more quickly, and possible and serious misdiagnoses or delayed diagnoses could thus be largely ruled out.?

The use of intelligent medical wearables could also relieve the workload of nursing staff in clinics or in home care by indicating, for example, when a patient is at risk of becoming sore and should therefore be moved. So-called active assisted living systems and services (ALL for short) are also likely to have great market potential due to demographic trends. These tools could help elderly people and those in need of care to lead a largely self-determined life in their own homes for as long as possible.?

?Taking advantage of eHealth opportunities?

Currently, the Federal Institute for Drugs and Medical Devices lists 19 apps with DiGA approval on its website. The hurdles for medical wearables and apps are high, and the European MDR poses a time-consuming and costly challenge. Because the development and certification processes are expensive and time-consuming, some manufacturers therefore choose the supposedly easier route of approval as a household device, or they remove lower-turnover products from the market altogether.?

However, in view of the eHealth megatrend, established healthcare companies should examine the extent to which their medtech products can be supplemented with a meaningful digital and mobile component so that they can be integrated into the telemedicine landscape. Realistic market opportunities that present themselves here should be exploited before the competition seizes them. In?this context, the following applies: Those who want to enter the market for telemedicine and mHealth should strengthen themselves?in good time with specific know-how and sufficient equity capital.