The term Internet of Things (IoT) is on everyone's lips. Specifically, it involves the digital networking of real-world objects with the internet. This promises significant added value for the customer, as processes can be automated, optimized, and new functions added. The IoT is aimed not only at professional customers, but also at the mass market. Watches (so-called smartwatches), for example, are increasingly equipped with sensors that can record heart rate, blood oxygen levels, and sporting activities. This data is collected in a cloud and could be used by doctors, among others, to obtain information about a patient's condition. Could this technology also be implemented in a medical device to make it a bit "smarter"?
Location
First, you should consider where the device will be used. Do I want to monitor a patient at home and intervene if their condition worsens, or will the medical device only be used in a mobile environment? Therefore, different technologies are used to establish an internet connection. The safest location is your own home, as a stable connection is possible through DSL, cable, or hybrid systems. This redundancy is not available in mobile use. You are exposed to inconsistent network coverage. Dead zones, technology changes, and slow data rates make use difficult. An example of a mobile application could be an ECG monitor or defibrillator installed in an ambulance. The patient is continuously monitored via sensors. Depending on what is being monitored, large amounts of data are generated. A doctor in the hospital should receive this data promptly so they can properly prepare for the upcoming intervention. They already receive important information that saves time and could potentially save the patient's life later on. Sending large amounts of data is no problem for the new Long Term Evolution (LTE) mobile communications standard. But what do you do if a village only has Enhanced Data Rates for GSM Evolution (EDGE) or no mobile internet at all? The worst case scenario in the example above is if the doctor doesn't receive any information. In this scenario, it would probably still be manageable, and the current approach would be followed. If important functions fail frequently, the customer will be more likely to choose a different manufacturer the next time they make a purchase. The manufacturer's reputation will be damaged. But what's even more important is the patient's safety, which could be jeopardized as a result.
Below are a few other possible locations:
Demographic change continues to advance, and consequently, more and more jobs in the care sector are needed. Unfortunately, there is already a shortage of trainees, and the situation isn't improving. Therefore, it is becoming increasingly important to promote new innovations in the field of Ambient Assisted Living (AAL). This involves the home monitoring of elderly, sick, and disadvantaged people. Possible applications include:
- Sensors in socks/shoes that detect the “running away” of dementia patients
- Sleep monitoring that alerts nursing staff to irregularities
- Sensor-equipped tablet dispensers that monitor the correct intake of medication and only open the compartment for the correct day of the week
- Fall sensors in the home, e.g., in the floor
The technology can also be used for preventative measures. Customers benefit much more from the products when diseases are nipped in the bud. Large technology companies have also recognized this trend and have been developing products for the mass market for some time. Devices that already exist include:
- Smartwatches and sports bracelets that record the user's activity behavior
- Networked scales
- Headsets with integrated heart rate measurement
- Networked blood pressure monitors
- Networked blood glucose meters
- Sports shoes with integrated sensors
Products that could be available in the future:
- Toilets equipped with sensors that detect deficiencies and provide recommendations for better nutrition, for example
- Sports bracelets with integrated sensors for measuring blood sugar and blood pressure
- Wearable and body-integrated sensors
But the Internet of Things can also be integrated into professional clinical settings. This can benefit doctors and patients alike. Possible use cases in a clinic could include:
- RFID chips that identify the patient and the correct treatment could prevent confusion in the future.
- Sensors in the beds detect heavy sweating or discomfort and call a nurse if necessary. In acute cases, the appropriate specialist can be called immediately.
- Monitoring inventory and automatic reordering of medications and equipment
Possible limitations
In mobile use, transmission speed limitations must be expected. In the worst case, connection interruptions can occur. You have to be clear from the outset how much data will be transferred later and how quickly it will be needed. With the fourth generation of mobile communications technology (LTE Advanced), peak upload data rates of up to 1000 Mbps are possible. Currently, upload rates of 20 to 40 Mbps are more practical. But caution is advised here too. LTE speeds vary from provider to provider. LTE is often advertised, but the speed is throttled to 12 Mbps. Such information is usually only found in the small print. In addition, LTE is not available everywhere. This is of course not a problem in metropolitan areas, but if you are using a mobile device, it may also be on the move in rural areas. You must therefore expect highly fluctuating data rates and constant technology changes. The data volume must also be sufficiently large. If the data volume is used up, the transfer rate is throttled to a few kbps. Technical problems with the gateway cannot be ruled out. However, limitations should not only be considered on the mobile side; the server to which the data is uploaded can also be the cause of throttling. Many LTE modules also offer a communication method via AT commands. These could also represent a possibility that the data rate is slower than expected.
Security and data protection
Last year, a major insulin pump manufacturer announced that its own products could be hacked. A security vulnerability allows attackers to tamper with the device and cause health damage to the user. Even if, in this case, one cannot be more than 800 meters away from the insulin pump and one requires technical knowledge to hijack the device, the patient can be severely unsettled. In principle, every device connected to the internet is exposed to this threat. This poses a particularly serious risk for medical devices in clinical use. Patient safety is therefore of the utmost importance. Data must not be tamperable, and the entire data processing chain must be secure. Criminals could steal data or paralyze entire processes. But hackers aren't the only threat; bugs in the data processing chain can also have devastating consequences. For example, a sensor measures incorrect data, triggering an emergency medical response. An error in the database results in the patient receiving the wrong medication. Connecting multiple devices creates a complex system in which every link must function properly. The more data collected about a patient (vital signs via fitness trackers, hospital visits, medications and illnesses, etc.), the more transparent they become. Insurance companies could use this to their advantage and adjust their prices accordingly.
With the ever-increasing number of sensors, one should ask how they can be maintained.
Patient data protection rights are set out in Section 6, Paragraph 1 of the German Federal Data Protection Act (BDSG). The rights of the affected patient are listed below:
- Right to information
- Right to notification
- Right to inspect files
- Right to data blocking
- Right to data deletion
- Right to data correction
- Right to object
- Claim for damages
- Right to outside help
- Right to file a criminal complaint
These patient rights cannot be limited or excluded by a legal transaction.
Conclusion
The IoT offers many possibilities that can also be applied to medical devices:
- Easier maintenance and more cost-effective products
- More features that provide added value for patients
- Completely new devices that have not been realized before
The IoT as described above already exists today. Devices are being equipped with increasingly sophisticated sensor technology every day. The opportunities have already been recognized. However, further questions remain. The consequences of the IoT for manufacturers, users, and patients are still unknown.