are typically used. This is quite challenging, particularly for biosensor implants as enzymes/

proteins used are damaged by ionizing radiation, causing strand breaks and denaturation.

In recent years, the smartphone has become increasingly qualified for the control of the

overall system, as it has highly developed interfaces for wireless data transmission via

BlueTooth or NFC. The use of apps and the sales realized with them also lead us to expect

that most bioelectronic implants will be controlled by smartphone-based apps in the future.

Implanted sensors and actuators will then appear to be merely devices in the developing

Internet of Things (IoT).

21.8 Ethical Aspects

The development and, in particular, the commercialization of human medical implants

require the testing of the system in animal models, i.e., the performance of animal experi­

ments. Animal testing and clinical trials are governed by extensive regulatory requirements

and are different for individual states or confederations of states such as the EU or the USA.

Approval generally requires a positive vote by an ethics committee, which usually includes

physicians and often also members of animal welfare organizations or patient associations.

The test series are associated with high costs so many scientific institutes or bioelectronic

working groups involved in implant developments do not reach this point. If this is the case,

adaptive developments often have to be carried out subsequently, e.g., to improve hermi­

ticity or transponder function. After a successful demonstration in the animal model, clinical

studies must be carried out in the course of which the system is implanted in a cohort of

patients on a trial basis, who must be continuously monitored.

A number of the problems associated with implants can usually be resolved within the

framework of ethics committees. Future developments and applications of human im­

plants, however, are associated with social implications that go far beyond this, cf. the

study collection [44]. For example, a large part of the digital world is dominated by

Internet corporations with extremely high sales and financial power. The five largest of

them generated nearly $1,200 billion in revenue in 2020 and 2021, respectively [45], which

exceeds the tax revenues of half of all EU countries [46]. As a result, non-state actors are

gaining a high degree of political power, which they also use for their benefit through

FIGURE 21.5

Biosensor implant in a form mimicking cardio implants: (a) open Ti package with PCB and battery, (b) overall

system as exploded view, and (c) photo of the fabricated implant (59 × 45 × 8 mm) with sensor and antenna in

the epoxy header [ 9].

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Bioelectronics