Interactive Implants: Ethical, legal and social implications

Wiebke Droste 1 , Peter Hoffmann 2 , Heidi Olze 3 , Werner Kneist 4 , Thilo Krüger 5 , Rüdiger Rupp 6  and Marc Ruta 7
  • 1 Institut für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim (IMGB), Schloss/Postfach, 68161, Mannheim, Deutschland
  • 2 Fraunhofer-Institut für Biomedizinische Technik,, Sulzbach, Germany
  • 3 Klinik für Hals-, Nasen-, Ohrenheilkunde, Charité – Universitätsmedizin Berlin,, Berlin, Germany
  • 4 Klinik für Allgemein-, Viszeral – und Transplantationschirurgie, Universitätsmedizin Mainz,, Mainz, Germany
  • 5 inomed Medizintechnik GmbH,, Emmendingen, Germany
  • 6 Klinik für Paraplegiologie, Universitätsklinikum Heidelberg,, Heidelberg, Germany
  • 7 Wilddesign GmbH & Co. KG,, Gelsenkirchen, Germany

Abstract

The use of intelligent implants and prostheses offers significant advances for optimizing medical treatment methods and is combined with an increasing technological modification of human body. This raises many exciting questions concerning law, ethics and social implications: Does the use of these techniques stay in line with our legal system and if yes, can the technical use be limited by governmental restrictions under certain conditions? Have moral values to be incorporated into technical artifacts? If machines are recreated from human beings, do they have to be provided with a legal subjectivity? Medical devices must be compatible with a high level of protection of health and safety. Therefore challenges, which are consequences of the indeterminate behaviour and the autonomous learning abilities of artificial intelligence, have to be faced. For avoidance of any hazards for legally protected rights medical product manufacturers have to assume legal duties, which affect construction, instruction and product development. For medical professionals there are also liabilities of maintenance measures and technical control that have to be accomplished. Associated with the use of intelligent medical devices is the processing of personal data on health. Health data have a high potential for misuse and discrimination and therefore they’re in need of special protection, particularly with regard to the development of “Big Data”, “Ubiquitous computing”, “Internet of Things” and constantly increasing cybercrime. If damages are suffered from the use of intelligent medical devices, difficulties in determining infringing acts, causality and culpability occur, especially because of the missing view into the technical progress of decision-making. It has to be explored, if the current liability law is able to assign responsibility adequately, otherwise there has to be found an appropriate concept for liability.

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Current Directions in Biomedical Engineering is an open access journal and closely related to the journal Biomedical Engineering - Biomedizinische Technik. CDBME is a forum for the exchange of knowledge in the fields of biomedical engineering, medical information technology and biotechnology/bioengineering for medicine and addresses engineers, natural scientists, and clinicians working in research, industry, or clinical practice.

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