![Sample our Law journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/5942/TOC-Subject-Sample-2021-Law.jpg"})
Abstract
This paper focuses on the regulation of body and neural implants used in healthcare. The current state of these ICT body implants is outlined, and the adequacy of the relevant legal regime regulating these implants is assessed in light of the ongoing scientific and technological advances in this field. Regulatory gaps are discussed, with a particular emphasis placed on clinical investigations with brain computer interfaces and advanced prosthetics, in order to better understand whether such gaps reduce innovation and act as an institutional barrier that diminishes the opportunities for the development of valuable technologies. Finally, the divide between therapy/treatment and enhancement/augmentation is examined in order to distinguish between the various kinds of body implants, in terms of the rules they ought to comply with and the limits that ought to be set.
Conflict of interest disclosure
No potential conflict of interest was reported by the author.
Notes
1. Council Directive 93/42/EC of 14 June 1993 concerning medical devices, OJ 1993 L 169/1.
2. Council Directive 90/385/EC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, OJ 1990 L 189/17.
3. Council Conclusions of 6 June 2011 on innovation in the medical device sector, OJ 2011 C 202/7.
4. Commission staff working document, Impact assessment on the revision of the regulatory framework for medical devices. Part I, 26 September 2012SWD (2012) 273 final, Brussels.
5. See Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals, of 26 September 2012 COM(2012) 540 final.
6. See for instance the bulletin Attack Surface: Healthcare and Public Health Sector, recently released by the National Cybersecurity and Communications Integration Center at the US Department of Homeland Security, which describes the vulnerabilities associated with medical devices in the healthcare environment (available at www.kslaw.com/library/publication/HH051412_Bulletin.pdf (last accessed 1 July 2015)
7. Case C-219/11, Brain Products GmbH v BioSemi VOF and Others, 22 November 2012, not yet published.
8. Commission staff working document, Impact assessment on the revision of the regulatory framework for medical devices. Part II, Annex I, of 26 September 2012 SWD(2012) 273 final.
9. European Commission, Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, of 26 September 2012 COM(2012) 542 final. See Art. 2(2).
10. Similar statements are to be found in the EC Guidelines on medical devices, which recalls that ‘another important consideration of the evaluation will be to assess whether the conduct of the investigation was in accordance with the current applicable ethical standards that have their origin in the Declaration of Helsinki and in accordance with applicable regulations’: European Commission, Enterprise and Industry DG, Guidelines on Medical Devices. Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, MEDDEV 2.7.1 Rev 3, Dec. 2009.
11. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market, OJ 2007 L 247/ 21.
12. Regulation 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ 2014 L 158/1.
13. Commission staff working document, Impact assessment on the revision of the regulatory framework for medical devices. Part II, Annex I, of 26 September 2012 SWD(2012) 273 final.
14. See for instance the Guidelines for Transcranial Magnetic Stimulation, which is, however, a non-invasive neurostimulatory technique used experimentally for the treatment of medication-resistant depression (Rossi et al. Citation2009).
15. A detailed description of the careful conditions, including psychological assessment, under which an experiment of elective amputation and bionic reconstruction involving three patients took place, is reported in Aszmann et al. (Citation2015).
16. See Ziv (Citation2014), reporting information on the testing of a ‘mind controlled prosthetic arm’ that took place in Sweden, and claiming that this is ‘the first successful implementation of neurocontrol using implanted electrodes that a patient is using at home’.
17. BGHZ 124, 52 VI. Civil Senate (VI ZR 62/93), 9 Nov. 1993.
18. See http://cyborgism.wix.com/cyborg#!our_story/component_74511 (last accessed 15 April 2015)
19. Nicolelis (Citation2011, 184 ff.) vividly narrates the experiment in which a monkey, Idoya, using a device (composed of a treadmill where she could walk in a bipedal position, set in front of a monitor transmitting images of the movements generated by a remote robotic device controlled through the BMI inserted in her brain) that was located in North Carolina, could control the movements of a robot located in Kyoto, Japan.
20. See http://www.openthefuture.com/2014/05/magna_cortica.html (last accessed 15 April 2015).
21. A comprehensive body of research and literature deals with the topic of human enhancement (Battaglia and Carnevale Citation2014; Boer and Fischer Citation2013; Coeckelbergh Citation2013; Gordijn and Chadwick Citation2008; Koops et al. Citation2013; Lucivero and Vedder Citation2013; Savulescu, ter Meulen, and Kahane Citation2011).