Wellness Application Preamble

Wellness Preamble Wellness is a modern word with ancient and wide-spread roots. The key tenets of wellness, as both preventive and holistic, draw from ancient civilizations from the East (India, China) to the West (Greece, Rome). In 19th-century Europe and the United States, a variety of intellectual, religious, and medical movements developed in parallel with conventional medicine. Wellnessfocused and holistic …

Medical Application: Educational & Training Resources

Académie Internationale d’Éthique et Politique Publique (IAMEPH) The International Academy of Medical Ethics and Public Health was founded in 2016 on the basis of a commitment to international multi-disciplinary reflection in bioethics. The mission of the Academy is to accomplish a permanent international review of innovative questions in bioethics which can benefit from a diversity of political perspectives, culture and …

Medical Application: Ethical Guideline & Soft Law

(ongoing) The Neurotech “Ethics and Future Discussions” Working Group A neuroethics workgroup within the neuromorphic engineering community working with ethics experts and researchers to formulate strategies that ensure Neuromorphic Computing technology makes a positive and sustainable contribution to society. If you are interested in joining this WG please contact neurotech.administrators@ini.uzh.ch. (2020) Guidance document, Use of International Standard ISO 10993- 1, …

Medical Application: Standards

Standards Roadmap: Neurotechnologies for Brain-Machine Interfacing, IEEE Standards Association This document aims at providing an overview of the existing and developing standards in the field of neurotechnologies for brain‐machine interfacing. It is mainly focused on systems that provide a closed‐loop interaction with artificial devices based on information extracted from measures of the activity in the nervous system. In addition to …

Medical Application: Regulatory Landscape – Agencies

Distinct regulatory agencies currently govern the administration of legal frameworks for each of these classes. Binding regulations for medical neurotechnologies are enforced in America by the Food and Drug Administration (FDA) and in Europe by the European Union. Additionally, the World Health Organization (WHO) is mandated to encourage the national adoption of regulatory practices in its member states, which currently …

Medical Application: Regulatory Landscape – Statutory Types

Legal frameworks for regulation of medical devices have traditionally been classed in one of three ways, binding regulation, standards, and soft law. Binding regulations are legally enforceable statutes required for the development and use of technologies in a medical setting. Standards provide for safety and risk control in technology use through the establishment of acceptable design practices and tolerances. Soft …

Medical Application: Regulatory Landscape – Principles

Legal frameworks for medical neurotechnologies can be expected to find their normative origin in universally agreed upon principles that have been developed to guide biomedical practice and bioethics. The 2005 Universal Declaration on Bioethics and Human Rights, for example, formulates a set of norms to guide biomedical practice, assigning first place to a principle of respect for “human dignity, human …

Medical Application: Regulatory Landscape overview

A fundamental aspect of medical neurotechnologies is their intervention within the nervous system, including the human brain. Developers of medical neurotechnologies must therefore confront the deeply ethical nature that such intervention entails. Accordingly, while existing regulatory agencies have traditionally limited prioritization to the risk and safety issues of medical devices, ethical and societal concerns associated with the creation, development, and …

Medical Application: ELSCI by Technology Categories

In addition to the general issues outlined above, each category of neurotechnology has ethical, legal, social, and cultural issues that are particularly salient. These are outlined below. Medical Technologies for Recording/Sensing There are multiple issues pertinent to sensing and recording devices, with privacy and data misuse being particularly relevant. These portable implementations have the intention of recording data in real-time ...