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 application of advanced, medical neurotechnologies can be expected to present novel or additional ethical, social, and legal challenges requiring more extensive regulatory oversight. Addressing these challenges is likely to involve the formation of new or more comprehensive statutory frameworks needed for overseeing the generation and application of these technologies.
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 rights and fundamental freedoms” (Article 3.1) This declaration stipulates in Article 3.2 that “the interests and welfare of the individual should have priority over the sole interest of science or society,” a principle initially outlined in 1964 in the Declaration of Helsinki for medical research on human subjects developed by the World Medical Association. The same principle has been incorporated into the 1997 Universal Declaration on the Human Genome and Human Rights (Article 10) and into the 1997 European Convention of Human Rights and Biomedicine (Article 2).
Recourse to a human rights approach in legal frameworks affords the significant advantage of assisting in the formulation of universal standards, since international human rights law can be grounded on the assumption that basic rights transcend cultural diversity. These rights are conceived as patient entitlements by virtue of their human condition, regardless of ethnic origin, sex, age, socio-economic status, health condition, or religious or political ideas. The linkage between human rights and the application of medical neurotechnologies can thus be understood in the context of a fundamental right of bodily and cognitive well being, namely human life and physical integrity, as well as subsidiary goods like that of privacy.
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 law instruments are distinguished from binding regulation by their potential rather than enforceable character. They constitute recommendations for desired policy execution and provide opportunity for legal evolution toward enforceable statutes, a classification that can be expected to aid in the evolution of legal approaches to medical neurotechnology
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 have widely variable legal statutes, and the harmonization of legal instruments across national boundaries.
In the United States, FDA is charged by statute with ensuring the protection of the rights, safety, and welfare of human subjects who use clinical articles or participate in clinical investigations involving medical articles, as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including, among others, medical devices and systems for human use. This is generally taken to mean that the FDA is responsible for assuring that medical devices available in the United States are safe and effective throughout their total product lifecycle. The FDA also recognizes that proper maintenance, repair, and servicing of medical devices is critical to maintaining the safe, effective, and reliable performance of devices used in the health care system.
Food and Drug Administration (United States)
The scope of FDA’s regulatory authority is very broad. With regard to medical devices FDA prioritizes safety, verifiability, and accountability. Accordingly, medical devices are stratified according to a risk classification scheme from Class I – III, with Class III posing the greatest level of risk, e.g., Medtronic deep brain stimulation device (DBS) (approved 1997) and Abbott’s Infinity directional DBS device (approved 2020). FDA is publicly advised through its FDA Advisory Committee System, where questions of health, disease, and ethical value are likely to be posed (FDA).
European Medicines Agency (European Union)
The Medical Device Regulation includes comprehensive legislation for a range of medical and borderline medical products that includes a required conformity assessment that determines the quality, safety, and performance of the device. These conformity assessments are carried out by accredited bodies designated by EU Member States. Special regulations exist for medicinal products used in conjunction with medical devices, in vitro diagnostics, devices that are systemically absorbed, high risk devices, and borderline medical devices where there is some uncertainty as to which regulatory framework applies (EMA).
World Health Organization
Regulation is directed to ensuring public health benefit and the safety of patients, health care workers and the community. WHO’s mandate, as outlined in the World Health Assembly (WHA) Resolution 60.29, is “to encourage member states to draw up national or regional guidelines for good manufacturing and regulatory practices, to establish surveillance systems and other measures to ensure the quality, safety and efficacy of medical devices and, where appropriate, to participate in international harmonization”. WHO assists in harmonization of legal instruments.
