스마트 치료기기에 관한 법ㆍ윤리적 연구

Electrical devices used for treatment purposes are called digital health or digital healthcare. Electroceuticals, a type of digital health that is undergoing recent technological development, is a compound word of ‘electronic’ and ‘pharmaceutical’, which treats various diseases by applying or stimulating electric current or magnetic fields to the brain or nerves in the human body. Transcranial Direct Current Stimulation (tDCS) and Transcutaneous Electrical Nerve Stimulation (TENS), which are used for therapeutic purposes, are considered ‘Electroceuticals’. They are a new type of health care practice that lies between pharmaceuticals and medical devices, and are important for the health and safety of the public from a long-term perspective. Discipline that takes into account the impact is needed. This paper conducted research on the legal basis for regulating smart treatment devices used in digital health, including Electroceuticals. After reviewing the framework of digital health technology from an ethical perspective and international human rights law perspective, the constitutional right to health and the responsibilities of the state were examined, and public law issues such as regulation of medical practice and use of medical data were reviewed, the direction of future legislative improvement was proposed as a public law task. Ethical principles and frameworks such as beneficence, autonomy, consent, privacy protection, participation, transparency, non-discrimination, equity, and accountability applied to digital health technologies are connected to the international human rights framework. At the same time, the human rights framework such as the right to health, the right to equality, the right to benefit from scientific progress, and the right to privacy are connected to the people's right to health and the regulation of medical practice guaranteed by the Constitutional law. It can be said that the public law task of digital health is to realize the constitutional values of the people's right to health and the guarantee of information human rights through the protection and appropriate use of the people's personal health data. In order to make this concrete, it is necessary to review the improvement of related laws, including the Medical Service Act, and the active introduction of health insurance.