우리나라의 디지털헬스케어 관련 법적 규제와 적용 방향에 관한 고찰

The rapid development of medical science and technology has opened the door to the era of longevity and as public interest in health management and slow aging to prevent diseases increases, the scale of consumption in the medical and health sectors is increasing. In addition, during the pandemic caused by COVID-19 in the second half of 2019, the world experienced a non-face-to-face society to prevent infection, and in the process, a digital transformation took place. This is in line with digital healthcare, which refers to the digitalization of health management and medical services in the healthcare sector. In Republic of Korea, the current laws include digital healthcare of the Medical Act, non-face-to-face treatment of the Act on Prevention and Management of Infectious Diseases, the Medical Devices Act and the Digital Medical Products Act, and the Basic Act on the Development of Artificial Intelligence and Creation of a Trust Base. The legislative trends in other countries are also increasingly responding to digital healthcare. For example, the United States has enacted the Telehealth Modernization Act of 24 to expand telemedicine and the 21st Century Cures Act to simplify procedures for digital healthcare devices. Japan has not enacted any specific laws on telemedicine, but it allows online treatment between doctors and patients through government guidelines, manages electronic prescriptions under the government's leadership, and enacted the 'Act on Anonymized Medical Information to Contribute to Research and Development in the Medical Field' to support the medical industry. In the case of the European Union, the world's first artificial intelligence regulation law EU AI Act was enacted to regulate artificial intelligence systems differently according to their risks. In this way, each country is responding to digital healthcare, but various problems are being raised in the process. In particular, as the scope of digital healthcare expands, the boundaries between medical practices and non-medical health management services are becoming blurred; the provisions on telemedicine in the Medical Act are limited to remote consultations and thus their scope should be expanded; there are concerns about the invasion of personal information self-determination rights and privacy in the process of sharing computerized personal medical records or health information; with the enactment of the Framework Act on Artificial Intelligence, artificial intelligence used in the healthcare field is evaluated as having high impact and may hinder the development of related industries; and there are gaps in digitalization among countries around the world and concerns about the generation of digital waste.