Ten years passed since Japan set out the Action Plan of Growth Strategy that declared the initiatives of digitalization for medicine, nursing care, and healthcare to achieve the world’s most advanced medical care. The initiatives formed the foundation of the Japanese national strategy and have been continuously refined, resulting in the current environment of digital health and digital medicine. Digital health–related terminologies are organized, such as “digital health,” “digital medicine,” and “digital therapeutics” (DTx), as well as several common digital technologies, including artificial intelligence, machine learning, and mobile health (mHealth). DTx is included in mHealth and is a novel disease treatment option. Also, this article thoroughly describes DTx in Japan and compares it with those in the US and Germany, the leading countries in digital health–related policies, regulations, and their development status. In Japan, two of three DTx applications that have been approved and reimbursed by the Ministry of Health, Labor, and Welfare are explained in detail in relation to cardiovascular medicine. When added to a standard smoking cessation program, the DTx system for nicotine dependence significantly improved the continuous abstinence rate. Moreover, the DTx for hypertension together with the guideline-based hypertension management was effective in patients aged 65 years or younger who were diagnosed with essential hypertension without antihypertensive agents, and it was also found to be cost-effective. DTx in cardiovascular medicine, with consideration on safety, efficacy, and cost-effectiveness, could be widely used not only through basic experiments and clinical studies but also through social implementation.

日本制定增长战略行动计划，宣布医疗、护理和保健数字化举措，以实现世界最先进的医疗保健，已经过去了十年。这些举措构成了日本国家战略的基础，并不断完善，形成了当前的数字健康和数字医疗环境。整理了与数字健康相关的术语，例如“数字健康”、“数字医学”和“数字治疗”（DTx），以及几种常见的数字技术，包括人工智能、机器学习和移动健康（mHealth） 。DTx 包含在 mHealth 中，是一种新型的疾病治疗选择。此外，本文还深入介绍了日本的DTx，并将其与数字健康相关政策、法规和发展状况领先的美国和德国进行了比较。在日本，厚生劳动省批准并报销的三份DTx申请中，有两份详细解释了与心血管医学相关的内容。当添加到标准戒烟计划中时，针对尼古丁依赖的 DTx 系统显着提高了持续戒烟率。此外，DTx治疗高血压结合基于指南的高血压管理对于65岁或以下被诊断为原发性高血压而无需服用抗高血压药物的患者来说是有效的，而且也被发现具有成本效益。DTx在心血管医学中的应用，考虑到安全性、有效性和成本效益，不仅可以通过基础实验和临床研究，还可以通过社会实施来广泛应用。