[目的/意义]在医疗大数据发展迅猛的今天，相应的法律体系建设仍不完善，如何对个人健康信息进行立法保护是目前亟待解决的问题之一。[方法/过程]基于健康医疗信息保护的视角，首次全面梳理了我国个人信息保护的现状及美国、欧盟的相关法律，并结合大数据时代下个人健康医疗信息保护的挑战和特殊性，对我国个人健康医疗信息的立法保护提出了综合建议。[结果/结论]研究建议主要包含加快对个人信息保护的立法，综合考虑和论证个人健康医疗信息的特殊性，结合时代特色出台相关法律法规以及维护大数据的健康有序发展等方面。研究结论为我国大数据医疗事业的发展提供了重要的理论参考。

[Purpose/significance] With the rapid development of medical big data, the construction of the corresponding legal system is still incomplete, and how to protect personal health information is one of the issues that need to be solved urgently. [Method/process] Based on the perspective of health and medical information protection, the first comprehensive review of the current status of China's personal information protection and related laws of the United States and the European Union, combined with the challenges and specialities of personal health medical information protection in the era of big data, legislative protection made comprehensive recommendations.[Result/conclusion] The suggestion including speeding up legislation on the protection of personal information, comprehensive consideraqtion and demonstration of the particularity of personal health and medical information, the introduction of relevant laws and regulations in the era of the times and the healthy and orderly development of the maintenance of big data. The research conclusions provide an important theoretical reference for the development of big data medical care in China.