[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.