中国健康医疗数据跨境流动规制探析

On Regulatory Issues of Health Data Cross-Border Flow in China

在全球医疗创新和数字化高度发展背景下,健康医疗数据的跨境流动需求日益增多,健康医疗数据跨境流动规制应在防控数据跨境风险的基础上促进健康医疗产业的有序发展,平衡“风险控制”和“行业促进”的双重目标。目前,中国健康医疗数据跨境规制存在规则不适应行业发展、健康医疗行业数据跨境合规管理能力不足、国际规范渠道建立存在障碍3个方面的问题。为有效应对健康医疗数据跨境流动规制的挑战,在规制方向的选择上,中国应充分考虑健康医疗数据的公共物品属性,尝试寻找平衡“风险控制”与“行业促进”的“最优解”。具体而言,需结合中国当前医疗行业实践的特点,通过推动规制场景化,促进建立国际规范机制,成立国家级健康医疗数据管理平台,运用合规科技提高合规能力。

Against the background of global medical innovation and digital development,the demand for cross-border flow of health data is increasing.We should promote the orderly development of the healthcare industry on the basis of preventing and decreasing the legal compliance risks of cross-border flow of health data,and achieving the right balance between the dual goals of“Risk Control”and“Industry Development”.At present,China’s regulation on cross-border flow of health data faces three problems:lack of industry-specific perspective in terms of regulatory rules,weak compliance management competence,and obstacles in terms of establishing international normative channels of cross-border data flow.By learning from the experiences of the United States and the European Union,in order to effectively deal with the challenges facing China’s cross-border flow of health data,China should take consideration of the public goods attribute of health data,and try to achieve the“Optimal Balance”between“Risk Control”and“Industry Development”.Specifically,it is necessary to take into consideration of the characteristics of China’s medical industry,increase scenario-specific insight,establish international regulatory mechanisms,build a national health data management platform,and apply relevant technology to improve compliance capabilities.