With the continuous development of cloud computing and internet of things technology, the internet is further reshaping the healthcare industry. Informatization in hospitals is effectively advancing, and the mobile medical industry has also seen rapid development. The integration of internet technology and the healthcare industry has yielded an unprecedented expansion in the breadth of medical data. An increasing number of enterprises have begun to pay attention to big data mining and applications in the healthcare industry.
In light of these developments, on October 25, 2016, the CPC Central Committee and State Council jointly issued the "Healthy China 2030" blueprint (the "Blueprint"), to outline the action plan for the creation of a healthier China in the next 15 years. The Blueprint places particular emphasis on the development of the health industry, healthcare data and the nurturing of new applications for big data in the healthcare industry. Under State guidance and encouragement, healthcare big data has the potential to become a future impetus for growth in the healthcare industry. Further, the Blueprint also clearly proposes to strengthen the construction of laws and regulations and standards related to big data in the healthcare industry.
At present, the laws and regulations for healthcare big data have not kept pace with developments in this field. The development of big data in the healthcare industry has been seriously constrained by the lack of comprehensive guidance. Many private enterprises and foreign-funded enterprises have expressed a strong interest in healthcare big data, but market access and industrial policy uncertainties remain an obstacle. Market enthusiasm and vitality have thus not been fully and effectively released.
This article aims to analyze the potential policy and legal issues related to big data in the healthcare industry for reference and decision-making purposes.
The Concept of Big Data in the Healthcare Industry
As with "cloud computing" and the "internet of things," big data is a new term that has been invented in recent years during this new phase of industrial revolution. According to the Notice on Promoting the Development of Big Data, issued by the State Council in August 2015, "big data" is a collection of data characterized by being of large capacity, of multiple types, and with fast access speed and high application value. Big data in the healthcare industry is classified as a subtype of big data and focuses on the integration and application of data in the healthcare industry.
The Administrative Measures for Population Health Information (for Trial Implementation) ("Administrative Measures"), promulgated in 2014 by the National Health and Family Planning Commission ("NHFPC"),defines "population health information" as personal health information, such as basic population information and medical treatment information generated from the provision of services and management by healthcare and family planning institutions at all levels and of all varieties in accordance with State laws, regulations and administrative duties. Thus, healthcare industry data mainly refers to personal immunization data, physical examination data, outpatient service data, hospitalization data and data related to other health activities. However, with the popularity of online smart devices, such as wearables, healthcare industry data may also include data generated by individuals using mobile healthcare applications.
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