How to Apply for Internet Medical and Health Information Service Qualification: A Guide for Startups Amid Tightening Regulations

Just as a driver’s license is required to operate a vehicle, healthcare apps must possess corresponding qualifications. The United States has taken the lead in this regard, whether in terms of data security or industry credentials. Click here“Medical Apps Pose Hidden Risks, Raising Doctors’ Concerns and Prompting FDA Intervention”、"Can Your Mobile Health App Bypass the FDA?"、“Detailed Analysis of the 31 Mobile Health Products Approved by the FDA in 2014”、“FDA Releases Two Draft Guidance Documents on Internet-Connected Medical Devices”。

Internet healthcare is the product of the convergence between TMT (Technology, Media, and Telecom) and the medical health sector, and it is currently one of the most dynamic industries. Numerous startups in China are engaged in the development of internet healthcare apps. To enhance product quality and improve structural and performance aspects, some app marketplaces have begun imposing qualification requirements on medical and health applications. However, many entrepreneurs have overlooked the fact that providing online doctor-patient communication services requires an Internet Healthcare Information Service License.

It remains to be seen whether the development of internet healthcare on mobile applications will face increasingly stringent policy constraints, akin to the current ride-hailing sector. However, insiders have revealed that due to the presence of non-compliant industry practitioners, relevant government authorities are closely monitoring emerging issues within the sector, and regulatory intervention is inevitable in the near future.

Regulation will be a double-edged sword. The benefits to the industry are evident: entry barriers will be raised, weeding out teams lacking medical expertise. On the negative side, as can be anticipated, regulatory oversight in China is typically extremely stringent. The ultimate form of regulation for this sector is that once licensing requirements are imposed, obtaining such licenses will become a protracted and arduous process involving complex stakeholder negotiations. Therefore, securing qualifications for providing internet-based healthcare information services is an urgent priority for all startups in the digital health sector; otherwise, regulatory scrutiny will inevitably intensify as the industry continues to develop.

Let’s now provide a popular-science overview of how to apply for the qualification for providing internet-based medical and healthcare information services. This flowchart is courtesy of Mr. Lin Xueren from Shanghai Jiahao Technology, who has illustrated the detailed steps involved in the application process:

Any enterprise applying to provide Internet-based medical and healthcare information services shall, in accordance with the principle of territorial administration, submit an application to the health administrative department and the traditional Chinese medicine management department of the people’s government of the province, autonomous region, or municipality directly under the Central Government where the sponsoring entity is located. Please refer to the diagram below for the specific process:

Supplement: Specific Content

For website-related policies included in the application materials, similar documents can be searched on Baidu Wenku for reference.

Finally, a reminder: The “Approval Certificate for Internet Healthcare Information Services” held by startups that have obtained qualifications for providing internet healthcare information services is valid for two years. Entities wishing to continue providing such services must apply for re-examination with the original reviewing authority within two months prior to the expiration of the validity period.

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