Translator：Wang Qiyu

On June 27th, the Hubei Provincial Market Supervision Administration issued a notice regarding the 2023 plan for the establishment and revision of local standards in Hubei Province (first batch). Shanghai Landing (Wuhan) Law Offices actively participated in the initiation, formulation, and application for approval of two provincial local standards, "Internet Hospital Service Specification Part 1: General Principles" (Plan No. T-Z-05-2023181) and "Internet Hospital Construction Specification" (Plan No. T-Z-05-2023182), which were officially approved for establishment.

01 Background of Establishment

With the global spread of the COVID-19 pandemic, the demand for medical care through the Internet using big data methods has become increasingly strong. Traditional medical institutions are incorporating the construction and services of Internet hospitals as a new breakthrough to meet the growing needs of the people. After years of development, there are currently no relevant standards for the construction and service specifications of Internet hospitals both domestically and internationally. Internet hospital construction and service involve multiple cross-over legal regulations, and not only is industry standardization lacking, but regulatory standards are also in the exploratory stage. Some aspects of the standardization of big data and information technology in Internet hospital diagnosis and treatment are not sufficiently systematic and complete. To address these issues, the use of standardized tools to regulate Internet hospital construction and services is undoubtedly the better choice.

Since the launch of the 2023 local standard project in Hubei Province in February, Shanghai Landing (Wuhan) Law Offices have actively responded to the call of the Provincial Market Supervision Administration. Under the active promotion of lawyers from the Landing Wuhan Big Data and Health Medical Professional Team, together with Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology as the lead institution, the Hubei Provincial Health and Health Committee in charge, Hubei Provincial Institute of Standardization and Quality Research, Hubei Provincial Outpatient Quality Control Center, Huazhong University of Science and Technology Institute of Medical Informatics, Wuhan Science and Technology and Health Committee of the Chinese Peasants and Workers Democratic Party, Shanghai Landing (Wuhan) Law Offices, and other units jointly participated in the drafting of the above-mentioned two Hubei provincial local standards. Through the preliminary research, draft formulation, project application, expert review, public opinion solicitation, and official release process, these standards were successfully established and approved.

02 Significance of Establishment

This project conducts research on the construction and service specifications of Internet hospitals, closely integrating with the policy requirements of relevant national fields, thoroughly implementing the requirements and guidance of the central government and the State Council on "Internet + Medical," implementing the national "14th Five-Year Plan" to expand domestic demand and the "Internet +" strategy, filling industry gaps, and providing basic guidance for the construction of Internet hospitals and compliant governance of Internet hospital services in Hubei Province. It is of great significance to guide the scientific, standardized, systematic, and safe service of Internet hospitals in Hubei Province, promote the Internet-based and digital development of medical services in Hubei Province, and enhance the high-quality development of Internet hospitals in Hubei Province.

03 Development Principles

To ensure the high-quality completion of the standard project plan, Shanghai Landing (Wuhan) Law Offices will strictly follow the "Local Standard Management Measures" and the requirements of the Provincial Market Supervision Administration in the subsequent standard development. The firm will adhere to the following principles:

In the drafting process, ensure the applicability of the standard, fully absorb the advanced achievements of science, technology, and practice, carefully study policies and regulations, adhere to the principles of purpose, functionality, and verifiability of standards, and ensure the scientific, applicable, and effective nature of the standards.

In the opinion solicitation process, adhere to the principles of openness and coordination, conduct thorough investigations and research, and extensively solicit opinions from all parties.

In the standard review and approval process, strictly follow the technical review procedures, submit materials such as standard review application letters, review drafts, preparation explanations, and opinion summary forms to the responsible unit in a timely manner, and after the review and approval of the responsible unit, submit them to the Standardization Department of the Provincial Market Supervision Administration for technical review.

In the standard publication and implementation process, pay attention to the implementation and promotion of standards, ensure the operability of the provisions, actively promote the dissemination of standards, and enhance the effectiveness of widespread implementation.

04 Participation and Application

The Landing Wuhan Big Data and Health Medical Professional Team will fully leverage the advantages of professional legal services in big data and health medical fields to participate in the standard development activities. At the same time, medical big data, medical informationization, and Internet medical service organizations, as well as relevant units and experts and scholars, are invited to actively participate in the preparation of standardized projects.

The timeline for this project is as follows:

Standard drafting: July to September 2023

Opinion solicitation: October to November 2023

Standard review and approval: December 2023 to June 2024

Standard publication and implementation: June to December 2024

Units and individuals interested in participating can sign up by contacting the project team:

Contact: Nie Shixia

Contact Number: 15827053240

Email: C.S@landinglawyer.com

Mailing Address: Room 805, Wuhan Center, No. 278 Qingnian Road, Jianghan District, Wuhan City, Hubei Province, China.