This post is the third in Foley's blog series, "Realizing the Potential of Telemedicine in China," meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market.
We continue to work with more and more U.S.-based providers to create international telemedicine programs, and without question China remains the region of hottest interest. Hospitals and health systems, academic medical centers, physician enterprises and innovative entrepreneurs continue to look to China for new opportunities to expand their geographic footprint and offer expertise and meaningful integration into that market.
On August 29, 2014, the National Health and Family Planning Commission of the People's Republic of China (NHFPC) published Interpretations (interpretive guidance) and associated guidelines regarding telemedicine services in China. The documents include the Interpretation and the "Opinions of the National Health and Family Planning Commission Regarding Promoting Medical Institutions' Telemedicine Services," reflecting China's efforts to promote the adoption and use of telemedicine in the country. These Opinions were useful for U.S. providers to understand some of the expectations China regulators hold for international telemedicine arrangements, but the focus of that set of Opinions was primarily institution-to-institution telemedicine arrangements.
On January 15, 2015, the NHFPC issued a new document, outlining an ambitious plan to build a uniform national telemedicine service network in China. The document, "Technical Guideline for Telemedicine Information System Construction (2014)" (Technical Guidance), is a visionary 200-page blueprint for the creation of an interoperable, uniform service network in China, designed to allow China patients and medical institutions to enjoy seamless telemedicine services anywhere in China.
The Technical Guidance points out that the various telemedicine systems currently existing in China are independently built without compatible design and technical standards, and generally lack interconnectivity either with hospitals and regional healthcare platforms or with each other. To address this problem, the Technical Guidance proposes construction of a uniform national telemedicine service network to enable large medical institutions and medical practitioners to extend their services to regional and rural healthcare platforms. The construction of the national telemedicine service network will focus on openness, uniformity, interconnectivity and geographical equality. The Technical Guidance indicates that the uniform telemedicine service network itself shall "exclude any artificially-set technical barriers," while stating that the intellectual property of healthcare providers shall be protected during the operation of uniform the telemedicine service network.
The Technical Guidance proposes to set up a comprehensive supervision and administration system for telemedicine services, which includes:
- A two-layer national and provincial (regional) telemedicine service and resource supervision center to be established and responsible for the supervision of telemedicine operations and service quality, as well as research on shared liability, medical liability identification, patient privacy protection and other relevant policies;
- Provisions whereby telemedicine services will be considered a medical service item to be included in China's healthcare insurance reimbursement program, with relevant policies to be issued subsequently; and
- Measures indicating that a qualification approval and service access mechanism for medical institutions and medical practitioners, as well as a business supervision and service quality control mechanism, will be established and implemented.
The Technical Guidance also lists recommended configurations for remote diagnostic systems, remote imaging consultation systems, remote ECG consultation systems, remote pathology consultation systems, remote operation room guidance systems, remote ICU systems, and data sharing and exchange platforms.
One emphasis of the Technical Guidance is the protection of patient privacy and data security. In this regard, the Technical Guidance proposes a number of specific security measures for managing patient information, which include but are not limited to:
- A uniform data acquisition channel should be used for data collection to ensure data security;
- Distributed discrete fragmentation storage technology should be used for storage of medical information; and
- VPN and encryption technology should be used for data transmission to secure data transmission channels.
Although the Technical Guidance aims at providing a uniform national telemedicine service network within China and does not expressly require foreign healthcare providers to conform to the proposed technical requirements, U.S. companies and healthcare providers interested in China's telemedicine market should consider the compatibility of their products and services to ensure better business opportunities and successful projects.
Without doubt, telemedicine continues to garner robust attention, both within China and from international partners, placing China squarely on track to become one of the largest telemedicine markets in the world, facilitated by its construction of a uniform national telemedicine service network.
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