CDISC announced the release of a freely available standard that maps existing international standards to facilitate interoperability of data and metadata related to vaccine administration. Developed in partnership with the Global Information for Public Health Transformation (GIPHT), an initiative of the Learning Health Community, the Vaccination Administration Version 1.0 standard represents a minimum set of key data elements for electronically documenting vaccinations.
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The goal of the GIPHT-CDISC collaboration is to achieve multinational agreement around one global core data standard that will enable the success of various vaccine credentialing and vaccine ‘passport’ applications to foster rapid and comprehensible sharing of essential information for uses such as safe international travel. Security, validation and privacy remain the responsibility and expertise of the technology developers and implementers.
“This global standard has been developed by consolidating key data element recommendations from the European eHealth Network, the World Health Organization and US Centers for Disease Control. Relevant standards developed through ISO, HL7 and CDISC have been applied and harmonized,” stated David Evans, CDISC President and CEO. “This standard represents the value of working in a collaborative way with subject matter experts in the global community to produce a high-value standard for international adoption and technical information exchange.”
The Good Health Pass Collaborative, the International Air Transport Association (IATA), the Vaccine Credentialing Initiative and others have announced efforts to develop technology to enable individuals to demonstrate digital proof of vaccination. Broad adoption of a common data standard across these initiatives and applications will ensure interoperability and ease of use.
The continuing evolution of the novel coronavirus presents humankind with the potential for genetic variants evincing higher levels of pathogenicity, transmissibility, and immune escape. Thus, travelers need assurance that they will readily have the necessary information to be efficiently screened at border crossings, regardless of the technology they choose. Software developers are scrambling to design and deploy apps that will allow societies to safely navigate this new normal. “The joint efforts of CDISC and the LHC to develop a technology-agnostic international data standard will enable software developers to focus on what they are best at: developing apps that interoperate with the vaccination verification technologies deployed at border crossings,” stated Dr. Brian Martin, Principal Digital Health Analyst with the MITRE Corporation.
Increasing adoption is anticipated as the value of this standard for public health is validated. It is the belief of those participating in the GIPHT Initiative that any organization interested in promoting public health and sharing relevant vaccine administration data internationally should engage in a global solution and implement this standard. “The information about a person’s COVID-19 vaccinations must be precise and clearly understood by any person or computer that needs to receive it,” commented Dr. Dipak Kalra, President of The European Institute for Innovation through Health Data (i~HD). “When viruses cross boundaries, the information to manage the disease must see no boundaries.”
ABOUT THE LEARNING HEALTH COMMUNITY and GIPHT
The Learning Health Community (LHC) is a global grassroots movement in which multiple and diverse stakeholders work together to transform healthcare and health by collaboratively realizing person-centered Learning Health Systems (LHSs) anchored in shared consensus Core Values; LHSs aim to efficiently and equitably serve the learning needs of all participants, as well as the overall public good. https://www.learninghealth.org/
The Global Information for Public Health Transformation is an initiative of the LHC. This multi-national collaboration was initially guided by experts from three countries–Spain, Italy, and the United States–all of which experienced serious challenges during the COVID-19 pandemic. The GIPHT mission is to design and explore a data-driven, standards-based systems approach to COVID-19 data management to inform real-time and strategic decisions during a pandemic or other public health emergencies.
ABOUT CDISC
CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC actively collaborates with Europe’s Innovative Medicines Initiative. CDISC is also strategically positioned as a global standards governance body that supports and maintains standards not only for clinical research but also for public health. As a global nonprofit charitable organization, CDISC has entities in Austin, Texas, and Brussels, Belgium with hundreds of volunteers, employees and member organizations around the world. https://www.cdisc.org/
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