The Global Information for Public Health Transformation (GIPHT) initiative of the Learning Health Community has collaborated with CDISC to develop a minimum set of key data elements for documenting vaccinations. The goal of the collaboration is to achieve multinational agreement around one global core data standard that will enable the success of vaccine credentialing applications and secure sharing of essential information for uses such as safe travel.
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The proposed standard is open for public comment through 20 May 2021. CDISC is inviting open public comment to build consensus towards a final standard that will be implemented globally in documenting vaccinations and developing digital certifications and related applications.
“Global consensus around the use of one common core set of data elements will help remove barriers to international travel while encouraging protections for public health,” said Pablo Rivero, Senior eHealth Expert, NTT Data and Member of the WHO Digital Health Roster of Experts.
The European Commission announced a Digital Green Certificate intended to facilitate safe travel among EU member countries; the European eHealth Network has published recommended data elements for interoperability and WHO has proposed recommended data elements for a Smart Vaccination Certificate. The Vaccine Credentialing Initiative is promoting an approach based on FHIR and a prior HL7 immunization messaging standard; there are many others working to develop vaccine “passports”, including the International Air Transport Association (IATA).
“We realize that vaccine passports have become politically charged with competing interests of personal privacy, fair access and safeguarding public health,” commented Joshua Rubin, President and CEO, Learning Health Community. “Regardless, there may be circumstances in which individuals wish to prove their vaccine status in a trusted way. A global standard will put that power in the hands of individuals.”
This draft standard has been developed by consolidating data element recommendations from the European eHealth Network, WHO and US Centers for Disease Control and harmonizing relevant standards from ISO, HL7 and CDISC. It focuses on core data elements and does not deal with credentialing, privacy, certification, safety data or technology; these areas are left to the relevant experts to create trustworthy, interoperable applications to reinvigorate global business.
“CDISC developed and published a COVID-19 data standard in less than a month by leveraging existing global clinical research standards, including those for vaccines, virology and Ebola,” stated Rhonda Facile, Vice President of Partnerships and Development, CDISC. “We are proud to support this effort to extend our work into the public health arena. This harmonized set of data elements will facilitate the implementation and semantic interoperability among various technology and tools being developed to facilitate safer international travel.”
ABOUT THE LEARNING HEALTH COMMUNITY
The Learning Health Community 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 LHC is non-profit entity and an open community endorsed by well over a hundred global organizations.
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. 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/