Standardization and simplification of vaccination records Expert Rev. Vaccines Early online, 1–15 (2014) Wolfgang Maurer 1‡ , Lea Seeber 2‡ , Gabriella Rundblad 3 , Sonali Kochhar 4 , Brett Trusko 5 , Bron Kisler 6 , Rebecca Kush 6 , Barbara Rath* 2 and The Vienna Vaccine Safety Initiative (www.vi-vi.org) 1 Center for Public Health, Medical University Vienna, Austria 2 Department of Pediatrics, Division of Pneumonology-Immunology, Charite ´ University Medical Center, Berlin, Germany 3 Department of Education and Professional Studies, King’s College London, London, UK 4 PATH, Qutab Institutional Area, New Delhi, India 5 Icahn School of Medicine at Mount Sinai, New York, NY, USA 6 Clinical Data Interchange Standards Consortium (CDISC), Austin, TX, USA *Author for correspondence: Tel.: +49 304 5066 6664 Barbara.Rath@gmail.com ‡ Authors contributed equally The majority of vaccines are administered during childhood. Vaccination records are important documents to be kept for a lifetime, but the documentation of immunization events is poorly standardized. At the point of care, paper records are often unavailable, making it impossible to obtain accurate vaccination histories. Vaccination records should include batch specifications to allow the tracking of licensed vaccines in cases of recall. The WHO have generated the International Certificate of Vaccination or Prophylaxis for the documentation of childhood and travel vaccinations as well as seasonal and booster immunizations. When moving vaccination records into the digital age, data standards and interoperability need to be considered. The ideal vaccination record should facilitate the interpretation of safety reports and promote a data continuum from pre-licensure trials to post-marketing surveillance. The current article describes which data elements are essential, and how vaccination documentation could be streamlined and simplified. KEYWORDS: AEFI • certificate of immunization • data interoperability • m-health • electronic health records • harmonization • pharmacovigilance • simplification • standardization • vaccination record Communicable diseases do not stop at national borders and may pose a threat to human health in different parts of the world. Vaccines are among the most important meas- ures to prevent infectious diseases, saving mil- lions of lives every year [1]. Immunization programs are viable only if vaccination events are monitored vigorously. The monitoring of immunization programs relies on accurate and standardized documentation of vaccination events, as well as the tracking of vaccine trans- port and logistics. Unfortunately, many health- care providers and administrative regions are still using inconsistent or poorly interoperable documentation systems. There are currently very few studies in the published literature investigating completeness of vaccination records or differences between record-keeping by lay people versus medical professionals (see section ‘Roles & responsibil- ities in record-keeping’). In order to enable informed decision-making, for which patients have to understand their own medical docu- ments, clear and intuitive vaccination records are required. New technologies allow different approaches to how and where vaccination data should be stored. As part of this development, a consensus should be reached on the question of who should be responsible for the maintenance and accuracy of vaccina- tion records: the physician, the vaccine recipi- ent or both. The importance of standardized require- ments for complete documentation will be discussed in ‘Standardization of vaccination records’. At the end of ‘Standardization of vaccination records’, we provide a literature review illustrating different views on roles and responsibilities with regards to vaccina- tion records. In ‘Simplification of vaccination records’, we address the need to simplify stan- dardized vaccination records to improve appli- cability in all settings, including low-resource environments. The feasibility of digital solu- tions will also be addressed in ‘Simplification of vaccination records’. This interdisciplinary field requires close collaboration between clinicians, public health experts and standards organizations, who would also constitute the target audience for this paper. We therefore include the perspectives of all three parties including a non-profit organization closely involved with data standards for clinical research and electronic health records (EHRs). informahealthcare.com 10.1586/14760584.2014.892833 Ó 2014 Informa UK Ltd ISSN 1476-0584 1 Review