World Health Organization · 1st edition, 2025 · 66 pages
Standardized digital content requirements for birth defects surveillance systems, enabling clinicians and public health teams to implement WHO-aligned PCPOSS.
- Issuer
- World Health Organization
- Edition
- 1st edition, 2025
- Audience
- Health programme managers, digital health/HIS teams, software developers, business analysts, surveillance data managers, birth defects specialists, data collectors (nurses, midwives, community health workers)
- Evidence
- Derived from WHO Birth Defects Surveillance Manual (2020), Quick Reference Handbook (2020), and training materials; DAK itself is operational guidance, not graded recommendations
- Reviewed
- 15 Oct 2026 · GMJ
What this guideline says
GMJ summary
This Digital Adaptation Kit (DAK) provides software-neutral, operational documentation for implementing WHO birth defects surveillance guidelines in digital systems. It translates narrative guidance into structured workflows, data elements, and functional requirements for person-centred point-of-service systems (PCPOSS) used by health workers to register, confirm, and report birth defects cases.
The DAK covers three core business processes: (A) data collection and abstraction by health workers who examine newborns and record birth defect data; (B) case confirmation by birth defects specialists who review diagnoses; and (C) data aggregation and dissemination by surveillance managers who generate reports on prevalence indicators. All data elements are mapped to ICD-10/11, LOINC, SNOMED, and other interoperability standards.
Designed as a modular, 80% generic framework requiring 20% local adaptation, the DAK supports countries transitioning from paper registers to digital surveillance, linking facility-level data to national HMIS, and ensuring fidelity to WHO recommendations in birth defects surveillance as outlined in the 2020 Manual for Programme Managers.
Key points
For clinicians — doses and thresholds as stated in the guideline
- Three main workflows: data collection and abstraction (BDS.A), case confirmation by specialists (BDS.B), and data aggregation for reporting (BDS.C)
- Core data elements include newborn identifiers, gestational age, weight, length, congenital anomaly diagnosis (using ICD codes), photographs of defects, and parental demographics (age, relation)
- Consent for data collection and photographs must be documented when required by national protocol; digital signatures are acceptable
- Birth defects specialists review photographs and clinical data to assign confirmed diagnosis status: 'possible', 'confirmed', 'excluded', or 'misdiagnosis'
- Prevalence indicators calculated as cases per 10,000 births, disaggregated by outcome at birth, maternal age, race/ethnicity, sex, and clinical presentation (isolated vs. multiple anomalies)
- Case inclusion criteria must be locally defined: typically age, pregnancy outcome, gestational age, birth weight, maternal residence, and specific defects under surveillance (e.g., anencephaly, spina bifida, encephalocele)
- System must support deduplication (multiple records for same newborn vs. twins), offline data entry, and automated calculation of aggregate reports
- Data elements mapped to ICD-10/11 Q codes, LOINC for observations (e.g., gestational age 11884-4), and SNOMED CT for clinical findings to enable interoperability
Core data elements for data collection and abstraction (Process BDS.A)
Table extracted from the guideline
| Activity | Data Element ID | Data Element Name | Description |
|---|---|---|---|
| BDS.A4. Create new case | BDS.A4.DE.1 | Case record ID | Unique ID of the case (newborn) moving through the health system |
| BDS.A4. Create new case | BDS.A4.DE.2 | Date of report | Date of reporting of the birth defect |
| BDS.A10. Seek consent | BDS.A10.DE.5 | Consent provided for data collection | Whether informant gave consent if required by protocol |
| BDS.A12. Collect data | BDS.A12.DE.7 | First name | Newborn's first name |
| BDS.A12. Collect data | BDS.A12.DE.9 | Unique ID | National unique ID, health ID, or system-generated ID |
| BDS.A12. Collect data | BDS.A12.DE.10 | Date of birth | Newborn's date of birth |
| BDS.A12. Collect data | BDS.A12.DE.13 | Sex | Sex of newborn assigned at birth |
| BDS.A15. Seek consent | BDS.A15.DE.102 | Consent for photographs | Whether consent for photographs was given if required |
Source: World Health Organization, Digital adaptation kit for birth defects surveillance: operational requirements for implementing WHO recommendations in digital systems. Reproduced in summary form.
From the guideline
Verbatim
“DAKs provide the generic content requirements that should be housed within digital systems, independent of a specific software application and with the intention that countries can customize them to local needs.”
Editor’s perspective
Why this matters for Georgia and the region
Prof. Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, Georgian Medical Journal · Chair, Public Health Institute of Georgia · WHO consultant, health and migration
As Editor-in-Chief of the Georgian Medical Journal and Chair of the Public Health Institute, I see this DAK as a critical bridge between WHO surveillance guidance and the digital health systems Georgia has invested in since 2013. Our eHealth infrastructure already captures vital events and IMCI data, but birth defects surveillance has remained fragmented across delivery units. The most actionable recommendation for Georgian colleagues is the three-step workflow: frontline nurses and midwives register cases with standardized ICD codes and photographs (BDS.A), regional geneticists or paediatricians confirm diagnoses remotely via the digital platform (BDS.B), and NCDC aggregates prevalence data for ministry reporting (BDS.C). However, realistic implementation will require defining our national inclusion criteria—Georgia's diverse geography means gestational age at delivery and access to neonatal imaging vary widely—and training rural health workers to recognize and photograph external anomalies using the WHO Quick Reference Handbook, which must be translated into Georgian and integrated into our continuing medical education platform.
ORCID 0000-0001-7609-4515 · Perspective written for the GMJ Guidelines Library, 15 Oct 2026
Applicability
Georgia and the South Caucasus
Georgia’s birth defects surveillance capacity would benefit from this DAK as the country strengthens vital registration and maternal-newborn health monitoring under its Universal Health Care programme. National adaptation would need to define: inclusion criteria (gestational age cut-offs, which defects to monitor), consent procedures aligned with Georgian data protection law, integration with the existing eHealth infrastructure and MoH HMIS, and capacity-building for health workers in rural regions to conduct physical examinations and assign ICD codes. The DAK’s emphasis on interoperability standards (ICD-11, HL7 FHIR) aligns with Georgia’s digital health investments, enabling linkage between antenatal care, delivery, and newborn registries for comprehensive birth outcomes tracking.
Questions this guideline answers
Quick answers
What is the difference between a 'case' and a 'newborn' in this surveillance system?
A 'case' is defined as a unique newborn delivered with at least one of the selected birth defects included in the surveillance system. The same newborn is one case regardless of how many congenital anomalies they have. Multiple records for the same newborn (e.g., from different teams) are duplicates and should be merged, not confused with twins or multiple births where each infant is a separate case.
When is consent required for birth defects surveillance data?
Consent requirements depend on local or national policy. Some countries do not require informed consent for public health surveillance. Where consent is needed, it can be documented in writing, digitally (e.g., digital signature in the app), or witnessed if the parent/guardian is illiterate. Separate consent may be required for taking photographs of the birth defect. Data collectors must follow the national protocol on consent at Steps BDS.A9-A10 and BDS.A14-A16.
What are the five key prevalence indicators in this DAK?
The DAK specifies five core indicators: prevalence per 10,000 births of (1) anencephaly, (2) craniorachischisis, (3) iniencephaly, (4) encephalocele, and (5) spina bifida. Each is calculated as confirmed and completed cases in the surveillance population divided by total births (livebirths + stillbirths), disaggregated by outcome at birth, clinical presentation (isolated vs. multiple), maternal age, race, ethnicity, and sex.
How does the birth defects specialist workflow handle cases needing more information?
In Process BDS.B, if the specialist cannot make a diagnosis from available data/photos (Step B5), they update the case record with requested information (Step B11) and return it to the surveillance data manager (Step B12). The data manager then requests follow-up from the original data collector (Steps B13-B14). The data collector attempts to gather the information (Step B15), updates the record (Step B16), or marks the case as incomplete with comments (Steps B17-B18) if follow-up is not possible, per national protocol on how long or how many times to follow up.
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- Issuer
- World Health Organization
- Type
- Guideline
- Edition
- 1st edition, 2025
- Status
- Current
- Published
- 2025-06-16
- Languages
- English
- Scope
- Operational requirements for digital systems to implement WHO birth defects surveillance guidelines; focuses on detection in the neonatal period (first 4 weeks after birth) at facility or community level
- Audience
- Health programme managers, digital health/HIS teams, software developers, business analysts, surveillance data managers, birth defects specialists, data collectors (nurses, midwives, community health workers)
- Pages
- 66
- Licence
- CC BY-NC-SA 3.0 IGO
- ISBN
- 978-92-4-011025-0
- Evidence
- Derived from WHO Birth Defects Surveillance Manual (2020), Quick Reference Handbook (2020), and training materials; DAK itself is operational guidance, not graded recommendations
- Record history
- Created 15 Oct 2026 · updated 15 Oct 2026 · next check Apr 2027
World Health Organization. Digital adaptation kit for birth defects surveillance: operational requirements for implementing WHO recommendations in digital systems. Geneva: World Health Organization; 2025. (SMART Guidelines collection). Licence: CC BY-NC-SA 3.0 IGO.GMJ Guidelines Library records are original summaries written by the GMJ editorial team from the issuer’s published document and reviewed by a physician. They do not replace the full guideline. The document is the copyright of its issuer and is linked, not hosted. Spotted an error or a newer edition? Tell the Guidelines Desk.
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