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Background: The limited availability of maternal and child health data has limited progress in reducing mortality and morbidity among pregnant women and children. Global health agencies, leaders, and funders are prioritizing strategies that focus on acquiring high quality health data. Electronic maternal and child health registries (eRegistries) offer a systematic data collection and management approach that can serve as an entry point for preventive, curative and promotive health services. Due to the highly sensitive nature of reproductive health information, careful consideration must be accorded to privacy, access, and data security. In the third paper of the eRegistries Series, we report on the current landscape of ethical and legal governance for maternal and child health registries in developing countries. Methods: This research utilizes findings from two web-based surveys, completed in 2015 that targeted public health officials and health care providers in 76 countries with high global maternal and child mortality burden. A sample of 298 public health officials from 64 countries and 490 health care providers from 59 countries completed the online survey. Based on formative research in the development of the eRegistries Governance Guidance Toolkit, the surveys were designed to investigate topics related to maternal and child health registries including ethical and legal issues. Results: According to survey respondents, the prevailing legal landscape is characterized by inadequate data security safeguards and weak support for core privacy principles. Respondents from the majority of countries indicated that health information from medical records is typically protected by legislation although legislation dealing specifically or comprehensively with data privacy may not be in place. Health care provider trust in the privacy of health data at their own facilities is associated with the presence of security safeguards. Conclusion: Addressing legal requirements and ensuring that privacy and data security of women’s and children’s health information is protected is an ethical responsibility that must not be ignored or postponed, particularly where the need is greatest. Not only are the potential harm and unintended consequences of inaction serious for individuals, but they could impact public trust in health registries leading to decreased participation and compromised data integrity.
This paper is based on findings from two web-based surveys that targeted public health officials and health care providers (i.e., midwives, nurses and doctors in reproductive, maternal, and child health). Based on formative research conducted in the development of the eRegistries Governance Guidance Toolkit (Frame 1), the aim of the surveys was to assess the current status of legal, privacy and security issues relevant to maternal and child health registries in LMICs. The eRegistries Governance Guidance Toolkit [56] was developed to advise countries on how to proceed with the establishment, operation, use, and maintenance of an eRegistry for maternal and child health that is lawful and compliant with existing legal requirements, protective of women’s rights and privacy, and supportive of the public health aims of the registry. Formative research undertaken in the development of this toolkit involved an extensive review of standards, methods, and procedures established by health registry systems (i.e., cancer, chronic disease, diabetes, and clinical) and vital statistics (i.e., birth registration). The Toolkit was reviewed by experts in registry law, informatics, and public health. The Toolkit identifies best practices, discusses benefits of legislation, regulations, and guidelines, and provides guidance for countries that can be adapted to local contexts. The Toolkit outlines the essential governance components including: purpose specification, legal, fiscal, and operational responsibility, reporting requirements and enforceability, data quality, data security, confidentiality policies, and data access, and public engagement. The Toolkit considers relevant international instruments, conventions, and declarations that focus on human rights, privacy, data protection, and data security as these may provide useful information, particularly for LMICs that lack national legislation or enforcement bodies. eRegistries for maternal and child health must function within the legal framework where they operate which can involve legal requirements pertaining to medical research, public health, women’s and children’s rights, and information law (i.e., data protection law, ethical use of data). One challenge of developing governance guidance in a global context is the inherent diversity in how countries approach law, ethics, and health. Social and cultural differences in how privacy, confidentiality, and security are managed may influence laws, policies and protocols. The Toolkit encourages country level adaptation and advises against transplanting legal language or documents from one country to another. Instead, country level policies should be rooted in their own institutional fabric. Translated adaptations, for example, often fail to embrace subtle social or cultural mores that may affect acceptance. The survey recruitment strategy consisted of individualized email invitations to reproductive, maternal, newborn and child health (RMNCH) medical and health organizations, Ministries of Health, Institutes of Public Health, and other related government offices (e.g., statistics bureaus, RMNCH departments, etc.) working in any of the 75 countries identified as the highest burden countries by CoIA and the occupied Palestinian territory, collectively called CoIA countries in this paper. Surveys and invitations were available in English, French and Portuguese. (The surveys are available upon request from the first author.) The public health official survey sample consists of 298 individuals from 64 countries (84 % of the invited countries). A total of 470 health care providers from 59 countries (78 % of invited countries) participated in the health care provider survey. Among public health officials, approximately two-thirds worked at the national or regional level in a Ministry or public health institute or agency. Among health care providers, the professional breakdown included 170 (37 %) doctors, 66 14 %) nurses, 149 (32 %) midwives and 81 (17 %) other RMNCH professionals. Eighty percent (n = 341) of the health care providers worked in urban or suburban areas while one- fifth (88) were in rural or isolated areas. Among the health care providers, 198 (44 %) reported working at a public or private hospital, 46 (10 %) worked at a district facility, community health post or maternity home, 91 (20 %) were employed at a public health organization, 62 (14 %) were employed at a MoH, and 49 (11 %) selected ‘other.’ A breakdown of the public health official survey respondents by the six WHO regions found that 37 of 42 CoIA countries (88 %) were represented from the African region (88 %), 4 out of 6 (67 %) in the America region, 2 out of 5 (40 %) CoIA countries in the European region, 5 out of 6 (83 %) CoIA countries in the South-East Asian region, 6 out of 7 countries (86 %) in the Western Pacific region, and all ten CoIA countries in the Eastern Mediterranean region (100 %). Among health care provider survey respondents in CoIA countries, 32 out of 42 (76 %) countries were represented in the African region, 8 out of 10 (80 %) countries in the Eastern Mediterranean region, 2 out of 5 (40 %) European countries, 4 out of 6 (67 %) of the South-East Asian countries, and all countries in the America (6/6) and Western Pacific region (7/7) were represented. The personalized invitations contained live links to the online surveys and requested that individuals participate and share the survey with peers, colleagues and professional networks (i.e., a snowball sampling recruitment method) in order to boost the sample size via a referral strategy. Paper-based surveys were made available in some circumstances. Launched in November 2013, responses were accepted until February 2015. Repeated efforts were attempted for all non-responsive countries. Thematic areas measured by the survey included national registry infrastructure, legal and ethical issues, data security, health care service provision, reporting and dissemination practices, data quality, and data usage. This paper focuses on the ethical and legal domains while results concerning the other topics are reported elsewhere [14, 15, 57] Frost et al, personal communication, 2016. The public health official and health care provider surveys contained overlap of core thematic content but also included questions adapted specifically to the different target groups in order to capture their unique professional and workplace perspectives. The public health official survey, for example, included detailed questions on civil registration systems and data utilization whereas the health care provider survey contained specific items on service provision and data reporting from a health care provider perspective. The survey was reviewed by the Regional Committees for Medical and Health Research Ethics in Norway and received a letter of exemption given that all information collected was fully anonymous (Reference number: IRB 0000 1870). All respondents were informed that their answers were completely anonymous and that they could withdraw from the survey at any time. Descriptive statistics were used to present most findings while generalized linear models (PROC GLM) were used to assess more complex associations. Exact confidence intervals were generated from tables. All analyses were done using SAS 9.4. Responses from the public health officials were collapsed to the country level while health care providers were analyzed on the individual level. This strategy was specifically chosen to avoid masking the inherent variability among health care provider settings while facilitating national level assessments with public health official responses. With regard to data security measures, the surveys asked about physical, technical, and administrative safeguards for protecting electronic registry medical records. Due to missing data among health care provider responses, only public health official data are reported. With regard to the question on level of trust that health care providers have in their own facility’s security, respondents were asked to rate how comfortable they would be having their own data stored at their work facility using a five-item Likert scale ranging from very comfortable to very uncomfortable.
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