The challenges regarding harmonised interoperable e-health services are enormous due to the complexity of the domain, comparatively high demands of privacy and security, implications of storing, sharing, and managing health data as well as unclear definitions and standards for patient's electronic health records. Therefore, the advantages of digitalisation are yet to reach the end user-patient, especially in the emergent regions where digital infrastructure is limited. The focus is on the north and northeast regions of Brazil, where a holistic understanding of the requirements for a digital transformation of the health care system is explored through the lens of an expert panel using a Delphi methodology, complemented by a comparison with related innovations in the digital health domain.
For the healthcare domain, the complexity of the digital transformation process is high due
to the high sensitivity of the health data and the privacy and security reservations
concerning the domain [
The project Electronic Identity-Enabled Standardized and Harmonized Health Record
Management (eSHARE) therefore tries to understand the demands of the complex context
of digital transformation of the health system through a feasibility pre-study [
Brazil’s Unified Health System (Sistema Único de Saúde - SUS) is mandated to provide equal
health services to all citizens, although regional finances and availability of professionals
have created a huge gap in the quality-of-care provisioning across different states. The
digital health strategy of Brazil predominantly aims at levelling up and leveraging efficient
and effective care provision. However, the digital solutions provided by the federal
government in support of the implementation are being pertained in diverse ways, due to
the federal government structure. In addition to the national digital health strategy, which
is the governing framework of digital transformation in the sector, operational strategies
for implementation and uptake at the municipal level are needed. Such local strategies
promote operational efficiency and effectiveness of the health service, transparency,
inclusion, and patient mobility aiming for an increase in patient satisfaction, and patient
meetings, fostering preventive health initiatives while attracting qualified healthcare
professionals [
Despite improvements in the healthcare infrastructure, a great gap in the dissemination
of care facilities between rural and urban areas still exists [
As described in the preceding section, an exploratory case study strategy is pursued to understand the prerequisites for requirements elicitation within the context. The case itself premises the features of an emerging region, where its current landscape of health service, legal and strategic demands play a pivotal role in discerning and outlining the essential prerequisites crucial for executing a successful digital health transformation. It intends to function as a guiding baseline, systematically identifying the specific needs, technological aspects, infrastructural demands, and potential challenges unique to the region, thereby paving the way for an effective implementation strategy tailored to its distinctive context.
General aspects characterising the territorial context of Brazilian healthcare were explored
before setting up the empirical approach within specific regions in the north and northeast
(states of Maranhão and Para). While responsibilities are governed centrally by the federal
government, some are by the region (State), and the main operational unit is by the
municipality [
Basic Health Units (Unidades Básicas de Saúde – UBS) form the foundation of primary care, which provides preventive care, vaccinations, basic treatments, and health promotion services to their communities. Each municipality typically has several UBS scattered across its territory. An example is Family Care, which assigns multidisciplinary teams, such as community health agents (ACS) and other professionals, to specific neighbourhoods, villages, or regions, to provide more comprehensive and continuous care. Municipalities may also specialise in outpatient clinics or centres for specific services, such as mental health support, physical therapy, and other treatments. The hospitals and emergency care units are typically located in the largest municipalities in the region (Unidades de Pronto Atendimento - UPA), which manage more complex cases and emergencies. Each municipality has a Health Secretariat responsible for overseeing and coordinating health policies, it manages budget allocation, resource distribution, and implementation of initiatives within its jurisdiction. The operational framework of the health sector within the municipalities is oriented, by design, towards ensuring universal access to healthcare services. Therefore, the requirement elicitation processes in this study are part of a focus on the electronic health record (EHR) for primary and secondary care.
Four stakeholder groups were identified to systematically capture the current landscape of healthcare provisions: patients (who require continuous visits for health service); healthcare professionals, such as doctors, nurses, and support staff in healthcare units; leadership in municipalities (head of healthcare) and heads of information technology from the municipalities in the selected regions. Patients were not directly included in the respondent group, due to heterogeneity of their knowledge level in the area, which might have led to difficulties in comprehension and a lack of awareness of patient rights in the context of digital transformation. However, representatives from one patient organisation were included.
A multi-method approach to engage expert groups consisting of health care professionals
active in the context of the case was adopted, complemented by a comparative study against
previously identified requirements for the health care domain. Similarly, Ref. [
The methodological base for the expert group discussions followed a Delphi approach, [
The healthcare domain resides in one of the most sensitive data in public service where
utmost care should be taken when collecting and managing information of patients. We
have not measured or taken any sensitive or personal data from any participants involved
in data collection. This article addresses ethical concerns outlined in [
Expert discussions provided a holistic perspective on the needs related to the EHR systems,
pointing out varying levels of requirements granularity. The discussion sessions were held
in an informal setting and three rounds until no new knowledge appeared. The
collaboration with expert panels was facilitated by the MIRO platform [
Ermakova et al. [17] were used as a basis to enrich security requirements, and [
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• • • • • • • • • • • • • • and Information (Security)
Confidentiality Anonymity Control of access rights Revocation of access rights Fine-grained access control (i.e. use of data that is only necessary and permitted) Access to patient data in emergencies Unlinkability (i.e. medical actions and identities are hidden from unauthorized users) Ownership of medical data Integrity of patients’ personal information Detection and prevention of security violations Non-repudiation Authenticity and authentication Auditability Archiving should be facilitated.
Fault tolerance Provide non-stale or up-todate data Storage should last for many years out consent options invalid. Additionally, the system must guarantee that personal information is accessible solely to authorised individuals. Requirements were matched and proposed in Table 1. Note that only the EHR System requirements are presented here. Requirements for EHR Journal compliant with security and privacy
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Secure authentication via trusted electronic ID (eID) Enable patients to set access control (revoke, grant, deny, etc.) of their health records after reviewing and accepting access policy rights Enable doctors to write, edit, and update the medical records of their patients only if they are granted access to Enable patients to decide which healthcare provider organization can view or update their health record or documents Enable healthcare workers to supersede restrictions to access to documents in case of emergency (e.g. accepting policy regarding the protection of patient privacy) Patients can mark some health record as personal/sensitive (optional) Default access to patients’ records is only accessible for registered healthcare provider organizations Notify patients when their health records or documents are viewed, updated, created, removed or reinstated Notify patients when the emergency access function is invoked by healthcare providers Notify patients when their primary doctor/healthcare provider is changed Log health record access for transparency and accountability. Enable patients’ to limit sharing time of documents via short-time access code (e.g. healthcare provider must be supplied with the code to access to documents for the ongoing medication) The system shall activate the eID authentication when healthcare provider demands access to restricted documents.
• • •
Scalability Usability Efficiency • Allows access emergency functions (e.g. policy should include conditions for allowing access documents/information) • Should allow add-ons integration for patients’ management (e.g. connecting with other health apps and importing/exporting data; manage subscriptions for integrating care) • Should facilitate communication between - Patient to doctor (1-1); Patients to health forums (1-many); share news for patients (1-many); direct messaging (e.g. legal compliance)
This paper instrumented an approach to understanding in a holistic perspective of a digital transformation of primary and secondary health care systems from a patient-centric perspective. A preliminary requirement list was aggregated through discussion sessions with experts and triangulated by desk research with the intention to be further trimmed down through the lenses of healthcare stakeholders, commenting on the challenges of dayto-day operations. It is evident that from the two exercises reported on in this paper alone, the resulting requirement set remains too broad to tackle the development of a minimum viable solution. Hence, we proceeded to distil these requirements into targeted use cases from primary and secondary care as a crucial step to identify core functionalities that directly address the more critical needs in the health care system.
The set of use cases can be used to elaborate the requirement set for each case and lay the ground for a patient-centric minimum viable solution for an electronic journal system in the context of northern Brazil. Further work includes stipulating a tangible minimum requirement set, identified through a series of participatory workshops using concrete patient use cases as a backdrop for revealing the necessary information flow between the actors involved in regular health care visits.
This research is partially funded by Sweden's innovation agency Vinnova under the framework of an international innovation collaboration with actors in Brazil in collaboration with EMBRAPII research institute 2021 through eSHARE project (Grant no. 2021-04593). The partners of the eSHARE project Consórcio Intermunicipal Multimodal CIM Brazil, and ARCT-PA Brazil are acknowledged for their contributions in the field work.