System definition and specification

EMTs work under severe constraints and potentially face shortages of every resource imaginable: from medications and personnel to electricity, connectivity, and patient information [15]. Additionally, time pressures make collecting, communicating, and documenting patient data difficult, as does the lack of a standardized framework for the users from many different countries and backgrounds [16]. An electronic patient record must be able to handle all of these challenges while being lightweight, scalable, and highly customizable [17]. Figure 1 illustrates how those requirements, especially features for electronic patient record and EMT management, integrate with data reporting and exchange. Flexibility and modularity in a pre-clinical setting allows for efficient utilization of such a system.

Fig. 1

Vision of a comprehensive information system for field hospitals with the four main features that are needed in the field: electronic patient records, emergency medical team (EMT) management, reporting and data exchange, modularity and flexibility

We performed extensive requirement analysis with users from different European EMTs to gather a collective knowledge on the specific needs and aggregated all the feedback to create a common ground for an electronic patient record system. The most important functions to fulfill these requirements are described in the following sections.

Clinical requirements

An EPR system for EMT must cover all clinical features that normal hospital information systems provide. This ranges from patient admission, treatment planning and documentation to referral documentation and the creation of medical reports. Other, non-medical features should also be included, e.g., material logistics and management, but are not covered within this article. The following paragraphs describe the specific clinical tasks in detail.

A)

Patient admission and identification: patients treated in an EMT must be admitted to the clinic, and therefore into the EPR. This comprises gathering identifying information and creating unique patient identifiers (PID). For the specific use case in an emergency setting, the triage category of a patient is vital to determine the cases urgency. This data should be available at all time and accessible by different clinical modules of EOS, as illustrated in Fig. 2, where clinical data will be used (or referenced) for other management processes, e.g., stock management or department administration. Thereby, more precise and personalized processes are achievable.

B)

Treatment planning and documentation: physicians and nurses attending the patients need to document their assessments and thoughts about a case. They need to be able to write down recommendations and plans for the next measures to take with a specific patient. Also, the performed actions must be stored within an EPR. All diagnostic data from examinations must be available.

C)

Referral to different places of therapy and special clinical procedures must be documented and the respective patient information needs to be communicated along all attending staff. This entails the request for diagnostic imaging of surgical treatment by specialized departments of an EMT.

D)

The finalization of treatment must be documented and all related information must be provided to the transferring entity (e.g., local hospital, general practitioner, other EMT).

Fig. 2

Clinical repositories in Emergency Medical Team Operating Systems (EOS) serve multiple purposes, patients’ master data and clinical data will be applied for administrative or logistical (e.g., stock management) use cases

Regulatory requirements

Data protection is one key aspect that must be implemented by any information system, especially clinical information and electronic patient record systems [18]. A system must provide a way for users demonstrate that the patient has consented to processing of his or her personal data [18].Footnote 1 Processing clinical data must by default only be allowed to personnel directly involved in the treatment. Any other data, e.g., patients from another ward or department, shall by default not be accessible [18].Footnote 2 Any clinical data recorded needs to be consistent and therefore an electronic record system shall maintain a record of processing activities under its responsibility [18].Footnote 3 This includes any changes of individual of clinical data by some user of the system.

EMTs, typically requested by foreign governments and deployed by domestic authorities, must provide regular reports to the respective authority, such as the domestic Ministry of Health or Ministry of Interior, or the local authorities of the country of operation. The “Emergency Medical Team Minimum Data Set Working Group” of the WHO has developed a standardized data sheet by the called EMT Minimum Data Set (MDS) [19, 20]. Reports must adhere to the given format and ideally be automatically generated from existing EPR data.

However, there is a need for commonly agreed standards for what organizational and technical aspects EMTs should adhere to, as well as what features software and hardware should offer, independent of products and manufacturers. Today, there are already globally recognized standards for hardware and information security, such as ISO 27001. Medical data standards are defined internationally by organizations such as HL7, and most vendors comply. The National Electrical Manufacturers Association has published a document on cybersecurity features of networked medical devices, known today as the Manufacturer Disclosure Statement for Medical Device Security.

Technical requirements

Clinical processes vary among EMTs due to the modular nature of their setup. Therefore, an EPR should also adhere to this structure. Different disaster scenarios involve varying medical conditions and interventions. To ensure prompt and adequate delivery of care with minimal misunderstandings between teams, highly configurable components should be provided. These components can be pre-populated at the onset of a disaster and updated during missions to accommodate changing conditions and requirements. This feature allows for the input of clinical or logistical details to be used in treatment documentation. For example, a list of medications commonly used by EMTs can be included in clinical records after being prescribed to a patient. Additionally, diagnoses established by EMTs (usually a subset of larger classification systems like ICD-10) can be assigned to patients in their electronic records.

The system must be fully functional and have stable performance. As the system is responsible for transmitting critical data to medical personnel, it must be crash-proof. Information must be conveyed reliably and at the same time the transmission and presentation should remain agile. The system must be able to register the right patient, call up their data, and ultimately display the results. In addition, it must respond correctly to requests from the users.

From a usability perspective, it is important to keep the users’ attention on treating the patient and distractions should be avoided. Therefore, the system should be easy to use and ideally intuitive, requiring minimal effort to master. During operation, time and information are critical to a patient’s condition. Accordingly, the system must be able to act and react quickly and appropriately. In order to minimize or avoid latency periods caused by the user’s difficulties in understanding, the display must be clear and easy to understand.

The environment for an EPR inside the infrastructure of an EMT is rather unfavorable. It is usually built outside in mobile housing or tents. Power supply is usually organized by the team itself, by bringing power generators and fuel. However, shortages are always a danger and relying on electronic systems requires a stable power supply, of course. Hence, the application needs to be slim and economical regarding its power demands.

Non-functional requirements

Qualitative aspects like usability, availability, or robustness are also very important when designing an electronic health record system. They directly affect user acceptance, user performance, and ultimately the patient safety [21]. In general, a system should be designed to be as unrestrictive as possible and as flexible as needed, especially in emergencies.