Table 3

Minimal and optimal target product profile characteristics focused on app characteristics, as defined by expert consensus process

CharacteristicsMinimal requirementsOptimal requirementsComments
System validationThe app has been validated in the intended implementation setting. There is evidence demonstrating:
  • Valid clinical association (clinical output based on input data is supported by well-established or novel evidence)

  • And analytical validation (input data are processed correctly into expected output data)

The app has been validated in the intended setting. There is evidence demonstrating:
  • Valid clinical association (clinical output based on input data is supported by well-established or novel evidence)

  • And analytical validation (input data are processed correctly into expected output data)

  • And clinical validation (clinical safety or other meaningful outcome relevant to the intended use)

There is evidence that the system is based on evidence and working to achieve the intended use for the intended setting
(See FDA’s SaMD clinical evaluation for current guidance20)
System access (public API)Publicly available API for data access protected by authentication and authorisation. At a minimum, technical standards are adhered toOptimally, HIE/HL7 standards are adhered to
Context configuration
  •  Language: UN official languages

  •  Local time

  •  Local weights and measures

Same as minimal, and the following:
  •  Option to customise to local official language

  •  Other country preferences

Language can be a major barrier to the proper use of the tool for patient management and can lead to errors and misinterpretation
CustomisationChanges to the app, such as updates to the list of medicines and POCs available in the setting, can be made by the healthcare programme. Validation of this change shall be providedSame as minimal
User access rightsAppropriate data access is provided based on specific rolesRoles may include data manager (facility supervisor) or data entry person (nurse)
Expert supportNoneBuilt-in access to online/remote expert advice to assist in patient consultation via SMS, audio call and video conferencing
App trainingOn-site trainingSame as minimal, and remote training and/or remote ‘Train the Trainer’
Internet availability
  •  Functions offline (allows for service delivery and key workflows)

  •  Allows automatic resynchronisation

Same as minimal, and trigger alerts on user device when data have not been synchronised for a long timeInternet connection can be very unstable, therefore the tool should work in offline mode so as to not disrupt the workflow of the user
Clinical data entryManual entry by the operatorSame as minimal, plus automatic upload of digital data (eg, from biosensors, medical devices)Optimal: this allows external integration of other app modules, built-in and third-party apps and devices
Patient management recommendationConsultation data are summarised and actionable recommendations provided (eg, treatment, referral, home care or follow-up)Same as minimal, and recommendations are integrated in EMRs and HIS
NavigationSequential: the user follows a strict sequence of data input to reach a final recommendationNon-sequential: the user can move in any direction through an assessment and change input data to reach a final recommendation
Workflow requirements to enable time-delayed POC data inputAbility for a user to perform multiple, simultaneous consultations, with pause and resume capability, to allow clinical and laboratory data entrySame as minimal, plus ability to disable simultaneous workflow feature in settings with minimally skilled workersThis is particularly relevant for implementation in settings where testing and clinical consultations are performed in different locations
Task managementMultiple algorithms can be supported simultaneously in one application against a common data setCan accommodate task-shifting capability, that is, multiple consultations can be opened at a time and patient profiles can be accessed using preset user access rights
Follow-upNoneAbility to retrieve patient information using patient registration informationThe optimal implies data recoverability, also covered in the Data section
System malfunction protectionSystem malfunctions are made clear to the user
ScalabilityThe app shall allow high transaction volumes with complex workflows to cover primary care workforce at a national scale
Updates and versioningProcesses are in place to control any app changes (including algorithm version updates) and provide the appropriate and correct update to the user
  • API, application programming interface; EMR, electronic medical record; FDA, Food and Drug Administration; HIE, Health Information Exchange; HIS, health information system; HL7, Health Level 7; POC, point-of-care; SaMD, software as a medical device; SMS, short message service; UN, United Nations.