How to manage and report incidents
If a serious incident occurs while using Doctrin (medical device Doctrin Source), report it to support@doctrin.se and the national competent authority.

Symbol Description
Manufacturer Manufacturer
Consult instructions for use Consult instructions for use
Catalogue Number Catalogue Number
Medical Device Medical Device
Date of manufacture Date of manufacture
Unique Device Identifier Unique Device Identifier
Caution Caution
Warning Warning
Intended use

The platform is intended for digital interviewing of patients with non-critical conditions. The medical device transforms and compiles outputs from the digital interview into a medical history report. The output from the medical device may be used as decision support for healthcare professionals in medical assessments and other tasks in healthcare. The platform does not diagnose nor treat patients.

Support in: Decision making and documentation of symptoms and/or medical conditions Decision making and documentation based on output from validated self assessment scales (SAS) Decision making and documentation based on rule based decision making in relation to the digital patient interview

Contra-indications

Contact initiated by a patient
Critical conditions defined as symptoms experienced as acutely life threatening by the patient.

Contact initiated by a healthcare professional (sendout)
Situations in which patient or healthcare professional response time is deemed critical to ensure patient safety.

Limitations in the use of the product
The product requires patients to be able to process information and interact with it digitally. For patients with cognitive or physical difficulties, where assistive tools are not sufficient, there are alternative ways to provide information, such as speaking with healthcare professionals.

Warnings and advised safety measures

1) Patients may not know that their condition requires urgent medical attention

  • Manage patients expectations on response time, especially if the platform is available outside of manned opening hours.
  • Inform patients on where to turn if their symptoms or condition is deteriorating.
  • Ensure that response times facilitate safe handling of patients submitting acute symptoms.
  • Ensure that staffing and ways of working align with communication on opening hours and response time.
  • Ensure adequate expertise among personnel working in the platform.
  • It is advised to adjust ways of working to enable peer support for recipients of patient errands.

Note that questions aiming to fetch potentially critical conditions are asked in order not to miss such information.

2) Patients can misunderstand questions and answer options

  • If the medical report raises a suspicion of acute or severe illness, details in the medical history regarding warning symptoms should be confirmed in dialogue with the patient, to ensure that the case is addressed at the right level of care and with the right degree of urgency.

3) The reason for contact (the questionnaire name) may differ from the needs and symptoms described by the patient in the medical report

  • Do not rely on the patient’s chosen reason for contact when prioritising cases
  • Always read the medical report

4) Immediate patient response cannot be expected in sendout (HCP initiated contact)

  • If an instant response is required, other means of communication such as phone should be used.

5) The amount of information in the medical history report can affect readability

  • Ensure that HCPs know how to assess information in the medical history report.
  • Please use the different versions of the medical history report if you experience difficulties understanding the information in the standard report.
  • If the medical history report is ambiguous, please ask the patient to verify your conclusions via chat or phone.

Please report any issues with the medical history report to Doctrin Support (support@doctrin.se)

6) Misleading presentation of the patient’s answers may appear in the history report

  • If information in the standard report is ambiguous, the patient’s exact questions and answers are available in the report version “Questions & Answers.”
  • If any information is ambiguous, ask the patient to verify your conclusions by chat or phone.

Please report any issues with the medical history report to Doctrin Support (support@doctrin.se)

7) Results from self assessment scales (SAS) can be misinterpreted

  • It is important that you understand how results from self assessment scales should be interpreted and used. Please note that the recommended usage may differ between different self assessment scales.
  • It is advised to adjust ways of working to enable peer support for recipients should they have issues interpreting the results from a self assessment scale.

In general, results from self assessment scales should be used in combination with other information about a patient’s condition. Results from self assessment scales are not directly transferable to a diagnosis or treatment recommendation.

8) Rule based decision making (RBDM) has limited analytical skills

  • The accuracy of the rule-based decision support is limited by the selected configurations and its ability to read information from free text. If rules are used to support prioritisation in the patient overview, non-prioritised patients should still be assessed within a reasonable time.
  • Ways of working should be adapted according to (1) and (2) even if rule-based decision support is used.

9) The medical history report may be unavailable due to technical errors

  • Ways of working should be adapted according to (1) and (2) to ensure patient safety in the event of technical errors.

Doctrin shares information about technical failures and their impact. Current communication channels can be found under “Contact Support” in Doctrin Help Centre.

Regulatory information

Device Identification: Doctrin platform, Doctrin AB
Doctrin platform is CE-marked as a class I device in accordance with the EU directive for medical devices.
EC declaration of conformity is available upon request.

Access to the instructions for use
The instructions for use can be found online in Doctrin’s Help Centre. A paper copy of the instructions for use can be sent to you free of charge. Contact Doctrin with your request.

Basic manufacturer and medical device information
   
Manufacturer name Doctrin AB
Manufacturer address Gävlegatan 16, 113 30 Stockholm, Sweden
SRN SE-MF-000043089
Product trade name Doctrin Source
Product name medical device Report Generating Service (RGS)
CE marking CE
Evaluation of safety and performance

Doctrin regularly evaluates three areas that are crucial for the product’s safety and performance: *The usability of medical history taking for patients *The usability of the medical report *Consistency between medical history taking and text strings in the medical report

Read the results from the latest evaluation here:

The usability of medical history taking
The usability of medical history taking was evaluated with 12 independent test participants in 2024. A tailored version of the System Usability Scale (SUS) was used. SUS is a standardised instrument for evaluating various aspects of usability in digital products. An acceptance level of at least 68 out of 100 points was applied (Lewis and Sauro, 2018).

All the test participants completed the test. The average usability rating was 82 out of 100 points, which is significantly higher than the acceptance level.

The usability of the medical report
The usability of the medical report was evaluated with 12 independent test participants from three different healthcare units in 2026. A tailored version of the System Usability Scale (SUS) was used.

SUS is a standardised instrument for evaluating various aspects of usability in digital products. An acceptance level of at least 68 out of 100 points was applied (Lewis and Sauro, 2018). All test participants completed the test. The average usability rating was 89 out of 100 points, which is significantly higher than the acceptance level.

Consistency between medical history taking and text strings in the medical report
The medical report is composed of text strings that present patients’ responses. Text strings can be configured in a way that makes them misleading or incorrect. Therefore, Doctrin regularly conducts checks on text strings in the product. In the tests, an acceptance level of <0.1% is used for errors that could affect clinical decision-making, and <1% for errors that may impact quality but do not affect clinical decision-making.

Text strings with particularly high relevance from a risk perspective were selected, such as text strings for yes/no questions where an incorrect text string could provide contradictory information to the staff. In the last review (2025), a total of 18,937 text strings were manually reviewed.

A total of 0 errors were found that could affect clinical decision-making. Additionally, 1 other error (0.05% of the total number of text strings), such as spelling mistakes, which were not considered to affect clinical decision-making, were identified. The error was immediately corrected.

Sources Lewis, J. R., & Sauro, J. (2018). Item benchmarks for the System Usability Scale. Journal of Usability Studies, 13(3).

Updated 2026-09-21 — Doctrin Source 1.X