User Interface
To enable users to interact with the device effectively, organisations may develop some kind of user interface (UI) that facilitates tasks such as uploading images, viewing reports, and utilizing the device's features.
To help organisations in the process of developing a user interface, and to comply with Annex I, Article 17.1 of the MDR, this section outlines the key elements of the user interface, their purposes, and how they assist healthcare professionals (HCPs) in making informed decisions about patient care.
The user interface is divided into three main sections:
- Instructions for capturing images.
- Reports generated by the device.
- Label for regulatory compliance.
Each section plays a crucial role in enhancing the user experience and should be designed for clarity, ease of use and regulatory compliance.
Instructions
This section provides guidelines to help users capture high-quality images of skin lesions. Clear and simple instructions help users capture images and contributes to the quality of the experience and the data.
Select Problem Type
Instructions vary depending on the type of condition. For instance, localized lesions require different guidance compared to other conditions. Users can navigate to the relevant instructions by clicking a button or link.
Type of issue
Select the type of issue
Localized Lesion
For example, a mole or a pigmentation.
Something else
Any problem that is not on a fixed spot.
Instructions for Localized Lesions
Localized lesions, such as moles, require close-up images where the lesion is the focal point.
The UI may show these steps to the user when capturing images of localized lesions:
Capture the photo with your mobile phone.
Center the photo on the lesion.
Take up to three images of the same lesion.
Crop the image.
For dermatoscopic images, specific instructions are unnecessary as the dermatoscope is designed to capture close-up, standardized images of skin lesions.
Instructions for Other Conditions
Conditions such as skin infections, inflammatory diseases, or rashes require different instructions due to their variability.
The UI may show these steps to the user when capturing images of localized lesions:
Capture the whole affected area with your mobile phone.
Only send one dermatological problem at a time.
Avoid covering the affected area with clothing, hair or accessories.
Report
Full Diagnostic Report
Interactive
An interactive report combines various components into a visually engaging interface. This format is ideal for web or native applications, whether desktop or mobile.
Left arm
6/26/2025, 2:28:37 PM
The normalized entropy value is high (69%), meaning the algorithm has low certainty about its analysis. Please keep this in mind when interpreting the results.
Select a condition
The algorithm has detected the following conditions.
- Condition A67.51%
- Condition B26.24%
- Condition C1.19%
- Condition D0.99%
- Condition E0.53%
Select other condition
- High-priority referral (15 days)Low (5.82%)That is, there is a low probability that the patient will need care in the next 15 days.
- Urgent referral (48 hours)High (35.07%)That is, there is a high probability that the patient will need care in the next 48 hours.Create Dermatology Referral ➤
Suspicion of malignancy
62%
Predicted by the algorithm
Report information
Information about the report.
- TimestampFeb 01, 2024, 10:06 PM
- Analysis performed in0.65 seconds
- Image modalityDermatoscopic
- Visual image quality82%
- Sensitivity92.22%
- Specificity89.88%
Severity score
Automatic psoriasis area and severity index
Mild
Scaling
Severe (3)
Erythema
Mild (1)
Induration
Moderate (2)
Affected area
30% (2)
Severity
(PASI)
Time
Interactive reports are highly recommended as they help users understand the output in a clear and compelling manner.
Plain Text
A plain text report integrates UI components into a straightforward format, suitable for older systems like PDF-based EHRs.
Images
The images used in this report are:
- 6895e3a2-6715-4f43-96bd-e6140fe455dc.jpg
- 1c68639b-24cd-496a-9535-2a1bdb90f705.jpg
To view the images, please refer to the links in the EHR.
General Anamnesis
Information provided by the patient during the consultation.
- Reason for Consultation: The problem started one month ago. It began with dry skin and has worsened.
- Symptoms: Itching and redness.
- Physician Assessment: -
- Pre-existing Conditions: Diabetes. I have never had anything like this on my skin.
- Previous Treatments: -
- Allergies: Penicillin and pollen.
- Lesion Location: Right arm.
Automatic Image Analysis
To assist in clinical decision-making, the medical device Legit.Healthhas analyzed the image and extracted relevant information. If you have doubts about any section, please consult the manufacturer's Instructions For Use.
Image Quality
The average image quality is sufficient (66%). Individually:
| Image ID | Quality | % |
|---|---|---|
| 6895e3a2-6715-4f43-96bd-e6140fe455dc.jpg | Sufficient | 68% |
| 1c68639b-24cd-496a-9535-2a1bdb90f705.jpg | Sufficient | 64% |
Differential Diagnosis
The most likely condition is Psoriasis (45.25%), followed by Plaque Psoriasis (9.84%) and Nonspecific Lesion (7.44%).
| Code | Condition | Probability |
|---|---|---|
| EA90 | Psoriasis | 45.25% |
| EA90.0 | Plaque Psoriasis | 9.84% |
| - | Nonspecific Lesion | 7.44% |
| 2C30 | Cutaneous Melanoma | 3.57% |
| EA89 | Eczematous Dermatitis | 3.03% |
The normalized entropy value is moderate (49.46%), meaning the algorithm has moderate certainty about its output. Please keep this in mind when interpreting the results.
Malignancy
The suspicion of malignancy is low (3%).
Physician-Confirmed Condition
For severity calculation, the healthcare professional has selected Psoriasis.
Severity According to Local PASI
The PASI score is 36. This score is considered moderate (2). The score for each sign is:
- Scaling: 2
- Erythema: 3
- Induration: 2
- Affected Area: 6
Urgency and Priority for Referral
- Urgent referral (48 hours): low (5.82%). There is a low probability that the patient will require assistance within the next 48 hours.
- High-priority referral (15 days): high (35.07%). There is a high probability that the patient will require assistance within the next 15 days.
Other Information
- Analysis date: 6/26/2025, 2:28:37 PM
- Image type: Clinical
- Sensitivity: 66.88%
- Specificity: 98.43%
- Number of images: 1
- Location: Left arm
Components
Image Quality
Image quality measures how well an image meets analysis requirements. It helps mitigate the risk of unsuitable images and may prompt users to retake images if necessary.
Thresholds
Thresholds for image quality depend on organizational policies and use cases. Based on validation data, the following thresholds are suggested:
| From | To | Outcome | Colour |
|---|---|---|---|
| 1 | 20 | Bad | 🔴 |
| 21 | 40 | Poor | 🟠 |
| 41 | 60 | Fair | 🟡 |
| 61 | 80 | Good | 🟢 |
| 81 | 100 | Excellent | 🟢 |
Location in the Device Output
Image quality is found in the imagingAnalysis key:
{
"imagingAnalysis": {
"mediaValidity": {
"quality": {
"score": 0
}
}
}
}
For multiple images, use the arithmetic average of the scores.
Images
Images are a critical part of the report, providing a quick overview of the patient's condition.
Original Image
The original image is displayed exactly as submitted by the user.
Image with Annotations
Annotated images highlight areas of interest, aiding dermatologists in their assessments.
Top-5 Predictions
The top-5 predictions provide a quick overview of the most likely diagnoses, helping HCPs make informed decisions.
Select a condition
The algorithm has detected the following conditions.
- Condition A67.51%
- Condition B26.24%
- Condition C1.19%
- Condition D0.99%
- Condition E0.53%
Select other condition
Location in the Device Output
Predictions are located in the conclusions key:
{
"conclusions": [
{
// 1st condition
},
{
// 2nd condition
}
// ...
]
}
Entropy
Entropy measures prediction uncertainty, helping HCPs evaluate the reliability of results.
The normalized entropy value is high (69%), meaning the algorithm has low certainty about its analysis. Please keep this in mind when interpreting the results.
Thresholds
Suggested thresholds for entropy:
| From | To | Entropy Value | Certainty | Colour |
|---|---|---|---|---|
| 0 | 20 | Very Low | Very High | 🟢 |
| 21 | 40 | Low | High | 🟢 |
| 41 | 60 | Moderate | Moderate | 🟡 |
| 61 | 80 | High | Low | 🟠 |
| 81 | 100 | Very High | Very Low | 🔴 |
Entropy is located in the performanceIndicator key:
[
{
"performanceIndicator": {
"entropy": 0
}
}
]
Referral
Referral information helps HCPs determine the urgency of a case.
- High-priority referral (15 days)Low (5.82%)That is, there is a low probability that the patient will need care in the next 15 days.
- Urgent referral (48 hours)High (35.07%)That is, there is a high probability that the patient will need care in the next 48 hours.Create Dermatology Referral ➤
Thresholds
Suggested thresholds for referral:
| From | To | Action | Colour |
|---|---|---|---|
| 0 | 15 | Low | 🟢 |
| 16 | 30 | Moderate | 🟠 |
| 31 | 100 | High | 🔴 |
Referral data is found in the clinicalIndicator key:
[
{
"clinicalIndicator": {
"highPriorityReferral": 0,
"urgentReferral": 0
}
}
]
Malignancy
Malignancy risk information aids dermatologists in assessing lesion risks.
Suspicion of malignancy
62%
Predicted by the algorithm
Thresholds
Suggested thresholds for malignancy:
| From | To | Action | Colour |
|---|---|---|---|
| 0 | 15 | Low | 🟢 |
| 16 | 30 | Moderate | 🟠 |
| 31 | 100 | High | 🔴 |
Severity
Severity measures the extent of skin lesion involvement, often using scoring systems like PASI.
Score
Severity scores can be displayed as numbers or on a color-coded scale:
Severity score
Automatic psoriasis area and severity index
Mild
Intensity of Clinical Signs
Individual clinical signs can be shown in a table:
Scaling
Severe (3)
Erythema
Mild (1)
Induration
Moderate (2)
Affected area
30% (2)
Evolution of Severity
Severity evolution over time is typically displayed in charts to help dermatologists track changes.
Severity
(PASI)
Time
Metadata
Metadata provides context for the report, including image quality, modality, and processing time.
Report information
Information about the report.
- TimestampFeb 01, 2024, 10:06 PM
- Analysis performed in0.65 seconds
- Image modalityDermatoscopic
- Visual image quality82%
- Sensitivity92.22%
- Specificity89.88%
- Visual Image Quality: Focus, lighting, resolution, etc.
- Image Modality: Type of image (e.g., dermoscopy).
- Analysis Time: Time taken to process the image.
- Sensitivity: Probability of a positive result for sick patients.
- Specificity: Probability of a negative result for healthy patients.
Quick Insights
Quick insights summarize key information for HCPs, enabling rapid decision-making.
The pathology Nevus has a probability of around 67.51%. The suspicion of malignancy is 26.46%.
Insights
- Refer to specialistMeets referral criteria
- Condition AIt could also be Condition B.
- Probably malignant or pre-malignant62% suspected malignancy
Label
To comply with ANNEX I, CHAPTER III, Requirements regarding the information supplied with the device of the European Medical Device Regulation (MDR 2017/745), the UI must include specific information to identify the device and its manufacturer.
According to Annex I, Chapter III (General Safety and Performance Requirements), section 23.1:
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user.
Ensure the UI provides clear identifying details about the device and manufacturer.
Consequences of Missing Labeling
According to Article 16 of the MDR 2017/745:
Cases in which obligations of manufacturers apply to importers, distributors or other persons
A distributor, importer, or other person shall assume the obligations of manufacturers if they:
(a) make the device available on the market under their name, trade name, or trademark, unless the manufacturer is clearly identified on the label.
Failure to include required information may result in being considered the manufacturer, with associated legal responsibilities.
Source Code for Symbols
ISO 15223-1:2021, the international standard for medical device symbols, provides a comprehensive list of symbols used in medical device labeling.
Furthermore, icons are also widely available in open source libraries, such as medical-device-symbols, which provides a collection of SVG icons for medical devices that can be directly used in web applications.