Table 3 Specific risks of gamification elements in mHealth apps.

From: The regulatory status of health apps that employ gamification

App_ID

Hazard

Foreseeable sequences of events

Hazardous situation

Harm

Severity

Association of gamification with risks

06_CARD

*

Incorrect medical information provided to the user that misleads them about the severity, urgency, or treatment of a medical problem

Used by a user for the described medical use case and due to an underlying software error (possible cause: insufficient or unstructured testing by the manufacturer), incorrect blood pressure information is displayed to the user, along with incorrect findings/ analysis over time

The user chooses to act on the basis of incomplete information and either receives incorrect or delayed treatment or is at risk of iatrogenic harm in a medical setting

Deterioration of health

3

Weak

10_CARD

*

Incorrect medical information provided to the user that misleads them about the severity, urgency, or treatment of a medical problem

Used by a user for the described medical use case and due to an underlying software error (possible cause: insufficient or unstructured testing by the manufacturer), incorrect blood pressure information is displayed to the user, along with incorrect findings/ analysis over time

The user chooses to act on the basis of incomplete information and either receives incorrect or delayed treatment or is at risk of iatrogenic harm in a medical setting

Deterioration of health

3

Weak

23_CARD

**

Incomplete assistance due to limited app functions when in-app currency is no longer available

User engages with AI doctor, writes relevant health concerns using in app currency, needs to stop writing when he has no currency left, waits until next day to get his daily reward, continues chatting

The user chooses to act on the basis of incomplete information and either receives incorrect or delayed treatment

Deterioration of health, Delay of therapy

3

Strong

**

Incorrect medical information provided to the user that misleads them about the severity, urgency, or treatment of a medical problem

Misleading the user by providing contradictory information in the app regarding the context of its advice (i.e. advice labeled as coming from a specialized "AI" doctor who is clearly labeled as being able to provide specific advice on certain diseases and disease syndromes, contradicting a disclaimer stating that the app is intended for general health information). This misleads the user into believing that the app is a medical service or a reliable AI doctor. The user asks medical questions for which the underlying GPT-4 model, or prompt engineering provides false and dangerous medical information

The user chooses to act on the basis of the incomplete information and either receives incorrect or delayed treatment or is at risk of iatrogenic harm in a medical setting

Deterioration of health

3

Strong

*

Neglect of non-gamified health features of the app

The app has different main functions, such as step counting, blood pressure measurement, weight measurement, a chat function. (AI doctor) and calory counting. Some of those functions are highly gamified, e.g., the chat function. A focus on these can lead to a neglect of non-gamified features (e.g., blood pressure measurement) leading to an incorrect or delayed treatment

The user neglects relevant non-gamified health functions of the app leading to incorrect or delayed treatment

Deterioration of health

3

Strong

39_MENH

*

Overreliance on the application

The user downloads the app, uses the daily mood tracking and typing features to assess their mental health, and begins to rely solely on the app for assessment. As a result, the user skips therapy sessions, believing that continued use of the gamified app is sufficient for their wellbeing

The User neglects an effective therapy in favor of the app and receives incorrect or delayed treatment

Deterioration of health, Delay of therapy

3

Moderate

*

Incorrect medical information provided to the user that misleads them about the severity, urgency, or treatment of a medical problem

The user suffers from a severe mental illness and relies too much on this digital application due to incorrect or inappropriate information

The user chooses to act on the basis of incomplete information and either receives incorrect or delayed treatment or is at risk of iatrogenic harm in a medical setting

Deterioration of health

3

Weak

43_DIAB

*

Incorrect data entered by the user leads to incorrect calculations by the app and displayed values

The user enters data in the daily entry. Each entry is rewarded with points. 50 points are required to tame the "monster". The user can add made-up entries to gain more points. This can lead to incorrect information on carbohydrate intake, exercise and activities and thus to incorrect calculations of the inulin dosage

The user chooses to act on the basis of incomplete information and either receives incorrect or delayed treatment

Deterioration of health

3

Strong

*

Incorrect medical information provided to the user that misleads them about the severity, urgency, or treatment of a medical problem

Used by a user for the described medical use case and due to an underlying software error (possible cause: insufficient or unstructured testing by the manufacturer), incorrect blood sugar or diabetes information is displayed to the user, along with incorrect findings/analysis over time

The user chooses to act on the basis of incomplete information and either receives incorrect or delayed treatment

Deterioration of health

3

Moderate

*

Neglect of less gamified health features of the app

The app has different main functions, related to blood sugar management. Some of those functions are gamified by a challenge system. A focus on these can lead to a neglect of less-gamified features leading to an incorrect or delayed treatment

The user neglects relevant less gamified health functions of the app leading delayed treatment

Deterioration of health

3

Strong

50_PREG

*

Incorrect medical information provided to the user that misleads them about the severity, urgency, or treatment of a medical problem

Used by a user for the described medical use case and due to an underlying software error (possible cause: insufficient or unstructured testing by the manufacturer), incorrect information on pregnancy is displayed to the user, along with incorrect findings over time

The user chooses to act on the basis of incomplete information and either receives incorrect or delayed treatment

Deterioration of health

2

Weak

51_CARD

*

Incorrect medical information provided to the user that misleads them about the severity, urgency, or treatment of a medical problem

Used by a user for the described medical use case and due to an underlying software error (possible cause: insufficient or unstructured testing by the manufacturer), incorrect blood pressure information is displayed to the user, along with incorrect findings/ analysis over time

The user chooses to act on the basis of incomplete information and either receives incorrect or delayed treatment or is at risk of iatrogenic harm in a medical setting

Deterioration of health

3

Weak

67_NEUR

*

Overreliance on application

The user interacts with the app, is very committed, neglects the lack of improvement due to the captivating gamified experience and seeks professional help later

The User neglects an effective therapy in favor of the app and receives incorrect or delayed treatment

Deterioration of health, Delay of therapy

2

Strong

*

The gamified approach does not accurately measure, monitor and treat visual acuity deficits, leading to user frustration and loss of willingness to engage in future approaches to improve visual acuity deficits

Used by a user for the described medical use case, and due to an underlying software error (possible cause: insufficient or unstructured testing by the manufacturer), the gamified approach does not accurately measure, monitor or treat visual acuity deficits, resulting in loss of engagement/adherence to future approaches to improve visual acuity deficits

The user is enthusiastic about the tool but over time realizes that the app is unsuitable/counter-productive, either through their own realization over time or through the advice of a healthcare professional. This leads to demotivation, frustration of the user and a loss of engagement/loyalty in future approaches to improve visual acuity deficits

Deterioration of health

2

Strong

  1. The risk analysis was done according to ISO 1497150. The strength of the association of gamification elements with risks was reported as none, weak, moderate, or strong. *The risk is hypothetical, as it could occur with an app of this type, particularly if quality control is inadequate but has not been shown to have occurred with the analyzed apps—it is common to consider hypothetical/potential risks in risk assessments. **The risk is not hypothetical, as several tests have shown the app to provide incorrect or harmful advice.