Section B: Classification of digital health technologies

Corporate document

Classifying digital health technologies (DHTs) by intended purpose (see figure 1) allows them to be stratified into tiers based on the potential risk to service users and to the system. The evidence level needed for each tier is proportionate to the potential risk to service users from the DHTs in that tier. The classification used in the evidence standards framework (ESF) has been designed so that most regulated medical devices and in vitro diagnostics (IVDs) will be in tier C. Table 1 describes each classification group in more detail and gives some examples. Specific examples of DHTs classified using the ESF classification system are in the ESF classification examples.

DHTs in tier C are divided into 4 classification groups to align with the software as a medical device (SaMD) classification framework proposed by the International Medical Device Regulators Forum (IMDRF). The IMDRF classification framework is based on 2 aspects of the technology: the significance of information and the state of the healthcare situation or condition. The tier C groups of the ESF reflect the significance of information part of the IMDRF framework and the impact of the healthcare situation or condition is captured in the evidence standards. IVDs are excluded from the IMDRF, but in the ESF classification, we would expect most IVDs to fall within tier C.

Table 2 is adapted from the IMDRF classification document showing the relationship between the ESF classification groups and the likely medical device classes. Medical device classifications may also consider other factors such as whether the user is a healthcare professional or not and whether calculations are easy to verify. The Medicines and Healthcare products Regulatory Agency (MHRA) consultation on the future regulation of medical devices in the UK contains a section on software as a medical device.

For more information about how to use the classification and how it was developed, please see the ESF user guide.

Figure 1 DHTs classified by intended purpose and stratified into risk tiers

**Table 1 ESF evidence tiers and classification groups**
Tier and group	Description	This tier includes (for example)	This tier excludes (for example)
Tier A: System service DHTs intended to release costs or staff time, or to improve efficiency.	Unlikely to have direct health outcomes measurable for individual service users.	Electronic prescribing systems that do not provide patient-level advice on prescribing, nor highlight any contraindications. Triaging systems that do not affect care decisions or access to care, such as those that manage non-clinical staffing or resources.	DHTs that influence treatment or diagnoses, such as early warning systems that monitor vital signs. Triaging systems that use individual patient health data (such as vital signs, symptoms or self-reported health measures) to guide treatment, diagnosis or care decisions.
Tier B: Communicating about health and care Communicating with health and care professionals or others, to help service users to manage their health and care.	Allows 2-way communication between service users and professionals, carers, third-party organisations or peers.	Instant messaging apps for health and social care. DHTs that provide platforms for communication with carers or professionals or other service users.	DHTs that provide clinical content themselves (such as cognitive behavioural programmes for depression).
Tier B: Health and care diaries Health and care diaries to help service users to manage their own health and wellness.	Allows service users to record information to create health diaries. Information and data stay with the service user and are not automatically shared with others for review.	Health tracking information, such as from fitness wearables. Symptom or mood diaries.	DHTs that automatically share data or information with professionals, carers or other service users in order to inform care decisions. DHTs that provide treatment for or diagnosis of a condition.
Tier B: Promoting good health Population-level information to help people and service users to maintain healthy lifestyles and manage conditions.	Provides non-personalised information and resources to service users. May encourage behaviours that promote good health and address issues such as smoking, eating and exercise. May also provide information about specific conditions.	DHTs used as part of general weight-loss programmes. DHTs that aid good sleep habits.	DHTs that describe themselves as a treatment for a diagnosed condition.
Tier C: Inform clinical management	DHTs that record and calculate data and transmit the data to a professional, carer or third-party organisation, to inform clinical management decisions in the future. Also, DHTs that provide personalised information or guidance to end users to promote healthy living. Information provided by the DHT will not trigger an immediate or near-term action by clinical or care staff.	DHT that records and transmits historical blood pressure information for a healthcare provider's later review. DHTs that provide personalised information or guidance using behaviour change techniques, to promote good health and healthy lifestyles. Symptom monitors where data is automatically shared with care teams for later review. May include simple calculators (may not be in remit for regulation as medical devices) as well as complex calculators (more likely to be in remit for regulation).	DHTs whose intended purpose is a treatment for a diagnosed condition. DHTs that monitor a condition to trigger immediate or near-term action. DHTs that offer population-level information or guidance.
Tier C: Drive clinical management	Information provided by the DHT will be used to aid in treatment, aid in diagnoses, to triage or identify early signs of a disease or condition, or will be used to guide next diagnostics or next treatment interventions.	DHT that analyses heart rate data intended for a clinician as an aid in diagnosing arrhythmia. Triaging systems that use individual patient health data, or which impact on care decisions or access to care. Prediction tools such as software to assess risk of developing a condition, likelihood of disease progression or response to a treatment.	DHTs that describe themselves as a treatment for a diagnosed condition. DHTs that provide information that triggers immediate or near-term action. Triaging systems that do not impact on care decisions or access to care.
Tier C: Diagnose a condition	Information provided by the DHT will be used to take an immediate or near-term action to diagnose, screen or detect a disease or condition.	DHT that performs diagnostic image analysis for making treatment decisions in service users with acute stroke.	DHT offering general (non-personalised) health or wellness advice.
Tier C: Treat a condition	Information provided by the DHT will be used to take an immediate or near-term action to treat, prevent or mitigate by means of providing therapy to a human body.	DHT that uses the microphone of a smart device to detect interrupted breathing during sleep and sounds a tone to rouse the sleeper.	DHT offering general (non-personalised) health or wellness advice.

Table abbreviations: DHT, digital health technology; ESF, evidence standards framework.

**Table 2 Potential mapping between the ESF classification groups in tier C and the medical devices classes**
ESF classification group in tier C	Description adapted from IMDRF	Healthcare situation or condition with the medical device class as per IMDRF categories mapped to the current UK medical device regulations
Inform clinical management	DHTs that record, calculate and transmit data to a professional, carer or third-party organisation to inform clinical management in the future. Informing clinical management infers that the information provided by the SaMD will not trigger an immediate or near-term action: To inform of options for treating, diagnosing, preventing or mitigating a disease or condition. To provide clinical information by aggregating relevant information (for example, disease, condition, drugs, medical devices and population).	Non-serious: Class 1 Serious: Class 1 Critical: Class 2a


Drive clinical management	Information provided by the DHT will be used to aid in treatment, aid in diagnoses, to triage or identify early signs of a disease or condition, and will be used to guide next diagnostics or next treatment interventions. Driving clinical management infers that the information provided by the SaMD will be used to aid in treatment, aid in diagnoses, to triage or identify early signs of a disease or condition, and will be used to guide next diagnostics or next treatment interventions: To aid in treatment by providing enhanced support to safe and effective use of medicinal products or a medical device. To aid in diagnosis by analysing relevant information to help predict risk of a disease or condition or as an aid to making a definitive diagnosis. To triage or identify early signs of a disease or conditions.	Non-serious: Class 1 Serious: Class 2a Critical: Class 2b


Diagnose a condition	Information provided by the DHT will be used to take an immediate or near-term action to diagnose, screen or detect a disease or condition.	Non-serious: Class 2a Serious: Class 2b Critical: Class 3


Treat a condition	Information provided by the DHT will be used to take an immediate or near-term action to treat, prevent or mitigate by means of providing therapy to a human body.	Non-serious: Class 2a Serious: Class 2b Critical: Class 3

Table abbreviations: DHT, digital health technology; ESF, evidence standards framework; IMDRF, International Medical Device Regulators Forum; SaMD, software as a medical device.

This table has been adapted from the table in section 7.2 of the IMDRF document Software as a Medical Device. The medical device class names included here align with the classes currently used by the MHRA (low risk: Class 1; high risk: Class 3). IVDs are excluded from the IMDRF and so are not included in this table. The medical device class may also be influenced by other factors including the user type (patient or professional) and level of professional oversight. This table will be reviewed and updated in line with changes to MHRA regulations.