Corporate document
Terms used in the evidence standards framework
Terms used in the evidence standards framework
This section defines terms that have been used in the evidence standards framework (ESF). Additional definitions are provided in the accompanying ESF user guide.
Company
Any commercial entity that is planning to sell or selling a digital health technology (DHT) to a healthcare provider. The company may be the same as the developer who created the DHT or it may be another organisation who is trying to promote the use of the technology in the health and care system.
Data driven
A data-driven DHT is a DHT that meets any of the following descriptions:
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It contains algorithms that were trained using patient data or datasets. These algorithms could be adaptive, meaning they change over time, or fixed.
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It uses decision thresholds or cut-off values (such as for diagnosing a condition or triaging patients for different treatments) that were created using patient data or datasets.
End user
Any person whose is operating the DHT. For software as a medical device or imaging software, this is likely to be the healthcare professional. For health and wellbeing apps, this is likely to be the service user.
Evaluator
Any person or group of people who judges the quality or value of a DHT based on information and evidence provided. These could include NHS commissioners, buyers of DHTs and local evaluators.
Intended purpose
The intended purpose is the objective intent of the manufacturer regarding the use of a DHT. It should state the indication and target population, including when, how and by whom the DHT should be used. The intended purpose of the DHT should be reflected in the information provided by the manufacturer but also needs to take into account how the technology is likely to be generally used. Use outside of an intended purpose may impact the performance and safety of the device. For technologies which fall under the medical device regulations, the intended purpose should allow consistent determination of the regulatory medical device classification and facilitate the development of an adequate risk management, clinical evaluation, quality management and post-market surveillance system.