Clinical Assurance and Safety

  1. Is the DHT safe?
  2. Is it clinically effective?

The TIER structure

TierFunctionality or Purpose of DHTExamplesAssurance of quality provided by the following
AProvides no measurable patient impact, but do provide services to a health and care system. 
BiProvides information, resources or guidance to the user about a specific condition or general health and lifestyle.
Allows a healthcare professional to provide advice via the app.
Allows two-way communication between patients or healthcare professionals.
Simple monitoring, defined as recording data over time for the user to review, with no “intelligent” manipulation of the data by the app, and where the monitoring is not condition-specific.
App does not interpret the data to produce a reminder, alert or notification.
Self-monitoring with a focus on well-being and general health.
App-based journal to log symptoms or other markers.
App may render the data in graphical views that illustrate trends and patterns.
Evidence that a suitably qualified professional or professional body is behind the DHT. 
BiiProvides condition-specific simple monitoring, or app which is not condition-specific but provides the automated assessment or interpretation of relevant data to deliver alerts, insights, reminders or adjustments,Activity tracker with reminders.Evidence that the DHT has been adopted and used (within a recognized healthcare setting if applicable) or evidence that the DHT is actively endorsed by a recognized healthcare system.
CiInvolves the automated assessment or interpretation of relevant data to deliver alerts, insights, reminders or adjustments regarding the management of a specific condition.
Delivers preventative behavior change.
Has a recognized clinical calculator within the app (i.e. novel clinical calculators are not included here). 
DHT which logs your manually entered blood sugar levels, and provides insights regarding whether you are controlling your diabetes better or worse than last month.Safety can be demonstrated through suitable test data if applicable I.e. accuracy of clinical calculators etc. or through high quality observational studies/RCT’s that demonstrate safety.
For clinical efficacy in Tier C, a high quality observational study is the minimum required.
High quality study indicated by:
Presence of a suitable comparator and p value of <0.05 (or non-overlapping confidence intervals).
Suitable sample group/size.
Alignment to claimed benefits/safety risks.
Tier CiiDiagnoses a condition.
Contains a novel clinical calculator.
Automatically measures/records and transmits specific condition data to a 3rd party without input from the user.
Provides treatment or guides the treatment of a condition.
Alleviates symptoms of an existing condition.
Medical devices as classified by the FDA.Safety can be demonstrated through suitable test data, or through high quality observational studies/RCT’s that demonstrate safety.
Default expectation around clinical efficacy is an RCT – although there are scenarios where an RCT might not be practical, including diagnostics where it would not intuitively make sense to randomize to one diagnostic or another, but rather compare the same patients (and diagnoses) using the old (and new) diagnostics and measuring agreement between the two.
High quality study indicated by:
Presence of a suitable comparator and p value of <0.05 (or non-overlapping confidence intervals).
Suitable sample group/size.
Alignment to claimed benefits/safety risks.