The NordDEC begins with a series of questions to capture a Digital Health Technology’s (DHT) core purpose and functionality. These include the target audience, the type of data the DHT collects and the DHT’s primary functions and features. None of the scene setter questions are intended to have any scoring or risk implications and are purely to decide on the line of enquiry further in the review.
Data and Privacy
For DHTs that collect and process personal and/or sensitive data, they will undergo the questions focused on the General Data Protection Regulation (GDPR), which in May 2018 came into force to replace the Data Protection Act 1998.
In the NordDEC there are further checks carried out within the data area that does not necessarily need publicly available information.
Following on from the questions answered in the Scene Setter section, this review area looks at a range of ‘indicators’ of Professional and/or Clinical Assurance.
If the DHT requires registration with a relevant regulatory body, we look for evidence of this such as registration with the Care Quality Commission (CQC).
With relation to medical devices, we first assess if the DHT is likely to be a medical device under the current guidance from the MDR (Overview ). We then evaluate if the DHT displays the relevant CE mark.
When we examine the evidence of effectiveness we use the Evidence Standards Framework published by NICE.
We also look for evidence of an appropriate professional being involved in the DHT’s design and development, or if the DHT has been externally accredited.
The Clinical Safety Assessment looks into whether the DHT developer put in place appropriate measures to assess and mitigate any potential clinical risks which may arise from the use of the DHT. This relies on looking at risk management documentation which the developer may have and assessing whether it covers the key areas. The assessment is undertaken in conjunction with a trained Clinical Safety Officer, who is able to comment and evaluate on both the risks recorded, and the suitability of the developers whole process.
Usability and Accessibility
This section of the review looks into DHT design, accessibility features, usability and user experience, forums and moderation, and support options.
The NordDEC considers the design and development of the DHT and whether it follows any recognised DHT design standards, such as WC3, WCAG 2.0 AA, WCAG 2.1 AA, ISO 9241, Apple HIG, or Android App Quality Guidelines. The review also considers whether there was any user involvement during the development of the DHT, or if any features were based on user feedback.
Security + Technical Stability
Security is one of the most challenging area for Digital Health assessments.
Overarching principles such as the OWASP guidelines for mobile and web applications provide a very high level frame of reference but this doesn’t equate to a very clear set of measurable requirements.
Whilst OWASP does differentiate between different types of applications, it is a relatively crude 2 tier model and does not account for the wide range of different features and functions that digital health solutions offer.
The focus is therefore switching now to a more tangible but flexible requirement that focuses on a graduated or tiered model with expected relevant security ‘credentials’ increasing as the complexity and risk of the relevant product increases.
This enables the specific features of the DHT and its associated security risks to be calibrated and aligned to different security characteristics/credentials.
This is however still an evolving model and the security ‘credentials’ can change in differing jurisdictions.
To view the full assessment framework questions documentation, please click here.