NHSX published a draft Digital Health Technology Standard and called for feedback from the industry.
The draft standard was been created in collaboration with stakeholders from across the digital health ecosystem. NHSX wanted to gather feedback from a wider range of voices who have an interest in digital health, including developers, clinicians, commissioners and patient groups, to ensure it is robust, ambitious and attainable.
The draft standard outlined 10 components on what the NHS expects. It’s based on existing standards and will support a process for reviewing, assessing and evaluating digital health technologies that meet the standard. It is also intended to speed up and streamline how health technologies are reviewed and commissioned by the NHS and social care.
Patient Safety Learning's response to the draft:
“The standard mentions safety up front as a fundamental principle which is good, but there are areas that still need addressing. For example, the need for user testing is implied, but not explicit; where a DHT provides any sort of personalised advice or output, it must gather sufficient context about the user to do this safely and the use of appropriately expert clinicians in the development of the DHT (including those who have worked on ML algorithms) should be tightened up.
There are also issues around data that ought to be addressed. Such as the user being able to see (if they have consented appropriately) who their data has been shared with and when; users should be able to change their mind about this when they want to and easily stop their data being shared; and should the DHT vendor no longer support the DHT, they should offer to give the user their data back and wipe it from their servers, or just say it will be deleted.”