Digital Health Technology Compliance With Clinical Safety Standards In the National Health Service in England:...

Area of Science:

• Digital Health Technologies
• Clinical Risk Management
• Healthcare Informatics

Background:

• Digital health technologies (DHTs) require mandatory clinical risk management standards (DCB0129 and DCB0160) for NHS use in England.
• NHS organizations must procure DHTs with DCB0129 assurance and deploy them with DCB0160 assurance.
• Public data on DHT deployment numbers and assurance status within the NHS are lacking.

Purpose of the Study:

• To quantify the number of DHTs in use across NHS organizations in England.
• To assess the assurance status of these DHTs against mandated clinical safety standards (DCB0129 and DCB0160).

Main Methods:

• A freedom of information notice was sent in early 2025 to 239 NHS organizations in England.
• Organizations were asked to report the number of DHTs in use and their assurance status against DCB0129 and DCB0160.

Main Results:

• 204 organizations responded, providing data on 14,747 DHT deployments.
• A median of only 25.6% of deployed DHTs were fully assured against both standards.
• 70.1% of DHTs with reported data lacked any documented assurance.

Conclusions:

• This study is the first to quantify DHT deployment scale and safety standard compliance in NHS England.
• A significant number of DHTs lack documented assurance, raising concerns about patient safety and legal compliance.
• Failure to assure DHTs jeopardizes the NHS's transition to digital care models and warrants global healthcare system review.