The report found significant unwarranted variation in how this software is designed, procured and regulated across acute hospitals.

Clare Crowley, senior safety investigator at HSSIB, said: ‘Our patient safety investigation highlights the need for greater clarity, consistency and national co-ordination so that ePMA software reliably supports safe care for patients.

‘In the absence of this, NHS hospital trusts are being asked to carry the responsibility of assuring themselves that the ePMA software they choose to use is safe.'

HSSIB warns the current framework does not adequately support safe adoption of digital technologies.

While ePMAs can reduce certain types of medication error, HSSIB's investigation found there were no core national patient safety standards guiding their design or procurement.

The investigation also highlighted confusion about the roles and responsibilities of national bodies, including the CQC and the MHRA in overseeing patient safety in this area. This lack of clarity contributes to gaps in accountability and assurance.

HSSIB also found patient safety learning about ePMAs was not consistently identified or shared across the healthcare system.

The responsibility for managing these safety risks largely fell to individual NHS hospital trusts. However, many trusts did not have the necessary resources, skills or support to robustly assess and manage the safety risks associated with ePMAs.

HSSIB has made a series of safety recommendations to national bodies, including calls to:

• develop a national framework for core ePMA safety
• improve regulatory clarity on when ePMAs should be classified as a medical device
• introduce national assurance mechanisms for digital clinical safety and interoperability standards relating to ePMA
• provide additional support to NHS acute hospital trusts to improve access to digital clinical safety capability and capacity
• support the integration of digital safety and patient safety across the healthcare system.