Final approval for the ‘pathfinder’ stage of the controversial programme to go ahead will not be given until early next year.

This means the patient data collection scheme will be delayed by at least two years after the patient information campaign was first launched in early 2014.

A number of issues need to be addressed by NHS England and final authorisation for patient data to be collected now sits with National Data Guardian for health and care Dame Fiona Caldicott.

The Health and Social Care Information Centre first approved a ‘direction’ from NHS England to deliver in December 2013. This covered a national project to extract data sets from different NHS organisations and link this information to an expanded set of Hospital Episode Statistics.

However, that will be revoked once a new direction is in place, as the scheme has been scaled back to four pathfinder areas following outcry from privacy groups about the ability of patients to opt-out of the scheme.

A draft direction for the revised ‘pathfinder’ project was considered at the HSCIC’s July board meeting and feedback provided to NHS England to update it before it can be issued.

As outlined by health secretary Jeremy Hunt at a speech in Manchester this month, final approval must also be given by Dame Fiona before it can proceed. Hunt said she was due to report back in January next year.

In minutes published ahead of its board meeting this week, the HSCIC describes five points that NHS England needed to address.

First was that the HSCIC’s programme team and information governance team should have seen the Privacy Impact Assessment form for and endorsed it. This document is a tool to identify, assess, mitigate or avoid privacy risks with the programme.

Other points raised include a note that the direction should explicitly state the role of HSCIC as data controller for the project and the direction should be revised with the inclusion of participating GPs and data set specification.

The direction should also explicitly reflect that the direction should have an end date or review date, given that it is now only applicable to the pathfinder stage of the project.

A final point made at the July meeting is that the direction should provide clarity on the role of public bodies, such as Public Health England, in the sharing of data.

A spokesperson for the HSCIC told Digital Health News: “The HSCIC board considered draft directions at their July meeting and has provided feedback to NHS England so that they can be updated before they are formally issued.

“Directions will not be formally issued until Dame Fiona has completed her evaluation of the pathfinder stage of the programme and advised she is satisfied with the proposals and safeguards.”

Four pathfinders were due to start testing new information materials related to the programme, starting with NHS Somerset Clinical Commissioning Group, this month.

NHS England has written to the pathfinders to tell them to put plans on hold until Dame Fiona has provided advice on the wording of the opt-out.