An independent review on the first stage of NHS England’s controversial programme says a wide range of “unresolved” questions must be answered before it can proceed.

Privacy watchdog medConfidential has described the report as “a nail into the coffin of this rolling botch job”, and says a “fundamental reset” must take place if is to proceed.

The report from the Independent Information Governance Oversight Panel, chaired by national data guardian for health and care Dame Fiona Caldicott, outlines 27 questions that it says must be answered by the programme board.

It also discusses seven issues that need to be addressed by the clinical commissioning groups participating in the pathfinder phase of the programme.

The programme will extract data sets from different organisations, starting with GP practices, and link them to an expanded set of Hospital Episode Statistics within the 'safe haven' of the Health and Social Care Information Centre.

NHS England was forced to “pause” the programme in February after medical and privacy groups objected to a public leaflet campaign that failed to include a clear account of the programme, who would receive the data, or an opt-out form for patients.

In October, clinical commissioning groups in Leeds, Blackburn, Somerset and West Hampshire were selected as ‘pathfinders’ as part of a revised roll-out plan.

Participating GP practices in the CCG areas will test different communication strategies with patients. The report says clarity of both policy and communication “seems to be the area of most concern” for the programme.

“Clarity of policy and clarity of communications are both absolutely essential…the public, patients and care professionals must receive clear messages about”

It says patients need to know their data is safe, with concerns about where it will go, how it will be stored, and how and with whom it will be shared.

Questions also need to be answered about the implications of opting out and whether it will have any impact on their care, as well as what the opt-out does not cover.

The report says GPs need clarity about how they are meeting their legal responsibilities as data controllers, how the pathfinder programme will support them to meet those requirements, and the “legal and ethical implications” for GPs considering an opt-out for their entire practice.

There are also governance issues that need to be addressed, including whether the content and governance of the data set to be extracted is “understood and clear”, and how the HSCIC will communicate with patients regarding their objections.

The report says there are also a number of issues that cannot be resolved at a national level but must be dealt with by the pathfinder CCGs.

Each pathfinder must be able to demonstrate that people in their area have a “sufficient understanding” of their rights and the implications of their decision, as well as ensuring they have equal access to the opt-out process an understanding of how their data may be used.

 “The national data guardian and [the panel] thinks that it would be reasonable to proceed to a data extraction in the pathfinder areas” once those questions have been answered,” the report says.

“We believe that this will provide a sufficiently robust framework within which we can be confident that patients have been reasonable informed… and are able to make choices about sharing.”

Phil Booth, the co-founder of medConfidential, told EHI the “sheer weight of questions” in the report means that needs a “fundamental reset” before it can go ahead.

“They might have been thinking, ‘Oh well, we’ll cross a few Ts and dot a few Is and start rolling in January, February’, but it’s inconceivable now that it won’t be pushed back past the election.”

Booth described the report as “a nail into the coffin of this rolling botch job”, and questioned the work that NHS England has done to address initial concerns about

“If they haven’t fully resolved all of this stuff, I can see the potential for it blowing up all over again…if they don’t have answers to these questions now, what the hell have they been doing?”

In a letter to Caldicott obtained by EHI, NHS England’s director for patients and information Tim Kelsey said the organisation “very much welcomes your observations and the insight it offers us in ensuring that we get the pathfinder stage of the programme right."

“We will come back to you in the New Year to discuss the report further once we have had the opportunity to speak with our colleagues in the pathfinder areas and to consider the questions and tests carefully.”