My Lords, this has been a very fruitful and excellent debate. I thank all noble Lords for their contributions. Before I address the amendments in the names of the noble Lords, Lord Hunt, Lord Turnberg and Lord Owen, I hope it will be thought to be in order for me to cover some of the questions that have been raised by noble Lords.
I start with the issues raised by the noble Lord, Lord Patel, who asked me a series of questions. First, he asked about the “one strike and you’re out” intention to which I referred. We believe that this will be a criterion that the Confidentiality Advisory Group, the CAG, will take into account in its advice to the HSCIC on the dissemination of data that might be used to identify an individual, so there is already scope for flexibility and common sense within this provision. We anticipate that the transparency of the information centre’s decisions to release data, which is provided for in the 2012 Act, would provide further safeguards and reassurances that a “one strike and you’re out” rule
was being used appropriately—so there is flexibility. This is one matter on which NHS England in particular will want assurance as the engagement exercise proceeds, as will Ministers.
The noble Lord asked about accredited safe havens. I can commit that the Government will consult on proposals to introduce regulations before bringing forward any new regulations that would enable greater access to data for commissioning purposes, for example through accredited safe havens. As affirmative regulations, any such changes would be subject to debate in both Houses. Will personal identifiers be excluded from the collection? The information centre will of course need identifiers in order to be able to link health and care data from different settings. That is vital if it is to become the source of linked data that all sides seem to desire. Of course, this would be with the protections set out in the 2012 Act, to ensure that the information centre could release information that could be used to identify individual patients and service users only where there is a legal basis for it to do so.
The noble Lord, Lord Patel, also asked about effective links to the patient records standards board, to define the content of patient records. Following the department’s recent review of informatics governance arrangements, it has proposed a committee that will focus specifically on information standards: the so-called SCCI. That committee has oversight of the operational framework and supporting infrastructure to enable the appraisal and approval of information standards and collection across health and care systems in England. The committee will be the mechanism by which the patient records standards board will be able to engage with the delivery community and the wider system, in order to define and gain approval for the content of patient records.
The noble Lord, Lord Patel, suggested that there should be straightforward mechanisms for the personal opt-out. NHS England’s extension period and engagement processes do allow space and time for fuller listening, engagement and debate on that vital programme. As part of the process, I understand that a wide range of stakeholders—including the BMA, medConfidential, Macmillan and indeed the noble Lord, Lord Turnberg—are invited to regular advisory group meetings with the NHS England team. Those processes will be key to helping work through how best to provide reassurance and trust in the care.data programme, not least on how best to ensure that the opt-out process will work in practice and can be clearly communicated and understood by both GPs and patients.
The noble Lord asked whether I would assure the House that no changes to the law would be made to provide for access by commissioners to this kind of data without consultation. I can give that assurance. I can commit that we will consult on proposals to introduce regulations, as I have already mentioned.
The noble Lord asked whether I could say anything about secure data labs or fume boxes for handling data. Yes, I can say a little. I understand that the information centre is working to see how best it can implement this kind of technology. It is tremendously encouraging and could offer real potential benefit from the wealth of information held by the information centre without putting people’s confidentiality at risk. That is the potential benefit.
My noble friend Lady Brinton asked about the extraction of musculoskeletal data from GP records. I understand that NHS England and the information centre are working to ensure that musculoskeletal data will be included in the GP extraction.
The noble Lord, Lord Hunt, suggested that patients should not have to go to their GP to opt out—a point that he has made to me on more than one occasion in the past. This is mostly a matter for NHS England, but GPs, as data controllers, have legal responsibilities under the Data Protection Act for ensuring that all patients are aware of how their information is being used and shared. That does not relate just to care.data but to any use of data for wider purposes. They also have professional and moral objectives to ensure that their patients are informed about the use of their data .