The Health and Social Care Information Centre are aware that the number of patients affected by the mistake with the ‘Type 2’ / 9Nu4 objection is indeed much higher than their Chair first stated to Parliament, and they continue to accept – as they did from the start – that they will have to write directly to everyone concerned.
HSCIC’s acceptance that individually-addressed letters are necessary is to be welcomed, not least because it shows some lessons may have been learned from the previous history of NHS England’s care.data fiasco. But to avoid a repeat of previous communications disasters – including the junk mail leaflet and widespread confusion between care.data, the Summary Care Record and local direct care data-sharing initiatives – lessons from 2014 must not only have been learned. They must be seen to be learned.
As last year clearly demonstrated, there can only be one patient communications programme going ahead at a time, and it must be carefully coordinated with any and all other existing data-sharing programmes.
As NHS England Director for Patients and Information and (interim) SRO for care.data, Tim Kelsey, has washed his hands of any responsibility for this latest screw up, this is a clear opportunity for HSCIC to lead and demonstrate itself to be the reformed agency that it is striving to be, absent any interference from NHS England.
What needs to be done?
Dame Fiona Caldicott has articulated a number of tests and questions for the care.data programme as a whole. It would therefore make sense, as a starting point, to apply these to any proposed communications intended to correct the current consent catastrophe. Some tests (e.g. those in section 5, relating specifically to the care.data pathfinders) may not apply directly, and other tests may need to be added, but the as-yet-unanswered questions on the substance of what patients are told – and how it will be made true – continue to apply across the board.
The ‘Type 2’ correction cannot be implemented as a postcode lottery; it must be national, for all affected patients at once. And, unless Mr Kelsey’s promises of “no arbitrary deadline” are untrue, the care.data pathfinder process can happen after the national re-contacting has taken place. (And, if done as we suggest below, at no additional overall cost to DH and the public purse.)
As medConfidential has repeatedly stated, the SRO for the 9Nu4 correction programme – as for all large-scale patient data programmes – must be someone who is subject to GMC regulation.
A process to respect patient choice
A letter must be sent to each affected patient, the content of which should go through a similar consultation process to the one which NHS England stated it would follow for any revision of care.data – though HSCIC should do a better job of actually listening to advice and suggestions.
Given the need to rebuild public confidence, and out of an abundance of caution, letters must be sent to everyone who has expressed a consent preference, whether that was 9Nu4 (‘Type 2’), 9Nu0 (‘Type 1’) or SCR. The bungled communications last year resulted in many patients being given the wrong forms, and it is reasonable to assume that someone who doesn’t want their data to leave their GP practice to be shared for direct care purposes is unlikely to want it sold on for ‘secondary uses’.
Critically, the state of each patient’s ‘consent settings’ immediately before the letter hits their doormat must be as safe as possible. This may involve the introduction of a new code or codes, but the defaults must be set to respect patients’ existing choices.
The communication materials themselves must clearly and accurately reflect what happened, how it has been addressed, and what will happen going forwards. Unambiguous promises must be given to patients around secondary uses, consent and notification. (This may be a good opportunity to introduce personalised data usage reports to a group of data-concerned patients, trialling the process and explanation ahead of a wider communication.)
The letter should provide each patient sufficient information and clear choices to be able to arrive at one of the following 3 outcomes:
- NO FURTHER ACTION BY PATIENT [DEFAULT] – implement what patients were told would happen last Jan/Feb, i.e. opt out of secondary uses of their data collected from anywhere across the NHS, with no impact on their direct care. This would require our Spine proposal to be implemented.
- ACTION: Patient has changed their mind – opt them back in for secondary uses of their data collected from places other than their GP. Unless patient gives explicit consent, do not override any other settings, e.g. 9Nu0 or SCR. This would most likely be a subset of those who opted out of SCR, whose decision was inferred as a precaution.
- ACTION: Patient wants the ‘full 9Nu4 opt out’ – apply the opt out as 9Nu4 was (mistakenly) specified, i.e. HSCIC cannot pass on patient’s data, even for direct care. This is likely to be for a very small number of patients, but the option is clearly important to some people.
“No action” must be the default, and the default must continue to be safe and in the patient’s best interests, i.e. a system-wide consent option on the Spine, respected by all care providers.
It is important these choices are not merely expressions of choice, but immediate and effective realities. Patients whose trust has already been abused should not have to wait a further year for their decisions to be enacted. Ideally, this would be able to be reflected in a personalised data usage report for each patient, so they can see that – this time – their wishes have been properly respected.
Moving forward with care.data (or its successor)
Only once the ‘Type 2’ correction process has been completed – letters have been sent, patients have been given time to act, and their consent choices have been enacted – can the care.data pathfinder process restart.
Those in the pathfinder practices who have not been sent a letter as part of this process, can then be sent a letter and opt-out form for care.data and all secondary uses. (These letters may be modified based on any further lessons learned from the ‘Type 2’ process.) That only those patients who have not already opted out will be written to as part of the ‘new’ opt-out process means that people will not be being asked to opt out of something they’ve already opted out of.
It also means that the cost to the public purse of the programme as a whole should be almost identical to what NHS England currently proposes. The same number of envelopes will be posted (which is the vast majority of the cost) but there will need to be some more meetings to design the two sets of communications, not one – to ensure that what everyone is told is completely consistent. And true.
In the meanwhile, rather than rushing into the extraction of data that may not even provide the benefits claimed, care.data can be revisited, future needs properly identified and the many flaws in the design of the current programme can (hopefully) be corrected. And proposals to reduce the number of individual-level data flows can continue to be applied.
While it looks like the projection of over a million people having opted out will prove correct, it should be remembered that only 29% of people asked at the time had received a leaflet and nearly half the population was still unaware of the scheme at the point it was “paused”. Opt-out rates across the country are likely to be significant, and NHS England cannot afford to cause yet another collapse in public confidence.
This time, there is no option but to do it right.