Caldicott Review – Future Fiascos?

(this is part 4 in a series – you may want to begin with part 1)

For some, care.data wasn’t a mess. It was practice...

But practice for what?

The new patient choice suggested on page 41 of the Review is: “information about me can only be used by the people directly providing my care.” That meets the promise in the Conservative’s election Manifesto, and it is a promise that is capable of being kept.

A longer term aim of the Review was to begin to restore public trust. It is only after the consultation, when we see the implementation, that we will be able to judge whether it was successful. Details of implementation were outside of the Terms of Reference, which is why there is so little detail on implementation.  It is also why the “NHS/non-NHS” proposal could be considered, as there was no need for anyone to think about how to do it.

This is the shadow boxing that has gone on for nearly two years since it become clear that care.data wasn’t coming back. But the problems remain unresolved.

To prevent the outcome of this consultation being changed at the whim of a future Secretary of State, the outcome has to be put into Legislation. Given the slow process to put the National Data Guardian on a statutory footing, that is entirely possible. If there are going to be new changes to patient dissent, they must be given a democratic basis by Parliament.

The Review has decided that there should be a “Caldicott Reset of Consent” even if the mechanism is currently unclear. Will they be positive, or in retrospect, will they turn out to be as compromised as the care.data “vision”?  It could go both ways.

Consensual, Safe, and Transparent?

Consensual: What is the promise to patients, and how will they know it was kept? How does it change from the current offer? How will patients be able to make an informed choice of whether to express dissent? The option of maintaining the current opt out for GPs, and extending the HSCIC opt out to cover all other care, is still possible.

Safe: “don’t leave medical records on trains” The Caldicott Review is strong here, and it just needs to happen. How will patients know if it hasn’t?

Transparent: Patients should know how their data gets used. At the moment, it’s a secretive process because there is no transparency. If DH wishes to override patients’ dissent (whatever that is), the patients should be able to know about it. It makes all of the discussions practical. This is the informed part of informed consent (dissent), and also the mechanism for Dame Fiona’s conversation into the future.


The opt out language

The “hard” part of Dame Fiona’s task was to suggest new language on opt outs that would both have public trust and was capable of being delivered. And it succeeded in offering that option, amongst others.

How that is interpreted is currently solely up to the Department of Health.

Data sharing will continue, as will AI, genomics, and whatever comes after AI and genomics. At some point, Google Deepmind will do something creepy, or the next startup in shoreditch will do something stupid. If a media firestorm is the only way to tell patients what happened, then eventually public confidence will lose, and lose badly.

Every patient should know how their data is used, and from that, innovation can be celebrated. At the moment, everyone prays really really hard that nothing goes wrong.

A transparent communications mechanism can build trust. It can also be used to talk about all the other innovations and benefits that already happen – it’s just no one knows about them.

Currently, the best way to find out whether your retina scan was fed to an AI, is by being on Google’s press list. That can not be right. If the only way Jeremy Hunt wants patients to hear how their medical records were used is via the press, then that is sheer lunacy.

There are few opportunities to make changes such as this. The Caldicott Reset of Consent coming after the collapse of the care.data is likely to be one of them. We hope the outcome will reflect the choices and interests of everyone, not just those who wish to ignore consent and profit off patients.

Patients have been given an option to opt out. Any attempt to remove it is likely to exacerbate the concerns of the vast majority who have so far not used it.