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Google and Royal Free trust consider data sharing issues

Neil Merrett Published 16 May 2016

Trust maintains that pilot work to develop kidney health app will support 'direct care' as privacy group questions whether sufficient approval processes are in place for project

 

AI company Google DeepMind and the Royal Free London hospital trust have rejected claims that they have not have obtained the required regulatory approval for a pilot programme seeking to develop an app to detect acute kidney injury (AKI) using its patient data.

The App, which is currently called Streams, is being developed to try and improve AKI detection by immediately reviewing blood test results for signs of deterioration and delivering results and alerts to relevant clinicians via a mobile device, the trust has claimed.

As news of the data sharing agreement between DeepMind and the trust came to light this month, privacy campaigners have raised concerns over how patient information will be used by the company, as well as whether technology development work with a third party can be classed as 'direct care'.

The distinction is an important one, as personal confidential information of patients can be shared locally within an organisation without additional legal basis if it is for the purpose of supporting direct care, according to the Health and Social Care Information Centre (HSCIC).

Under the Caldicott Review published in 2013, direct care is defined "as a clinical, social or public health activity concerned with the prevention, investigation and treatment of illness and the alleviation of suffering of individuals."

Proponents of the data sharing agreement with DeepMind have said the app will support clinical staff to undertake diagnosis functions and it therefore meets these requirements.

In defending the project, the Royal Free London trust believes that it has obtained the relevant policies and regulation to collect and process patient data given that the intended purpose of developing the Streams app with DeepMind was for direct care.

"Throughout the NHS, patient data is routinely collected and processed by IT companies for the purpose of direct patient care under the principle of implied consent," said the statement.

"Our agreement with DeepMind is our standard third-party data sharing agreement, with the trust being the data controller and DeepMind being the data processor.'

Streams is understood to be in the early development phase at present, with no clinical trial having taken place around the new technology that will make use of algorithms to predict potential AKI risks from patient data.

Although there is an exclusive partnership between the Royal Free and DeepMind, the trust previously argued that its agreement was based on the standard corporate information sharing terms currently used by over 1,500 third party organisations working with NHS bodies.

Sources with knowledge of the development have argued that all required processes to support direct care have been met. They also added that although Streams is not intended to support treatment, it will assist health care professional with diagnosis and meets the 'direct care' requirements for data sharing agreements.

Google DeepMind is also understood to be in talks about the project with the Health Research Authority (HRA) that oversees health and social care research for the NHS in England.

HRA also publishes a database of approved applications, although the Streams app is not expected to be included on this list at present due to its early stage of development.

In a statement, Google said it was working with the Royal Free clinicians around focusing on methods of better detecting patient deterioration linked to kidney injury.

"We have, and will always, hold ourselves to the highest possible standards of patient data protection," said the company.

Google added: "All the identifiable data under this agreement can only ever be used to assist clinicians with direct patient care and can never be used for research. We and our partners at the Royal Free are in touch with HRA regarding our development work."

However, the Medconfidential campaign group has argued that Google's own use of the term "development work" to describe the present status of the Streams app showed the project should be classed as secondary care and therefore be required to meet stricter regulatory requirements.

A spokesperson for the organisation added that the pilot work around the development of Streams should be closely regulated by HRA, while adding that the company should have sought so-called training datasets with the aim of developing a tool for detecting AKI.

Scrutiny of the app comes at a time when health authorities are waiting for the findings of a review of security and consent standards for patient information sharing across the NHS that has been led by national data guardian Dame Fiona Caldicott.

The completed findings, which will not be published until after the EU referendum in June, are likely to impact flagship initiatives like NHS England's care.data programme.

HSCIC has said that until publication of the findings, it would not speculate on how existing data sharing schemes with private organisations like Google could be affected.

The organisation said it would be supporting "the implementation of any actions" put forward by the data guardian around consent models and how information may be shared.

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