Data sharing in genomic medicines to be a 2018 focus for Caldicott

The 2018 priorities for Dame Fiona Caldicott's work are set out in her health and care 2017 report (19-page / 341KB PDF).

The report listed eight priorities that Dame Fiona will pursue in 2018 prior to her role being placed on a statutory footing. One of those priorities is "to work alongside others to encourage proper sharing of data in genomic medicine and to contribute to the thinking about how patients should be engaged about this".

Genomics data sharing is an issue Dame Fiona has already explored, in a paper published earlier this summer.

That August 2017 paper said that "more should be done to explore what information might be needed for patients to give valid consent to the use of data for their own individual care and to be used more broadly, including for research purposes", and also said that "a project to reconfigure NHS genetic laboratories should conduct a privacy impact assessment to examine the privacy implications of services sharing data", according to her latest report.

Both steps need to be taken to "progress confidence in the sharing of data to support NHS clinical genetics and genomics services", the report said.

Earlier this year, the UK's chief medical officer, professor Dame Sally Davies, outlined a vision to put genomics at the centre of more personalised health care in the country. According to Dame Sally's report, genomics is "the study of all the DNA in the genome together with the technologies that allow it to be sequenced, analysed and interpreted".

Dame Sally said that there are believed to be "over 10,000 potential drug targets in the human genome" and she described this as a "potential goldmine" for influencing the development of new treatments, including where there are "areas of unmet medical need".

Helen Cline, expert in life sciences at Pinsent Masons, the law firm behind Out-Law.com, said: "Failure to communicate the benefits of sharing data appropriately caused the government to abandon the care.data programme in 2016. It is good to see that the need to have patients engaged and onboard is specifically addressed."

"Genomics can be harnessed to tailor drug choice, dosages and interventions to the biology of an individual patient, personalising healthcare, so that limited NHS resources are used most effectively. However, there is tension between the interests of the patients and developers of these personalised therapies and devices. The genetic information essential for their development may reveal both personal and family health and ancestry information so issues of consent and privacy are of great importance," she said.

A further 2018 priority for Dame Fiona is to "support the successful implementation" of new data security standards that she recommended and further recommendations concerning the creation of a new consent and opt-out model for data sharing in the NHS in England. 

In July, the UK government endorsed the 10 data security standards that Dame Fiona had outlined, and said that a new "national opt-out" will be implemented from March 2018 through a transitional period which will apply until 2020 when the new system will become fully effective.

Cline said: "It can be argued that a patient cannot give informed consent to future research that is as yet undefined. However, the necessity of re-consent, allowing withdrawal of consent and the use of coded pseudo-anonymised data could act as a barrier to the development of personalised healthcare. Finding the right balance between research needs and the protection of patients is obviously going to be part of this ongoing exercise."

In 2018, it will also be a priority of Dame Fiona's to consider how she can "best support the use of data in new healthcare technologies in line with patient expectations and preferences", according to her new report.

"This should include consideration of the proposal … for a regulatory and commercial framework capable of ensuring that the value of innovations, built for example on algorithms generated using health data, is properly recognised by the NHS," the report said. "Such an approach may help to address some of the public concern expressed about commercial organisations using health and care data."