Higher safety hurdle needed for health apps – Hancock

In an interview with HSJ on Monday, Matt Hancock said the regulation of algorithms and other software involved in delivering clinical care needed to be more like pharmaceuticals, with trials and a high evidence hurdle before being licensed for NHS use.

“In the digital space, we don’t yet have a similar pathway, with the appropriate level of hurdle that must be gotten over to be used,” he said. 

Asked whether the public should be concerned about the safety and effectiveness of health apps currently used in the NHS, Mr Hancock said there was “a big piece of work to be done”.

He added: “For something that is a clinical intervention digital technology, MHRA [the Medicines and Healthcare products Regulatory Agency] and NICE [National Institute for Health and Care Excellence] are just at the starting point of being able to work out what should and shouldn’t be used.

“The apps in use now are being developed to the best of their capability and I think it’s very positive that there’s an awful lot of innovation going on in this space. But we also need to make sure we get the best out of it so I think we should have higher expectations.”

He said medical software that met this new higher bar, proving both safe and effective, should be promoted for uptake across the NHS.

Mr Hancock was speaking ahead of the publication of the Department of Health and Social Care’s code of conduct for the use of digital technology in the NHS on Tuesday. The guidance focused on standards for commercial access to NHS patient data, but it also said algorithms used to deliver care should “generate evidence of effectiveness”.

Concerns have been raised that the regime for regulating the growing number of medical apps used in the NHS is fragmented and weak, potentially putting patients at risk.

Specific concerns have been raised about the quality of advice offered to patients by some symptom checker apps used in the NHS, including Babylon Health.

HSJ revealed earlier this month that the Care Quality Commission will now inspect the use of triage apps. MHRA will also require independent assessments of medical software from 2020, while NICE is increasingly involved in assessing new digital technology.

In the interview with HSJ, which focused on technology, Mr Hancock also said NHS organisations need to ensure they get the full benefits from sharing NHS data with industry.

This could be an equity stake or licensing agreement, but he said the NHS must make sure “individual companies can’t run off with intellectual property that couldn’t have been created without the NHS”.

Asked to comment on the deal that allowed Google Deepmind to unlawfully access Royal Free London Foundation Trust patients’ data to develop a clinical app for free, Mr Hancock said the deal was well-intentioned but should not be repeated.

“What I care about is that the intellectual property that the NHS generates is dealt with fairly and the NHS isn’t taken for a ride,” he added.

Mr Hancock also said he did not support the creation of any new national NHS patient database.

“I am not a fan of a big national database because of the peril that it could bring,” he remarked. 

HSJ reported last month that NHS England wants to use regional health records, known as local health care record exemplars, to create a single national longitudinal record available for planning and research.

However, Digital Health reported last week that this approach has been met with resistance from some regional record leads, who believed the focus should be on caring for local patients rather than feeding into a national database.

Mr Hancock told HSJ on Monday he supports the local approach with patient data “handled on a local basis”.

He added: “I am not supportive of the single national database, but I do support systems that talk to each other with appropriate privacy safeguards.

“The modern approach to data management is not to chuck the data into a big database but to have strictly set access rules that allow for datasets to talk to each [other] and be queried where necessary. I think that’s what patients want and it is very important for industry as well.”