It’s fair to say that Google-owned AI company DeepMind’s big push into the health space via data-access collaborations with the UK’s National Health Service — announced with much fanfare in February this year — has not been running entirely smoothly so far.
But there are more regulatory bumps in the road ahead for DeepMind Health.
TechCrunch has learned the company won’t continue using one of the apps it co-designed with the NHS until the software has been registered as a medical device with the relevant regulatory body, the MHRA.
That’s especially interesting given that this app, called Streams, has already been used for patient care in multiple NHS hospitals. The Royal Free NHS Trust previously told TechCrunch the app had been used by up to six of its clinicians in three “user tests” in its London hospitals.
Which, put another way, means a profit-driven commercial entity has been involved in a real-world test of an unregistered medical device on actual hospital patients.
As TechCrunch previously reported, the Royal Free Trust stopped using the app in question in May, in the wake of another controversy pertaining to its DeepMind collaboration. At that point we learned the pair were contacted by the MHRA to discuss whether the app should be registered as a medical device.
A spokesman for the MHRA told TechCrunch at the time that regulatory compliance is helped by parties pro-actively having “a discussion” before going ahead with tests — something which did not happen in the DeepMind/Royal Free case.
It has now emerged that the upshot of those after-the-fact discussions is DeepMind believes it does need to register the app.
A spokesman for the regulator told TechCrunch: “MHRA understands that the Streams software is based on the NHS England AKI algorithm and is likely to be a class I medical device.
“As a class 1 device it is subject to self-declaration. The manufacturer of the device must hold all relevant test and validation data [including for software] to support the intended purpose for the device. The Competent Authorities within the EU (MHRA in the UK) can request to review all documentation pertaining to the device at any time.”
Announcing a second collaboration with another NHS Trust earlier this month, DeepMind’s co-founder Mustafa Suleyman took to Medium to write how treating NHS health data with respect “really matters”.
He went on to note: “There are different authorities that give different types of approvals and oversight for NHS data use: HSCIC, HRA, MHRA, ICO, Caldicott Guardians, and many, many more. We’re committed to working with all these groups, and making sure with their help that we get it right.”
Evidently DeepMind is going to need to rethink its modus operandi vis-a-vis pro-actively contacting the relevant healthcare regulators before it accelerates ahead with any more “user tests” powered by NHS data-sets.
Commenting on the latest development in its discussions with the MHRA, a DeepMind spokesperson told TechCrunch: “We’re still developing the prototype for the Streams app at this stage.