The Download: A matter of trust

The major increase in the use of digital healthcare technology over the past six months has revolutionised some aspects of healthcare.

Now the focus has turned towards how the positive digital changes can be maintained, while learning from mistakes as winter fast approaches and the second wave of covid-19 grows.

In recent months procurement barriers that previously dragged out the adoption of new tech were dropped, enabling the rapid rollout of video consultations.

However, health tech companies fear new regulatory measures could hamper the digital progress made during the pandemic.

In May this year regulation of medical devices was due to be changed by the European Commission, which would have meant more digital healthcare products could have been stamped with the CE mark – a certification which shows the product complies with EU standards for health and safety.

Previously this medical device regulation predominantly excluded digital health products, so it was recognised that something needed to be done to mark new digital products as safe. 

While this sounds like a positive step, it would have meant thousands more products would need to go through regulation this way – dragging out an already arduous process for innovators.

These changes were then delayed by a year due to the pandemic. However, fresh guidance on medical device regulation published by the government on 1 September stated there will be a UK-specific assessment process for products used in the country, called the UK Compliance Assessment.

Getting this process in place for January is ambitious, according to Liz Ashall-Payne, chief executive of digital health company Orcha. She told HSJ that while the UKCA is supposed to come into force in January, the previous certification can still be in effect until 2023.

This is likely to make investors nervous, according to Miss Ashall-Payne, as they will be in a regulatory “no-man’s land” for three years, potentially lengthening the already long and expensive regulatory process.

She told HSJ: “The ultimate barrier to digital health adoption is trust. People don’t know whether they can trust it or not.

“And what this puts into play is potentially another layer of confusion which could build mistrust further and push out access to innovations from patients and healthcare systems at a time when we really need them.

“We have got a real opportunity to influence that and help the UK.

“We could have this amazing opportunity if we get it right, or it could create more confusion and more mistrust. For developers and innovators they are not aware this is happening, they are not aware of the impact of this.”

She added that this “regulatory hurdle” could potentially deter investors from investing in companies who want to work with the NHS. In turn this could drive innovations away from patients and the health system at a time when they are needed most.

However, the UK compliance assessment has real potential for the UK to be a leader in device regulation, encouraging international companies to set up shop here.

The importance of streamlined regulation is particularly stark at the moment as the demand for digital health products from the public has increased dramatically.

Figures published by Orcha from its health app libraries - provided to NHS patients -  have shown an 850 per cent increase in people search for healthy living apps, a 385 per cent increase in searches for healthy eating apps while searches for diabetes related apps have increased by 168 per cent.

Miss Ashall-Payne added: “We do need to think about regulation differently, as at the moment it’s outdated, burdensome, but if the UK can address it and adopt a modern assessment approach then the UK could become a real model for effective regulation.”

The MHRA told HSJ that from January manufacturers will be able to use the UKCA certification on a voluntary basis until it becomes mandatory in July 2023. Until then CE marked products will still be accepted.

A spokesman said: “The Independent Medicines and Medical Devices Safety Review, which delivered its report this July, has highlighted the importance of strengthened regulations that do more to protect patients.

“We will engage with stakeholders within the life sciences and healthcare sectors this autumn to develop a robust, world-leading regulatory system for medical devices that puts patient safety at its heart.”