The Evolving Landscape of Digital Technology Assessment & Regulation

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In recent years, digital technologies, particularly health apps, have surged in popularity and now play a pivotal role within the healthcare system. With demand growing, questions about their regulation become increasingly pertinent.

The COVID-19 pandemic saw an explosion in the use of, and interest in, digital innovations, and many of these solutions are now a part of the wider healthcare landscape focused on improving the mental health of the population and the delivery of health services.

But, significant challenges remain in how digital is described; how innovation, research and development is supported; and how clarity is given to the system on the role and place of digital mental health. This includes concerns regarding the NHS’s Digital Technology Assessment Criteria (DTAC), designed to be used by healthcare organisations to assess suppliers at the point of procurement or as part of a due diligence process, to make sure digital technologies meet the organisation’s minimum baseline standards.

Whilst there is a consensus amongst industry that a framework for assessing digital technologies is necessary, and that DTAC performs a useful and important role in clarifying what Trusts are required by various laws and regulations to consider when buying technology, concerns have been raised regarding the process. This has prompted the Department of Health and Social Care (DHSC), jointly with the NHS, to undertake a review of DTAC.

Concerns include a lack of consistency in how different firms interpret DTAC and the level of assurances and legal formality offered to buyers and suppliers, the lack of standardisation in process and supporting forms, a general lack of support in filling out and completing the process, and the fact that DTAC is being conducted in isolation of other assurance and control processes looking at the same or similar issues. This is effectively resulting in duplicated processes as DTAC is not recognised as an equivalent.

The main aim of the review is to standardise and streamline the process, so that suppliers do not have to duplicate their assessments, or complete different assessments for different NHS Trusts. In the short-term, the structure of the assessment form, public facing guidance, and DTAC support for SMEs and support are all under review. DHSC have also proposed refreshing the DTAC form and clarifying the position on some outstanding policy questions such as the application of DTAC to products which are not-fully compliant.

Looking to the future, the review will explore creating a DTAC repository to streamline information storage and form completion, revising assessment criteria, and potentially implementing a certification scheme to replace the current process.

DHSC will also consider opportunities for alignment between DTAC and the MedTech Directorate’s new value-based procurement methodology, which, for the first time, will place patient choice and outcomes at the heart of NHS purchasing policy. When I asked him about this alignment recently, DHSC’s Director of MedTech, David Lawson, suggested that a revitalised DTAC system could provide suppliers, particularly SME’s, with a recognised “passport” to enable them to demonstrate their product’s credentials in future procurements without having to jump through all the hoops again every time.

The review is expected to continue for the next 12-18 months, with the relaunch of DTAC anticipated in the 2025/26 financial year. To support this transformation, DHSC plans to establish an industry advisory board comprising representatives from industry bodies and system colleagues, ensuring practical and effective developments.

As this critical review unfolds, it is imperative for the digital technology industry actively to engage with DHSC, ensuring that the sector’s perspectives are prominently voiced and understood. The outcome of this review holds significant implications for the future of digital health technology regulation, with the potential to shape a more efficient and cohesive healthcare landscape.

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