The National Institute for health and Care Excellence (NICE) provides guidance to the
NHS in England on the clinical and cost effectiveness of selected
new and established technologies through its healthcare technology assessment (HTA)
program. Using the experience it has gained from this program,
NICE intends to develop a system for evaluating digital apps. The
pilot phase for this project was set in place in November 2016, and, from March 2017, NICE will
publish non-guidance briefings on mobile technology health apps, to
be known as "Health App Briefings". These briefings will
set out the evidence for an app, but will not provide a
recommendation on its use; this will remain subject to the judgment
of the treating physician.
The existing HTA program consists of an initial scoping process,
during which NICE defines the specific questions that the HTA will
address. NICE then conducts an assessment of the technology, in
which an independent academic review group conducts a review of the
quality, findings and implications of the available evidence for a
technology, followed by an economic evaluation. Finally, an
Appraisal Committee considers the report prepared by the academic
review group and decides whether to recommend the technology for
use in the NHS.
The new program builds on the current Paperless 2020 simplified app assessment
process, which was recommended in the Accelerated Access Review
Report discussed in a previous post. It has many parallels with the HTA
program. In particular, it will be a four-stage process,
comprising: (1) the app developer's self-assessment against
defined criteria; (2) a community evaluation involving
crowd-sourced feedback from professionals, the public and local
commissioners; (3) preparation of a benefit case; and (4) an
independent impact evaluation, considering both efficacy and
NICE is currently preparing five Health App Briefings, of which
NICE's Deputy Chief Executive and Director of Health and Social
Care, Professor Gillian Leng, has confirmed one will relate to Sleepio, an app shown in
placebo-controlled clinical trials to improve sleep through a
virtual course of cognitive behavioral therapy.
We understand that future Health App Briefings will also focus
on digital tools with applications in mental health and chronic
conditions, consistent with NHS England's plans to improve its
mental healthcare provision and, in particular, access to tailored
For apps that have evidence to support their use and the claims
made about them, the new Innovation and Technology Tariff,
announced by the Chief Executive of NHS England in June
2016, could provide a reimbursement route for the app. This
will provide a national route to market for a small number of
technologies, and will incentivize providers to use digital
products with proven health outcomes and economic benefits.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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