The UK’s National Institute for Health and Care Excellence (NICE) has recently published an evidence standards framework for DHTs (the Standards), available here.  It did so through a working group led by NHS England, but supported by representatives from Public Health England, MedCity and DigitalHealth.London.

The Standards cover DHTs, such as apps, programs and software – both standalone or combined with other products like medical devices or diagnostic tests – intended for use within the UK’s health and care system.  They seek to address some of the challenges faced by both companies developing DHTs and those within the UK healthcare system that commission and deploy these new technologies.  Both sides needed guidance on the criteria and evidence to demonstrate and assess the performance of DHTs and to measure their cost impact, so that all stakeholders assess these new technologies consistently.

The Standards classify DHTs in three tiers by function. The lowest tier 1 comprises DHTs with no measurable patient outcomes but that provide services to the health and social care system.  Tier 2 comprises DHTs that provide information, resources or activities about a condition or general health and lifestyle.  Tier 2 also includes DHTs that perform simple monitoring of general health using fitness wearables and simple symptom-measuring devices and DHTs that allow two-way communication.

The third tier is split into tier 3a, which includes DHTs intended to facilitate preventative behaviour change to address public health issues like smoking, alcohol, sexual health, eating, sleeping and exercise.  It also covers DHTs that allow people to self-manage a condition.  Tier 3b includes DHTs that guide treatment, e.g., that perform calculations that impact treatment diagnosis or care, and DHTs that diagnose conditions, including those involved in active monitoring of a specified condition.

For each tier, the Standards provide guidance on the evidence required to demonstrate effectiveness or performance.  Obviously, the lower the tier, the lower the evidentiary burden, required to demonstrate performance, reliability and accuracy.  In all cases the Standards set out the “minimum evidence standard” and a “best practice standard.”  At tier 1, “a plausible mode of action that is viewed as useful and relevant” by those in the relevant field may suffice as the minimum evidence required. At tier 3b, the best practice standard is “high-quality randomized controlled study or studies done in a setting relevant to the UK health and social care system, comparing the DHT with a relevant comparator and demonstrating consistent benefit including in clinical outcomes to the target population…”

From an economic impact perspective, NICE offers some guidance based on its current experiences of digital health offerings and its experience in evaluating other medical technologies, such as devices and diagnostics.  Again, NICE uses a tier-based approach, but one based on whether the DHT presents a low or high financial risk to a payer or commissioner.  For low financial risk DHTs, a simple budget impact analysis may suffice. For high-risk, publicly funded DHTs, an estimated incremental cost-effectiveness ratio (ICER) or some other formal health economic assessment may be necessary.

NICE and the DHT working group intends to release further educational, case study and other supporting resources in early 2019.

Tags: Data Quality, digital health, health standards, National Institute for Health and Care Excellence (NICE)
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Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law…

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

He is one of the Co-chairs of Covington’s Life Sciences Industry Group and is Head of Covington’s European Life Sciences Regulatory Practice.

Grant regularly advises on:

EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
Advertising and promotion of both pharmaceuticals and medical devices; and
Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 21 years. He is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.” He is praised by clients for his “absolutely first-rate” European regulatory practice. Legal 500 UK notes that he is “highly competent in understanding legal and technical biological issues.”

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