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.

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Photo of Grant Castle Grant Castle

Grant Castle practices in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management.

Grant Castle practices in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation. His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management. He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products. He has developed considerable expertise in coordinating regulatory projects covering jurisdictions outside of Europe, including Canada, South America, Eastern Europe, the former Soviet Union, Africa, the Near East, Japan, and Australia. His transactional work includes advice on regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.