Understanding the NICE Evidence Standard Framework: A Blueprint for Your Health App Scientific Validation

4 min read

Contextualization — Challenges of Scientific Validation

As a developer, it can be challenging to figure out how much is enough to prove that our product is truly useful and effective. This becomes especially tricky when trying to convince investors or healthcare professionals to use our tools. It's crucial to clearly define how much scientific evidence is needed. This not only strengthens the credibility of our product but also builds trust in it. It's like laying a solid foundation to show that what we're doing has a real impact.

The answer to this challenge largely depends on the nature of the app's intervention and how we describe it, whether through product labelling or health claims.

This is where the NICE approach comes in to address this issue. Operating on the assumption that each application carries its level of risk, NICE offers a solution by categorizing these risks. Based on this categorization, specific levels of requirements are applied, providing a clear framework to determine the appropriate degree of scientific validation required for each type of application. This simplifies the process by providing guidelines tailored to the specific nature of each app.

In this article, we will explore the concept of digital health tool categories and the associated evidence levels. You will grasp the essence of this innovative approach proposed by TherAppX, based on the NICE ESF, to tailor your scientific validation efforts according to the specific risks of your application.

Categorization of digital tools by NICE ESF

To regulate this thriving ecosystem, jurisdictions in several countries have developed a classification system for digital health tools and eventually achieved harmonization. At TherAppX, we have studied and dissected many of these classifications and have relied on the NICE standard, called NICE ESF (Evidence Standard Framework).

First and foremost, what is NICE?

It is a regulatory body for digital tools in England. Their goal is to suggest an approach that takes into account clinical effectiveness, of course, but also the cost-effectiveness.

How does the NICE ESF categorization work?

This categorization is, in our opinion, simple and effective. You will quickly understand why. First, it consists of three “risk tiers”: A, B, and C.

— Tier A: It concerns digital tools oriented towards industry and hospitals, with no direct impact on patient health.

— Tier B: It includes tools focused on patients, aiming to improve their overall health and well-being without direct clinical intervention.

— Tier C: It encompasses digital tools aiming to treat or diagnose a condition, presenting the highest degree of risk.

The categories within each tier provide an additional level of precision. You should have an idea of where your app fits in this regard. However, formal definitions exist to understand what each type of digital tool includes, and it is important to refer to them. We will delve into them in the following sections.

Importance of Classification in Application Development

The classification system guides the level of clinical claims you can afford to make. Market expectations vary depending on the classification of your tool. This influences the level of requirements related to clinical intent, acceptability proof, feasibility, health benefits, and existing regulations.

In simple terms, if you overclassify, you will need to provide extensive evidence, with lengthy and costly procedures, to demonstrate your reliability in the face of a risk that does not apply to you. Conversely, under classifying your app will lead to developing insufficient evidence that will not persuade clinicians, investors, or even your most informed clientele.

However, be aware that your classification can evolve as your app develops.

How to classify?

A crucial question then arises for digital tool developers: how to classify their applications according to the NICE ESF.

This step is fundamental to determine the levels of requirements related to clinical intent, acceptability proof, feasibility, health benefit, and existing regulations. Here is a practical guide to help you:

1a. Consider the users targeted by your app

Analyze your target audience in detail. Is it industry-focused, patient-centred for their well-being, or aiming to treat specific conditions? This initial understanding will help determine the appropriate tier.

1b. Assess associated clinical risks

Identify potential clinical risks of your application. The more likely the application is to have a direct impact on user health, the higher it may be classified. Evaluating these risks will guide you to the suitable tier.

2. Consider the app's features

Next, analyze your app's features to understand which category of digital tools yours falls into. By focusing on your features, you will truly concentrate on the intended use of your app, and what it does concretely.

3. Consult with us!

Consider consultation with digital health experts. We can provide clarifications on specific points and facilitate your classification process.

TherAppX Validation Approach

By turning to us, you will benefit from our systematic and rigorous approach to help ensure the reliability of your app. Specifically, our methodology is based on three fundamental principles:

1. Proportionality: Validation requirements are adjusted based on the features and intended use of the app, aligned with the NICE ESF framework.

2. Appropriateness: Each provided evidence document is evaluated for its quality, including methodology and sample size.

3. Cumulative: Higher-tier applications must meet the scientific requirements established in lower tiers, ensuring progressive validation as the app develops.

Risk Reduction and Opportunity Maximization

As you understand, by following the NICE ESF framework, you can de-risk your projects, offering assurance not only for yourself but also for investors and clients. This customized approach also allows startups to seek funding more easily and successfully navigate crucial stages of their development.

Breaking Through Encounters

In conclusion, understanding digital health categories and associated levels of evidence is essential to navigate successfully in the digital health landscape. By following innovative validation methodologies, such as the one proposed by TherAppX, you can minimize risks, maximize opportunities, and contribute significantly to the evolution of the digital health sector. Don't wait any longer, and reach out to us for assistance in advancing.