Introduction: Navigating the Digital Health Landscape
Are you struggling to prove the value of your digital health solution?
Do you find it challenging to meet the evidence requirements for NHS adoption?
Are you unsure how to demonstrate the effectiveness and safety of your technology?
As a digital health leader, you’re likely facing these questions and concerns.
The rapidly evolving digital health landscape can be daunting, especially when it comes to meeting evidence standards.
This article will demystify the Evidence Standards Framework for Digital Health Technologies and help you navigate the path to NHS adoption.
Why This Matters: The ‘So What’ of Evidence Standards
Understanding and implementing the Evidence Standards Framework is crucial for digital health leaders.
It’s not just about ticking boxes; it’s about ensuring your technology is safe, effective, and capable of improving patient outcomes within health and care systems.
Aligning with these standards will increase your chances of NHS adoption, gain credibility in the healthcare market, and ultimately make a more significant impact on patient care.
Think of it as your roadmap to success in the digital health space.
What is the Evidence Standards Framework?
Definition and Purpose
The Evidence Standards Framework is a set of guidelines developed by NICE (National Institute for Health and Care Excellence) in collaboration with NHS England.
It’s designed to help digital health innovators understand what evidence they need to demonstrate the value of their products, including those utilising artificial intelligence.
The framework ensures that digital health technologies are safe, effective, and provide economic value to the NHS.
Key Stakeholders Involved
The framework involves multiple stakeholders:
- NICE: Develops and maintains the framework
- NHS England: Collaborates on framework development and implementation
- Public Health England: Collaborates with NICE and NHS England to ensure an appropriate level of rigour and assurance for the health and care system
- Digital health innovators: Use the framework to guide their evidence generation
- Healthcare providers: Use the framework to assess digital health technologies
- Patients: Benefit from safe and effective digital health solutions
The Structure of the Framework
The framework classifies medical technologies, including Digital Health Technologies (DHTs), into three main tiers, each with subcategories:
Tier A: Services
DHTs intended to save costs or release staff time, no direct patient, health or care outcomes.
- System services
- These are DHTs intended to release costs or staff time, or to improve efficiency.
- Unlikely to have direct health outcomes measurable for individual service users.
Tier B: Inform
DHTs for helping citizens and patients manage their own health and wellness
- Communicating about health and care
- Communicating with health and care professionals or others, to help service users to manage their health and care.
- Allows 2-way communication between service users and professionals, carers, third party organisations or peers.
- Health and care diaries
- Health and care diaries to help service users to manage their own health and wellness.
- Allows service users to record information to create health diaries.
- Information and data stay with the service user and are not automatically shared with others for review.
- Promoting good health
- Population-level information to help people and service users to maintain healthy lifestyles and manage conditions.
- Provides non-personalised information and resources to service users.
- May encourage behaviours that promote good health and address issues such as smoking, eating and exercise.
- May also provide information about specific conditions.
Tier C: Intervene
DHTs for treating and diagnosing medical conditions, or guiding care choices, often incorporate adaptive algorithms. These include DHTs with direct health outcomes, and those that are likely to be regulated medical devices.
DHTs in tier C are divided into 4 classification groups to align with the software as a medical device (SaMD) classification framework proposed by the International Medical Device Regulators Forum (IMDRF).
- Inform clinical management
- DHTs that record and calculate data and transmit the data to a professional, carer or third-party organisation, to inform clinical management decisions in the future.
- Also, DHTs that provide personalised information or guidance to end users to promote healthy living.
- Information provided by the DHT will not trigger an immediate or near-term action by clinical or care staff.
- Drive clinical management
- Information provided by the DHT will be used to aid in treatment, aid in diagnoses, to triage or identify early signs of a disease or condition, or will be used to guide next diagnostics or next treatment interventions.
- Diagnose a condition
- Information provided by the DHT will be used to take an immediate or near-term action to diagnose, screen or detect a disease or condition.
- Treat a condition
- Information provided by the DHT will be used to take an immediate or near-term action to treat, prevent or mitigate by means of providing therapy to a human body
The NICE Evidence Standards
This section is your one-stop shop for understanding these standards within the context of the NHS and care system. We’ve broken it down into bite-sized chunks, so you can digest it easily.
The standards are presented in groups related to phases of the DHT product life cycle. There are 21 standards arranged in 5 groups.
Each link takes you to a deep dive on that standard. Just straight talk on what you need to know and do.
Design Factors
The 9 standards identify key aspects of the design process that impact the DHT’s value to the health and care system, including ensuring the technology has the appropriate technical standards for safety and reliability.
Standards 1 to 6 apply to tier A, B and C DHTs. Standards 7 to 9 do not apply to tier A DHTs.
Standard 2: The DHT should incorporate intended user group acceptability in its design
Standard 3: The DHT should consider environmental sustainability
Standard 4: The DHT should consider health and care inequalities and bias mitigation
Standard 5: The DHT should embed good data practices in its design
Standard 6: The DHT should define the level of professional oversight
Standard 7: The DHT should show processes for creating reliable health information
Standard 8: The DHT should show that it is credible with UK professionals
Standard 9: The DHT should provide safeguarding assurances where users are considered to be in vulnerable groups, or where peer-to-peer interaction is enabled
Describing Value
The 4 standards apply across all tiers and provide information to build the value proposition of the DHT.
Standards 10 to 13 apply to tier A, B and C DHTs.
- Standard 10: Describe the intended purpose and target population
- Standard 11: Describe the current pathway or system process
- Standard 12: Describe the proposed pathway or system process using the DHT
- Standard 13: Describe the expected health, cost and resource impacts compared with current care or system processes
Demonstrating Performance
Standards 14 to 16 are designed to help ensure that the DHT meets its performance expectations.
Standard 14 only applies to tier C DHTs. Standards 15 and 16 apply to tier A, B and C DHTs.
- Standard 14: Provide evidence of the DHT’s effectiveness to support its claimed benefits
- Standard 15: Show real-world evidence that the claimed benefits can be realised in practice
- Standard 16: The company and evaluator should agree a plan for measuring usage and changes in the DHT’s performance overtime
Delivering Value
The 2 standards apply to DHTs in all tiers and show how DHTs should demonstrate their value for money.
- Standard 17: Provide a budget impact analysis
- Standard 18: For DHTs with higher financial risk, provide a cost-effectiveness analysis
Deployment Considerations
The 3 standards help to ensure that the claimed benefits of the DHT can be realised in practice, and apply to all 3 tiers.
- Standard 19: Ensure transparency about requirements for deployment
- Standard 20: Describe strategies for communication, consent and training processes to allow the DHT to be understood
- Standard 21: Ensure appropriate scalability
Evidence Requirements
Evidence for Effectiveness
Evidence requirements vary depending on the tier and subcategory:
- Tier A: Typically requires evidence of accurate performance and reliability.
- Tier B: Needs evidence of relevance, quality of information, and user testing.
- Tier C: Requires more robust clinical evidence, often including randomised controlled trials (RCTs).
Evidence for Economic Impact
Economic evidence requirements also differ by tier:
- Tier A: May require cost analysis or budget impact analysis.
- Tier B: Often needs budget impact analysis or cost-consequence analysis.
- Tier C: Usually requires more comprehensive economic analysis, potentially including cost-effectiveness or cost-utility analysis.
Implementing the Framework: A Step-by-Step Guide
Step 1: Determine Your Tier
Conduct a thorough assessment of your technology’s function, risk level, and intended use
Consult the NICE Evidence Standards Framework tier classification system
Consider seeking expert advice if your technology spans multiple tiers
Document your rationale for tier selection, as this may be scrutinised later
Step 2: Understand the Evidence Requirements
Review the specific evidence requirements for your tier in detail
Identify both effectiveness and economic evidence needs
Pay attention to the level of evidence required (e.g., RCTs, observational studies)
Note any specific outcome measures or comparators required by NICE
Consider how your evidence will address the five evidence perspectives: Credibility, Relevance, Fairness, Robustness, and Impact
Step 3: Plan Your Evidence Generation Strategy
Develop a comprehensive evidence generation plan
Consider a mix of evidence types: clinical trials, real-world data, economic modelling
Identify potential research partners (e.g., academic institutions, NHS trusts)
Plan for patient and public involvement in your research
Create a timeline and budget for evidence generation activities
Consider how you’ll address potential challenges (e.g., recruitment, long-term follow-up)
Step 4: Collect and Analyse Data
Implement your evidence generation plan
Ensure adherence to Good Clinical Practice (GCP) and other relevant standards
Regularly monitor data quality and study progress
Conduct interim analyses if using adaptive trial designs
Apply appropriate statistical methods for data analysis
Consider using advanced techniques like propensity score matching for observational data
Ensure your analysis plan aligns with NICE’s preferred methods
Step 5: Synthesise and Present Your Evidence
Compile all relevant evidence into a clear, concise format
Develop a compelling value proposition based on your evidence
Create visual aids (e.g., infographics, dashboards) to communicate key findings
Prepare for common questions and potential critiques
Consider conducting a mock NICE appraisal to test your evidence package
Ensure your presentation addresses all five evidence perspectives
Be prepared to discuss uncertainties and limitations in your evidence
Step 6: Engage with NICE and Other Stakeholders
Consider requesting a NICE Scientific Advice consultation
Engage with relevant NHS stakeholders (e.g., Clinical Commissioning Groups, Academic Health Science Networks)
Prepare for and participate in NICE committee meetings
Be ready to provide additional analyses or clarifications as requested
Plan for post-approval evidence generation if required
Step 7: Implement and Monitor
Develop an implementation plan for NHS adoption
Set up systems for ongoing data collection and analysis
Monitor real-world performance against your initial evidence claims
Be prepared to conduct post-market studies if required
Stay informed about updates to the Evidence Standards Framework
Challenges and Success Strategies for Meeting Evidence Standards
Common Challenges and Expert Solutions
Limited resources for large-scale studies
- High costs of randomised controlled trials (RCTs)
- Lack of in-house expertise for complex study designs
→ Partnering with experienced health economists can optimise study designs, potentially reducing costs whilst maintaining scientific rigour.
Demonstrating long-term outcomes
- Digital health interventions often require extended periods to show significant impact
- Difficulty in maintaining user engagement for long-term studies
→ Health economic modelling can project long-term outcomes, providing valuable evidence without waiting years for results.
Rapidly evolving technology outpacing evidence generation
- Risk of technology becoming obsolete before study completion
- Challenges in updating interventions during ongoing trials
→ Design flexible study protocols that accommodate technological updates without compromising validity.
Recruitment and retention of study participants
- Difficulty in reaching diverse populations
- High dropout rates in digital interventions
→ Clinical experts can advise on innovative recruitment strategies and incentive structures to boost participation and retention.
Data privacy and security concerns
- Navigating GDPR and NHS data protection requirements
- Ensuring secure data transfer and storage in digital trials
→ Digital Healthcare consultants familiar with NHS data regulations can guide you through compliance, minimising risks and delays.
Innovative Strategies for Success
Collaborate strategically
- Partner with academic institutions and experienced consultancies
- Access a wealth of research expertise and resources
- Benefit from joint funding opportunities (e.g., Innovate UK grants)
→ Establish relationships with key academic partners to facilitate powerful collaborations.
Implement adaptive trial designs
- Allows for modifications based on interim results
- Can reduce study duration and costs
→ Skilled clinical development teams can design and analyse adaptive trials, maximising efficiency and evidence quality.
Leverage real-world data (RWD)
- Use NHS Digital’s datasets to supplement trial data
- Implement continuous data collection post-market launch
→ Experienced analysts can help you navigate complex NHS datasets and design robust real-world evidence strategies.
Engage in regulatory sandboxes
- Test innovations in controlled environments
- Gain early feedback from regulators through Regulatory and/or HTA advice.
→ Health economic consultants with regulatory expertise can guide you through sandbox processes, optimising your regulatory strategy.
Utilise synthetic control arms
- Reduce the need for large control groups
- Accelerate trial timelines
→ Skilled modellers can develop robust synthetic control arms, potentially saving millions in trial costs.
Implement decentralised trial designs
- Increase participant diversity and retention
- Reduce costs associated with site management
→ Experienced trial designers can help you navigate the complexities of decentralised trials, ensuring scientific validity and regulatory compliance.
Frequently Asked Questions (FAQs)
How long does it typically take to gather the required evidence?
Timelines vary, but with expert guidance, you can often streamline the process:
- Tier A: 2-4 months (with efficient planning)
- Tier B: 4-8 months (leveraging existing data where possible)
- Tier C: 8-24 months (using innovative trial designs)
Can I use evidence from other countries to support my technology in the UK?
Yes, but it requires careful adaptation:
- Evidence must be relevant to the UK healthcare context
- You may need to conduct additional UK-specific studies
- Consider differences in healthcare systems, demographics, and clinical practices
What if my technology doesn’t fit neatly into one tier?
This is a common challenge. Steps to take:
- Consult NICE’s Evidence Standards Framework
- Request a Scientific Advice consultation from NICE
- Consider a hybrid approach, meeting requirements from multiple tiers
How often are the evidence standards updated?
NICE reviews the framework annually and updates as needed:
- Last major update: December 2021
- Minor updates occur more frequently.
Are there resources available to help with evidence generation?
Yes, several valuable resources exist, including:
- NICE Scientific Advice service
- NIHR Study Support Service
- DigitalHealth.London Evidence Generation Bootcamps
- The Health Innovation Network (previously AHSNs)
Conclusion: Empowering Digital Health Innovation through Expert Guidance
Navigating the Evidence Standards Framework is crucial for success in digital health, but it needn’t be a solo journey.
With the right expertise at your side, you can transform this challenge into a strategic advantage, accelerating your path to NHS adoption and market success.
Are you ready to leverage expert knowledge and take your digital health technology to the next level?
Consider partnering with Healthonomix to develop a tailored, efficient evidence generation strategy that aligns perfectly with NICE requirements and your business goals.
