I’m writing this from the Advamed MedTech Conference in Philadelphia, where I have just spoken at an event hosted by the Department for International Trade, about a collaborative project we’re a part which aims to solve the complex issue of digital health evidence. Digital health innovations are dramatically changing and improving the way in which patients can track, manage and improve their health. Digital health is enabling the NHS to improve the way information is communicated and patient data is analysed; for faster diagnoses, streamlining hospital systems and workflows, and opening up new, smarter pathways for personalised care. But there’s a lot of hoops to jump through and misinformation amongst innovators and commissioners as to what is expected, before it gets to that point.

In June this year, MedCity embarked on a project led by NHS England, with NICE, Public Health England, and DigitalHealth.London, which aims to develop a tangible set of standards and guidance that takes into account what the innovative technology is, the risk it entails, and what level of evidence would be suitable for a commissioner to be confident that has reached the required mark for clinical effectiveness and economic impact.

We want to make it easier for innovators and commissioners to understand what ‘good’ evidence for digital innovations looks like, while meeting the needs of the NHS and patients. Developing technologies is a collaborative process and we are bringing key parties together, including industry, commissioners and other stakeholders, to address their needs and experiences.

Through our work in supporting companies to manufacture, develop and commercialise within the region, we know that:

  • There is a lack of clarity of what ‘good looks like’ with respect to clinical and health economic evidence for digital health tools and innovations at national level. The NHS landscape is confusing and the standardisation is not any better internationally.
  • This results in innovators not being clear what evidence they need to produce and often need to repeat trials and pilots, costing considerable expense and time without a clear prospect of scale-up.
  • Commissioners, on the other hand, are often unclear of the benchmarks that they should be looking for with respect to clinical effectiveness and economic impact, or where they are clear, there is regional variance.

The goal is to develop a tool that points to appropriate evidence generation plans for different types of digital health innovations by including a set of standards for generating evidence of effectiveness and economic impact. This will allow for better NHS commissioning, understanding of how the NHS makes decisions and the standards expected of SMEs, and facilitate a dynamic, value driven market.

 What’s in it for digital health companies?

Companies will be able to design and build a product knowing what the standards are for clinical effectiveness and economic impact, which will:

  • Enable a more streamlined pathway for product and evidence development, saving them time and money
  • Save innovator time in seeking advice
  • Provide them with early advice as to whether their innovations are viable.

What’s in it for commissioners?

Commissioners will be able to provide early advice and support and save time in receiving applications for products which are not viable. It will:

  • Enable a more streamlined pathway for product and evidence development, resulting in more targeted, meaningful evidence generation for evaluators, saving the health system time and money
  • Save commissioners time in giving advice/signposting.
  • Ensure they receive quality applications for digital health programmes, for example in the Innovation Technology Tariff, NHS England received 270 applications and none of them had sufficient evidence.
  • Promote the ‘kill quick’ philosophy for those innovations that are not viable.
  • Promote England as the place to manufacture and develop quality innovations.

We have held two sets of workshops, inviting industry and commissioners to share their experiences of evidence generation looking at two streams: clinical effectiveness and economic impact. Collated case studies have fed into the framework, to ensure it covers the breadth of experiences in this area.

The Health Minister, Lord O Shaughnessy, recently announced a new Code of Conduct for AI and data driven technologies, aimed at allowing NHS patients to benefit from the latest innovations. The EFE project is a part of that, and in essence, the Code will be standard for the digital health marketplace, providing transparent guidance on what should be considered when developing and buying digital health innovations, including the data standards, ethical considerations, information governance, clinical safety and commercial requirements.

What’s coming up?

 We are working towards a time where informed clinicians across the healthcare landscape have easy access to the right evidence-based technology tailored to their patients’ needs, and users are providing data to ensure ongoing surveillance of the technology and its safety and efficacy.

We are now at a stage where we are sharing the draft standards with accelerators and programmes including the DigitalHealth.London Accelerator, NHS Innovation Accelerator, the NHS Clinical Entrepreneur Programme, and the Small Business Research Initiative. These programmes will be pivotal in being early adopters of the framework, to test and provide early feedback on how the standards can be used to support the evidence generation plans for companies within their cohorts. We are also working with the NHS, investors, trade bodies, regulators and health research groups, to ensure that these standards apply across the board.

 You can get involved in this project, which aims to complete by January 2019, by sending your case studies against which the evolving framework can be tested, to ensure that the diversity of digital health innovations can be accommodated. Find out more about what we are looking for here: https://medcityhq.com/evidence-for-effectiveness/