Digital and data driven technologies: considerations for developers
Previously, many new health technologies, such as pharmaceuticals and diagnostic tests, have been developed by large multi-national companies. These organisations have the resources to conduct high cost and time-consuming Research & Development (R&D), have the institutional knowledge to understand and navigate the complex regulatory and reimbursement environments and have the capital to mitigate against the risks of failure. The revolution in data capture, storage and analysis has created an environment where innovative data driven and digital health technologies (DDHTs) can meet some of the key demands of the NHS whilst being developed by small to medium enterprises (SMEs) in a more openly competitive environment. The Covid-19 pandemic has markedly accelerated the advance of digital integration and demonstrated that it is possible to deliver digital innovation. However, as many DDHT developers will be acutely aware, whilst it is known that there are a set of key steps that need to be overcome before the adoption of their technologies, what those steps are is sometimes vague, confusing or seemingly ever-changing. Moreover, as the health care system moves out of an emergency pandemic setting into a longer-term equilibrium, the processes for DDHT integration will become much more standardised, and importantly, transparent. But before then and into the medium term, there is still likely to be ongoing uncertainty on what ‘the correct things to do’ are, particularly for those who are moving into the health and care setting for the first time.
This report has been developed alongside the work conducted for an Innovate UK funded ‘Datalab’ catalyst which provided guidance on the health economics and data standards for sixteen companies. Consequently, the intended audience of this report is the small and medium enterprises themselves, and those like them, who are at various stages in their own DDHT product life cycle. We present results from a series of interviews and surveys with key commissioners and transformation managers working within the NHS from both primary care and secondary care. We provide insights on the priorities for these individuals, the types of technologies coming through the system and their views on the types of evidence that is needed. We also report results from a high-level review of the international field and how health technology assessment agencies (HTAs) from key countries around the world are handling the challenges of regulating, evaluating and reimbursing DDHTs.
Based on the findings of our research, and the work conducted with the companies over a 2-year period, the report summarises some key learnings for how health economics along with regulatory support can support SMEs in the development, evaluation and potential reimbursement. As it is not possible to summarise the vast area of policy and knowledge in this rapidly developing field, the report also seeks to sign-post to relevant organisations, literature and policy that is publicly available. The report is loosely organised as follows:
• Part 1 summarises the research conducted with innovation managers and commissioners working within the NHS on their experience so far with DDHTs, the factors which influences how their priorities are being set and their views on the evidence base which they are seeing being reimbursed.
• Part 2 provides a background to health economics and what the results from Part 1 suggest for the development of a ‘value proposition’ and for the types of evidence required.
• Part 3 summarises research conducted on the international landscape for DDHTs and how health technology assessment agencies across key countries including Australia and Germany are developing their policies to assess and reimburse DDHTs.
• Part 4 provides an overview of the regulatory process within the UK for DDHTs and in a basket of comparator countries and jurisdictions including the US and EU.
