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  • Des Conroy, Gianluca Fontana & Saira Ghafur

Reaching a global consensus on evidence for digital health

A new white paper by Roche Information Solutions and Prova Health offers solutions on how to improve evidence standards and reimbursement pathways in digital health.


Navigating evidence generation and reimbursement pathways in digital health

Prova Health collaborated with Roche Information Solutions on an ambitious effort to progress the global conversation on evidence for digital health. The majority of top digital health solutions have little to no evidence supporting them.¹ This needs to change if digital health is to truly fulfil its potential.


To chart a path forward, we convened 20 top global digital health experts to form a consensus on how evidence generation for digital health should change, resulting in the white paper “Generating evidence for digital health solutions”.


The report is based on a robust research process, including a review of the relevant literature, individual interviews with experts, three roundtables (focused on the US, UK and EU markets respectively) and a survey of 144 healthcare leaders.


We are proud of the effort that went into this project as it has provided a strong understanding of the viewpoints of global experts, and greater consensus on the future of evidence generation in digital health. Ultimately however, this is just a starting point. Innovation in evidence generation is necessary for truly robust digital solutions that deliver value to patients, clinicians and health systems.


Discussion

Key recommendations from the white paper²

  • Innovators should work together with policymakers, regulators, clinicians and payors to ensure that the type and level of evidence expected at key stages are robust, realistic and reasonable for the particular solution and the relative risk posed to patients. At industry level, specific types of digital innovations should be better defined, as well as the types of evidence required in each category.

  • Innovators need to understand how to match appropriate evidence generation methods to the current stage of development, how to iterate rapidly in the early stages and make adaptations before moving forward with a more defined product, requiring more rigorous assessment.

  • Evidence requirements should be formalised and communicated clearly by policymakers, regulatory bodies and payors. These stakeholders should engage constructively with innovators to support the development of safe and effective solutions.

  • Innovators should be aware of other benefits of evidence generation, which includes accelerating product development.

  • Greater awareness among healthcare professionals about digital solutions, including therapeutics, is necessary to enable increased prescription of these tools. Professional bodies and medical societies are well positioned to play a key role in providing healthcare professionals with this education and guidance.

  • Public and regulatory bodies should formally establish the use of real-world evidence (RWE) in their decision-making processes and provide clear guidance to developers on how RWE can be used to support these decisions.

  • Health systems should aim to establish clear pathways to reimbursement at national scale for digital health solutions through frameworks similar to Germany’s Fast Track pathway. These should be accompanied with clear guidelines for innovators on what evidence is required for inclusion.

  • Payors must clearly communicate the type of evidence that they expect for approving the reimbursement of different types of digital health solutions.

To read all of the findings and recommendations, download the white paper.


Prova Health supports digital health innovators with evidence generation. To discuss how we can help with evidence generation for your digital solutions, email hello@provahealth.com


Dr Des Conroy is a Digital Health Consultant at Prova Health. He is a medical doctor who has worked in clinical practice in the UK and Ireland. He has experience developing and clinically validating artificial intelligence-based Software as a Medical Device (SaMD) products and supporting their deployment on a global scale. At Prova Health, he has led research into evolving evidence standards and reimbursement models in digital health.


Gianluca Fontana is Co-founder and Chief Executive Officer of Prova Health. He has overseen the delivery of high-profile research, education and consulting projects, including the NHS Digital Academy, the REACT Covid-19 prevalence study, the World Innovation Summit for Health and the Centre for Health Policy of Imperial College London. He started his career as a management consultant at McKinsey & Company.


Dr Saira Ghafur is Co-founder and Chief Medical Officer of Prova Health. She is an honorary consultant Respiratory Physician at St Mary’s Hospital, London, and a digital health expert who has published on topics such as cybersecurity, digital health adoption and reimbursement, data privacy and commercialising health data. She is Co-founder of mental health start-up Psyma and holds a MSc in Health Policy from Imperial. She was a Harkness Fellow in Health Policy and Practice in New York (2017).

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