Target product profiles for digital health technologies including those with artificial intelligence: a systematic review.

Journal: Frontiers in health services
Published Date: May 20, 2025

Abstract

Digital health technologies (DHTs), including those incorporating artificial intelligence (AI), have the potential to improve healthcare access, efficiency, and quality, reducing gaps between healthcare capacity and demand. Despite prioritisation in health policy, the adoption of DHTs remains limited, especially for AI, in part due to complex system requirements. Target product profiles (TPPs) are documents outlining the characteristics necessary for medical technologies to be utilised in practice and offer a way to align DHTs' research and development with health systems' needs. This systematic review examines current DHT TPPs' methodologies, stakeholders, and contents. A total of 14 TPPs were identified, most targeted at low- and middle-income settings and communicable diseases. Only one TPP outlined the requirements for an AI device specifically. In total, 248 different characteristics were reported across the TPPs identified and were consolidated down to 33 key characteristics. Some considerations for DHTs' successful adoption, such as regulatory requirements or environmental sustainability, were reported inconsistently or not at all. There was little standardisation in TPP development or contents, and limited transparency in reporting. Our findings emphasise the need for guidelines for TPP development, could help inform these, and could be used as a basis to develop future DHT TPPs. : https://www.researchprotocols.org/2024/1/e50568/authors.

Authors

  • Trystan B Macdonald
    University Hospitals Birmingham NHSFT, Birmingham, United Kingdom.
  • H D Jeffry Hogg
    University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.
  • Jacqueline Dinnes
    Test Evaluation Research Group, Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, UK. j.dinnes@bham.ac.uk.
  • Lucy Verrinder
    Lion Health, Stourbridge, United Kingdom.
  • Gregory Maniatopoulos
    Population Health Science Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.
  • Sian Taylor-Phillips
    Division of Health Sciences, University of Warwick, Coventry, UK S.Taylor-Phillips@warwick.ac.uk.
  • Bethany Shinkins
    University of Leeds, Leeds, UK.
  • J Kevin Dunbar
    Regional Head of Screening Quality Assurance Service (SQAS) - South, NHS England, England, UK.
  • Ameenat Lola Solebo
    Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom.
  • Hannah Sutton
    Independent Researcher, Oxford, United Kingdom.
  • John Attwood
    Alder Hey Children's Hospital, Liverpool, United Kingdom.
  • Michael Pogose
    Hardian Health, Bolton, United Kingdom.
  • Rosalind Given-Wilson
    St George's University Hospitals NHS Foundation Trust, London, UK.
  • Felix Greaves
    Imperial College London, London, UK.
  • Carl Macrae
    Nottingham University Business School, Centre for Health Innovation, Leadership and Learning, University of Nottingham, Nottingham NG7 2RD, UK carlmacrae@mac.com.
  • Russell Pearson
    Medicines and Healthcare Products Regulatory Agency, London, UK.
  • Adnan Tufail
    London, United Kingdom. Electronic address: Adnan.Tufail@moorfields.nhs.uk.
  • Xiaoxuan Liu
    Birmingham Health Partners Centre for Regulatory Science and Innovation University of Birmingham Birmingham Reino Unido Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, Reino Unido.
  • Alastair K Denniston
    Centre for Patient Reported Outcomes Research Institute of Applied Health Research University of Birmingham Birmingham Reino Unido Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, Reino Unido.

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