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

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 limite...

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Main Authors: Trystan B. Macdonald, H. D. Jeffry Hogg, Jacqueline Dinnes, Lucy Verrinder, Gregory Maniatopoulos, Sian Taylor-Phillips, Bethany Shinkins, J. Kevin Dunbar, Ameenat Lola Solebo, Hannah Sutton, John Attwood, Michael Pogose, Rosalind Given-Wilson, Felix Greaves, Carl Macrae, Russell Pearson, Adnan Tufail, Xiaoxuan Liu, Alastair K. Denniston
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-05-01
Series:Frontiers in Health Services
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Online Access:https://www.frontiersin.org/articles/10.3389/frhs.2025.1537016/full
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author Trystan B. Macdonald
Trystan B. Macdonald
Trystan B. Macdonald
H. D. Jeffry Hogg
H. D. Jeffry Hogg
Jacqueline Dinnes
Jacqueline Dinnes
Lucy Verrinder
Gregory Maniatopoulos
Sian Taylor-Phillips
Bethany Shinkins
J. Kevin Dunbar
Ameenat Lola Solebo
Ameenat Lola Solebo
Hannah Sutton
John Attwood
Michael Pogose
Rosalind Given-Wilson
Felix Greaves
Felix Greaves
Carl Macrae
Carl Macrae
Russell Pearson
Adnan Tufail
Adnan Tufail
Xiaoxuan Liu
Xiaoxuan Liu
Xiaoxuan Liu
Alastair K. Denniston
Alastair K. Denniston
Alastair K. Denniston
Alastair K. Denniston
author_facet Trystan B. Macdonald
Trystan B. Macdonald
Trystan B. Macdonald
H. D. Jeffry Hogg
H. D. Jeffry Hogg
Jacqueline Dinnes
Jacqueline Dinnes
Lucy Verrinder
Gregory Maniatopoulos
Sian Taylor-Phillips
Bethany Shinkins
J. Kevin Dunbar
Ameenat Lola Solebo
Ameenat Lola Solebo
Hannah Sutton
John Attwood
Michael Pogose
Rosalind Given-Wilson
Felix Greaves
Felix Greaves
Carl Macrae
Carl Macrae
Russell Pearson
Adnan Tufail
Adnan Tufail
Xiaoxuan Liu
Xiaoxuan Liu
Xiaoxuan Liu
Alastair K. Denniston
Alastair K. Denniston
Alastair K. Denniston
Alastair K. Denniston
author_sort Trystan B. Macdonald
collection DOAJ
description 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.Systematic Review Registration: https://www.researchprotocols.org/2024/1/e50568/authors.
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spelling doaj-art-053c34db2f2f443c8b61362b68c43d642025-08-20T03:47:40ZengFrontiers Media S.A.Frontiers in Health Services2813-01462025-05-01510.3389/frhs.2025.15370161537016Target product profiles for digital health technologies including those with artificial intelligence: a systematic reviewTrystan B. Macdonald0Trystan B. Macdonald1Trystan B. Macdonald2H. D. Jeffry Hogg3H. D. Jeffry Hogg4Jacqueline Dinnes5Jacqueline Dinnes6Lucy Verrinder7Gregory Maniatopoulos8Sian Taylor-Phillips9Bethany Shinkins10J. Kevin Dunbar11Ameenat Lola Solebo12Ameenat Lola Solebo13Hannah Sutton14John Attwood15Michael Pogose16Rosalind Given-Wilson17Felix Greaves18Felix Greaves19Carl Macrae20Carl Macrae21Russell Pearson22Adnan Tufail23Adnan Tufail24Xiaoxuan Liu25Xiaoxuan Liu26Xiaoxuan Liu27Alastair K. Denniston28Alastair K. Denniston29Alastair K. Denniston30Alastair K. Denniston31University Hospitals Birmingham NHSFT, Birmingham, United KingdomAcademic Unit of Ophthalmology, Institute of Inflammation and Aging, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United KingdomNIHR Birmingham Biomedical Research Centre, Birmingham, United KingdomUniversity Hospitals Birmingham NHSFT, Birmingham, United KingdomDepartment of Applied Health Research, School of Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, United KingdomNIHR Birmingham Biomedical Research Centre, Birmingham, United KingdomBiostatistics, Evidence Synthesis and Test Evaluation and Modelling, Institute of Applied Health Sciences, University of Birmingham, Birmingham, United KingdomLion Health, Stourbridge, United KingdomThe University of Leicester, Leicester, United KingdomWarwick Screening, Warwick Medical School, University of Warwick, Coventry, United KingdomWarwick Applied Health, University of Warwick, Coventry, United Kingdom0Vaccination and Screening Directorate, NHS England, London, United Kingdom1Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom2Population Policy and Practice, UCL Great Ormond Street Institute of Child Health, London, United Kingdom3Independent Researcher, Oxford, United Kingdom4Alder Hey Children’s Hospital, Liverpool, United Kingdom5Hardian Health, London, United Kingdom6St. George’s University Hospitals NHSFT, London, United Kingdom7Digital Policy Unit, Department of Health and Social Care, London, United Kingdom8Faculty of Medicine, School of Public Health, Imperial College London, London, United Kingdom9Nottingham University Business School, University of Nottingham, Nottingham, United Kingdom0Care Quality Commission, London, United Kingdom1Medicines and Healthcare Products Regulatory Agency, London, United Kingdom1Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom2Institute of Ophthalmology, University College London, London, United KingdomNIHR Birmingham Biomedical Research Centre, Birmingham, United Kingdom3College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom4Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, United KingdomUniversity Hospitals Birmingham NHSFT, Birmingham, United KingdomAcademic Unit of Ophthalmology, Institute of Inflammation and Aging, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United KingdomNIHR Birmingham Biomedical Research Centre, Birmingham, United Kingdom5NIHR Biomedical Research Centre at Moorfields and UCL Institute of Ophthalmology, London, United KingdomDigital 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.Systematic Review Registration: https://www.researchprotocols.org/2024/1/e50568/authors.https://www.frontiersin.org/articles/10.3389/frhs.2025.1537016/fulltarget product profileTPPquality by designdigital health technologyAI
spellingShingle Trystan B. Macdonald
Trystan B. Macdonald
Trystan B. Macdonald
H. D. Jeffry Hogg
H. D. Jeffry Hogg
Jacqueline Dinnes
Jacqueline Dinnes
Lucy Verrinder
Gregory Maniatopoulos
Sian Taylor-Phillips
Bethany Shinkins
J. Kevin Dunbar
Ameenat Lola Solebo
Ameenat Lola Solebo
Hannah Sutton
John Attwood
Michael Pogose
Rosalind Given-Wilson
Felix Greaves
Felix Greaves
Carl Macrae
Carl Macrae
Russell Pearson
Adnan Tufail
Adnan Tufail
Xiaoxuan Liu
Xiaoxuan Liu
Xiaoxuan Liu
Alastair K. Denniston
Alastair K. Denniston
Alastair K. Denniston
Alastair K. Denniston
Target product profiles for digital health technologies including those with artificial intelligence: a systematic review
Frontiers in Health Services
target product profile
TPP
quality by design
digital health technology
AI
title Target product profiles for digital health technologies including those with artificial intelligence: a systematic review
title_full Target product profiles for digital health technologies including those with artificial intelligence: a systematic review
title_fullStr Target product profiles for digital health technologies including those with artificial intelligence: a systematic review
title_full_unstemmed Target product profiles for digital health technologies including those with artificial intelligence: a systematic review
title_short Target product profiles for digital health technologies including those with artificial intelligence: a systematic review
title_sort target product profiles for digital health technologies including those with artificial intelligence a systematic review
topic target product profile
TPP
quality by design
digital health technology
AI
url https://www.frontiersin.org/articles/10.3389/frhs.2025.1537016/full
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