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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Frontiers Media S.A.
2025-05-01
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| 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. |
| format | Article |
| id | doaj-art-053c34db2f2f443c8b61362b68c43d64 |
| institution | Kabale University |
| issn | 2813-0146 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Health Services |
| 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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