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Development of a target product profile for artificial intelligence in diabetic eye screening in England: a modified
Trystan B Macdonald1, Jacqueline Dinnes2, Gregory Maniatopoulos3
1University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; College of Medicine and Health, University of Birmingham, Birmingham, UK; National Institute for Health and Care Research Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, UK.
The Lancet. Digital Health
|July 8, 2026
Summary
Developing artificial intelligence (AI) for diabetic eye screening (DES) in England requires a clear Target Product Profile (TPP). This TPP ensures AI health technologies meet complex healthcare system needs for successful adoption.
Area of Science:
- Health Informatics
- Artificial Intelligence in Healthcare
- Ophthalmology
Background:
- Healthcare systems face increasing demand, necessitating innovative solutions like AI.
- Adoption of AI health technologies is hindered by complex system requirements.
- Diabetic eye screening (DES) in England highlights challenges in implementing AI.
Purpose of the Study:
- To develop a Target Product Profile (TPP) for an AI system for diabetic eye screening (DES) in England.
- To define the specific requirements of the English healthcare system for DES AI adoption.
- To provide a template for TPP development for other AI health technologies.
Main Methods:
- A modified Delphi consensus process was employed.
- Methods included interviews, surveys, and a consensus meeting.
- Participants represented diverse stakeholders: patients, clinicians, managers, policymakers, and developers.
Main Results:
- Thirty-five product specifications were agreed upon for the DES AI TPP.
- Specifications covered clinical validity, utility, and environmental sustainability.
- The TPP provides clear criteria for DES AI development and deployment in England.
Conclusions:
- The developed TPP offers a clear framework for DES AI in England.
- The TPP development process can be replicated for other AI healthcare initiatives.
- Establishing clear criteria is crucial for successful AI health technology implementation.