Sonya Makhni MD, MBA, MS , Jose Rico MBA , Paul Cerrato MA , Brenton Hill JD, MHA , Shauna Overgaard PhD , Jeffrey Wu MPH , Justin Fairbanks MS , Rachelann Tripp MPH , Justin Redziniak DPT , Roberto Blundo MPH , Clark Otley MD , John Halamka MD, MS
{"title":"A Comprehensive Approach to Responsible AI Development and Deployment","authors":"Sonya Makhni MD, MBA, MS , Jose Rico MBA , Paul Cerrato MA , Brenton Hill JD, MHA , Shauna Overgaard PhD , Jeffrey Wu MPH , Justin Fairbanks MS , Rachelann Tripp MPH , Justin Redziniak DPT , Roberto Blundo MPH , Clark Otley MD , John Halamka MD, MS","doi":"10.1016/j.mcpdig.2025.100294","DOIUrl":null,"url":null,"abstract":"<div><div>Integrating artificial intelligence (AI) into health care offers the potential to address critical challenges related to access to care, workforce burnout, and health inequities. Despite its promise, AI adoption remains limited due to safety, efficacy, and equity concerns. This paper presents a novel and comprehensive framework for responsible AI development, evaluation, and deployment in health care, encompassing four key phases: (1) AI Solution Design and Development, (2) AI Solution Qualification, (3) AI Solution Efficacy and Safety Evaluation, and (4) AI Solution Impact. By establishing rigorous standards for operational, clinical, and technical quality, the framework aims to guide AI developers and health care professionals toward creating AI solutions that are ethical, effective, and scalable. This structured approach fosters collaboration and mitigates risks to help AI achieve its full potential in improving patient outcomes and health care efficiency.</div></div>","PeriodicalId":74127,"journal":{"name":"Mayo Clinic Proceedings. Digital health","volume":"3 4","pages":"Article 100294"},"PeriodicalIF":5.0000,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Mayo Clinic Proceedings. Digital health","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2949761225001014","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/10/10 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Integrating artificial intelligence (AI) into health care offers the potential to address critical challenges related to access to care, workforce burnout, and health inequities. Despite its promise, AI adoption remains limited due to safety, efficacy, and equity concerns. This paper presents a novel and comprehensive framework for responsible AI development, evaluation, and deployment in health care, encompassing four key phases: (1) AI Solution Design and Development, (2) AI Solution Qualification, (3) AI Solution Efficacy and Safety Evaluation, and (4) AI Solution Impact. By establishing rigorous standards for operational, clinical, and technical quality, the framework aims to guide AI developers and health care professionals toward creating AI solutions that are ethical, effective, and scalable. This structured approach fosters collaboration and mitigates risks to help AI achieve its full potential in improving patient outcomes and health care efficiency.