The rapid rise of healthcare chatbots, valued at $787.1 million in 2022 and projected to grow at 23.9% annually through 2030, underscores the need for robust evaluation frameworks. Despite their potential, the absence of standardized evaluation criteria and rapid AI advancements complicate assessments. This study addresses these challenges by developing a the first comprehensive evaluation framework inspired by health app regulations and integrating insights from diverse stakeholders. Following PRISMA guidelines, we reviewed 11 existing frameworks, refining 271 questions into a structured framework encompassing three priority constructs, 18 second-level constructs, and 60 third-level constructs. Our framework emphasizes safety, privacy, trustworthiness, and usefulness, aligning with recent concerns about AI in healthcare. This adaptable framework aims to serve as the initial step in facilitating the responsible integration of chatbots into healthcare settings.

JT reports grants from Otsuka and is an advisor to Precision Mental Wellness, outside of the submitted work. DWB reports grants and personal fees from EarlySense, personal fees from CDI Negev, equity from ValeraHealth, equity from Clew, equity from MDClone, personal fees and equity from AESOP, personal fees and equity from Feelbetter, equity from Guided Clinical Solutions, and grants from IBM Watson Health, outside the submitted work. He has a patent pending (PHC-028564 US PCT), on intraoperative clinical decision support. BWN reports employment and equity ownership in Verily Life Sciences. JS is employed by Microsoft Research. All other authors declare no competing interests.

This study did not receive any funding.

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