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Innovating With Trust: Regulation and Organizational Field Maturity in the Era of Emerging Health Technologies
Innovating With Trust: Regulation and Organizational Field Maturity in the Era of Emerging...
Innovating With Trust: Regulation and Organizational Field Maturity in the Era of Emerging Health Technologies

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자료유형  
 학위논문 서양
최종처리일시  
20260202105218
ISBN  
9798291565933
DDC  
614
저자명  
Hoffman-Peterson, Ariella.
서명/저자  
Innovating With Trust: Regulation and Organizational Field Maturity in the Era of Emerging Health Technologies
발행사항  
[Sl] : University of Michigan, 2025
발행사항  
Ann Arbor : ProQuest Dissertations & Theses, 2025
형태사항  
186 p
주기사항  
Source: Dissertations Abstracts International, Volume: 87-03, Section: A.
주기사항  
Advisor: Platt, Jodyn.
학위논문주기  
Thesis (Ph.D.)--University of Michigan, 2025.
초록/해제  
요약This dissertation examines how trust in emerging healthcare technologies can be built through organizational and regulatory strategies that advance maturity in technologically-driven fields. Using artificial intelligence (AI) and Precision Oncology (PO) as case studies, this research explores the relationships between governance, organizational field dynamics, regulation, and public trust through three empirical studies.Chapter 2 analyzes how health policy and governance influence trust in healthcare AI through a nationally representative survey of 1,855 adults. Results demonstrate that trust in AI is positively associated with comfort with stakeholders in AI governance (especially physicians, health administrators, and patients; b=0.36, p0.001), while concerns about fast-paced innovation predict lower trust (b=-0.10, p0.001). Perceptions of health law sufficiency and privacy policy clarity significantly moderate these relationships. For those perceiving health laws as insufficient, the positive association between stakeholder comfort and trust in AI is substantially weakened, suggesting that robust legal frameworks are important conditions for trust. Similarly, unclear institutional policies exacerbate the negative relationship between innovation concerns and trust. Demographic analysis shows that women, political independents and uninsured individuals have lower trust in AI, indicating the need for targeted trust-building initiatives. The findings demonstrate the importance of multi-level governance frameworks that drive clear policies and diverse stakeholder engagement.Chapter 3 examines how organizational field mechanisms advance maturity in the emerging field of PO through 34 semi-structured interviews across three academic medical centers (AMCs) and one precision medicine company. Analysis shows that precision medicine companies shape the boundaries of the field by using claiming, demarcating and controlling strategies to establish legitimacy. They complement the needs of established AMC and pharmaceutical companies by offering specialized capabilities, utilizing molecular tumor boards as boundary organizations that facilitate collaboration among competitors within the field. The study also highlights the isomorphic impacts that drive organizational similarities within the field, including FDA regulation, insurance policies, technological infrastructure and professional guidelines. Complementary relationships demonstrate how organizational factors such as specialization, aptitude towards innovative and network ties advance field maturity. Results indicate formalization of practices and organizational roles, suggesting that that the field is advancing from emergence to standardization.Chapter 4 investigates how FDA regulation of companion diagnostics (CDx) shapes the field of PO through 21 interviews of people who work on CDx projects across nine organizations. The study reveals complex regulatory co-creation processes where organizations and FDA regulators collaborate through formal submissions, informal communications, and advocacy coalitions to adapt regulatory frameworks. Organizations experienced structural changes to accommodate regulatory requirements, including expansion of regulatory teams, development of cross-functional mechanisms and systematic learning processes. While participants understood the regulatory benefits of operational guidance, patient safety protections, and quality improvement, they also identified limitations such as inconsistent decision-making, misalignment between regulatory frameworks and clinical implementation, and barriers to innovation through resource-intensive regulatory processes. Participants saw limited public awareness of FDA's diagnostic oversight, suggesting that regulation lacks direct trust-building capacity. However, regulatory approvals signal legitimacy to providers and insurers, potentially building trust through institutional mechanisms.Collectively, these studies demonstrate how building trust in emerging healthcare technologies requires coordinated strategies across multiple levels, combining robust national regulatory frameworks with clear institutional policies, diverse stakeholder engagement and adaptive organizational structures that demonstrate mature capabilities. This work contributes to understanding how organizational and field-level maturity can serve as pathways to trustworthiness, informing future governance and regulatory strategies for emerging healthcare technologies.
일반주제명  
Public health
일반주제명  
Oncology
일반주제명  
Public policy
키워드  
Healthcare AI
키워드  
Precision Oncology
키워드  
Regulation
키워드  
Companion diagnostics
키워드  
Emerging health technologies
기타저자  
University of Michigan Health Services Organization & Policy
기본자료저록  
Dissertations Abstracts International. 87-03A.
전자적 위치 및 접속  
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■500    ▼aSource:  Dissertations  Abstracts  International,  Volume:  87-03,  Section:  A.
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■5021  ▼aThesis  (Ph.D.)--University  of  Michigan,  2025.
■520    ▼aThis  dissertation  examines  how  trust  in  emerging  healthcare  technologies  can  be  built  through  organizational  and  regulatory  strategies  that  advance  maturity  in  technologically-driven  fields.  Using  artificial  intelligence  (AI)  and  Precision  Oncology  (PO)  as  case  studies,  this  research  explores  the  relationships  between  governance,  organizational  field  dynamics,  regulation,  and  public  trust  through  three  empirical  studies.Chapter  2  analyzes  how  health  policy  and  governance  influence  trust  in  healthcare  AI  through  a  nationally  representative  survey  of  1,855  adults.  Results  demonstrate  that  trust  in  AI  is  positively  associated  with  comfort  with  stakeholders  in  AI  governance  (especially  physicians,  health  administrators,  and  patients;  b=0.36,  p0.001),  while  concerns  about  fast-paced  innovation  predict  lower  trust  (b=-0.10,  p0.001).  Perceptions  of  health  law  sufficiency  and  privacy  policy  clarity  significantly  moderate  these  relationships.  For  those  perceiving  health  laws  as  insufficient,  the  positive  association  between  stakeholder  comfort  and  trust  in  AI  is  substantially  weakened,  suggesting  that  robust  legal  frameworks  are  important  conditions  for  trust.  Similarly,  unclear  institutional  policies  exacerbate  the  negative  relationship  between  innovation  concerns  and  trust.  Demographic  analysis  shows  that  women,  political  independents  and  uninsured  individuals  have  lower  trust  in  AI,  indicating  the  need  for  targeted  trust-building  initiatives.  The  findings  demonstrate  the  importance  of  multi-level  governance  frameworks  that  drive  clear  policies  and  diverse  stakeholder  engagement.Chapter  3  examines  how  organizational  field  mechanisms  advance  maturity  in  the  emerging  field  of  PO  through  34  semi-structured  interviews  across  three  academic  medical  centers  (AMCs)  and  one  precision  medicine  company.  Analysis  shows  that  precision  medicine  companies  shape  the  boundaries  of  the  field  by  using  claiming,  demarcating  and  controlling  strategies  to  establish  legitimacy.  They  complement  the  needs  of  established  AMC  and  pharmaceutical  companies  by  offering  specialized  capabilities,  utilizing  molecular  tumor  boards  as  boundary  organizations  that  facilitate  collaboration  among  competitors  within  the  field.  The  study  also  highlights  the  isomorphic  impacts  that  drive  organizational  similarities  within  the  field,  including  FDA  regulation,  insurance  policies,  technological  infrastructure  and  professional  guidelines.  Complementary  relationships  demonstrate  how  organizational  factors  such  as  specialization,  aptitude  towards  innovative  and  network  ties  advance  field  maturity.  Results  indicate  formalization  of  practices  and  organizational  roles,  suggesting  that  that  the  field  is  advancing  from  emergence  to  standardization.Chapter  4  investigates  how  FDA  regulation  of  companion  diagnostics  (CDx)  shapes  the  field  of  PO  through  21  interviews  of  people  who  work  on  CDx  projects  across  nine  organizations.  The  study  reveals  complex  regulatory  co-creation  processes  where  organizations  and  FDA  regulators  collaborate  through  formal  submissions,  informal  communications,  and  advocacy  coalitions  to  adapt  regulatory  frameworks.  Organizations  experienced  structural  changes  to  accommodate  regulatory  requirements,  including  expansion  of  regulatory  teams,  development  of  cross-functional  mechanisms  and  systematic  learning  processes.  While  participants  understood  the  regulatory  benefits  of  operational  guidance,  patient  safety  protections,  and  quality  improvement,  they  also  identified  limitations  such  as  inconsistent  decision-making,  misalignment  between  regulatory  frameworks  and  clinical  implementation,  and  barriers  to  innovation  through  resource-intensive  regulatory  processes.  Participants  saw  limited  public  awareness  of  FDA's  diagnostic  oversight,  suggesting  that  regulation  lacks  direct  trust-building  capacity.  However,  regulatory  approvals  signal  legitimacy  to  providers  and  insurers,  potentially  building  trust  through  institutional  mechanisms.Collectively,  these  studies  demonstrate  how  building  trust  in  emerging  healthcare  technologies  requires  coordinated  strategies  across  multiple  levels,  combining  robust  national  regulatory  frameworks  with  clear  institutional  policies,  diverse  stakeholder  engagement  and  adaptive  organizational  structures  that  demonstrate  mature  capabilities.  This  work  contributes  to  understanding  how  organizational  and  field-level  maturity  can  serve  as  pathways  to  trustworthiness,  informing  future  governance  and  regulatory  strategies  for  emerging  healthcare  technologies.
■590    ▼aSchool  code:  0127.
■650  4▼aPublic  health
■650  4▼aOncology
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■653    ▼aHealthcare  AI
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■792    ▼a2025
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■85640▼uhttp://www.riss.kr/pdu/ddodLink.do?id=T17359808▼nKERIS▼z이  자료의  원문은  한국교육학술정보원에서  제공합니다.

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