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Background: In recognition of the limitations of technology-led standards for practitioner implementation of electronic care records, the Professional Record Standards Body for health and social care (PRSB) was established in the UK in 2013. The remit of PRSB is to develop and assure standards for the content and structure of records across all care sectors, based upon professionally-led and patient-guided requirements as endorsed by the professional bodies of the constituent health and social care disciplines. This new initiative is a very different approach from previous national information projects and faces challenges including organizational culture, operational procurement requirements and the logistics of collaborative design. Objective: This paper describes the progress of PRSB and the practical issues it faces to achieve deep stakeholder engagement and widespread adoption of its standards and guidance. The goal is to offer a sustainable approach that builds on the strengths of work to date, learns from past experience of what works and what fails, and draws upon theoretical models of transformational change. Methods: We conceptualize the PRSB strategy in terms of organizational change frameworks, evaluate it against models of success factors in health information technology and employ Normalization Process Theory (NPT) to articulate the activity stages required for realization of its goals. Results: We present an NPT model of how PRSB standards can become embedded in routine practice for care practitioners, patients/citizens, government agencies and information technology providers. We suggest some critical success factors for cultural change, moving the supplier market and sustaining a genuine co-design approach. Conclusions: It is abundantly clear that interoperability involves far more than just technology. Improving information sharing between care practitioners and with patients and citizens requires the innovative professionally-led and patient-guided approach that PRSB has pioneered. It is necessary to formally evaluate the impacts of implementation, both to build a compelling evidence base and to generate a virtuous cycle of iterative maintenance and general adoption.

A New Approach to Interoperable Information Standards for Health and Social Care: Normalizing Culture, Contracts and Co-design