DiMe Releases New AI Implementation Playbook

By Shannon Campbell, PhD, Principal Consultant, Frank Healthcare Advisors

November 28, 2025

The Digital Medicine Society (DiMe) has released “The Playbook: Implementing AI in Healthcare”, a comprehensive, practice-oriented guide designed to help healthcare organizations adopt and scale artificial intelligence responsibly. While the Playbook is positioned primarily for health systems and digital transformation leaders, its implications for manufacturers developing AI-enabled medical devices and SaMD, particularly start-up companies, are substantial.

Built in collaboration with more than 30 partners, including Google for Health, major health systems, and leading digital-medicine organizations, the Playbook offers a structured, end-to-end framework for evaluating AI readiness, selecting appropriate technologies, and executing governance-driven deployment. But beyond health-system adoption, the document offers a transparent window into what hospitals, clinicians, and administrators expect from AI vendors…before, during, and after product launch.

Why This Matters for AI Device Manufacturers and Start-Ups

Early-stage companies often face a gap between algorithmic promise and real-world adoption. Many AI-enabled devices struggle not because of performance limitations, but because hospitals and regulators lack confidence in how the technology will be integrated, monitored, and governed over time. DiMe highlights that 70% of health-AI pilots fail due to process and workflow issues, not technology. This underscores a critical barrier for manufacturers trying to gain traction.

The Playbook directly addresses this adoption gap. It articulates the operational, governance, and safety expectations that health systems will increasingly use as a basis for selecting AI vendors. For manufacturers, this provides a clear, external benchmark against which to align product design, labeling, implementation strategy, and post-market plans.

Specifically, the Playbook will benefit AI-enabled device companies by:

Commercial & Adoption Readiness

 o Clarifying buyer expectations around transparency, data provenance, performance monitoring, and drift detection, areas that increasingly influence regulatory review as well.

 o Highlighting the importance of implementation readiness, including workflow integration, training, cybersecurity, and measurable ROI, all critical factors in payer and provider adoption.

 o Helping start-ups demonstrate maturity by aligning with a widely-endorsed, multidisciplinary standard, reducing perceived risk for early customers.

Communication & Documentation Alignment

 o Providing a shared vocabulary for discussions with hospital CIOs, CMIOs, and digital-health steering committees.

 o Offering templates and decision frameworks that manufacturers can incorporate into Instructions-for-Use development, human factors testing, post-market surveillance strategies, and PCCP documentation.

Industry Response: A Playbook that Aligns Technology, Governance, and Trust

Leaders across digital health have praised the Playbook as a needed bridge between AI innovation and safe deployment. DiMe’s CEO, Jennifer Goldsack, emphasized that without structured implementation, a generational opportunity could be wasted. Industry observers note that this framework may become a de facto expectation for vendors seeking credibility with hospital systems.

For manufacturers, and particularly start-ups, the Playbook signals a shift: technical

excellence is necessary, but not sufficient. Success will increasingly depend on whether companies can demonstrate readiness for real-world use, integration into clinical workflows, and long-term safety monitoring. DiMe’s Playbook offers a roadmap to help them get there.