CPIA Module 19: Introduction to Governance, Policy & Ethics
CPIA Certification Program

Module 19: Governance, Policy & Ethics

Architecting the Rules of the Road for Clinical Systems.

From Practitioner to Policymaker

As a pharmacist, your entire professional identity is built upon a foundation of rules. You operate within a complex framework of federal and state laws, Board of Pharmacy regulations, institutional policies, and a deep-seated code of ethics. You are an expert at interpreting and applying these rules to ensure every action you take is safe, legal, and in the best interest of the patient. You don’t just follow the P&P manual—you understand why it exists.

This module transitions your role from a follower of rules to an architect of them. A clinical information system without strong governance is the digital equivalent of an unregulated pharmacy—a chaotic “Wild West” where inconsistent practices, unilateral decisions, and unmanaged risks lead to inefficiency and patient harm. Governance is the act of building the formal structures, policies, and ethical frameworks that ensure a system is managed with transparency, accountability, and a steadfast focus on the organization’s strategic and clinical goals.

Here, you will learn to move beyond system build and into system strategy. We will cover how to establish the committees that oversee change, how to write the policies that standardize best practices, and how to navigate the complex ethical and legal landscape of patient data. Mastering governance is the final step in the evolution from a skilled informatics practitioner to a true strategic leader, responsible not just for implementing technology, but for ensuring its long-term integrity, safety, and value.

Your Guide to System Leadership

This module provides the framework for establishing the structures that ensure clinical information systems are managed safely, ethically, and effectively for the long term.

Informatics Governance Structures and Committees

Learn how to build the decision-making bodies that guide system strategy. We’ll deconstruct the roles of steering committees, clinical advisory groups, and change control boards that ensure transparent and multi-disciplinary oversight.

Policy Development and Standardization

Translate clinical best practices into enforceable system policies. This section covers the lifecycle of a policy—from drafting and approval to implementation and maintenance—to ensure consistent use of informatics tools across the enterprise.

Data Stewardship and Ethical Frameworks

Move beyond technical data management to true stewardship. We’ll explore the ethical obligations of handling patient data, including secondary use for research and quality improvement, and how to build frameworks that prioritize patient trust.

Legal Compliance and Audit Readiness

A deep dive into the legal landscape of health IT. This section covers key regulations like HIPAA and the 21st Century Cures Act, and how to prepare your systems for the intense scrutiny of audits from The Joint Commission or CMS.

Case Study – Governance Failure Analysis

Learn from the mistakes of others. We will perform a root cause analysis on a real-world case of informatics governance failure, dissecting how a lack of oversight led to patient harm and what structures could have prevented it.