USのヘルスITの取り組み(9) 品質マネジメントの原則の利用促進

5.1 Promote the Use of Quality Management Principles
5.1 品質管理の原則の利用促進

Quality management principles and processes, as part of a quality system, have been adopted and implemented by more than 1 million companies and organizations worldwide to improve quality, efficiency, safety and reliability.

The selective adoption and application of existing quality management principles and processes to health IT has been advocated by the IOM, the FDASIA Workgroup, and numerous health IT stakeholders including developers, implementers and users.

ヘルスITの対する既存の品質管理の原則及びプロセスの選択的採用は、開発者、実装者、およびユーザを含む、IOM、FDASIA Workgroup、および多数のヘルスITのステークホルダによって支持された。

Some, but not all, health IT developers and healthcare facilities already adopt quality management principles.


A number of different approaches to quality management exist;

however, they share certain common, underlying principles.

Quality management principles help to identify, prevent, track, and monitor safety hazards and to reduce risks.

They can be applied throughout the product lifecycle to design and development activities, to implementation, customization, integration, upgrades, maintenance, and operations, as well as to surveillance, reporting, risk mitigation and remediation.


Importantly, quality management principles are flexible, scalable and adaptable so organizations (e.g. health IT developers, healthcare facilities, etc.) can tailor the application of these standardized processes to their individual circumstances and needs.

Ultimately, quality management principles and processes provide a quality framework for companies and organizations to ensure that their products and services consistently meet their customers’ needs and requirements, that risk management principles are applied to identify, evaluate, mitigate and remediate hazards, and that overall quality is continually improved.


The judicious application of quality management principles and processes by health IT stakeholders can promote the safe design, development, implementation, customization, integration, and use of health IT while fostering an environment that promotes innovation and continual improvement.

However, because health IT represents a broad spectrum of products and services, health IT developers and organizations must have flexibility to determine the necessity of individual quality elements and to tailor the development and implementation of quality management processes appropriate for their products and services.

As part of the 2014 Edition Standards and Certification Criteria final rule, ONC adopted two safety-related certification criteria for EHRs:
2014年版の標準と証明評価基準最終規則の一部として、ONCは EHRの2つの安全関連の評価基準を採用した。

one that focuses on the application of user-centered design to medication- related certification criteria and another that focuses on the quality management system (QMS) used during the EHR technology design.

一つは評価基準に関連して医薬品のための人間中心設計の適用に焦点を当てたもので、もう一つはEHR(Electronic Health Record)の技術的設計で使用されるQMS(品質管理システム)に焦点を当てたものである。

In general, the Agencies believe that additional value to health IT purchasers and users could be realized if greater transparency existed around the quality management principles that were applied in the design and development, customization and implementation, and post-deployment use of health IT.

Summary and Conclusion:

The application of quality management principles, including a quality systems approach by health IT stakeholders, is necessary for the safe design, development, implementation, customization, and use of health IT.

The Agencies will work with health IT stakeholders to identify the essential elements of a health IT quality framework, leveraging existing quality management principles and identifying areas where quality management principles can or should be applied.

The Agencies view this strategy, rather than a formal regulatory approach, as the appropriate method for advancing a health IT quality framework.

The Agencies seek input on the following questions related to promoting the use of quality management principles in health IT:

+What essential quality management principles should apply to health IT?
+ どんな不可欠の品質マネジメントの原則がヘルスITに適用されるべきか?

How should they apply to different stakeholders and at different stages of the health IT product lifecycle?

+How do we assure stakeholder accountability for adoption of quality management principles?
+ どのように、品質マネジメントの原則の採用によって、利害関係者の説明責任を明かにするのか

Is there a role for a non-governmental, independent program to assess stakeholder adherence to quality management principles?

Is there a role for government?