Clinical decision support systems: A discussion of quality, safety and legal liability issues

Introduction

The paper examines safety and quality practices currently in use and proposes various options to deal with legal exposure associated with Clinical Decision Support Systems CDSSs.

Quality and safety engineering

Quality and safety standards such as ISO 9000 and IEC 61508 are being widely adopted in software engineering to achieve best practices in designing and development of systems . However, medical software is a complex technology and current standards are unable to assure safety.

Risk and liability assessment

Legal liability of the provider of CDSSs is currently unclear but even in absence of case law in legal view they will have duty of care towards patients and clinical professionals. Suppliers depend on disclaimer and insurance for legal and financial protection.

Quality and safety protocol

The authors propose the use of flexible framework for quality and safety of CDSS application rather than a “one size fits all” approach. They suggest that Hazards and Operability Analysis (HAZOP) can be used to assess the risk levels. The quality of CDSSs will need to be assessed in two parts: the technology used and the knowledge content within the CDSSs.

Safety management

With unusual circumstances and lack of resources, a well-developed and functioning CDSS can give inappropriate clinical suggestion. Thus such avoidable hazards should be assessed and their management should be implemented during the safety consideration phase.

• Safety by design: Author suggests use both of “safety life cycle” and “usual quality life cycle”.
• Operational safety: Can be achieved by limiting access, audit trails (Black box function) and guardian function.
• The safety case: Documentation of HAZOP related analysis, method, scope and safety related design decisions should be made available to all users.
• Safety culture: This need to be developed so all staff is committed to safety and understand their actions and decisions will affect the patient.

Conclusion

This paper provides various options for management of quality and safety of CDSSs to enable its providers to demonstrate their duty of care.

Comments

CDSS is widely getting accepted in the clinical field as a tool to improve safety and quality of patient care. Unfortunately, the CDSS itself, its use, the surrounding circumstances, and the user all may lead to possible harm sometimes. There has been no clear legal guidelines established as to the liability issues that may arise in future. This paper examines such issues and suggest various way the safety of CDSS can be enhanced as well as legal liability issues can be dealt with.