Are Regulations Safe? Reflections From Developing a Digital Cancer Decision-Support Tool.

Area of Science:

• Health Informatics
• Medical Device Regulation
• Patient Safety

Background:

• Informatics solutions for early cancer diagnosis are growing in primary care.
• Existing standards and regulations may not sufficiently address patient safety or be fit for purpose.

Purpose of the Study:

• To evaluate the adequacy of current regulations for patient safety in cancer informatics tools.
• To reflect on the development of a computerized cancer risk assessment tool within a UK primary care electronic health record system.

Main Methods:

• Developed a computerized cancer risk assessment tool compliant with European Union Medical Device Regulations.
• Identified patient safety concerns and proposed nine practical recommendations.

Main Results:

• Medical device regulations were primarily designed for hardware, not software.
• Regulations favor one-shot approval over iterative development and are biased toward known hazards.
• Nine recommendations emphasize stronger system perspectives for regulations and standards.

Conclusions:

• European Union regulations inadequately address the complexities of healthcare information systems and patient safety.
• Future standards and regulations must adopt a system-based approach for risk, safety, and accident avoidance in health informatics.