Why certification of medical software would be useful?

Area of Science:

• Health Informatics
• Medical Software Regulation
• Digital Health Quality Assurance

Background:

• Unlike human drugs and medical devices, medical software bypasses mandatory health authority approval.
• The argument against regulating medical software centers on the inherent difficulty of guaranteeing error-free code.
• The critical importance of accurate medical knowledge within software, beyond code correctness, is often overlooked.

Purpose of the Study:

• To highlight the regulatory gap for medical software.
• To address the risks associated with unverified medical software available online.
• To discuss the essential aspects of evaluating medical software quality.

Main Methods:

• Analysis of the current regulatory landscape for medical software.
• Examination of the challenges in ensuring the medical accuracy of software.
• Discussion of the implications of internet-based commercial health services.

Main Results:

• Medical software is not subject to the same rigorous approval processes as drugs or devices.
• The internet enables non-professionals to offer commercial health services, including medical software, without quality assurance.
• Both healthcare professionals and patients may encounter untested and potentially unsafe medical software online.

Conclusions:

• The lack of regulation for medical software creates significant risks for public health.
• Ensuring the quality and accuracy of medical software is paramount, especially with the rise of online services.
• Guiding users toward high-quality medical software is essential due to the difficulty of removing substandard services from the internet.