Legal Aspects of Automatic Equipment in Medical Laboratories
DOI:
https://doi.org/10.15575/jis.v6i3.56012Keywords:
automatic equipment, health law, medical laboratoryAbstract
The advancement of technology in medical laboratory equipment has created legal challenges due to regulatory lag. Errors arising from the use of such technology may jeopardize patient safety, given the vital role of laboratory test results in diagnostic accuracy. According to ISO 15189:2022, laboratories are required to implement a series of procedures, ranging from equipment selection to the termination of its operation, as part of quality assurance efforts. Errors within these processes may lead to equipment malfunction and trigger medical disputes. Since the equipment itself is inanimate, legal responsibility lies with the individual or legal entity managing the laboratory. This retrospective normative legal study collects primary and secondary legal materials along with their legal subjects, analyzed through qualitative descriptive methods to assess the legal dimensions in reference to the principles of justice, the legal theories of lex naturalis and lex aeterna, as well as Montesquieu’s concept of law. In principle, the comparative analysis between the legal framework and these legal concepts reveals a consistent alignment. The legal perspective on automated laboratory equipment thus reflects the underlying principles, theories, and legal concepts applied.
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