Navigating the legal and regulatory landscape for digital pathology in Malaysia.

چکیده اصلی

The transition from traditional microscopy-based diagnostic workflows to digital pathology for primary diagnosis necessitates a robust understanding of the applicable legal and regulatory frameworks. This review synthesises the multi-layered regulatory landscape governing digital pathology adoption in Malaysia. Key statutory and professional requirements are examined, including the Medical Device Act 2012 for system registration; MS ISO 15189 and STR 2.2 for laboratory accreditation and clinical validation; and the Malaysian Medical Council's 2024 Telemedicine Guideline for its implications on telepathology practice. In addition, the integration of digitised slides into formal medical records is considered under the Private Healthcare Facilities and Services Regulations 2006, alongside data privacy obligations under the Personal Data Protection Act 2010 and evidentiary admissibility requirements under the Evidence Act 1950 Malaysia. This review underscores that safe and legally compliant implementation of digital pathology requires rigorous system validation, strict data security protocols, appropriate institutional credentialing, and comprehensive audit trail maintenance.

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