Healthcare IT Today
AUGUST 21, 2023
FDA’s Drug Supply Chain Security Act (DSCSA). Health Insurance Portability and Accountability Act (HIPAA) is another significant regulation that can impact RFID in healthcare applications.
AIHC
JUNE 14, 2023
Artificial Intelligence & Regulatory Compliance Written by Joanne Byron , BS, LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, COCAS, CORCM, OHCC, ICDCT-CM/PCS This article follows Part 1 - Basics of Artificial Intelligence (AI) and Healthcare Compliance published by AIHC on June 6, 2023.
Bill of Health
APRIL 4, 2024
Although the cross-sectoral AI legislation that is now introduced by the European Commission’s Digital Strategy aims to be integrated with existing sectoral legislation such as the MDR, the IVDR and the Machinery Directive, it is uncertain how overlapping regulatory compliance requirements for AI-driven medical devices will be managed in practice.
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