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Regulatory Compliance in Healthcare: Navigating the Complex Landscape

Compliancy Group

Regulatory compliance in the healthcare industry plays a crucial role in patient safety, maintaining quality standards, and preventing fraud and abuse. There are key strategies that should be followed to achieve regulatory compliance. Something is wrong with your submission.

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RFID in Healthcare: Navigating Security & Privacy Regulations

Healthcare IT Today

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.

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Part 2: Who Regulates Healthcare AI?

AIHC

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.

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Key Legal Issues Facing Telehealth Platforms, as Compliance Concerns Bubble for Platforms Launched During the Public Health Emergency

Health Care Law Brief

How will the marketing comply with the FDA rules regarding the marketing of prescription drugs and/or professional practice rules applicable to licensees? If so, at what point during the consumer’s interaction with the platform is the data generated governed exclusively by HIPAA? Does the platform treat certain data as consumer data?

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EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill of Health

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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The Ins and Outs of Healthcare Communication Platforms

Healthcare IT Today

Additionally, the FDA requires medical device developers to include a plan in their submissions or applications for regulatory review. Once you understand this, you can focus on which regulations have to be considered, such as HIPAA and GDPR.

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