HIT Consultant

FEBRUARY 1, 2024

The challenges of pharma influencing also present avenues for influencers to bridge the communication gap between brands and consumers. According to the FDA’s website , here are some regulations: Ads must be truthful. Must accurately communicate both the benefits and risks of medications.

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Exeed Regulatory Compliance

MARCH 22, 2020

Timely MDR reporting is a challenging regulatory requirement for the industry. A new FDA guidance provides much-needed relief during a pandemic. Adverse event reporting requirements are very stringent, and late reporting of such events is a routine focus of FDA inspections and subsequent warning letters.

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Health Care Law Brief

JUNE 2, 2022

In addition, the PHE fueled a boom in the number of direct-to-consumer (“DTC”) telehealth platforms, many of which have relied upon COVID-19 regulatory waivers to launch and operate in multiple states across the nation. Variety of Risks Present in Telehealth Arrangements. Concerns Proliferate for Telehealth Platforms.

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Public Health Compliance COVID-19 Licensing 52

Dot Compliance

JANUARY 4, 2022

Remote patient monitoring (RPM) presents unique challenges to device quality and safety, such as secure wireless data transmission and integration with healthcare IT networks and systems (e.g., The post 2022 Life Sciences Technology Predictions appeared first on Dot Compliance.

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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.

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Exeed Regulatory Compliance

MARCH 9, 2020

Here is an update on recent FDA activities. Cybersecurity of medical devices is on FDA’s radar! Just last week, the FDA issued a safety communication about the recently identified SweynTooth family of cybersecurity vulnerabilities which may affect medical devices. Please click on the video link below.

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Dot Compliance

SEPTEMBER 11, 2022

The United States Food and Drug Administration (FDA) has the authority to enforce compliance with the Code of Federal Regulations , which has significant consequences if disregarded. Considering ISO 9001:2015 certifications makes sense for pharmaceutical managers given the requirement for compliance, quality, and safety.

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