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.

FDA 45

FDA HIPAA Compliance Regulatory Compliance 45

Healthcare IT Today

AUGUST 21, 2023

Industry Guidelines and Regulations Governing RFID Use in Healthcare Organizations such as the UnitVisID Alliance and GS1 Healthcare have established guidelines defining an industry-wide performance and data-handling specification for RFID-tagged products as they move through the supply chain with security and patient safety in mind.

HIPAA 94

HIPAA Regulatory Compliance Hospitals FDA 94

Dot Compliance

JANUARY 14, 2022

Common risk areas often include (but aren’t limited to): Cybersecurity Audit management Government pricing General data protection regulation. FDA’s Safer Technologies Program (SteP) for Medical Devices. For companies in the life sciences sector, risk refers to the probability of harm occurring and its potential severity.

Compliance 52

Compliance FDA Regulatory Compliance Governance 52

Healthcare IT Today

NOVEMBER 8, 2023

Besides the assessment of existing systems, an organization needs to consider the following when settling on the choice of a communication platform: Understand workflow-based needs, Identify redundancies, and understand ease of user training & adoption, scalability, security and compliance needs, and interoperability of data.

HIPAA 73

HIPAA Compliance Regulatory Compliance Public Health 73

Exeed Regulatory Compliance

MARCH 21, 2020

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA. There is one piece of good news that the FDA has very rapidly approved several tests in the last 2 weeks under the Emergency Use Authorization and more are expected to follow. What’s the secret to its success?

FDA 52

FDA Governance 52

SQA

OCTOBER 18, 2022

List Health Advance as an “Official Canadian Distributor” Include the text “Health Canada Approved” (Claims of endorsement by government authorities, such as Health Canada, are not permitted.). The entire shipment, which contained 435 boxes of the 25-pack, was sent to Health Canada for compliance follow-up.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

Exeed Regulatory Compliance

MARCH 5, 2020

FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

Health Care Law Brief

OCTOBER 27, 2021

This means that although ketamine is approved by the FDA for some medical uses, it is not specifically approved to treat depression. Such laws and regulations are largely governed at the state level, and there may be (i) considerable variations among state laws and (ii) frequent updates to such laws. Regulatory Licensure.

Licensing 40

Licensing Telemedicine COVID-19 FDA 40

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. Polansky v. 3d 239 (Cal.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

JANUARY 25, 2024

Put simply, among the morass of Medicare are provisions governing Medicare Advantage programs, which companies can elect to provide and eligible people can elect to receive. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do. Darue Eng’g & Mfg. ,

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Medicare Medicare FDA Regulatory Compliance 52