HIT Consultant

FEBRUARY 16, 2023

million annually on administrative activities to support regulatory compliance. With the impending end of the COVID-19 public health emergency set to shake up healthcare regulations , ongoing healthcare labor shortages, and skyrocketing levels of clinician burnout, a perfect storm for non-compliance is brewing.

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Compliance Hospitals Regulatory Compliance COVID-19 52

Healthcare IT Today

JUNE 28, 2023

The healthcare worker burnout crisis in this country began before the COVID-19 pandemic, but the public health emergency made the situation even worse as frontline health workers risked their lives to service others. It’s estimated that the U.S.

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Regulatory Compliance COVID-19 Nurses Governance 75

Exeed Regulatory Compliance

JULY 6, 2020

That is why all of our medical experts are strongly encouraging the use of face masks in public, especially in indoor spaces where social distancing is not possible. When used for this purpose, a face mask becomes an important tool for public health policy as a source control device.

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COVID-19 FDA Medical Device Industry Public Health 52

Exeed Regulatory Compliance

MARCH 5, 2020

Travel is being restricted, large scale public events are likely to be cancelled, and schools and businesses may be closed to contain the spread of the virus. Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. There is now an FDA policy released on 29 Feb.

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

Exeed Regulatory Compliance

JULY 20, 2020

During the current public health emergency due to COVID-19, the FDA has relaxed some of these requirements. We need to be careful about any clinical or public health policy decisions we make based on the results of these tests. The second risk is related to the FDA Emergency Use Authorization process itself.

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COVID-19 FDA Public Health 52

Health Care Law Brief

JUNE 24, 2022

This guidance is a direct response to a December 2021 Executive Order that tasked HHS with developing HIPAA guidance for telehealth services, with the stated goals of improving “patient experience and convenience” as the COVID-19 public health emergency subsides. The new HIPAA guidance affects covered entities in four key ways.

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HIPAA Fraud Compliance COVID-19 52

Health Care Law Brief

JANUARY 6, 2022

Public Health Law 2805-m(2) affords similar protection from disclosure for “records, documentation or committee actions or records” required by law, which includes peer review activity.

Malpractice 40

Malpractice Public Health Hospitals Regulatory Compliance 40

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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FDA HIPAA Compliance Regulatory Compliance 45

Exeed Regulatory Compliance

OCTOBER 26, 2020

COVID-19 continues to cause damage to both the public health and the economy at large. A double-blinded, placebo-controlled, randomized clinical trial provides support for FDA approval of Remdesivir for treating COVID-19. There is some good news on the horizon.

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COVID-19 FDA Hospitals Public Health 52

Exeed Regulatory Compliance

JULY 31, 2020

It is a public health emergency of massive scale that has affected nearly all aspects of our life. As we write this blog, over 60,000 new infections are being reported on a daily basis in the United States, with a cumulative total of over 4 million cases and over 150,000 deaths reported since the pandemic first began here.

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

Dot Compliance

FEBRUARY 22, 2022

According to the FDA’s mission statement , its role is to protect public health by ensuring that food, drugs, cosmetics, biotechnology, and medical devices are safe to use and effective at providing any claimed health benefits.

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FDA Compliance Governance Public Health 98

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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FDA Regulatory Compliance Malpractice Health Insurance 282

Exeed Regulatory Compliance

JULY 10, 2020

Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised). Plus, subscribe here to start receiving our exclusive, in-depth analysis of new developments in the medical device industry. References FDA (2020, May).

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COVID-19 FDA Medical Device Industry Public Health 52

Health Care Law Brief

FEBRUARY 6, 2023

The legislative proposals related to health care, as contained in the Governor’s budget, were introduced as Senate Bill 4007 and Assembly Bill A3007. The bills propose to amend the Public Health Law (“ PHL ”) to introduce a new Article 45-A, named “Review and Oversight of Material Transactions.”

Patient Satisfaction 52

Patient Satisfaction Licensing Health Insurance Health Outcomes 52

AIHC

NOVEMBER 3, 2023

One of the major challenges in effectively deploying AI in health care is managing implementation and maintenance costs. North Carolina State Health Plan and Johns Hopkins Bloomberg School of Public Health, 2021). Read more about current regulatory oversight on the AIHC blog: Who Regulates Healthcare AI?

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Department of Veterans Affairs Hospitals Compliance Nurses 59

Dot Compliance

JANUARY 20, 2022

ICH Q10 is a framework developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use , an organization in which regulatory agencies and pharmaceutical companies work together to improve industry practices in the interest of public health.

Compliance 52

Compliance Pharmaceutical Industry Public Health Regulatory Compliance 52

Healthcare IT Today

AUGUST 15, 2023

Digitizing patient care records empowered MCHD to move from multiple systems to a centralized repository, leading to more efficient records management with proper retention schedules and regulatory compliance. Though the agency serves more than a half million people, our process automation department is a two-person team.

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Regulatory Compliance Public Health Hospitals Records Management 79

MedTrainer

NOVEMBER 15, 2023

In the United States, there are several compliance frameworks and entities that govern requirements for the healthcare industry. Each governing body oversees a different aspect of regulatory compliance. To understand which compliance frameworks govern which requirements, we need to break it down entity by entity.

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Compliance Framework Governance Compliance Medicaid 52

Healthcare IT Today

NOVEMBER 8, 2023

Many clinical data records can be exchanged between providers and regional public health agencies through health information exchanges. Moving beyond health system-wide or regional interoperability has been a challenge due to several financial and operational hurdles.

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HIPAA Compliance Regulatory Compliance Public Health 71

Healthcare IT Today

JANUARY 9, 2024

Within healthcare, the technology and expertise exist to help providers, payers, public health, health information exchanges, and healthcare IT companies exchange data. Not all workloads are suitable for the cloud, especially when safety, regulatory, or reliability issues are a concern.

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Hospitals Regulatory Compliance Compliance Licensing 100

Exeed Regulatory Compliance

APRIL 6, 2020

In this blog, we review this practice of reusing disposable FFRs after decontamination within the context of a benefit-risk assessment relevant to the current Covid-19 public health emergency. To be clear, these FFRs are disposable Class II medical devices (FDA Device Code MSH), not cleared for reuse.

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COVID-19 FDA Public Health 52

SQA

OCTOBER 18, 2022

The UK sees the plans as an opportunity to introduce new regulations after Brexit in order to strengthen the public health sector. These plans concern both medical devices and in vitro diagnostics. The aim is to promote patient safety and innovation. Judicious use of vaccines can support this response.

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

Drug & Device Law

DECEMBER 29, 2023

Negligence requires an evaluation of a defendant’s reasonableness, and all relevant NC authority includes relevant regulatory compliance in that mix. The case was governed by North Carolina substantive law, and NC rejects strict liability altogether. Strike one. 2023 WL 2565853 (N.D. April 21, 2023) ( here ). 13) McGee v.

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