HIT Consultant

MARCH 25, 2024

Although the attack vector in the Change Healthcare breach has not been identified as of this writing, the same group was responsible for the massive MGM Resorts hack in September 2023 which started on LinkedIn with a social engineering-driven exploit. The number of attacks continues to surge.

Ransomware 113

Ransomware US Department of Health and Human Services Regulatory Compliance Compliance 113

Verisys

OCTOBER 23, 2023

A big thanks to our compliance team, who monitors state, federal, and international updates. Alabama : License renewals for pharmacy technicians, pharmacy interns, and facilities are open as of 9/15/2023. The renewals are due by 12/31/2023. CA BRN Fall 2023 Report: Transcripts submission (pg.

Licensing 52

Licensing Nurses Compliance Medicaid 52

Healthcare IT Today

AUGUST 21, 2023

billion in 2022, RFID in the global healthcare market is projected to grow at a CAGR of 17.85% from 2023 to 2030. RFID’s Potential: Improved Efficiency, Safety, and Regulatory Compliance RFID technology offers significant potential for improving efficiency and patient safety in healthcare applications. Valued at USD 3.95

HIPAA 84

HIPAA Regulatory Compliance Hospitals FDA 84

Health Law Advisor

JULY 14, 2023

On July 13, 2023, the White House issued the first iteration of its National Cybersecurity Strategy Implementation Plan (the “Implementation Plan”), which will be updated annually. These include an initiative for the Department of Defense (DOD) to publish an updated cyber strategy by first quarter of fiscal year 2024 (1Q FY24) (i.e.,

Regulatory Compliance 52

Regulatory Compliance Fraud Compliance Governance 52

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. Much has happened since then.

FDA 45

FDA HIPAA Compliance Regulatory Compliance 45

MedTrainer

AUGUST 2, 2023

Listen to a candid discussion on lessons learned from the 2023 federal investigation that uncovered fraudulent medical practice nationwide in this on-demand webinar: Moving Forward From the Nursing Fraud Scheme. However, it’s important to remember how critical this process is for mitigating risk, improving compliance, and earning trust.

Malpractice 52

Malpractice Due Diligence Compliance Licensing 52

AIHC

NOVEMBER 3, 2023

Weight and Height Juxtaposition in the Electronic Medical Record Causing an Accidental Medication Overdose (posted on the Patient Safety Network October 31, 2023) A 2-year-old girl presented to the emergency department (ED) with joint swelling and rash following an upper respiratory infection. 1 through June 30, 2023.

Department of Veterans Affairs 59

Department of Veterans Affairs Hospitals Compliance Nurses 59

Health Care Law Brief

AUGUST 10, 2023

On July 27, 2023, California’s Office of Health Care Access and Information (the “ Office ”) released its long-awaited proposed regulations on the notice requirements for material health care transactions in California. A transaction involving a transfer or change in control, responsibility, or governance.

Governance 52

Governance Health Care Access Regulatory Compliance Compliance 52

Health Care Law Brief

MARCH 8, 2022

On February 24, 2022, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), announced the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model, which will begin January 1, 2023, and replace the Global and Professional Direct Contracting (GPDC) Model.

Medicare 52

Medicare Medicare Fraud Compliance 52

Health Care Law Brief

JULY 25, 2023

On June 27, 2023, the Office of Inspector General (“ OIG ”) for the U.S. Unlike developers, exchanges, and networks, the Act does not empower OIG to directly assess penalties for non-compliance against health care providers. [6] 1] See 21st Century Cures Act, Pub.

HIPAA 52

HIPAA Payment Systems Compliance Licensing 52

Healthcare IT Today

JANUARY 9, 2024

As 2023 uncovered some less-than-optimal situations where automation and AI were at odds on either side of the fence, my hope is in 2024 that deeper connectivity and collaboration will make those solutions obsolete in some form or fashion. Given the health tech market’s rapid growth, there is certainly more to come.

Hospitals 97

Hospitals Regulatory Compliance Compliance Licensing 97

Bill of Health

APRIL 4, 2024

On top of that comprehensive rulebook, the European Data Strategy bundle of laws encompasses the EU General Data Protection Regulation (GDPR), the Free Flow of Non-Personal Data Regulation, the Data Governance Act and the Data Act, as part of the EC’s ambition to establish a single unified market for data. Sectoral US Laws In the U.S.,

FDA 282

FDA Regulatory Compliance Malpractice Health Insurance 282

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

Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

FDA 105

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

Drug & Device Law

JANUARY 25, 2024

23-cv-01060-AJB-DDL, 2023 WL 9010545 (S.D. 15, 2023), a California plaintiff alleged that the medical walker he purchased broke, causing him to fall and sustain injury. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do. In Rubalcava v. Medline Indus.,

Medicare 52

Medicare Medicare FDA Regulatory Compliance 52