Health Care Law Brief

JUNE 2, 2022

The onset of the COVID-19 public health emergency (“PHE”) led to a surge in the use of telehealth by health care providers. For the reasons discussed below, DTC telehealth platforms should re-visit their compliance plans and be prepared for increased state and federal regulatory scrutiny.

Public Health 52

Public Health Compliance COVID-19 Licensing 52

Dot Compliance

FEBRUARY 22, 2022

If you’ve developed a new pharmaceutical and want to market it to health care providers or the general public, you must take one first, unskippable step: you need to get it approved by the Food and Drug Administration. FDA regulations govern what you can claim about your product and whether you can even sell it at all.

FDA 98

FDA Compliance Governance Public Health 98

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.

US Department of Health and Human Services 52

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

FDA 45

FDA HIPAA Compliance Regulatory Compliance 45

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

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.

HIPAA 71

HIPAA Compliance Regulatory Compliance Public Health 71

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.). Counterfeit health products are imitations of authentic products. .” instead of BTNX Inc.

US Department of Health and Human Services 40

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