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

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

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.

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