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Department of Health and Human Services (HHS) Office of the Inspector General Digital Health

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

McDermott Will & Emery

Private Investors and Digital Health Attracting OIG Attention: General Compliance Program Guidance to Watch

McDermott Will & Emery on

On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more

Jones Day

Vital Signs Digital Health Law Update | Summer 2023

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we take an in-depth look at generative artificial intelligence...more

Proskauer - Health Care Law Brief

OIG Issues Final Information Blocking Enforcement Rule and Highlights the Potential for Referrals to the FTC and FCA Liability

On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more

Jones Day

Vital Signs Digital Health Law Update | Spring 2023

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Note From the Editors - This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more

McDermott Will & Emery

McDermott Health 2023 Annual Report - Digital Health: 2022 Year in Review

McDermott Will & Emery on

Digital health is one of the fast-growing segments of the healthcare market, with patients, clinicians and regulators increasingly aligned behind the opportunities that digitization presents. Over the last three years,...more

Arnall Golden Gregory LLP

OIG Approves Arrangement That Provides Cash Equivalents to Patients in Digital Contingency Management Program

On March 2, 2022, the Department of Health and Human Services, Office of Inspector General (OIG) published Advisory Opinion No. 22-04 (the “Opinion”), analyzing a program whereby the Requestor provides comprehensive digital...more

Bradley Arant Boult Cummings LLP

Enforcement and Health Care Technology: Navigating Fraud and Abuse Issues in Emerging Digital Health Care Areas

Like many industries, the health care industry has become increasingly digitized and reliant on technology. Technology advancements also have had a major effect on enforcement. In his comments to the Federal Bar Association...more

Hinshaw & Culbertson - Health Care

New OIG Guidance Permits Federally Qualified Health Centers to Offer Remote Patient Monitoring, Big-Box Store Gift Cards, and...

Federally Qualified Health Centers (FQHCs) deliver care to some of the nation's most vulnerable individuals and families, including federal Medicare and Medicaid health care program beneficiaries. As safety net providers,...more

ArentFox Schiff

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

ArentFox Schiff on

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more

Manatt, Phelps & Phillips, LLP

[Webinar] Unpacking the Anti-Kickback and Stark Reforms: Promoting Value-Based Care and Easing Regulatory Compliance - January...

A New Manatt Webinar Guides You Through New Reforms Promoting Value-Based Care and Easing Regulatory Compliance—the Most Significant Changes to the Federal Fraud and Abuse Landscape in the Last Decade. On November 20,...more

K&L Gates LLP

K&L Gates Triage: Digital Health Update: ONC Information Blocking Proposal Aims to Remove Barriers to Data Sharing

K&L Gates LLP on

The Office of the National Coordinator for Health Information Technology (ONC) recently released a proposed rule aimed at promoting the interoperability of health information technology and enabling access to electronic...more

McDermott Will & Emery

2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement

In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

McDermott Will & Emery

Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

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Introduction - Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more

King & Spalding

OIG Issues Advisory Opinion Regarding Proposed Pilot Program Involving Health Technology Collaboration Between Health System and...

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On December 4, 2017, the HHS Office of Inspector General (OIG) issued an Advisory Opinion No. 17-07 regarding a proposed pilot program involving a health technology collaboration funded by a pharmaceutical manufacturer and...more

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