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Digital Health › Department of Health and Human Services (HHS) › Safe Harbors

Robinson+Cole Health Law Diagnosis

OIG Green Lights MSO Model Arrangement for Telehealth Platforms in New Advisory Opinion

Robinson+Cole Health Law Diagnosis on

On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03 (the Advisory Opinion), in which OIG approved of a proposed arrangement under which a management...more

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...more

Arnall Golden Gregory LLP

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

Arnall Golden Gregory LLP on

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

Hinshaw & Culbertson - Health Care

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

Hinshaw & Culbertson - Health Care on

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

Nilan Johnson Lewis PA

Anti-Kickback Statute and Stark Law Regulations: Final Rules Issued

Nilan Johnson Lewis PA on

On November 20, 2020, the Department of Health and Human Services (HHS) published two final rules that aim to reduce regulatory barriers to care coordination and accelerate the transformation of the healthcare system to...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

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

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