Remove Fraud Remove Governance Remove Informed Consent Remove Presentation
article thumbnail

OIG Advisory Opinion Alert: Yet Another Favorable Decision for Medical Device Manufacturers

Healthcare Law Blog

Like these other AOs, OIG found that while the Proposed Arrangement could generate fraud and abuse risks under both the Federal anti-kickback statute (i.e., Section 1128A(a)(5) of the Act), the Proposed Arrangement nevertheless presented a minimal risk of fraud and abuse under the law on the facts presented.

article thumbnail

Introduction to Telebehavioral Health

AIHC

The lack of multistate licensure presents a barrier to telehealth because providers must obtain and uphold licensure (and the associated medical education and financial obligations) in multiple states. This requirement can sometimes apply to specific types of professionals when located in law or regulations governing their profession.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Episode 23: The Emerging Investigatory Focus on Telehealth: What You Need to Know

Healthcare Law Today

In this episode of Health Care Law Today, Nate Lacktman and Maureen Stewart are joined by Mark Josephs, Deputy General Counsel of LifeMD to discuss the current regulatory and legal environment for telemedicine companies regarding online subscription services, and the recent investigations by the federal government of these services.

article thumbnail

Is Your Data Supply Chain Ethical? Don’t Restrict Due Diligence to Physical Operations.

C&M Health Law

bribery, fraud, misuse). Health Insurance Portability and Accountability Act (HIPAA) can present several areas of exposure. Suppose that a biopharmaceutical enterprise submits regulatory approval for a new product, only to realize that the data collected from outsourced clinical trials is based on insufficiently informed consent.

article thumbnail

AI in Healthcare

HIPAA Journal

AI is used by the finance industry to detect potential credit card fraud. It is hoped that, as a tool for public health, AI can be used in the future to predict and track the spread of other infectious diseases by analyzing data from government, healthcare, and other sources. Ethics of AI in Healthcare .

article thumbnail

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. 2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. In 2023, these include United States ex rel. Polansky v. 3d 239 (Cal.

FDA 105
article thumbnail

Suing the Certifiers – A Dangerous Undertaking

Drug & Device Law

Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. Furthermore, trade associations often serve to assist the government in areas that it does not regulate. Sizemore v.

Doctors 52