Naomi J.L. Halpern

FDA Regulation of HCT/Ps: What Wound Care Practitioners Need to Know

12/16/2016

Editor’s Note: The following article discusses products characterized as “cellular and/or tissue-based products” (CTPs) by ASTM International. For purposes of this article, the legal and regulatory definition “human cells, tissues, and...

Editor’s Note: The following...

12/16/2016

Today's Wound Clinic

Legal Counsel

Open Payments Program & The Sunshine Act: What Wound Care Practitioners Need to Know

11/07/2018

James R. Ravitz ;

Naomi J.L. Halpern ;

The Physician Payments Sunshine Act was enacted in 2010 as part of the Patient Protection and Affordable Care Act1 and requires that pharmaceutical and medical device companies make publicly available reports to the government concerning...

The Physician Payments Sunshine...

11/07/2018

Today's Wound Clinic

Legal Counsel

Advancing Regenerative Medicine: FDA Implementation of 21st Century Cures Act

04/05/2018

James R. Ravitz ;

Naomi J.L. Halpern ;

The treatment of the skyrocketing number of patients in the United States living with chronic wounds represents an enormous public health challenge, but has also created significant incentives for the development of advanced wound care...

The treatment of the...

04/05/2018

Today's Wound Clinic

Malpractice

Malpractice Liability Considerations for Wound Clinics

09/06/2017

James R. Ravitz ;

Naomi J.L. Halpern ;

History shows that wound care providers have faced litigation for many reasons. This article discusses the state of malpractice and related law as it impacts wound care clinicians, and provides good practice recommendations that can help...

History shows that wound care...

09/06/2017

Today's Wound Clinic

Legal Counsel

Wound Care Practitioners Must Pay Attention to Fraud & Abuse Laws

03/08/2017

James R. Ravitz ;

Naomi J.L. Halpern ;

Rachel Hold-Weiss ;

It’s widely anticipated that, in many areas, the advent of the new Trump administration will result in a significant reduction in the number of enforcement actions against commercial entities alleging violations of federal laws and...

It’s widely anticipated that, in...

03/08/2017

Today's Wound Clinic