State AG Pulse | CT AG Reacts to Genetic Data Breach
Modern warfare is no longer restricted to physical battlefields and professional military. Countries like North Korea and Russia have few qualms about using cyberspace to reach well beyond their physical borders to target...more
Washington’s My Health My Data Act implements strict—and separate—consent requirements for the collection and sharing of an individual’s health data, with few exceptions. As of March 31, 2024 the Washington My Health My...more
Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals. ...more
Recently, Womble Bond Dickinson held its First Annual Health Care Fraud Symposium, a webinar designed to discuss critical healthcare fraud topics. WBD Partner Joe Whitley moderated a discussion with WBD attorneys Luke Cass,...more
Please join us for the first Lunch and Learn of 2023, as Geoffrey Kaiser and Jeffrey Ehrhardt present on the OIG. The program will: 1. Discuss select Advisory Opinions from last year on a variety of topics,...more
On June 6, 2022, the U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG), released its spring 2022 semiannual report to Congress. The semiannual report covers the period of October 1, 2021 to...more
On April 11, 2022, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published Advisory Opinion No. 22-06, concluding that a pharmaceutical manufacturer’s sponsored genetic testing and...more
Issue: The U.S. Government is warning American health care entities that personal health data, including genetic information, from diagnostic tests and services could end up in the hands of foreign governments for unintended...more
Genetic testing had its origins in the 1950s when scientists discovered that an additional copy of chromosome 21 causes Trisomy 21, also known as Down syndrome. Methods for staining chromosomes were used to sort and count...more
Editor’s Note: In a recent webinar, Manatt Health’s Anthony Fiori, Senior Managing Director, and Alex Dworkowitz, Partner, hosted a panel of innovative thought leaders—including Dr. Sanjiv Shah, Chief Medical Officer of...more
Many allied health professionals are subject to state-level licensing requirements that can vary from jurisdiction-to-jurisdiction. What may be required in New York to hold a medical professional license may differ...more
Precision health has the potential to dramatically transform the healthcare landscape by developing cutting-edge solutions that significantly improve patient outcomes. Now, following its contributions to the groundbreaking...more
Some app developers know more about our health than our doctors do. Take, for instance, FitBit, which is attached to our wrist and measuring in real time our temperature, our heart rate, our steps and whether we have had...more
In the world of rare diseases, patient testimonies about the extreme difficulties of receiving an accurate diagnosis for an illness are numerous. For instance, one woman, sick for most of her young life, was not properly...more
The Justice Department, in coordination with HHS-OIG and the FBI recently announced the arrest and prosecution of 35 individuals for a massive genetic testing fraud scheme involving dozens of telemedicine companies and cancer...more
Consistent with our experience, security firm McAfee has confirmed in a report that ransomware attacks have doubled in 2019. Medical providers have been hit hard this year, and one provider, Wood Ranch Medical, located in...more
There seems to be a never-ending outbreak of a certain kind of pathology in the United States. Big Pharma has it and spreads it around, a lot. So, too, do public health figures. Let’s call this scourge what it is —...more
The U.S. Department of Justice (DOJ) continues to actively target the healthcare industry for False Claims Act (FCA) and other alleged violations, and it took significant steps to further its reach into the telehealth and...more
The Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: A Progress & Outlook Report” (Report) that monitors current successes and challenges in bringing personalized therapies to market....more
• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more
The Personalized Medicine Coalition, or the “PMC” is an organization of over 250 members that seeks to promote the understanding and adoption of personalized or precision medicine concepts, services, and products by health...more
In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication...more
Recently, the Centers for Medicare & Medicaid Services (CMS) decided to provide nationwide reimbursement for certain in vitro, companion diagnostic tests that employ Next Generation Sequencing (NGS) for patients with advanced...more
A controversial new Medicare national coverage determination (“Medicare NCD”) for certain next-generation sequencing (“NGS”) tests published by the Centers for Medicare & Medicaid Services (“CMS”) on March 16, 2018, could...more
On February 15, 2018, representatives Eric Swalwell (CA-15), John Shimkus (IL-15), Scott Peters (CA-52), Erik Paulson (MN-03), and Juan Vargas (CA-51), introduced the Advancing Access to Precision Medicine Act (H.R....more