News & Analysis as of

Health Care Providers Genetic Testing

Nelson Hardiman, LLP

Hacking and Healing: Nation-States, Cyber Attacks, and Healthcare Law

Nelson Hardiman, LLP on

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

Benesch

REMINDER: Washington’s “My Health My Data” Act Now In Effect

Benesch on

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

Hogan Lovells

The “Borne Mission” Report analysis: Between hope and disappointment for the pharmaceutical industries

Hogan Lovells on

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

Womble Bond Dickinson

Current Trends and Real-World Best Practices in Healthcare Fraud Compliance

Womble Bond Dickinson on

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

Rivkin Radler LLP

[Webinar] Lunch and Learn Series: A Survey of OIG’s 2022 Advisory Opinions: What They Could Mean for Your Organization - January...

Rivkin Radler LLP on

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

Venable LLP

HHS 2021 Semiannual Report to Congress Draws Attention to Genetic Testing, Durable Medical Equipment, and Opioid Disorder...

Venable LLP on

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

Hogan Lovells

OIG green lights drug manufacturer-sponsored genetic testing program

Hogan Lovells on

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

Wiley Rein LLP

Personal Health Data at Risk of Foreign Exploitation

Wiley Rein LLP on

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

Robins Kaplan LLP

Robins Kaplan Justice Report December 2021 | Vol. 15 No. 4

Robins Kaplan LLP on

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

Manatt, Phelps & Phillips, LLP

Delivering Breakthrough Treatments Affordably

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

Goodwin

Florida Joins List of States Requiring Licensure for Genetic Counselors

Goodwin on

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

McDermott Will & Emery

[Ongoing Program] Precision Health: Trends And Future Potential - Exploring Consumer Engagement with Precision Medicine - July...

McDermott Will & Emery on

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

Robinson+Cole Data Privacy + Security Insider

Changing the Conversation About Sharing and Using Health Information

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

Holland & Knight LLP

Sequence of Events: Genetic Testing Offers Significant Promise, But Coverage and Access Limited

Holland & Knight LLP on

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 Volkov Law Group

Department of Justice Brings Criminal Charges Against 35 Individuals for Involvement in $2.1 Billion in Fraudulent Genetic Testing...

The Volkov Law Group on

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

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - October 2019

Robinson & Cole LLP on

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

Patrick Malone & Associates P.C. | DC Injury...

Health care plagued by cases of a persistent pathology — unmitigated gall

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

Foley Hoag LLP - White Collar Law &...

DOJ Takes Aim at Telehealth and Genetic Testing Markets

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

Foley & Lardner LLP

The Era of Personalized Medicine Has Arrived - PMC’s Annual Progress and Outlook Report

Foley & Lardner LLP on

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

Akin Gump Strauss Hauer & Feld LLP

Checking In On FDA’s Enforcement Discretion Policy for Laboratory Developed Tests

• 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

Foley & Lardner LLP

PMC Releases "A Consumers Guide to Genetic Health Testing"

Foley & Lardner LLP on

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

Sheppard Mullin Richter & Hampton LLP

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

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

Wilson Sonsini Goodrich & Rosati

CMS Expands Coverage of Certain Advanced Cancer Companion Diagnostic Tests Employing Next Generation Sequencing

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

Epstein Becker & Green

Obstacles in the Path? Medicare’s National Coverage Determination on Next-Generation Sequencing Has Significant Implications for...

Epstein Becker & Green on

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

Foley & Lardner LLP

Advancing Access to Precision Medicine Act - A Bipartisan Bill

Foley & Lardner LLP on

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

29 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide