Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
Changes in FDA, Cannabis Policies and AI Developments
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 181: South Carolina’s Life Sciences Economy with Ashely Teasdel, Deputy Secretary of SC Department of Commerce
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 166 — Christine Vannais, COO of Fujifilm Diosynth Biotechnologies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Episode 150 - Jane Pine Wood, Senior Vice President & Chief Legal Officer, BioReference
Jones Day Talks Health Care: The Eliminating Kickbacks in Recovery Act
On November 6, 2023, OIG released new General Compliance Program Guidance (General CPG). The General CPG applies to all individuals and entities involved in the healthcare industry. The release of the General CPG was not...more
The privacy landscape in the United States and much of the world is quickly evolving around the framework of the General Data Protection Regulation (GDPR) within the European Economic Alliance (EEA). Clinical trials involve...more
On February 17, 2023, the state attorneys general of Pennsylvania and Ohio reached a settlement with Ohio-based DNA Diagnostics Center (“DDC”) for a 2021 data breach that affected 2.1 million individuals nationwide and...more
By January 31, 2023, general acute care hospitals, clinical labs and certain physician organizations and medical groups in California are required to enter into the Single Data Sharing Agreement (DSA) to participate in the...more
On May 25, 2021, the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS), announced that Peachstate Health Management, LLC d/b/a AEON Clinical Laboratories (Peachstate) agreed to pay...more
HCCA's Health Care Research Compliance Academy is a three-and-a-half-day intensive training program focuses on compliance issues related solely to research. Its faculty is made up of experts in the field. With a wide range of...more
It is being reported that LifeLabs, a Canadian lab company that is the largest provider of laboratory diagnostics and lab testing services in Canada, recently paid an undisclosed ransom to hackers who compromised its computer...more
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has released its Work Plan for Fiscal Year 2016. The annual work plan can provide valuable insights into the OIG’s planned areas of...more
On Oct. 6, 2014, a final rule issued jointly by the Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), and Office for Civil Rights (OCR) will require all HIPAA-covered labs...more
The Federal Trade Commission (FTC) is moving forward with an administrative action against a small medical laboratory that suffered two data security breaches, resulting in its patients’ protected health information falling...more
A new final rule (the “Final Rule”) from the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, and the Office for Civil Rights (collectively, the “Agencies”) gives patients and their...more
Yesterday the Centers for Medicare & Medicaid Services (CMS) finally published the long-awaited final rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and...more
The Office of Management and Budget has extended its review of a proposed rule that would require HIPAA-covered laboratories to make test results available to patients. In our previous post on this issue way back in...more
Last week the Department of Health and Human Services (“HHS”) announced that it has postponed the Sept. 23, 2013, HIPAA Omnibus Rule deadline for many clinical laboratories to revise their notices of privacy practices...more
In a reminder that the U.S. Department of Health and Human Services (“HHS”), with its HIPAA security requirements and enforcement authority, is not the only game in town when it comes to health information privacy, the...more