Rethinking Records Retention
Compliance Tip of the Day: Internal Controls for GTE
FCPA Compliance Report: Revolutionizing Speak Up: Ariel D. Weindling on Enhancing Whistleblower Systems
Compliance Tip of the Day: Implementing Internal Controls
Podcast: Addressing Patient Complaints About Privacy Violations
Compliance Amidst a Global Consensus Breakdown
Compliance Tip of the Day: What are Internal Controls?
Compliance Tip of the Day: Compliance Training Frequency
Compliance Tip of the Day: Design Objectives for Compliance Training
FCPA Compliance Report: The Power of Peer Support and Purpose Driven Leadership with Sarah Cole
Innovation in Compliance: Innovative Approaches to Compliance and Training with Catherine Choe
Compliance Tip of the Day: Multiplying the Influence of Compliance
Compliance tip of the Day: Communication Through Persuasion
Compliance Tip of the Day: Empowering Middle Managers to Drive Compliance Transformation
Compliance Tip of the Day: Middle Managers as the Eyes and Ears of Compliance
Compliance Tip of the Day – Role of Chatbots in Compliance
Beyond the Bylaws: The Medical Staff Show | The Role of Bylaws in Medical Staff Governance, Part II
The Presumption of Innocence Podcast: Episode 60 - Enforcement Priorities of the Second Trump Administration: Employee Retention Tax Credit
Compliance Tip Of the Day: Using AI to Transform Whistleblower Response
FCPA Compliance Report: Amanda Carty on a Due Diligence and Risk Management
In the FDA-regulated industry, a compliance program isn’t just a formality—it’s a critical tool for protecting your business, patients, and reputation. Still, too many companies treat compliance policies as static...more
On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more
MIT Report Details New Cybersecurity Risks - “Cloud misconfigurations, more sophisticated ransomware, and vendor exploitation attacks are contributing to rising cyberattacks.” Why this is important: Worldwide spending...more
Late last month, the Association of Corporate Counsel (ACC) hosted a panel on Trade Secret Protection in Life Sciences: Strategies for Success. In today's rapidly evolving business environment, trade secrets are becoming...more
On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal...more
Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more
The life sciences and pharmaceutical industry is investigating potential applications in the Metaverse to reduce costs, increase efficiency, and develop novel functionalities. The Metaverse is becoming a new forum for...more
In April 2022, the U.K. Health Secretary, Sajid Javid, announced plans to prohibit the United Kingdom’s National Health Service (“NHS”) from buying goods and services connected with forced labour or human trafficking. This...more
A series of panels co-hosted by EY and McDermott Will & Emery during the 2022 J.P. Morgan Healthcare Conference examined how hospitals and health systems continue to weather the pandemic. Leaders from the health system...more
How will the election affect life sciences in 2021 and beyond? What’s ahead for the regulatory and policy environment? In this session, our elite group of policy analysts reviewed the election results and the far-reaching...more
‘Tis the season to be jolly! This holiday season may be merrier if the recently announced COVID-19 vaccination candidates obtain approval and/or authorization for use in preventing COVID-19 by the U.S. Food and Drug...more
China is cautiously recovering from the peak of the COVID-19 outbreak and is moving into a new period of investor-friendly policies aimed at restarting China’s economic engine....more
As the COVID-19 pandemic unfolds, our drug, biologic, and medical device clients conducting or planning to conduct clinical trials may be faced with challenges related to quarantines, travel limitations, site closures or...more
On March 11, 2020, the World Health Organization declared that COVID-19 is now a pandemic. The effects continue to be felt in the United States, which now has well over 1,000 confirmed novel Coronavirus disease (COVID-19)...more
U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more
On August 20, 2019, the US Securities and Exchange Commission (SEC) charged TherapeuticsMD Inc., a Boca Raton, Florida, headquartered life sciences company, with violations of Regulation FD for sharing material, non-public...more
For the first time in six years, the U.S. Securities and Exchange Commission issued an enforcement action against a company solely for Regulation FD violations. On Aug. 20, the SEC announced that it charged life sciences...more
Key Considerations and Updates for Life Sciences Companies - On April 30, 2019, the Criminal Division of the U.S. Department of Justice (DOJ) issued updated guidance for white-collar prosecutors on evaluating the...more
As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more