News & Analysis as of

Life Sciences Policies and Procedures

Spilman Thomas & Battle, PLLC

Decoded Technology Law Insights, V 5, Issue 4, May 2024

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

TransPerfect Legal

Trade Secret Protection in Life Sciences: Strategies for Success

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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

Goodwin

A Practical Look at OIG’s New Compliance Guidance

Goodwin on

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

Health Care Compliance Association (HCCA)

Artificial intelligence: Compliance considerations for provider organizations

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

ArentFox Schiff

Life Sciences in the Metaverse: A New Forum

ArentFox Schiff on

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

Paul Hastings LLP

No Longer a ‘Nice to Have’: ESG and What it Means for Life Sciences Companies

Paul Hastings LLP on

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

McDermott Will & Emery

2022 J.P. Morgan Healthcare Conference: Hospitals and Health Systems Forum

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

McDermott Will & Emery

Life Sciences Dealmaking Symposium: As the Dust Settles: Post-Election Update and Impact on the Life Sciences Industry

McDermott Will & Emery on

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

Bricker Graydon LLP

Will you be ready when the COVID-19 vaccines arrive?

Bricker Graydon LLP on

‘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

Seyfarth Shaw LLP

Outlook of China’s Health Care Sector in Light of COVID-19

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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

Goodwin

Conduct of Clinical Trials During the COVID-19 Pandemic: Recommendations from FDA

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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

Epstein Becker & Green

Recommendations for Health Care Providers in Managing COVID-19

Epstein Becker & Green on

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

Polsinelli

What COVID-19 Means for FDA-Regulated Industry

Polsinelli on

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

McDermott Will & Emery

Life Sciences Company Settles Regulation FD Charges with SEC

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

Fenwick & West LLP

SEC Fines Life Sciences Company for Regulation FD Violations

Fenwick & West LLP on

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

Akin Gump Strauss Hauer & Feld LLP

DOJ’s New Corporate Compliance Evaluation Guidance

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

Foley & Lardner LLP

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

Foley & Lardner LLP on

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

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