News & Analysis as of

Regulatory Requirements New Guidance Risk Management

Troutman Pepper

New FDA Guidance on AI and Medical Products

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n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

NAVEX

How to Meet the Letter, Spirit and Intent of the DOJ’s Evolving Compliance Program Expectations

NAVEX on

With any new administration, the U.S. Department of Justice (DOJ) often shifts focus from one set of enforcement priorities to another. However, one area has remained a focus from administration to administration: guidance...more

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - February 22nd - 23rd, Anchorage, AK

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - February 22nd - 23rd, Anchorage, AK

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - September 15th, Minneapolis, MN

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education that covers a wide variety of current and emerging...more

Dechert LLP

Measure Twice, Cut Once: New DOJ Compliance Certifications Put CEOs and CCOs at Risk of Individual Criminal Liability

Dechert LLP on

Key Takeaways - As DOJ senior leadership signaled it would do since March, DOJ has now officially required as part of resolving a corporate enforcement action, that a Chief Compliance Officer (CCO) and Chief Executive...more

Polsinelli

Federal Banking Regulators Issue Rule Requiring 36 Hour Notice of Ransomware and Other Disruptive Cybersecurity Incidents

Polsinelli on

On November 18, 2021, the Federal Deposit Insurance Corporation, the Board of Governors of the Federal Reserve System, and the Office of the Comptroller of the Currency issued a joint final rule to require banking...more

Jones Day

California Attorney General Issues Bulletin on Health Data Breach Reporting Requirements

Jones Day on

The California Attorney General ("AG") has issued guidance reminding health care providers of their duty to report health care data breaches and to comply with other state and federal data privacy laws....more

NAVEX

[Virtual Conference] NAVEX Next: Beyond the Moment - October 22nd, 8:00 am - 2:00 pm PDT

NAVEX on

Register for NAVEX Next, our annual risk and compliance virtual conference. Formerly the Ethics & Compliance Virtual Conference (ECVC), the new name recognizes that we must be forward-looking as we face an increasingly...more

Seyfarth Shaw LLP

EPA Reacts to Coronavirus Concerns With Disinfectant Guidance

Seyfarth Shaw LLP on

Seyfarth Synopsis: As an early and aggressive response to potential threats related to the novel coronavirus disease, now identified as COVID-19, the United States Environmental Protection Agency (EPA) activated its Emerging...more

Morgan Lewis

UPDATED: Responding to the 2019 Novel Coronavirus: An Initial Guide for Multinational Employers in the PRC

Morgan Lewis on

This Lawflash provides multinational companies with operations in the People’s Republic of China (PRC) with some guidance on how to handle the challenging employment issues during this time. The situation is fluid and rapidly...more

Hogan Lovells

The EMA has adopted new guidelines on good pharmacovigilance practices in paediatric populations

Hogan Lovells on

The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations Chapter (IV) regarding specific considerations for the paediatric...more

Vedder Price

Investment Services Regulatory Update - February 2018

Vedder Price on

New Rules, Proposed Rules, Guidance and Alerts – SEC STAFF GUIDANCE AND ALERTS - SEC Staff Issues Guidance on Cryptocurrency-related Holdings - On January 18, 2018, the staff of the SEC’s Division of Investment...more

Vedder Price

Investment Services Regulatory Update - November 2017

Vedder Price on

New Rules, Proposed Rules, Guidance and Alerts - SEC STAFF GUIDANCE AND ALERTS - SEC Staff Issues No-Action Letters to Facilitate Cross-Border Compliance with the Research “Unbundling” Provisions of the European...more

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