News & Analysis as of

Compliance Health Insurance Portability and Accountability Act (HIPAA) Department of Justice (DOJ)

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Baker Donelson

DOJ Bulk Data Rule: Key Takeaways for Healthcare and Life Sciences

Baker Donelson on

The Data Security Program (DSP), implemented by the Department of Justice's National Security Division (DOJ/NSD) under Executive Order 14117 (Preventing Access to Americans' Bulk Sensitive Personal Data and United States...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - July 21st - 24th, Nashville, TN

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

Foley & Lardner LLP

OCR Says HIPAA Audits Will Resume: OIG Makes Recommendations for Enhancement

Foley & Lardner LLP on

Recognizing the increasing number of successful cyberattacks targeting health care organizations and their valuable patient data, the Office of the Inspector General (OIG) is calling for enhancements to the HIPAA audit...more

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to DOJ and HHS OIG Guidance on Effective Compliance Programs

The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more

NAVEX

Healthcare Organizations are Facing Increased Scrutiny – Here's What You Need to Know

NAVEX on

2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry – developments that concern not just hospitals and nursing facilities, but many non-healthcare companies as...more

NAVEX

Addressing Cybersecurity Expectations in Healthcare

NAVEX on

2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry – developments that concern not just hospitals and nursing facilities, but many non-healthcare companies as...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

McDermott Will & Schulte

OIG Issues General Compliance Program Guidance Updates

McDermott Will & Schulte on

On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more

Health Care Compliance Association (HCCA)

Privacy Briefs: October 2023

Report on Patient Privacy 23, no. 10 (October, 2023) Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals will pay California $49 million to resolve allegations that they unlawfully disposed of hazardous waste,...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

Health Care Compliance Association (HCCA)

Supreme Court leaves open a major risk to internal corporate communications

It is commonplace for attorneys and compliance officers (particularly those who are also attorneys) to receive communications from clients that have more than one purpose. Take, for example, a doctor who calls a friend and...more

Ankura

eDiscovery and Life Sciences Industry - Challenges and Solutions

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The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more

Buchalter

Taste-Testing Cybersecurity Compliance: A Recipe for Disaster in Government Contracting

Buchalter on

The Department of Justice (DOJ) Civil Cyber-Fraud Initiative continues to raise the stakes for government contractors. This initiative uses the False Claims Act (“FCA”) to hold government contractors accountable for knowingly...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Health Care Compliance Association (HCCA)

[Virtual Event] Richmond Regional Healthcare Compliance Conference - December 9th, 8:25 am - 4:30 pm EST

General and specialty compliance training from the comfort of your home or office! HCCA’s Regional Healthcare Compliance Conferences provide practitioners with virtual compliance training that includes updates on the...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - October 28th, Louisville, KY

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - January 28th, Orlando, FL

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

Health Care Compliance Association (HCCA)

[Event] Chicago Regional Healthcare Compliance Conference - October 22nd, Chicago, IL

Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 5. News Briefs: February 2020 #2

Report on Medicare Compliance 29, no. 5 (February 10, 2020)  - David Laufer, the former chief of the Prosthetics and Orthotics Department at Walter Reed National Military Medical Center in Bethesda, Maryland, was charged...more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - February 27th - 28th, Anchorage, AK

This two-day Regional Compliance and Ethics Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

King & Spalding

General Counsels Decision Tree for Investigations of Life Sciences Companies

King & Spalding on

Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Womble Bond Dickinson

Is Your HIPAA Compliance Program Ready for the FTC?

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Everyone in healthcare knows that the next round of HIPAA audits is coming. Covered entities and business associates have long been advised to review and update their HIPAA security risk analyses, have business associate...more

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