The Legal Tightrope: Surviving Parallel Investigations
Navigating Government Contracts: Diana Shaw on Oversight and Whistleblower Protections
The Presumption of Innocence Podcast: Episode 45 - The Grit, Grace and Gift of Second Chances
The Justice Insiders Podcast - The Ever-Expanding Net: Corporate Compliance in an Era of Increasing Trade Sanctions and Restrictions
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Episode 333 -- The Boeing Proposed Plea Agreement
DOJ’s New Self-Disclosure Policy and Corporate Whistleblower Awards Pilot Program
False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict
FCPA Survival Guide - Step 8 - Investing in Compliance
Exploring the AI and Crypto Intersection
The Justice Insiders Podcast: Jarkesy’s Implications for the Administrative State
The Presumption of Innocence Podcast: Episode 41 - The Dynamics of Decision-Making: Psychology and the Criminal Justice System
INTERPOL and Child Kidnapping Cases. What are INTERPOL’s Abilities and Limitations?
False Claims Act Insights - Eureka! Government Investigators Seek Out Research Misconduct
The Justice Insiders Podcast - AI-Washing: Everything Old Is New Again
The CFPB and State AGs Act Jointly Against Online Educational Company
Will the U.S. Have a GDPR? With Rachael Ormiston of Osano
Episode 328 -- Sanctions Enforcement Risks and Redlines
FCPA Survival Guide: Step 3 - Extensive Remediation
Episode 324 -- Third-Party Risks and Sanctions Compliance
While many healthcare providers are generally aware of their obligations under HIPAA, most do not have a clear sense of what happens if they fail to meet these obligations. At best, most probably are familiar with headlines...more
A recently announced settlement with online alcohol addiction treatment service Monument Inc. demonstrates the Federal Trade Commission’s (FTC) continued focus on the use and disclosure of health data. The proposed settlement...more
The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently published an executive summary (Report) outlining key enforcement activities of the Health Insurance Portability and...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
On February 14, 2024, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued two reports to Congress as required by the Health Information Technology for Economic and Clinical Health...more
As we have detailed previously, 2023 was a landmark year for privacy law, featuring numerous developments at the federal, state and international levels, ranging from newly enacted statutes to massive regulatory enforcement...more
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more
2023 marked 20 years since the first compliance deadline under the Health Insurance Portability and Accountability Act’s (“HIPAA”) privacy rule. Despite the two decades of experience with HIPAA, compliance continues to remain...more
State regulators across the country continue to increase their focus on cyber security and data privacy compliance and enforcement. For years, cloud company Blackbaud, a service provider to thousands of nonprofit enterprises,...more
A recent enforcement action by the Federal Trade Commission (“FTC”) against 1Health.io—which sells “DNA Health Test Kits” to consumers for health and ancestry insights—serves as a reminder that the FTC is increasingly...more
On February 1, 2023, the FTC announced a proposed $1.5 million settlement with GoodRx Holdings, based on alleged violations of the Federal Trade Commission Act (“FTC Act”) and Health Breach Notification Rule (“HBNR”) for...more
Report on Patient Privacy 22, no. 5 (May, 2022) - Compared to other agencies, the HHS Office for Civil Rights (OCR) is a little fish in the big federal pond, but it has an outsize effect on HIPAA covered entities (CEs) and...more
UNITED STATES - Regulatory—Policy, Best Practices, and Standards - President Biden Issues Cybersecurity Executive Order - On May 12, 2021, President Biden issued an executive order that placed new standards on the...more
Report on Patient Privacy 21, no. 5 (May 2021) - Given the hundreds of thousands of HIPAA covered entities (CEs) and business associates (BAs) and the two dozen or so enforcement actions the HHS Office for Civil Rights...more
Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more
Consumer-directed health apps are experiencing a boom thanks to COVID-19, as consumers seeking to avoid doctors’ office waiting rooms are increasingly relying on apps to measure and maintain their health. That trend is...more
The COVID-19 pandemic has had a disparate effect on privacy regulators, with varying levels of enforcement advocated by different government entities; the California Attorney General, the U.S. Department of Health & Human...more
The Office for Civil Rights (OCR) announced that it has fined the Texas Health and Human Services Commission (TXHHS) $1.6 million for HIPAA violations. This is one of the few fines the OCR has levied against a state agency....more
On October 23, 2019, the Office for Civil Rights (OCR) at HHS announced the imposition of a $2,154,000 civil monetary penalty against a Florida hospital system (Hospital System) for alleged violations of the HIPAA Security...more
New York recently amended its existing data breach notification law to expand the data breach notification obligations of persons and businesses (and state agencies) and impose specific data security requirements on persons...more
In 2018, privacy and data security crossed a number of thresholds. In the public mind, through high-profile data breaches and revelations about unexpected uses of personal information, questions of privacy became much more...more
According to a February 12, 2019 Press Release from Protenus, a developer of analytics for patient privacy monitoring and compliance, 15,085,302 patient records were breached in 2018 – a startling number made even more...more
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services recently announced that 2018 was a significant year in Health Insurance Portability and Accountability Act (HIPAA) enforcement activity. ...more
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
JONES DAY CYBERSECURITY, PRIVACY & DATA PROTECTION ATTORNEY SPOTLIGHT: Richard Martinez - Europe's new General Data Protection Regulation ("GDPR") is driving an evolution in corporate privacy practices globally. As...more