News & Analysis as of

Risk Management Healthcare Compliance

Health Care Compliance Association (HCCA)

HHS Abandons Appeal in Public Website Pixel Case, But CEs and BAs Should Expect Continued Scrutiny

The HHS Office for Civil Rights (OCR) has abandoned its appeal of a federal judge’s ruling overturning OCR’s guidance prohibiting covered entities (CEs) and business associates (BAs) from using the web-tracking technologies...more

Guidepost Solutions LLC

Artificial Intelligence Governance – First, Build On What You Have

As artificial intelligence (AI) continues to advance rapidly, organizations of all types are seeking to deploy this powerful tool to increase the effectiveness and efficiency of their operations, improve service to their...more

Dentons

Ep. 10 - How to Conduct an Effective Risk Assessment… And Why You Need One!

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The most successful compliance programs are constantly evolving and always in motion.  They are both action-oriented and flexible. How do you build a program that’s action-oriented and flexible?  You implement a detailed work...more

Health Care Compliance Association (HCCA)

The compliance lessons in the wake of the Supreme Court decision in U.S. ex rel Schutte v. SuperValu, Inc.

The False Claims Act (FCA) permits private individuals to bring lawsuits in the name of the United States—called qui tam—against those they believe have defrauded the federal government: 31 U.S.C. § 3730(b). The FCA thereby...more

Fenwick & West LLP

Washington’s My Health My Data Act – A Roadmap for Compliance

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What is the new Washington My Health My Data Act (MHMDA)? MHMDA aims to provide stronger privacy protections for “consumer health data” by: - Requiring additional disclosures for the collection, use, and sharing of...more

Dentons

Ep. 7 – Be a Problem Solver, Not a Prosecutor

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The compliance officer is one of the most important positions within the organization, but also one of the most challenging. You’re expected to be a teacher, a coach, a project manager, a good listener, and a role model....more

Health Care Compliance Association (HCCA)

Behavioral health, artificial intelligence, and compliance

Technology’s exponential development and use in healthcare provides potentially significant benefits for behavioral health patients but also raises ethical and compliance concerns. The most recent technological advance...more

AEON Law

Patent Poetry: European Union Approves First Wide-Scale AI Law

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European lawmakers have reached an agreement on the world’s first comprehensive law on artificial intelligence (AI). According to the MIT Technology Review, The AI Act was conceived as a landmark bill that would mitigate...more

Health Care Compliance Association (HCCA)

BA Depicted by OCR as Example of Ransomware Dangers Recovered Quickly, Didn’t Expect Fine

Report on Patient Privacy 23, no. 11 (November, 2023) Tim DiBona clearly remembers Christmas Eve 2018 when the staff of his small firm—Doctors’ Management Service (DMS)—arrived at their West Bridgewater, Mass., office to...more

Health Care Compliance Association (HCCA)

11 Years After First Disclosure, L.A. Care Pays $1.3M, Says ‘Processing Errors’ Caused Breaches

Report on Patient Privacy 23, no. 10 (October, 2023) By 2016, it should have been clear to HIPAA covered entities that a security risk analysis—and corresponding risk management plan—were compliance basics. Yet, a new...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

Butler Snow LLP

Health Care Due Diligence: An Ounce of Prevention is Worth a Pound of Cure

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Due diligence properly performed in connection with the purchase and sale of a health care entity is simply different—vastly so—than due diligence performed in other contexts. Failure to recognize this reality can lead to...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

Health Care Compliance Association (HCCA)

Adding some spice to your compliance program

Every quarter, each acute care hospital that is paid under the Inpatient Prospective Payment System has access to an Excel workbook that contains valuable information about your hospital’s compliance with myriad Medicare...more

Health Care Compliance Association (HCCA)

Patient Safety

Patient safety remains a challenge for organizations, and not for want of trying to address the problem. Improving it is an issue addressed here and at the 2023 HCCA Compliance Institute by Deb McCracken, Chief Risk Officer,...more

Gardner Law

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

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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

The Volkov Law Group

Hospitals and Physician Relationships – Navigating Stark, AKS and Fraud Risks (Part III of III)

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Chief compliance officers at hospitals face a crushing burden of risks. The HHS-OIG has vigorously scrutinized hospitals compensation of physicians, especially for potential anti-kickback and Stark law violations. Most of...more

Thomas Fox - Compliance Evangelist

Risk in Compliance Week: Part I – Forecasting

This week I will feature a series on risk in compliance where I will be joined by Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to explore risk forecast, risk assessment...more

The Volkov Law Group

FCPA Recidivists: Zimmer Biomet (Part I of II)

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The drug and medical device industries have been taking it on the FCPA chin for years. The risk factors in the international marketplace are significant – healthcare professionals are normally government employees; government...more

Burr & Forman

Meaningful Compliance Equals Sound Financial Management

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In traditional finance parlance the term "risk management" involves identifying events that can have adverse financial consequences and then taking action to prevent and/or minimize the damage caused by these events. Thus...more

NAVEX

Enterprise Risk Management: The benefits of online policy and procedure management systems

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ABSTRACT - Operational inefficiencies, sub-optimal patient care, financial losses and missing or ineffective sanctions for non-compliance are all potential outcomes that can stem from passive policy and procedure management....more

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