News & Analysis as of

Healthcare Risk Assessment

Oberheiden P.C.

Understanding the Risks (and Costs) of Defective Abiomed Impella Heart Pumps

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Abiomed, Inc., a subsidiary of Johnson & Johnson, is facing lawsuits across the country related to the company’s Impella heart pumps. Since June of last year, the company has issued multiple recalls for these implantable...more

Davis Wright Tremaine LLP

Project W: Takeaways From WEB | Health Tech and the Women Transforming Healthcare

On June 13, in Culver City, twelve founders and over two dozen investors and experts convened for Project W's Women Entrepreneurs Boot Camp | Health Tech to drive innovation that is transforming the delivery of healthcare and...more

Mintz - Health Care Viewpoints

Colorado AI Systems Regulation: What Health Care Deployers and Developers Need to Know

As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more

Ankura

OIG Testimony Puts a Spotlight on Clinical Documentation and Payer Risk

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In recent testimony before the United States House Committee on Energy and Commerce Subcommittee on Oversight and Investigations, Christi A. Grimm, Inspector General of the Department of Health and Human Services (HHS)...more

ArentFox Schiff

Da Brat and The Latest (Rap) Battle: FDA Expected to Drop Sperm Donation Ban for Gay Men

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Under current US Food and Drug Administration (FDA) guidance, sexually active gay and bisexual men are prohibited from anonymously donating sperm. The FDA is expected to reverse this longstanding practice and adopt a system...more

Dentons

Ep. 14 - Implementing AI and Mitigating Compliance Risks – Part I

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At the Health Care Compliance Association’s recent Annual Compliance Institute in Nashville, artificial intelligence (AI) dominated the conversation. A common theme: how does the compliance officer keep pace with this...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)

Employees’ Misdeeds, Lack of Risk Analysis Cost NY Hospital $4.75M; OCR Issues Warning

Although the HHS Office for Civil Rights (OCR) described its recent $4.75 million agreement with a Bronx, New York, hospital as settling a “malicious insider cybersecurity investigation,” the agency considered a total of 11...more

Gardner Law

Highlights from OIG’s New Compliance Program Guidance

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The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) released an important new compliance resource in November 2023. The HHS OIG’s new General Compliance Program Guidance (GCPG) is intended...more

Burr & Forman

A New Year’s Resolution: Update Your Compliance Program Based on New Government Guidance

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For the year ending September 30, 2023, federal False Claims Act settlements and judgments exceeded $2.5 billion, much of which came from the health care industry. The largest, at over $487 million, stems from a finding by a...more

Health Care Compliance Association (HCCA)

Privacy Briefs: January 2024

New York has released proposed cybersecurity regulations for hospitals. The regulations, which were published in The State Register on Dec. 6 and will undergo a 60-day public comment period ending on Feb. 5, are designed to...more

Manatt, Phelps & Phillips, LLP

New York Announces Two Major Artificial Intelligence Initiatives

On January 8, 2024, New York Governor Kathy Hochul and the New York Office of Information Technology Services (NY ITS) announced two major initiatives on artificial intelligence (AI) that will impact private and public...more

The Volkov Law Group

HHS-OIG Guidance — Practical Steps to Achieve Effective Compliance (Part III of III)

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Within the specific element discussions in HHS-OIG’s Guidance, are important operational details and strategies for an effective compliance program.  GCPG provides important suggestions and innovations for consideration by...more

Manatt, Phelps & Phillips, LLP

HHS OIG Unveils First New Compliance Program Guidance for Health Care Stakeholders Since 2008

The Big Picture - Many health care stakeholders have long relied on the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) guidance regarding an effective compliance program when...more

Mintz - Health Care Viewpoints

State AGs Demand Action on Pulse Oximeter Inaccuracy as FDA's Efforts Lag

A new battle is emerging in the fight for health equity, and it’s centered on the humble pulse oximeter. On November 1, 2023, 25 state attorneys general sent a letter to the Food and Drug Administration (FDA) demanding that...more

Mintz - Health Care Viewpoints

Key Takeaways from the OIG’s New Comprehensive General Compliance Program Guidance

The Department of Health and Human Services’ Office of Inspector General (OIG) published a General Compliance Program Guidance (GCPG) on November 6, 2023, marking the first update to OIG’s compliance program guidance...more

Burr & Forman

HHS OCR/ONC Announce an Updated Version of Its HIPAA Security Risk Assessment Tool

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The Office of the National Coordinator for Health Information Technology (ONC) and the HHS Office for Civil Rights (OCR) have recently launched a joint HIPAA Security Risk Assessment (SRA) Tool. The tool is designed to assist...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

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

Butler Snow LLP

Cybersecurity: What Businesses Need to Know

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Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more

The Volkov Law Group

The Unique Elements of Healthcare Compliance Programs (Part II of II)

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Corporate compliance programs in the healthcare industry include many of the same elements that we are all familiar with – risk assessments, code of ethics, written policies and procedures, comprehensive training...more

Health Care Compliance Association (HCCA)

Can compliance officers unring the bell?

Ideally, compliance officers are brought into their organization’s discussions about potential business deals at the outset to help ensure they start on a compliant path. Unfortunately, compliance officers are sometimes asked...more

Health Care Compliance Association (HCCA)

Five Years After ‘a Singular Human Error,’ Two Breach Notices, Revenue Firm Settles With OCR

Five Years After ‘a Singular Human Error,’ Two Breach Notices, Revenue Firm Settles With OCR - As far as settlements for alleged HIPAA violations go, a recent agreement announced by the HHS Office for Civil Rights (OCR)...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 2, February 2023

Illinois Supreme Court Allows Massive Damages in Biometric Privacy Cases - “The case involves Ohio-based fast-food company White Castle.” Why this is important: Illinois has the strictest biometric privacy law in the...more

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