News & Analysis as of

Software Health Insurance Portability and Accountability Act (HIPAA)

Hanzo

Compliance Under Pressure: Audit Readiness for Healthcare Providers

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In today’s healthcare environment, compliance is a defining element of patient care quality, operational integrity, and public trust. Oversight from agencies such as the Office for Civil Rights (OCR), the Centers for Medicare...more

Orrick, Herrington & Sutcliffe LLP

Medical Devices, Cybersecurity & The False Claims Act: What are the Key Takeaways from the Illumina - DOJ Settlement?

Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...more

Proskauer - Health Care Law Brief

This New Year, California Imposes Guardrails on the Use of AI by Payors for Utilization Management Determinations

SB 1120 (the “Bill”), which takes effect on January 1, 2025, amends existing California law to adopt guardrails around the use of artificial intelligence tools for the purpose of utilization management. As discussed in a...more

Clark Hill PLC

Right To Know - December 2024, Vol. 24

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Cyber, Privacy, and Technology Report - Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed....more

Mitratech Holdings, Inc

10 SMART Goals for Legal Operations Professionals in 2025

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Targeted, Actionable SMART Goals to Help Your Team Drive Greater Efficiency, Compliance, and Strategic Value - We’ve known for a while that legal operations teams are a strategic partner to the wider business, but thanks...more

Nelson Mullins Riley & Scarborough LLP

Particle Health, Epic, Carequality, and the Economics of Health Information Exchange

Particle Health Inc's 81-page antitrust lawsuit against Epic Systems Corporation, filed in federal court in New York on September 23, raises a number of important questions, including what extent of information sharing is...more

Foley & Lardner LLP

Rolling With the Punches in a Networked World: CCOE Cybersecurity Panel Discussion

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Whether the game is football, baseball, hockey, or Indy Car racing, no team goes into their major championship matchup without training. Companies need to train as well if they intend to operate on the internet and expect to...more

Mintz

Healthcare Provider Beware: Massachusetts Federal Court Largely Permits Tracking Technologies and Wiretapping Claims To Proceed

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In the privacy world, pixels, cookies, and tracking technologies get all the attention these days. Plaintiffs and regulators alike have been working to persuade courts nationwide that the presence of third-party tracking...more

Venable LLP

Navigating the Future: Medicare Advantage Plan Rules on the Use of Artificial Intelligence

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The use of technology in healthcare services and payment for healthcare is evolving at an unprecedented pace, reshaping how medical services are delivered, managed, and paid for. The use of artificial intelligence systems...more

King & Spalding

Florida Digital Bill of Rights

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On June 6, 2023, the Florida Digital Bill of Rights (“FDBR”) was signed into law, and goes into effect on July 1, 2024 with some exceptions—the prohibition of government-directed content moderation of social media platforms...more

Ankura

Updates to the Translation and Accessibility Standards for Required Materials and Content in the Medicare 2024 Final Rule

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Medicare Advantage Organizations and Part D sponsors have a responsibility to ensure they offer and provide their members and potential enrollees with content and materials in alternate languages or accessible formats for...more

Holland & Hart LLP

To BAA or Not to BAA: Must You Have One?

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HIPAA applies to both covered entities (e.g., healthcare providers and health plans) and their business associates. A “business associate” is generally a person or entity that “creates, receives, maintains or transmits”...more

Cozen O'Connor

The State AG Report – 10.19.2023

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: • Healthcare Co.’s Coding Error Allegedly PHI-cilitates...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

White & Case LLP

Florida Enacts the Digital Bill of Rights, Joining the Growing Privacy Landscape

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Florida Governor Ron DeSantis recently signed Senate Bill 262 into law, adopting the "Digital Bill of Rights" proposed by his office in February. Florida joins the rapidly increasing group of states, California, Utah,...more

Jones Day

Vital Signs Digital Health Law Update | Summer 2023

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we take an in-depth look at generative artificial intelligence...more

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 10

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A mobile application developer of ovulation and period tracking software agrees to pay civil penalties and 20 years of independent monitoring for violating the Health Breach Notification Rule for sharing sensitive personal...more

Health Care Compliance Association (HCCA)

Privacy Briefs: June 2023

Privacy Briefs: June 2023 - Long-term care pharmacy network PharMerica disclosed a breach involving more than 5.8 million patients, making it the largest breach reported to the HHS Office for Civil Rights (OCR) in the last...more

Robinson+Cole Data Privacy + Security Insider

MedEvolve OCR Settlement for $350,000 due to Alleged Failures to Protect Data

On May 17, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced a settlement with MedEvolve, Inc. for $350,000. MedEvolve provides practice and revenue cycle management and practice...more

J.S. Held

Litigation Surge From the Use of Tracking Technology & the Sharing of Healthcare and Personal Data

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Introduction: Tracking Software in the Healthcare Industry - Privacy-related concerns have become increasingly prominent in recent years, especially with the widespread use of third-party tracking tools such as tracking...more

Buchalter

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

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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

Foley & Lardner LLP

Anatomy of an Agreement: Unique SaaS Contract Structures and Key Terms to Address in the Cloud

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Companies procuring or providing Software-as-a Service (SaaS) technology need some form of contract to govern the relationship between the SaaS provider and customer. As with many intellectual property (IP) and technology...more

BakerHostetler

Latest FTC Health Privacy Case Sheds Light on Agency Health Privacy Approaches

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Health privacy has been a Federal Trade Commission (FTC) priority for decades, and indeed, one of its very first privacy cases, in the early 2000s, involved the inadvertent sharing of user health data. Fast-forward a few...more

Ankura

5 Best Practices for Third Party Risk Management

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Organizations are becoming increasingly reliant on external parties to manage parts of their business. The centralized knowledge, expertise, and economies of scale that third parties provide enables organizations to focus...more

MoFo Life Sciences

Global Healthtech CEO Connect: Software As A Medical Device In The U.S. And EU Recap

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On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device...more

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