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Latham & Watkins LLP

US AI Standards Take Shape: Key 180-Day Developments Following White House AI Executive Order

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Companies should consider how new AI risk standards may align to their operations and whether to comment on the draft standards to shape their development. On April 29, 2024, the White House announced that several federal...more

Fenwick & West LLP

Cyber Resilience After the Change Healthcare Breach

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More than two months after the February 2024 Change Healthcare cyber-ransom attack, the healthcare industry continues to grapple with the fallout, creating significant challenges, disruptions, and outages to the healthcare...more

Health Care Compliance Association (HCCA)

Privacy Briefs: April 2024

The Cybersecurity and Infrastructure Agency (CISA) is seeking comment on a proposed rule to implement reporting requirements for critical infrastructure entities, including health care entities, on cyberattacks and ransomware...more

Robinson+Cole Health Law Diagnosis

Forecasting the Integration of AI into Health Care Compliance Programs

Health care entities maintain compliance programs in order to comply with the myriad changing laws and regulations that apply to the health care industry. Although laws and regulations specific to the use of artificial...more

Epstein Becker & Green

2024 Update: Regulators Use “Carrots and Sticks” to Incentivize Healthcare Sector Cybersecurity Compliance

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Healthcare organizations continue to be prime targets of cyberattacks. It is well-established that cyberattacks can lead to financial loss, reputational damage, and, in some cases, risks to patient care and safety. The recent...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Federal Regulators Unveil Revised Final Guidance for Healthcare Cybersecurity and HIPAA Compliance

On February 14, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) published a new, final version of their guidance for...more

BakerHostetler

HHS Publishes ‘Voluntary’ Healthcare Cybersecurity Performance Goals in Record Time but Leaves Questions Unanswered

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As previously reported in this blog, on Dec. 6, 2023, the Department of Health and Human Services (HHS or the Department) released a “concept paper,” which laid out its vision of future action regarding healthcare...more

Alston & Bird

HHS Issues Cybersecurity Performance Goals Specific to the Health Care and Public Health Sector

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Our Health Care and Privacy, Cyber & Data Strategy Groups delve into the Department of Health and Human Services’ extensive efforts to encourage health care organizations to better protect patients’ privacy through better...more

Bradley Arant Boult Cummings LLP

Florida Bill Proposes Safe Harbor Against Breach Suits to Businesses Maintaining Recognized Cybersecurity Programs

A recently introduced bill in the Florida Legislature would provide businesses operating in Florida, including health care providers, with a legal defense to data breach lawsuits if they maintain robust cybersecurity measures...more

WilmerHale

President Biden’s Executive Order Sets Ambitious Agenda for AI Development and Use

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Our initial thoughts on the Biden Executive Order first appeared on WilmerHale’s Privacy and Cybersecurity Blog the day that the Executive Order was released. On October 30, 2023, the Biden Administration issued its...more

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

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President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...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

Akin Gump Strauss Hauer & Feld LLP

HHS Unveils New Cybersecurity Guide

The U.S. Department of Health and Human Services (HHS) continues to play a central role in helping health care organizations defend against cybersecurity threats, issuing cybersecurity briefs and a new cybersecurity framework...more

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

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On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

Orrick, Herrington & Sutcliffe LLP

HHS releases health care cybersecurity guide

On March 8, the Department of Health and Human Services (HHS) released a cybersecurity implementation guide to assist public and private health care sectors prevent cybersecurity incidents. The Cybersecurity Framework...more

Hogan Lovells

FDA M-CERSI AI workshop highlights future FDA comment period on AI in drug development

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The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a one-day virtual public workshop entitled,...more

BakerHostetler

OCR releases YouTube Addressing “Recognized Security Practices” in HIPAA Enforcement Context

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As a Halloween treat for HIPAA-covered entities and business associates, on October 31, the Department of Health and Human Services Office for Civil Rights (OCR) released a new video on its YouTube channel, in which senior...more

K&L Gates LLP

Health Care Triage: Cybersecurity & HIPAA: NIST’s Practical Guidance Updates for Covered Entities and Business Associates

K&L Gates LLP on

In this episode, Rebecca Schaefer and J.D. Koesters review key components of the recent National Institute of Standards and Technology (NIST) revised publication regarding cybersecurity. They highlight how this resource...more

BakerHostetler

‘Unboxing’ the New NIST Guidance: NIST Publishes Significant Update to Healthcare Cybersecurity Guide

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​​​​​​​Without question, healthcare providers and the companies that support them operate in an elevated cybersecurity risk environment. And when a cybersecurity incident occurs, the ensuing regulatory inquiries and/or...more

Hogan Lovells

HHS seeks comment by June 6 on recognized security practices as mitigating factor in HIPAA enforcement

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The US Department of Health Human Services (HHS) is seeking public comments about the appropriate role of “recognized security practices” in enforcement of the HIPAA Security Rule. Congress, through an amendment to the HITECH...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Holland & Knight LLP

Get Ready for HIPAA Questions on Your Recognized Security Practices

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An amendment to the Health Information Technology for Economic and Clinical Health (HITECH) Act was signed into law on Jan. 5, 2021, directing U.S. Health and Human Services (HHS) to consider "recognized security practices"...more

Hogan Lovells

NIST seeks public comment to inform updates to HIPAA Security Rule guidance

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The National Institute of Standards and Technology (NIST) is seeking public comment as it prepares to update its Introductory Resource Guide on implementing the Health Insurance Portability and Accountability Act (HIPAA)...more

Bradley Arant Boult Cummings LLP

Information Blocking Rule Compliance Date Extended Due to Pandemic

The U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released an interim final rule on October 29, 2020, delaying the implementation of the...more

Epstein Becker & Green

Data Breaches and HIPAA Enforcement Remain Endemic Amidst the COVID-19 Pandemic

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Recently, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS), the agency enforcing the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach...more

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