News & Analysis as of

Risk Mitigation Healthcare

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

Robinson+Cole Data Privacy + Security Insider

HC3 Issues Threat Reports on Qilin + MoveIt

The Health Sector Cybersecurity Coordination Center (HC3) provides timely updates to the health care sector on cybersecurity threats and mitigation. In the last several weeks, HC3 has issued two alerts worth paying close...more

American Conference Institute (ACI)

U.S. Implications of the EU AI Act

The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more

Akin Gump Strauss Hauer & Feld LLP

Senate AI Working Group Releases Long-Anticipated Roadmap for AI Policy

On May 15, 2024, the Senate AI Working Group—Senate Majority Leader Chuck Schumer (D-NY) and Sens. Mike Rounds (R-SD), Todd Young (R-IN), and Martin Heinrich (D-NM)—issued their long-anticipated Roadmap for Artificial...more

King & Spalding

Senators Introduce New Bill for Transparency and Oversight in Health Care Transactions and Investment

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On April 3, 2024, Senators Ed Markey (D-Mass) and Elizabeth Warren (D-Mass) released draft legislation titled the “Health Over Wealth Act” (the Proposed Bill). This Proposed Bill is another attempt to regulate private...more

Pillsbury Winthrop Shaw Pittman LLP

Congress Continues to Address AI in Bipartisan Fashion, Launching House AI Task Force as Latest Step

House leadership announced the launch of the Task Force on Artificial Intelligence (AI), a bipartisan group that will develop a report outlining AI regulatory priorities and setting guiding principles to help shape the AI...more

Spilman Thomas & Battle, PLLC

HHS Cybersecurity Performance Goals and the Healthcare Industry

The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare industry is such a ripe hunting ground for cybercriminals, the...more

Buckingham, Doolittle & Burroughs, LLC

Hey Doc, Be Careful on TikTok - Legal Pitfalls of Healthcare Providers in the Social Media Age

Imagine you are scrolling on TikTok, Facebook, Instagram, or one of the multitude of other social media platforms that almost every one of us have on our devices, and you come across a video of a physician discussing medical...more

Society of Corporate Compliance and Ethics...

Good news, bad news

There’s good and bad news out there for compliance departments, and it’s also the same news: Governments now very much appreciate strong compliance programs. On the one hand, that is very good (if not great!) news....more

Jones Day

HHS Announces Upcoming Federal Strategies to Enhance Cybersecurity for Health Care and Public Health Sectors

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The Department of Health and Human Services ("HHS") has released a concept paper outlining its new cybersecurity strategies for the health care sector, identifying cybersecurity priorities, potential future regulations and...more

NAVEX

From Healthcare Sector, a Big Push for CCO Autonomy

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For the better part of a decade, the U.S. Justice Department has led the way on calls for a strong, independent corporate compliance function – until recently, that is. Then the Department of Health and Human Services leaped...more

Robinson+Cole Data Privacy + Security Insider

CISA Issues Mitigation Guide for Healthcare + Public Health Sector

On November 17, 2023, the Cybersecurity & Infrastructure Security Agency (CISA) released a supplemental mitigation guide for the healthcare and public health sector to the Cyber Risk Summary for those sectors published on...more

Baker Donelson

Health Care Remains a Top Target for Hackers

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The recently released 2023 IBM Security Cost of a Data Breach Report highlights that cyberattacks against the Health Care Sector continue to increase, leading the list of most expensive remediations for the 13th year in a...more

Mitratech Holdings, Inc

Inside the U.S. Government’s First AI Executive Order: 8 Pillars of Action

A first-of-its-kind executive order issued October 2023 already has the voluntary commitment of several major technology companies — here’s why. Just last week, President Joe Biden signed a new, first-of-its-kind AI...more

Ankura

Is Your DNA Safe? DNA Sequencing Machines Found to Contain Critical Vulnerabilities

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Key Points: Illumina DNA sequencing machines are vulnerable to exploitation. Both the Cybersecurity and Infrastructure Security Agency (CISA) and the Food and Drug Administration (FDA) have published advisories urging all...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

Foley & Lardner LLP

AI in Health Care: Regulatory Landscape & Risk Mitigation

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Health care, like most industries, is grappling with the proliferation of artificial intelligence (AI) and the novel risks and benefits it presents. Balancing these risks and benefits can be especially challenging for...more

King & Spalding

DOJ’s Recent Loss in Antitrust Labor Case Highlights Ongoing Focus on Alleged Healthcare Labor Market Restrictions

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The Government Continues to Seek Criminal Sanctions in Cases Regarding Wage-Fixing and No-Poach Agreements - On Wednesday, March 22, a Maine federal jury acquitted four operators of home health agencies who were accused of...more

King & Spalding

Twenty-One State Attorneys General and the District of Columbia Back HHS’s Plan to Hold Hospitals and Other Providers Liable for...

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On October 3, 2022, the Attorneys General for California, New York, and Massachusetts, in collaboration with Attorneys General from 18 other states and the District of Columbia (State Attorneys General) submitted a comment...more

Robinson+Cole Health Law Diagnosis

Privacy Tip – Health Care Sector Continues to Be Hit with Ransomware

According to the 2022 State of Ransomware Report issued recently by Sophos, it surveyed 5,600 IT professionals from 31 countries, including professionals in the health care sector. Those professionals in the health care...more

Arnall Golden Gregory LLP

Georgia COVID-19 Prevention and Mitigation Assisted Living Communities and Personal Care Homes Grant To Provide $47 Million for...

Georgia assisted living communities and personal care homes will be eligible for up to $100,000 of grant funding to reimburse COVID-related expenses. Georgia Governor Brian P. Kemp announced he will award over $217 million...more

King & Spalding

Focus on Data Governance in Healthcare: Part One of a Three-part Series on Data Governance, Data Analytics and Artificial...

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Hospital systems, provider groups, and other healthcare organizations are uniquely situated to drive technological innovation in the provision of healthcare services in large part because of the patient and other data to...more

Nelson Mullins Riley & Scarborough LLP

Health Care Companies Face Financial Strain from Data Breaches

The intersection of health and bankruptcy law could not be more pronounced in the event of a cataclysmic event. A cyberattack is such an event. Following the cyberattack on Colonial Pipeline, which led to a multiday shutdown...more

Ballard Spahr LLP

HIPAA: Privacy Required, Even When Information Goes Public

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A celebrity collapses on stage and is rushed to the hospital. Rumors race through social media faster than the ambulance can navigate city streets. Was it exhaustion? Was it her heart? Was there a gunshot? ...more

Stinson LLP

FDA: The Powdered Gloves Come Off

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In a rare move, the Food and Drug Administration (FDA) announced on Friday that it is banning the following devices after determining that they present an unreasonable and substantial risk of illness or injury that cannot be...more

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