News & Analysis as of

New Guidance Department of Health and Human Services (HHS) Hospitals

Morgan Lewis

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

Morgan Lewis on

On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

Verrill

Don’t Wait – CMS Expects Hospitals to Take Action on Informed Consent for Certain Exams and Procedures

Verrill on

Hospitals should not delay in reviewing and revising their surgical informed consent forms and policies. On April 1, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued new guidance regarding informed consent...more

Holland & Knight LLP

While You Were Sleeping: HHS Releases New Guidance on Sensitive Examinations

Holland & Knight LLP on

"Informed consent" has been described as "a bedrock principle of healthcare in a free society," and if a "patient is denied the ability to exercise or even consider informed consent, the patient's personal liberty suffers."1...more

Epstein Becker & Green

Updated Requirements for Informed Consent: HHS Issues New Guidance on Sensitive Exams

On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”) released new guidance which requires hospitals to obtain informed consent from patients before practitioners, or medical or other students, perform...more

Proskauer - Health Care Law Brief

HHS Publishes Roadmap of New Strategy for Cybersecurity in the Healthcare Sector

The U.S. Department of Health and Human Services (HHS) recently issued a strategy paper highlighting key aspects of its plan to revamp cybersecurity requirements in the healthcare industry. Citing a 93% increase in large data...more

McDermott Will & Emery

HHS Announces New Guidance on Reproductive Healthcare

McDermott Will & Emery on

On July 8, President Biden signed an executive order for abortion access. In this order, the US Department of Health and Human Services (HHS) pledged to take steps to ensure that all patients have access to the full rights...more

Foley & Lardner LLP

U.S. Cybersecurity Organizations Issue Warning on Ransomware Activity Targeting Healthcare with Guidance Applicable to All...

Foley & Lardner LLP on

On October 28, 2020, the U.S. Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of Investigation (FBI), and the U.S. Department of Health and Human Services (HHS) issued a joint warning that they...more

Bass, Berry & Sims PLC

HHS Issues Guidance Regarding Relief Fund Reporting and Auditing Requirements

Bass, Berry & Sims PLC on

The U.S. Department of Health and Human Services (HHS) recently issued new guidance regarding reporting and auditing requirements that may impact providers and suppliers who retain payments received from the Public Health and...more

Foley Hoag LLP - Medicaid and the Law

CMS Issues Guidance to States on 340B Duplicate Discounts

Late last year, we noted that the Massachusetts Medicaid program had proposed regulations to address issues related to the prohibition on duplicate discounts in the 340B program. The Massachusetts solution was relatively...more

Sands Anderson PC

New Cybersecurity Threat Identification and Prevention Guidance from HHS

Sands Anderson PC on

As a result of ongoing efforts under the Cybersecurity Act of 2015, the Department of Health and Human Services (HHS) has partnered with public and private sector entities to develop guidance for healthcare entities seeking...more

Baker Donelson

CMS Issues Updated Medicare Payment and Billing Policies for 340B Hospitals

Baker Donelson on

On April 2, 2018, CMS issued updated guidance related to the dramatic Medicare payment reductions that went into effect this year for certain 340B hospitals. The guidance explains the planned application of the payment cuts...more

Holland & Knight LLP

Religious Institutions Update: January 2018 - Lex Est Sanctio Sancta

Holland & Knight LLP on

Timely Topics - By Shannon B. Hartsfield - The U.S. Department of Health and Human Services (HHS) announced on Jan. 18, 2018, the creation of a new division within its Office for Civil Rights (OCR). OCR is described as...more

Patterson Belknap Webb & Tyler LLP

HSS Issues New Guidance on Ransomware Attacks Against HIPAA-Covered Entities

Ransomware attacks at hospitals and other healthcare facilities have dramatically increased over the last several years, putting healthcare providers in the uncomfortable position of having to consider paying thousands of...more

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

King & Spalding on

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

Foley & Lardner LLP on

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

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