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Regulatory Standards Department of Health and Human Services (HHS) Healthcare Reform

Health Care Compliance Association (HCCA)

An international standard for healthcare quality management

In October 2023, the International Organization for Standardization (ISO) published ISO 7101, Healthcare organization management: Management systems for quality in healthcare organizations. ISO 7101 is the latest in a series...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Manatt, Phelps & Phillips, LLP

When California Minors Need Mental Health Treatment, Who Can Consent, and to What?

Increasing mental health care needs for minors present a range of legal issues for children, parents, health care providers and health care payors. While state laws typically govern who has the power to consent to or refuse...more

Hogan Lovells

HHS Publishes Final SUNSET Rule With New Exemptions and Timelines

Hogan Lovells on

On 19 January 2021, the U.S. Department of Health and Human Services (the Department or HHS) published in the Federal Register Final Rule entitled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET).” The...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Obermayer Rebmann Maxwell & Hippel LLP

Trump’s Administration Plans to Fix U.S. Healthcare System through Choice and Competition

The Trump administration has issued a 119-page report Reforming America’s Healthcare System Through Choice and Competition that reaffirms the administration’s effort to deregulate the healthcare industry in an attempt to...more

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