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On July 10, 2024, the Office of the National Coordinator for Health Information Technology ('ONC') within the U.S. Department of Health and Human Services ('HHS') issued a proposed rule titled [...]

Introduction On January 5, 2024, the U.S. Food and Drug Administration ('FDA') approved Florida's Section 804 Importation Program ('SIP'), pursuant to FDA's authority under Section 804 of the Federal Food, [...]

In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued [...]

Will the United States Attorney General, via the U.S. Drug Enforcement Administration ('DEA') follow the recent recommendation of the U.S. Department of Health and Human Services ('HHS') to reschedule cannabis [...]

Just two business days before the first of many critical components of the new 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the [...]

Under the orders, health care regulators are to address alleged kickbacks, access to 'life-saving medications,' drug importation, and 'most-favored-nation' proposal. On July 24, 2020, President Trump signed four executive orders [...]

Historically, complaints regarding price gouging have arisen following hurricanes, tornadoes or other natural disasters. These disasters usually affect a limited geographic area and lead to local price increases for food, [...]

The U.S. Department of Health and Human Services (HHS) started the new decade by keeping up its momentum to encourage patient engagement and support the secure expansion of digital health [...]

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how [...]