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Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests

Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more

Telehealth Awareness Week: Insights on Telehealth

In support of the American Telemedicine Association's Telehealth Awareness Week (September 19-25, 2021), Jones Day's Digital Health team shared key insights on various legal topics applicable to telehealth. Jones Day's...more

DOJ Ramps Up Coordinated Law Enforcement Action to Combat Health Care Fraud Related to COVID-19

On May 26, 2021, DOJ announced a series of coordinated law enforcement actions against 14 defendants across seven federal districts for alleged participation in fraudulent health care schemes that, according to the...more

DOJ Announces $2.2 Billion in 2020 FCA Recoveries and Identifies 2021 Priorities

The Situation: The U.S. Department of Justice ("DOJ") published its annual report regarding False Claims Act ("FCA") recoveries for fiscal year 2020 (ending September 2020) and announced its priorities for 2021. The...more

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