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FTC Announces Final Rule Sweeping Consumer Digital Health Tech Under the Health Breach Notification Rule

On April 26, the Federal Trade Commission (FTC) approved its Final Rule revising the Health Breach Notification Rule (HBNR) (“Final Rule”) by a 3-2 vote. The HBNR requires vendors of personal health records (PHR) and related...more

FTC Announces First Enforcement of the Health Breach Notification Rule

On February 1, the Federal Trade Commission (“FTC”) announced its first enforcement action under the Health Breach Notification Rule (“HBNR” or “Rule”) against GoodRx, a direct-to-consumer digital healthcare and prescription...more

FTC Warns Health Apps and Connected Device Companies to Comply with the Health Breach Notification Rule

On September 15, 2021, the Federal Trade Commission (“FTC”) issued a Policy Statement instructing health app and connected device companies to comply with the Health Breach Notification Rule (“the Rule”). The Rule, codified...more

HRSA Implements Administrative Dispute Resolution Process for 340B Program

On December 10, 2020, HRSA issued a final rule (the Final Rule) implementing the 340B Drug Pricing Program administrative dispute resolution (ADR) process–an overdue mandate from the Affordable Care Act. Under the Final...more

CMS and ONC Release Interoperability and Patient Access Final Rules

On March 9, 2020, CMS released its final rule creating certain interoperability and patient access standards (CMS Final Rule). On the same day, the ONC released a rule that addressed interoperability as well (ONC Final...more

CMS Issues CY 2020 End-Stage Renal Disease / Durable Medical Equipment Final Rule

On October 31, 2019, CMS issued a final rule (the Final Rule) that updates payment policies and rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) effective for calendar year (CY) 2020 and makes...more

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