Tag Archives: Mobile Apps

Bipartisan Bill Introduced in Senate Would Regulate COVID-19 Apps

Senators Maria Cantwell (D-WA) and Bill Cassidy (R-LA) introduced bipartisan legislation this week to address privacy issues in the COVID-19 era.  The proposal, entitled the “Exposure Notification Privacy Act,” would regulate “automated exposure notification services” developed to respond to COVID-19.  This bipartisan legislation comes on the heels of dueling privacy proposals from both political parties.  … Continue Reading

Germany Publishes Draft Regulation on the Reimbursement of Digital Health Applications

Germany recently enacted a law that enables state health insurance schemes to reimburse costs related to the use of digital health applications (“health apps”), but the law requires the Federal Ministry of Health to first develop the reimbursement process for such apps.  Accordingly, on January 15, 2020, the German government published a draft regulation setting … Continue Reading

Pharmaceutical Digital Health Innovators Take Note: FDA Public Hearing on an Innovative Approach to Devices Referencing Drugs

On November 16, 2017, the Food and Drug Administration (“FDA” or the “Agency”) will hold a public hearing on a proposed approach for sponsors seeking to market devices referencing drugs (“DRDs”) when the drug sponsor does not wish to collaborate with the sponsor of the device. FDA will accept comments to the docket until January … Continue Reading
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