Yesterday, the Federal Communications Commission (“FCC”) granted GE Healthcare (“GEHC”) a waiver of its equipment authorization rules to allow for the importation, marketing, and operation of certain medical devices that have yet to receive authorization under applicable FCC requirements. The GEHC devices at issue include bedside and wearable patient monitors; telemetry transmitters; antenna infrastructure; wireless
FCC Embarks on New Rural Health Initiatives with CARES Act Funding
In light of the COVID-19 pandemic, Congress and the Federal Communications Commission (FCC) have ramped up efforts to subsidize the provision of the telecommunications and broadband services necessary to deliver telehealth solutions. This includes steps to make it easier for eligible health care providers to secure funding under the FCC’s existing Rural Healthcare (RHC) program,…
FCC Clarifies that COVID-19 “Emergency Purposes” Calls/Text are Not Subject to “Prior Express Consent” Requirement
On March 20, the Federal Communications Commission (“FCC”) on its own motion released a Declaratory Ruling to confirm that the COVID-19 pandemic constitutes an “emergency” under the Telephone Consumer Protection Act (“TCPA”); as a consequence, hospitals, health care providers, state and local health officials, and other government officials may lawfully communicate through automated or prerecorded calls (which include text messages) information about the coronavirus and mitigation measures to mobile telephone numbers and certain other numbers (such as those of first responders) without “prior express consent.”…
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U.S. FCC Repeals 2015 Net Neutrality Rules; Impact on Digital Health Solutions Debated
Today, as expected, the U.S. Federal Communications Commission (“FCC”) adopted an order repealing the agency’s 2015 net neutrality rules and changing the legal framework that governs Internet Service Providers (“ISPs”). The vote split along party lines, with the agency’s three Republicans voting in favor and its two Democrats dissenting.
Once today’s order goes into effect,…
FDA Releases FDASIA Health IT Report With Recommendations for a Risk-Based Regulatory Framework
On April 3, 2014, the Food and Drug Administration (“FDA”) proposed a risk-based approach to determining the level of oversight that should apply to health information technology (“HIT”). The FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework divides HIT into three functional categories that pose varying levels of safety risks and require proportionate levels of oversight. The Report proposes no new FDA regulations or oversight; instead, it clarifies the manner in which FDA proposes to exercise its existing authorities. For example, the Report states that FDA will continue to focus oversight on medical device functionality and “does not intend to focus oversight” on health management HIT functionality, if that functionality is contained within a product that meets the definition of a medical device. Finally, the Report suggests priority areas in which next steps could be taken to more fully realize the benefits of “health management” HIT functionality.
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