Background: The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and heterogeneous user engagement with digital health apps can lead to trial…
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Koa Health has announced that the results of its 2022-2023 external ethics audit show a 24% improvement in comparison to the year before.The company, a provider of digital-first mental healthcare, regularly submits its products…
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Background: Digital technologies, especially contact tracing apps, have been crucial in monitoring and tracing the transmission of COVID-19 worldwide. China has developed health code apps as an emergency response to the pandemic and are…
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ISO 27001 is the premier global standard for establishing and maintaining an Information Security Management System (ISMS). Here’s a deeper look into ISO 27001 and its critical role in safeguarding patient data.The Scope of…
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The following is a guest article by Nick Barger, PharmD, Vice President, Product at DrFirst. This article kicks off the Healthcare Regulatory Talk series.
There’s a collective holding of breath right now in health IT…
The Scope of ISO 13485Lifecycle Coverage: The standard encompasses all stages of a medical device’s lifecycle, from design to post-production, ensuring quality and safety at every phase.Auditing Utility: It is also utilized by certification…
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In a recent interview with Healthcare IT Today, Aidan Lee, Director of the Certification Program at OntarioMD, and Matt LaDuke, Director of Products, Integrations, and Service Management, shed light on the evolving landscape of…
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What You Should Know:
Health Payment Systems (HPS) today announced it has selected Madaket Health to help manage its provider directory and roster requirements for No Surprises Act (NSA) compliance.HPS, which supports 27,000 providers across 96 hospitals, selected…
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Shankar Somasundaram, CEO of Asimily
The recently proposed U.S. Cyber Trust Mark is a voluntary cybersecurity labeling program operated by the FCC. It will initially provide IoT manufacturers with a certification label that signifies their…
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What You Should Know:
– Health Catalyst has acquired Electronic Registry Systems, Inc. (ERS), a prominent cancer registry software and services provider. Financial details of the acquisition were not disclosed.
– The acquisition aims to strengthen…
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