The U.S. Drug Enforcement Administration has proposed draft guidance to establish a framework for prescribing controlled substances via telemedicine.The proposal introduces three types of special registrations. Telemedicine prescribing registration allows qualified practitioners to prescribe…
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Groundbreaking AI Healthcare Regulations Unveiled
The U.S. Food and Drug Administration (FDA) has initiated a transformative step in healthcare technology by releasing comprehensive draft guidance for AI-enabled medical devices on January 6, 2025. This pioneering…
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FDA issues draft guidance for supporting development and marketing of AI-enabled devices throughout the Total Product Life Cycle. It also publishes draft guidance for the use of AI to support development of drugs and…
To support the continued development and marketing of safe and effective medical devices enhanced by artificial intelligence, the U.S. Food and Drug Administration will offer marketing submission recommendations, including the documentation and information needed…
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Two technologies that could reduce the severity of the symptoms of chronic tic disorders and Tourette syndrome have been recommended in by the National Institute for Health and Care Excellence (NICE).
The technologies, Online Remote Behavioural…
The National Institute for Health and Care Excellence (NICE) has approved the use of four AI technologies to help doctors detect broken bones on X-rays.
Draft guidance, published on 22 October 2024, recommends TechCare Alert,…
In this episode of Health+Tech, Andrea Lee Linna and Jonathan Ishee are joined by fellow McGuireWoods digital health team member Michael Paluzzi to discuss proposed HIPAA changes that may require covered entities and business associates to overhaul their HIPAA policies and procedures in 2022.After providing a high-level overview of the proposed changes, the podcast turns to a live recording of Andrea and Jonathan’s recent webinar, “Preparing for Major HIPAA Changes in 2022,” offering in-depth details about the proposed changes and how to prepare for them in the new year….
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In this episode of Health+Tech, McGuireWoods healthcare attorneys Janice Suchyta, Kate Hardey, Kae Gruner and Royce DuBiner discuss the latest digital health updates from the Food and Drug Administration and Federal Trade Commission. Join the conversation as we wrap up Cybersecurity Awareness Month and discuss the following topics:• FDA draft guidance on electronic health records and medical claims data• FDA new resource for approved artificial intelligence/machine learning medical devices• FDA Digital Health Center of Excellence• FTC rules for health apps outside of HIPAA…
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In this episode of Health+Tech, McGuireWoods healthcare partner Janice Suchyta talks to Michele Satterlund, senior vice president in the state government relations practice of McGuireWoods Consulting and a partner with McGuireWoods, on the emergence of telehealth, particularly during the pandemic. They also look at how telehealth is evaluated state by state and discuss the need for uniform best practices….
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In this episode of Health+Tech, McGuireWoods healthcare partner Janice M. Suchyta talks to Donna Chang, founder and CEO of Hope Biosciences. Donna discusses how Texas — particularly Houston — is making a name for itself in biotechnology by attracting research funding, supporting premier academic medical centers and welcoming investment by major pharmaceutical companies. Hope Biosciences, a stem cell biotechnology company that has flourished as part of the biotech cluster in the Houston area, is helping to make Texas the third coast for biotechnology….
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