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FDA issues Digital Health Innovation Action Plan

Providers and other stakeholders are using digital health technologies in their efforts to: 1. Reduce inefficiencies, 2. Improve access, 3. Reduce costs, 4. Increase quality, and, 5. Make medicine more personalized … See more

Actived: 3 days ago

URL: https://www.medsyscon.com/en/blog-fda-plan/

FDA launches Digital Health Center of Excellence

WEBThe FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment to advancing use of technology such as mobile health …

Category:  Health Go Health

FDA – Digital Health Software Precertification (Pre-Cert) Program

WEBThe Software Precertification Pilot Program version 1.0 Working Model (PDF) explains how the FDA has reimagined its way of regulating digital health products and details the …

Category:  Health Go Health

FDA proposed Regulatory Framework for Al/ML- Software as a …

WEBOn April 2, 2019, the FDA published a discussion paper “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a …

Category:  Health Go Health

Digital Health Innovation Action Plan

WEBThis Digital Health Innovation Action Plan outlines our efforts to reimagine FDA’s approach for assuring that all Americans, including patients, consumers and other health care …

Category:  Health Go Health

What Do Artificial Intelligence And Continuous Validation Have In

WEBKathleen Warner, Ph.D., RCM Technologies wrote in the current issue of MedTechIntelligence: “In 2011, the Center for Devices and Radiological Health (CDRH) …

Category:  Health Go Health

Mobile Health Apps – which U.S. federal laws may apply

WEBThe Federal Trade Commission (FTC) has published on its web site an interactive tool that helps mobile health apps manufacturer to navigate laws and rules that may

Category:  Health Go Health

The health benefits and business potential of digital therapeutics

WEBThe health benefits and business potential of digital therapeutics. Chirag Adatia a partner in McKinsey’s Gurugram office, Samarth Shah consultant. Ralf Dreischmeier senior …

Category:  Health Go Health

The Buzz About Medical Device Cybersecurity in 2022 and Beyond

WEBPaul Rothermel, Associate Attorney, Gardner Law, shares insights in https://gardner.law/alerts: “Medical device cybersecurity continues to create buzz, as the …

Category:  Medical Go Health

Digital Health Apps & SaMD

WEBJohn Giantsidis, president, CyberActa, Inc. wrote in the current issue of “meddeviceonline”: Technologies like artificial intelligence (AI) and digital health have made a positive …

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Clinical Decision Support Software Regulations

WEBRuth Beckers and Pascale Van Hoydonck wrote an groundbreaking article about the application of Clinical Decision Support Software regulations which was published by …

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FDA gives full recognition to AAMI cybersecurity guidance …

WEBThe Association for the Advancement of Medical Instrumentation (AAMI) is celebrating a significant achievement as the U.S. Food and Drug Administration (FDA) grants full …

Category:  Food,  Medical Go Health

GPT Applications in Healthcare

WEBRealistic applications of GPT-3 must start in areas of high value, high feasibility, and low risk for all stakeholders, including (at a minimum) patients, clinicians, administrators, and …

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FDA's Transition From Computer System Validation To Computer …

WEBFDA is preparing to release new guidance, Computer Software Assurance for Manufacturing, Operations and Quality Systems Software, in late 2020. This new …

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Five ways that life science companies can build tech talent

WEBMike Joyce, partner in McKinsey’s Washington, DC, office; Jeffrey Lewis, senior partner in the New Jersey office, Suman Thareja; and Robert Machinek, associate partner in the …

Category:  Health Go Health

The promise of digital therapeutics

WEBThe promise of digital therapeutics. Austin Hackett, Amy Hung, Olivier Leclerc, and Sri Velamoor wrote a blog at https://www.mckinsey.com about the promise of digital …

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The FDA & EU IVDR Regulatory Frameworks For IVD SaMD

WEBFDA and EU recognize IMDRF/SaMD/WG/N41 Final: 2017 for demonstrating clinical evaluation of SaMD in general. In the EU, there is an additional guidance provided for …

Category:  Health Go Health

ISO 14971:2019 — Clarifying Benefit, Risk, & Benefit-Risk

WEBISO 14971:2019 — Clarifying Benefit, Risk, & Benefit-Risk. Edwin L. Bills, member, ISO TC 210 JWG, wrote in the Guest Column on Med Device Online from February 8, 2021: …

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