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  1. www.fda.gov › medical-devices › software-medical-device-samdTransparency for Machine Learning-Enabled Medical Devices

    13 de jun. de 2024 · Learn more: The FDA, Health Canada, and MHRA have further identified guiding principles for transparency for machine learning-enabled medical devices (MLMDs). These principles build upon the GMLP ...

  2. www.nature.com › articles › s41746/024/01147-zDigital health technologies need regulation and reimbursement...

    Hace 2 días · Digital health technologies (DHTs) include wearables and devices for mobile health (mHealth), health information technology (IT), telehealth and telemedicine, and personalized medicine 1,2.There ...

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  4. www.gov.uk › government › publicationsTransparency for machine learning-enabled medical devices:...

    13 de jun. de 2024 · use or receive healthcare with the device; make decisions about the device to support patient outcomes; Why: motivation for transparency. Transparency supports: safe and effective use; patient ...

  5. remmed.com › fda-best-practices-for-medical-device-patient-labelsFDA Best Practices for Medical Device Patient Labels

    11 de jun. de 2024 · Medical device labeling is a critical FDA best practice that ensures patients use the device safely and effectively, providing users with vital device information about proper uses, risks, and benefits.

  6. www.nature.com › articles › s41591/024/03028-0Novel medical devices to address the opioid crisis - Nature

    7 de jun. de 2024 · Funding opportunities, patient-driven design, regulatory clarity and available reimbursement paths could spur high-quality, safe and effective medical devices for people who use opioids.

  7. www.canada.ca › en › health-canadaTransparency for machine learning-enabled medical devices:...

    13 de jun. de 2024 · Health Canada, FDA and MHRA have further identified guiding principles for transparency for machine learning-enabled medical devices ( MLMDs ). These principles build upon the GMLP principles, especially: principle 7: Focus is placed on the performance of the human-AI team. principle 9: Users are provided clear, essential information.

  8. www.fda.gov › medical-devices › medical-devices-news-and-eventsPublic Workshop - PGHD in Medical Device Development

    29 de may. de 2024 · The purpose of this co-sponsored public workshop is to illustrate how patient-generated health data (PGHD) can promote medical device innovation throughout the total product life cycle...