NCHR Comment on Regulating Artificial Intelligence/Machine Learning-Based Software

June 3, 2019. Artificial Intelligence/Machine Learning (AI/ML)-based software device that incorporates special computer techniques (algorithms) capable of detecting relevant medical patterns from large amounts of data.  These very sophisticated pattern recognition capabilities (AI/ML) have broad potential healthcare applications, including making recommendations to healthcare providers and patients about the diagnosis, prognosis, treatment, or prevention of disease.1  The complexity, scalability, and broad scope of these new technologies thus raise important issues regarding their safety and effectiveness as it pertains to patients’ health.

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NCHR Comments on CPSC Agenda and Priorities for FY2020/2021

May 1, 2019. CPSC has a key role to play in protecting children and adults from harmful products used in their daily life. CPSC should consider artificial turf and playground surfaces, organohalogen flame retardants, and sport and recreational helmets as priorities for FY2020 and 2021.

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NCHR Comment on Proposed Draft Guidance Relating to Patient Experience Data

March 21, 2019. Patient perspectives and experience are important considerations for medical product development and regulation.  Patients, caregivers, and patient and consumer groups can provide a valuable resource for product developers and the FDA.  Transparency in how the FDA evaluates and uses proposed draft guidances as well as who and how they are developed will be important if they are to provide meaningful and accurate information about patients.

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