December 23, 2019.We appreciate FDA clarifying plans for regulating Clinical Decision Support (CDS) software; however, we have concerns regarding the draft guidance.
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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.
Read More »NCHR Comments on Prescription Drug-Use-Related Software
January 10, 2019. Digital Health is a new area of healthcare covering a broad set of technologies with diverse applications in healthcare. The proposed risk-based framework provides an important foundation for prescription drug-use-related software, but several important issues remain.
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