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 »On Health Policy
NCHR Comments on Modernizing FDA’s 510(k) Program
May 22, 2019. The 510(k) pathway system is flawed, and should be replaced with pathways that require controlled clinical trials for all implanted devices and many other devices as well. Meanwhile, safety can be improved with our recommendations.
Read More »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.
Read More »Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Informed Consent
NCHR testified at the FDA advisory committee meeting on Breast Implants on improving informed consent procedures for informing patients on risks of BIA-ALCL
Read More »NCHR Comment on Proposed Draft Guidance Relating to Patient Experience Data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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