What are the legal implications of using artificial intelligence in biomedical research?
In Delaware, biomedical research conducted with the use of artificial intelligence (AI) is subject to the same legal requirements of any other type of research. This includes laws governing the safety of participants, informed consent, privacy and security, data collection, data storage, and ethical oversight. AI-enabled research that focuses on the development of medical treatments or diagnoses may be subject to the same federal regulations, like the Food and Drug Administration, that apply to traditional biomedical research. Research conducted in Delaware must also adhere to the Delaware Medical Research Act, which was passed in 2010 and requires organizations and facilities to meet certain safety and ethical criteria before engaging in research. AI in biomedical research may also be subject to the same intellectual property laws that apply to other forms of research. AI-enabled research often involves the acquisition, processing, and analysis of large datasets, and the parties collecting or using the data may need to secure permission from the data owners and adhere to any existing data-use agreement. If the research involves the development of new algorithms or methods, appropriate legal protection, such as patents or copyright, should be pursued. Finally, AI research is subject to the same privacy laws as any other biomedical research. These laws require organizations to manage the security and privacy of personal information, including data collected for research purposes. Compliance with data privacy laws is essential, as it helps ensure that any personal data used in biomedical research is used only for the intended purpose and is stored securely.
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