Harnessing Mobile Devices for Nervous System Disorders Proceedings of a Workshop (2018) / Chapter Skim
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4 Regulatory Considerations and Pathways
4 Regulatory Considerations and Pathways
Pages 21-28
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. • Organizations working to advance the use of digital and mo bile technologies in clinical trials include the Clinical Trial Transformation Initiative and the Critical Path for Alz heimer's Disease (Arnerić, Corrigan-Curay)
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As a result, iterative designs and more agile methodologies are needed, as well as new regulatory pathways that enable rigorous evaluation of digital solutions and that are responsive to the different time scales at which these solutions evolve, he said. Although digital technologies may help increase the efficiency of clinical trials in terms of recruiting and consenting participants as well as in maximizing adherence and retention, they also introduce several potential regulatory challenges, said Narayan.
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The abundance of these apps makes it challenging for developers to create and promote rigorously designed products in the behavioral health field. Peña responded that a digital health software precertification 1The definition of a medical device is specified in Section 201(h)
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and FDA, have also been coordinating efforts to advance device development by including in their funding announcements a requirement for presubmissions. REGULATORY USE OF DIGITAL DATA IN CLINICAL TRIALS Digital technologies offer potential benefits for patient-centric drug development through electronic data transmission from patients at home or remote locations and from the ability to capture clinically meaningful measurements continuously in real-life situations, said Jacqueline Corrigan-Curay, director of the Office of Medical Policy at FDA's Center for Drug Evaluation and Research (CDER)
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, the organization has worked over the past 10 years to establish data standards and clinical trial simulation tools to support AD clinical trials, said Stephen Arnerić. They established the first integrated database of anonymized information from AD trials and worked with the Clinical Data Interchange 2To learn more about the CTTI recommendations, see https://www.ctti-clinical trials.org/projects/mobile-technologies (accessed August 8, 2018)
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. CAMD also developed the first clinical trial simulation tool to be endorsed by regulatory agencies as a tool to model disease progression, placebo and treatment effects, and patient dropouts in clinical trials (Romero et al., 2014, 2015)
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For example, in the United States, although HIPAA applies to the health care industry, which is the source of electronic clinical data, mobile medical device companies may fall outside the scope of HIPAA. In 2013, HIPAA was amended to give individuals the right to access their own data and also direct their health care providers to share their electronic data with a third party.
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Another reason for following the new, but not yet implemented, Common Rule is that other elements related to the information included in informed consent documents and informational confidentiality may be more closely aligned with the GDPR and possibly other state health informational confidentiality laws, said Rosati. The new Common Rule also has a new HIPAA exemption for secondary research using data or information derived from biospecimens (although not the biospecimens themselves)
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