Health in Digital World: A Regulatory Overview in United States

Mishra, Ashutosh; Gowrav, M P; Balamuralidhara, V.; Reddy, Kolli Suhas

doi:10.9734/jpri/2021/v33i43b32573

Cited by 6 publications

(5 citation statements)

References 45 publications

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“…In Washington, accelerated discussions on AI regulation are occurring, with various conferences and workshops being convened alongside major institutions and academia. However, predicting the exact content and scope of the U.S.'s AI regulatory direction is challenging as it is still in its nascent stage (Mishra et al 2021). Despite this, there has been some activity, such as the submission of AI-related bills by certain Congressional members, although these bills are in preliminary stages without widespread support and consensus (Gourraud and Simon, 2020).…”

Section: The Necessity Of Safety Regulatory Policiesmentioning

confidence: 99%

Towards an international regulatory framework for AI safety: lessons from the IAEA’s nuclear safety regulations

Cha

2024

Humanit Soc Sci Commun

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This study explores the necessity and direction of safety regulations for Artificial Intelligence (AI), drawing parallels from the regulatory practices of the International Atomic Energy Agency (IAEA) for nuclear safety. The rapid advancement and global proliferation of AI technologies necessitate the establishment of standardized safety norms to minimize discrepancies between national regulations and enhance the consistency and effectiveness of these rules. The study emphasizes the importance of international collaboration and the engagement of various stakeholders to strengthen the appropriateness of regulations and ensure their continuous updating in response to the evolving risks associated with technological advancements. The paper highlights the critical role of subgoal setting mechanisms in AI’s decision-making processes, underscoring their significance in ensuring the technology’s stability and social acceptability. Improperly tuned subgoal setting mechanisms may lead to outcomes that conflict with human intentions, posing risks to users and society at large. The study draws attention to the hidden risks often embedded within AI’s core decision-making mechanisms and advocates for regulatory approaches to guarantee safe and predictable AI operations. Furthermore, the study acknowledges the limitations of directly applying IAEA’s nuclear safety cases to AI due to the distinct characteristics and risks of the two fields. The paper calls for future research to delve deeper into the need for an independent regulatory framework tailored to AI’s unique features. Additionally, the study emphasizes the importance of accelerating international consensus, developing flexible regulatory models that reflect the situation in each country, exploring harmonization with existing regulations, and researching timely regulatory responses to the fast-paced development of AI technology.

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Section: The Necessity Of Safety Regulatory Policiesmentioning

confidence: 99%

Towards an international regulatory framework for AI safety: lessons from the IAEA’s nuclear safety regulations

Cha

2024

Humanit Soc Sci Commun

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“…AI/ML is currently being employed extensively in the pharmaceutical and healthcare industries, and it is also having a significant impact on clinical trials because of the adaptation of electronic health records, consumer safety reports, etc. 16 Deep learning (DL) techniques, which are part of AI/ML, can be used to fine-tune the model based on new data obtained from ongoing studies, and predictive analytics, which is used to determine trial risk, can be used in centralized/risk-based monitoring to assess investigator site performance and predict it based on previous performance. This study could be utilized to develop adaptive site monitoring strategies for high-risk locations, such as increasing monitoring frequency and resource allocation.…”

Section: Use Of Ai/ml In the Risk-based Monitoring Processmentioning

confidence: 99%

Clinical Trial Monitoring: An Overview of Risk-based Approach

Verma¹,

Mishra²,

Gowrav

et al. 2023

J. Young Pharm.

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Clinical Trial Monitoring is the fundamental necessity to direct high-quality clinical research to guarantee research quality and subject protection according to regulatory standards. It is a sophisticated, innovation-based approach to utilizing a company's data, allowing for better-informed decisions regarding where and how to allocate resources. However, the monitoring plan is grouped into two kinds i.e., on-site and centralized monitoring. But recently, regulators have been urged to take on a risk-based monitoring system, as such sponsors are preferring centralized monitoring from the beginning of the trial. Risk-based monitoring assures the quality of trials by managing risks. Furthermore, the Food and Drug Administration (FDA) and European Medicine Agency (EMA) have embraced the risk-based approach and released a guideline paper on the subject. The FDA's proposed advice from 2013 discusses how to oversee clinical trials using a risk-based approach. Still, on-site monitoring, which is carried out by site visits, and centralized monitoring, which is carried out remotely or offsite, have their self-worth and advantages. Because of the greater complexity of grasping those monitoring procedures, in this review article, we will discuss both monitoring plans with an emphasis on centralized monitoring, which will aid in a better understanding of the entire in a nutshell. Also, we will emphasize the benefits, future, and implementation of Artificial Intelligence/Machine Learning in the risk-based monitoring strategy.

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“…Companies who are unable to satisfy requests for unfriendly event disclosures at the establishment level should get in touch with the relevant FDA legitimate unit responsible for ensuring consistency in unfriendly event disclosures. 16…”

Section: Readiness To Report Adverse Events During Eumentioning

confidence: 99%

“…►Table 1 likewise incorporates definite ideas for a few items as well as additional subtleties. 16 A) Revealing after the pandemic Organizations are expected to continue meeting all disclosure requirements on time and submitting reports that were delayed because of the pandemic-related high worker absenteeism after the calamity has passed and the situation has returned to pre-pandemic levels. Companies must follow the procedures they have in place for storing reports that were not captured during the relevant timeframes.…”

Section: Approach To Requirements Through An Epidemic By High Employe...mentioning

confidence: 99%

“…FDA Method to Postmarketing Safety Reporting During an Epidemic if Progressions of Mandatory Antagonistic Incident Reportage Are Not Achievable Because of High Employee Absenteeism of 30 days or fewer (such as 15-day reports and 30-day reports). Companies who are unable to satisfy requests for unfriendly event disclosures at the establishment level should get in touch with the relevant FDA legitimate unit responsible for ensuring consistency in unfriendly event disclosures 16. …”

mentioning

confidence: 99%

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Emergency Use Authorization for COVID-19 Vaccines and Practical Considerations for the Future

Monika,

R.,

et al. 2023

Journal of Health and Allied Sciences NU

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An Emergency use authorization (EUA) is a permission granted by the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as revised and upgraded by numerous Federal legislations, which includes the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, accumulated by 21 U.S.C. 360bbb-3, to enable the utilization of medicines before approving. Ensuing regulative specialists expanded the scope of testing to which the medication or treatment has been submitted, as well as the class of drugs qualified for thought. The scope and relevance of EUAs are further governed by actual pioneer, which may change the significance of situations classified as general prosperity crises and within which the FDA might release EUAs Considering the COVID-19 flare-up, the HHS (Health and Human Services) Secretary articulated a general prosperity emergency on February 4, 2020, for the brand-new SARS-CoV-2 disorder these consequences in illness COVID-19. In response to the COVID-19 epidemic, the FDA granted EUAs in 2020 for remdesivir, enhanced blood, Fresenius Propoven 2 percent emulsion (propofol), and bamlanivimab. The FDA cancelled the Emergency use authorization (EUA) that drew in the exploratory monoclonal adjusting proficient medicine Bamlanivimab for use without assistance in the treatment of difficult-to-organize COVID-19 in grown-ups and positive pediatric victims on April 16, 2021.

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Health in Digital World: A Regulatory Overview in United States

Cited by 6 publications

References 45 publications

Towards an international regulatory framework for AI safety: lessons from the IAEA’s nuclear safety regulations

Towards an international regulatory framework for AI safety: lessons from the IAEA’s nuclear safety regulations

Clinical Trial Monitoring: An Overview of Risk-based Approach

Emergency Use Authorization for COVID-19 Vaccines and Practical Considerations for the Future

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