Impact of recent regulations

George, Bobby

doi:10.4103/2229-3485.115369

Cited by 5 publications

(6 citation statements)

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“…Technology risk concerns refer to users' concerns about the potential risks associated with new technologies ( 27 ). It has been argued that it is often detrimental to the adoption and diffusion of innovation when users have a high level of technical risk concern ( 41 ).…”

Section: Methodsmentioning

confidence: 99%

“…Existing research has already supported that personal innovation has an important impact on the use of mobile commerce ( 7 ). Technology risk concerns refer to users' concerns about privacy and security when using new technologies ( 27 ). Most existing studies classified privacy into information privacy, spatial privacy, and decision privacy, specifically as a personal home address, cell phone number, hobbies, physical characteristics, lifestyle habits, emotional experiences, etc., ( 28 ).…”

Section: Introductionmentioning

confidence: 99%

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The impact of users' trust on intention to use the mobile medical platform: Evidence from China

2023

Front. Public Health

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IntroductionThe mobile medical platform effectively complements offline medical services as it can provide patients with broader and more convenient medical services, effectively solving the shortage of medical resources in the public health system. Although the public interest in healthcare service platforms continues to rise, the market data shows that the adoption and acceptance have not reached a high level. How to increase the utilization rate of the mobile medical platform to relieve medical pressure has become an urgent issue to be discussed. Based on the framework of “trust-intention” this research introduces innovation acceptance and technical risk concerns as the two moderating variables to attempt to build a research model of users' intention to use the mobile medical platform. The analysis illustrated that users' trust in the mobile medical platform would positively affect their use intention. The researchers further explored the moderating role of innovation acceptance and technical risk concerns.MethodsUse questionnaire to collect data in China, then use the OLS least square method for the regression test.ResultsThe results showed that users with high personal innovation acceptance would positively promote the relationship between trust and use intention. In contrast, users who are more concerned about the risks of innovative technologies will weaken the relationship between trust and use intention.DiscussionThe findings theoretically extend the academic research of use intention to the specific context of the mobile medical platform and enrich the research framework of “trust-intention”.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The impact of users' trust on intention to use the mobile medical platform: Evidence from China

2023

Front. Public Health

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“…In Asia also, wound-healing items are often classified as medical devices and are subject to special regulatory regimes [150]. Each nation in the area has its own regulatory authority responsible for assessing and approving medical devices, such as wound-healing treatments, prior to their commercialization and distribution inside its boundaries [151]. These regulatory authorities include the National Medical Products Administration (NMPA) in China, the Central Drugs Standard Control Organization (CDSCO) in India, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, the Ministry of Food and Drug Safety (MFDS) in South Korea, the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia, the National Agency for Drug and Food Control (NADFC) in Indonesia, the Health Sciences Authority (HSA) in Singapore and the Food and Drug Administration (FDA) in both Thailand and Philippines [152].…”

Section: Asian Regulatory Issuesmentioning

confidence: 99%

Progress in Wound-Healing Products Based on Natural Compounds, Stem Cells, and MicroRNA-Based Biopolymers in the European, USA, and Asian Markets: Opportunities, Barriers, and Regulatory Issues

Srivastava,

Martinez-Rodriguez,

Md Fadilah

et al. 2024

Polymers

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Wounds are breaks in the continuity of the skin and underlying tissues, resulting from external causes such as cuts, blows, impacts, or surgical interventions. Countless individuals suffer minor to severe injuries, with unfortunate cases even leading to death. In today’s scenario, several commercial products are available to facilitate the healing process of wounds, although chronic wounds still present more challenges than acute wounds. Nevertheless, the huge demand for wound-care products within the healthcare sector has given rise to a rapidly growing market, fostering continuous research and development endeavors for innovative wound-healing solutions. Today, there are many commercially available products including those based on natural biopolymers, stem cells, and microRNAs that promote healing from wounds. This article explores the recent breakthroughs in wound-healing products that harness the potential of natural biopolymers, stem cells, and microRNAs. A comprehensive exploration is undertaken, covering not only commercially available products but also those still in the research phase. Additionally, we provide a thorough examination of the opportunities, obstacles, and regulatory considerations influencing the potential commercialization of wound-healing products across the diverse markets of Europe, America, and Asia.

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“…Indian investigators who had always strived towards bringing quality in patient care as well as in clinical research were deeply perturbed by the new mandates as clinical trials conducted by them virtually came to a standstill. [ 8 ]…”

Section: Introductionmentioning

confidence: 99%

Opinions and perceptions regarding the impact of new regulatory guidelines: A survey in Indian Clinical Trial Investigators

Kadam¹,

Borde²,

Madas³

et al. 2016

Perspect Clin Res

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Background:Clinical research in India experienced dramatic changes with series of stringent guidelines introduced by regulatory authorities. These guidelines posed significant challenges for the clinical trial industry.Objective:To assess the perceptions and opinion of Indian Investigators about the new regulatory guidelines.Methods:We developed a survey questionnaire on recent regulatory guidelines which was hosted on a web portal. Seventy-three investigators from India participated in the survey.Results:Central registration of Ethics Committees (ECs) was agreed by 90.1% participants, 76.8% participants agreed to compensation of subjects for study related Serious Adverse Events (SAE's). The compulsion to include government sites in clinical trials was not agreed by 49.3% participants while 21.2% agreed to it. Restriction on a number of trials per investigator was agreed by 49.3% of participants while 40.9% disagreed. Participants (50.7%) disagreed to the introduction of audio-video (AV) recording of informed consent, 36.6% agreed and 12.7% were neutral.Discussion:Participants observed that post central registration; ECs have improved systems with adequate member composition, functional Standard Operating Procedures, and timely approvals. Participants agreed that compensation of study related SAE's would assure subject protection and safety. The introduction of AV consenting was strongly debated sighting sociocultural issues in the implementation of the same.Conclusion:Participants endorsed guidelines pertaining to the central registration of ECs, SAE related compensation. Restrictions on a number of trials per investigator and AV consenting were debated ardently. The response of the survey participants who are clinical trial investigators in India showed general acceptance, effectiveness and anticipated compliance to the new regulatory guidelines.

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Impact of recent regulations

Cited by 5 publications

References 0 publications

The impact of users' trust on intention to use the mobile medical platform: Evidence from China

The impact of users' trust on intention to use the mobile medical platform: Evidence from China

Progress in Wound-Healing Products Based on Natural Compounds, Stem Cells, and MicroRNA-Based Biopolymers in the European, USA, and Asian Markets: Opportunities, Barriers, and Regulatory Issues

Opinions and perceptions regarding the impact of new regulatory guidelines: A survey in Indian Clinical Trial Investigators

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