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Purpose: In 2024, medical researchers in the Republic of Korea were invited to amend the health and medical data utilization guidelines (Government Publications Registration Number: 11-1352000-0052828-14). This study aimed to show the overall impact of the guideline revision, with a focus on clinical genomic data. Materials and Methods: This study amended the pseudonymization of genomic data defined in the previous version through a joint study led by the Ministry of Health and Welfare, the Korea Health Information Service, and the Korea Genome Organization. To develop the previous version, we held three conferences with four main medical research institutes and seven academic societies. We conducted two surveys targeting special genome experts in academia, industry, and institutes. Results: We found that cases of pseudonymization in the application of genome data were rare and that there was ambiguity in the terminology used in the previous version of the guidelines. Most experts (> ~90%) agreed that the 'reserved' condition should be eliminated to make genomic data available after pseudonymization. In this study, the scope of genomic data was defined as clinical next generation sequencing data, including FASTQ, BAM/SAM, VCF, and medical records. Pseudonymization targets genomic sequences and metadata, embedding specific elements, such as germline mutations, short tandem repeats, single-nucleotide polymorphisms, and identifiable data (for example, ID or environmental values). Expression data generated from multi-omics can be used without pseudonymization. Conclusion: This amendment will not only enhance the safe use of healthcare data but also promote advancements in disease prevention, diagnosis, and treatment.
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BACKGROUND: Hospital apps are increasingly being adopted in many countries, especially since the start of the COVID-19 pandemic. Web-based hospitals can provide valuable medical services and enhanced accessibility. However, increasing concerns about personal information (PI) and strict legal compliance requirements necessitate privacy assessments for these platforms. Guided by the theory of contextual integrity, this study investigates the regulatory compliance of privacy policies for internet hospital apps in the mainland of China. OBJECTIVE: In this paper, we aim to evaluate the regulatory compliance of privacy policies of internet hospital apps in the mainland of China and offer recommendations for improvement. METHODS: We obtained 59 internet hospital apps on November 7, 2023, and reviewed 52 privacy policies available between November 8 and 23, 2023. We developed a 3-level indicator scale based on the information processing activities, as stipulated in relevant regulations. The scale comprised 7 level-1 indicators, 26 level-2 indicators, and 70 level-3 indicators. RESULTS: The mean compliance score of the 52 assessed apps was 73/100 (SD 22.4%), revealing a varied spectrum of compliance. Sensitive PI protection compliance (mean 73.9%, SD 24.2%) lagged behind general PI protection (mean 90.4%, SD 14.7%), with only 12 apps requiring separate consent for processing sensitive PI (mean 73.9%, SD 24.2%). Although most apps (n=41, 79%) committed to supervising subcontractors, only a quarter (n=13, 25%) required users' explicit consent for subcontracting activities. Concerning PI storage security (mean 71.2%, SD 29.3%) and incident management (mean 71.8%, SD 36.6%), half of the assessed apps (n=27, 52%) committed to bear corresponding legal responsibility, whereas fewer than half (n=24, 46%) specified the security level obtained. Most privacy policies stated the PI retention period (n=40, 77%) and instances of PI deletion or anonymization (n=41, 79%), but fewer (n=20, 38.5%) committed to prompt third-party PI deletion. Most apps delineated various individual rights, but only a fraction addressed the rights to obtain copies (n=22, 42%) or to refuse advertisement based on automated decision-making (n=13, 25%). Significant deficiencies remained in regular compliance audits (mean 11.5%, SD 37.8%), impact assessments (mean 13.5%, SD 15.2%), and PI officer disclosure (mean 48.1%, SD 49.3%). CONCLUSIONS: Our analysis revealed both strengths and significant shortcomings in the compliance of internet hospital apps' privacy policies with relevant regulations. As China continues to implement internet hospital apps, it should ensure the informed consent of users for PI processing activities, enhance compliance levels of relevant privacy policies, and fortify PI protection enforcement across the information processing stages.
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Aplicativos Móveis , China , Humanos , Aplicativos Móveis/normas , Aplicativos Móveis/estatística & dados numéricos , Aplicativos Móveis/legislação & jurisprudência , Segurança Computacional/normas , Segurança Computacional/legislação & jurisprudência , COVID-19/prevenção & controle , COVID-19/epidemiologia , Confidencialidade/normas , Confidencialidade/legislação & jurisprudência , Internet , Pandemias/prevenção & controleRESUMO
Systematic assessments of interprofessional collaboration barriers and enablers in long-term care settings are critical for delivering person-centered healthcare. However, research on factors influencing interprofessional collaboration in long-term care settings is limited. For this study, 65 healthcare professionals across multiple facilities experienced in long-term care in Japan participated in online focus group discussions and individual interviews to discuss cases. The qualitative data were analyzed using qualitative content analysis. Seven themes emerged: coordination, the need for care manager training, hierarchy among healthcare professionals, specialization but not the mind-set of overspecialization, casual conversations, electronic group communication tools, and excessive fear of personal information protection. These findings highlight the need to develop coordinator roles and for interprofessional education on the proper approach to personal information protection laws. Furthermore, daily casual conversations, the use of online platforms, and the prevention of patients being left behind due to overspecialization are required.
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The medical data processed and analyzed in clinical research often contain a large number of personal information. Therefore, researchers should pay attention to the safety management of medical data during clinical research. The Data Security Law of People's Republic of China and the Personal Information Protection Law of People's Republic of China implemented on 1 st September and 1 st November 2021 respectively establish legal basis for data security and personal information protection and point out the direction for medical data security, which indicate that data governance has entered the 'strong regulatory era'. In the process of medical data collection and application of clinical research, respecting and protecting the privacy and safety of patients, ensuring the quality of medical data, safely managing medical data and carrying out high-quality clinical research will be an important test for the collection and application of clinical scientific research data under the new legal background.
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Those of us in the pharmaceutical industry are in favor of using SS-MIX standardized storage to alleviate the burden on medical professionals. As previously suggested, in addition to the benefits of reducing study periods, supporting a variety of investigative research and safety measures, and obtaining more accurate data on disease states and treatments, actively using this kind of new technology is a societal imperative in an information-driven society. Possible practical uses include (1) general application in drug use surveillance and special drug use surveillance, (2) appropriate sampling surveys, (3) patient monitoring, (4) observational studies with controls, such as those using disease registries, and (5) reviewing the results of safety measures. However, there is the issue of regulatory interpretation and consensus, with debate on information protection, and the issue of social infrastructure. Therefore, industry, government, and academia must continue its active, cooperative discussion to enable true implementation of this technology. (Jpn J Clin Pharmacoepidemiol 2013; 18(1): 57-64)