Privacy Enhanced Healthcare Information Sharing System for Home-Based Care Environments / 대한의료정보학회지

OBJECTIVES: Home-based nursing care services have increased over the past decade. However, accountability and privacy issues as well as security concerns become more challenging during care provider visits. Because of the heterogeneous combination of mobile and stationary assistive medical care devices, conventional systems lack architectural consistency, which leads to inherent time delays and inaccuracies in sharing information. The goal of our study is to develop an architecture that meets the competing goals of accountability and privacy and enhances security in distributed home-based care systems. METHODS: We realized this by using a context-aware approach to manage access to remote data. Our architecture uses a public certification service for individuals, the Japanese Public Key Infrastructure and Health Informatics-PKI to identify and validate the attributes of medical personnel. Both PKI mechanisms are provided by using separate smart cards issued by the government. RESULTS: Context-awareness enables users to have appropriate data access in home-based nursing environments. Our architecture ensures that healthcare providers perform the needed home care services by accessing patient data online and recording transactions. CONCLUSIONS: The proposed method aims to enhance healthcare data access and secure information delivery to preserve user's privacy. We implemented a prototype system and confirmed its feasibility by experimental evaluation. Our research can contribute to reducing patient neglect and wrongful treatment, and thus reduce health insurance costs by ensuring correct insurance claims. Our study can provide a baseline towards building distinctive intelligent treatment options to clinicians and serve as a model for home-based nursing care.

Determination of the worst case for cleaning validation of equipment used in the radiopharmaceutical production of lyophilized reagents for 99mTc labeling

ABSTRACT Cleaning validation, a requirement of the current Good Manufacturing Practices (cGMP) for Drugs, consists of documented evidence that cleaning procedures are capable of removing residues to predetermined acceptance levels. This report describes a strategy for the selection of the worst case product for the production of lyophilized reagents (LRs) for labeling with 99mTc from the Instituto de Pesquisas Energéticas e Nucleares (IPEN-CNEN/São Paulo). The strategy is based on the calculation of a "worst case index" that incorporates information about drug solubility, cleaning difficulty, and occupancy rate in the production line. It allowed a reduction in the required number of validations considering the possible manufacturing flow of a given product and the subsequent flow, thus facilitating the process by reducing operation time and cost. The products identified as "worst case" were LRs PUL-TEC and MIBI-TEC.

RESUMO A validação de limpeza é uma exigência dos atuais regulamentos de Boas Práticas de Fabricação de Medicamentos (BPF) e consiste na evidência documentada, que demonstra que os procedimentos de limpeza removem os resíduos em níveis de aceitação pré-determinados. Este estudo apresenta uma estratégia para escolha do produto "pior caso" da linha de produção de reagentes liofilizados para marcação com 99mTc do Instituto de Pesquisas Energéticas e Nucleares (IPEN-CNEN/São Paulo). A estratégia baseia-se no cálculo de um índice denominado "índice para pior caso," que utiliza informações de solubilidade dos fármacos, dificuldade de limpeza dos equipamentos e ocupação dos produtos na linha de produção. A estratégia adotada proporcionou a diminuição no número de validações necessárias, considerando-se as possibilidades de sequências de fabricação de um determinado produto e do produto subsequente, possibilitando a simplificação do processo e redução no tempo e nos custos das atividades envolvidas. Os produtos indicados como pior caso foram os reagentes liofilizados (RL) PUL-TEC e MIBI-TEC.