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  1. Kang HN, Thorpe R, Knezevic I, Casas Levano M, Chilufya MB, Chirachanakul P, et al.
    Ann N Y Acad Sci, 2021 05;1491(1):42-59.
    PMID: 33222245 DOI: 10.1111/nyas.14522
    The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices. Despite this effort, a recent WHO survey (conducted in 2019-2020) has revealed four main remaining challenges: unavailable/insufficient reference products in the country; lack of resources; problems with the quality of some biosimilars (and even more with noninnovator products); and difficulties with the practice of interchangeability and naming of biosimilars. The following have been identified as opportunities/solutions for regulatory authorities to deal with the existing challenges: (1) exchange of information on products with other regulatory authorities and accepting foreign licensed and sourced reference products, hence avoiding conducting unnecessary (duplicate) bridging studies; (2) use of a "reliance" concept and/or joint review for the assessment and approval of biosimilars; (3) review and reassessment of the products already approved before the establishment of a regulatory framework for biosimilar approval; and (4) setting appropriate regulatory oversight for good pharmacovigilance, which is essential for the identification of problems with products and establishing the safety and efficacy of interchangeability of biosimilars.
    Matched MeSH terms: Health Information Exchange
  2. Esmaeilzadeh P, Sambasivan M
    BMC Med Inform Decis Mak, 2017 04 04;17(1):33.
    PMID: 28376785 DOI: 10.1186/s12911-017-0436-2
    BACKGROUND: Literature indicates that one of the most important factors affecting the widespread adoption of Health Information Exchange (HIE) is patient support and endorsement. In order to reap all the expected benefits of HIE, patients' acceptance of technology is a challenge that is not fully studied. There are a few studies which have focused on requirements of electronic medical information exchange from consumers' views and expectations. This study is aimed at reviewing the literature to articulate factors that affect patients to support HIE efforts.

    METHODS: A literature review of current studies addressing patients' views on HIE from 2005 was undertaken. Five electronic research databases (Science Direct, PubMed, Web of Science, CINAHL, and Academic Search Premiere) were searched to retrieve articles reporting pros and cons of HIE from patients' opinion.

    RESULTS: One hundred and ninety six articles were initially retrieved from the databases. Out of 196, 36 studies met the inclusion criteria and were fully reviewed. Our findings indicate that patient's attitude toward HIE is affected by seven main factors: perceived benefits, perceived concerns, patient characteristics, patient participation level in HIE, type of health information, identity of recipients, and patient preferences regarding consent and features.

    CONCLUSIONS: The findings provide useful theoretical implications for research by developing a classification of significant factors and a framework based on the lessons learned from the literature to help guide HIE efforts. Our results also have fundamental practical implications for policy makers, current and potential organizers of HIEs by highlighting the role of patients in the widespread implementation of HIE. The study indicates that new approaches should be applied to completely underline HIE benefits for patients and also address their concerns.

    Matched MeSH terms: Health Information Exchange*
  3. Abdulnabi M, Al-Haiqi A, Kiah MLM, Zaidan AA, Zaidan BB, Hussain M
    J Biomed Inform, 2017 05;69:230-250.
    PMID: 28433825 DOI: 10.1016/j.jbi.2017.04.013
    Nationwide health information exchange (NHIE) continues to be a persistent concern for government agencies, despite the many efforts and the conceived benefits of sharing patient data among healthcare providers. Difficulties in ensuring global connectivity, interoperability, and concerns on security have always hampered the government from successfully deploying NHIE. By looking at NHIE from a fresh perspective and bearing in mind the pervasiveness and power of modern mobile platforms, this paper proposes a new approach to NHIE that builds on the notion of consumer-mediated HIE, albeit without the focus on central health record banks. With the growing acceptance of smartphones as reliable, indispensable, and most personal devices, we suggest to leverage the concept of mobile personal health records (PHRs installed on smartphones) to the next level. We envision mPHRs that take the form of distributed storage units for health information, under the full control and direct possession of patients, who can have ready access to their personal data whenever needed. However, for the actual exchange of data with health information systems managed by healthcare providers, the latter have to be interoperable with patient-carried mPHRs. Computer industry has long ago solved a similar problem of interoperability between peripheral devices and operating systems. We borrow from that solution the idea of providing special interfaces between mPHRs and provider systems. This interface enables the two entities to communicate with no change to either end. The design and operation of the proposed approach is explained. Additional pointers on potential implementations are provided, and issues that pertain to any solution to implement NHIE are discussed.
    Matched MeSH terms: Health Information Exchange*
  4. Esmaeilzadeh P, Sambasivan M
    J Biomed Inform, 2016 12;64:74-86.
    PMID: 27645322 DOI: 10.1016/j.jbi.2016.09.011
    OBJECTIVES: Literature shows existence of barriers to Healthcare Information Exchange (HIE) assimilation process. A number of studies have considered assimilation of HIE as a whole phenomenon without regard to its multifaceted nature. Thus, the pattern of HIE assimilation in healthcare providers has not been clearly studied due to the effects of contingency factors on different assimilation phases. This study is aimed at defining HIE assimilation phases, recognizing assimilation pattern, and proposing a classification to highlight unique issues associated with HIE assimilation.

    METHODS: A literature review of existing studies related to HIE efforts from 2005 was undertaken. Four electronic research databases (PubMed, Web of Science, CINAHL, and Academic Search Premiere) were searched for articles addressing different phases of HIE assimilation process.

    RESULTS: Two hundred and fifty-four articles were initially selected. Out of 254, 44 studies met the inclusion criteria and were reviewed. The assimilation of HIE is a complicated and a multi-staged process. Our findings indicated that HIE assimilation process consisted of four main phases: initiation, organizational adoption decision, implementation and institutionalization. The data helped us recognize the assimilation pattern of HIE in healthcare organizations.

    CONCLUSIONS: The results provide useful theoretical implications for research by defining HIE assimilation pattern. The findings of the study also have practical implications for policy makers. The findings show the importance of raising national awareness of HIE potential benefits, financial incentive programs, use of standard guidelines, implementation of certified technology, technical assistance, training programs and trust between healthcare providers. The study highlights deficiencies in the current policy using the literature and identifies the "pattern" as an indication for a new policy approach.

    Matched MeSH terms: Health Information Exchange*
  5. Badshah G, Liew SC, Zain JM, Ali M
    J Digit Imaging, 2016 Apr;29(2):216-25.
    PMID: 26429361 DOI: 10.1007/s10278-015-9822-4
    In teleradiology, image contents may be altered due to noisy communication channels and hacker manipulation. Medical image data is very sensitive and can not tolerate any illegal change. Illegally changed image-based analysis could result in wrong medical decision. Digital watermarking technique can be used to authenticate images and detect as well as recover illegal changes made to teleradiology images. Watermarking of medical images with heavy payload watermarks causes image perceptual degradation. The image perceptual degradation directly affects medical diagnosis. To maintain the image perceptual and diagnostic qualities standard during watermarking, the watermark should be lossless compressed. This paper focuses on watermarking of ultrasound medical images with Lempel-Ziv-Welch (LZW) lossless-compressed watermarks. The watermark lossless compression reduces watermark payload without data loss. In this research work, watermark is the combination of defined region of interest (ROI) and image watermarking secret key. The performance of the LZW compression technique was compared with other conventional compression methods based on compression ratio. LZW was found better and used for watermark lossless compression in ultrasound medical images watermarking. Tabulated results show the watermark bits reduction, image watermarking with effective tamper detection and lossless recovery.
    Matched MeSH terms: Health Information Exchange/standards*
  6. Zakaria N, Mohd Yusof SA
    J Infect Public Health, 2016 Nov-Dec;9(6):774-780.
    PMID: 27686258 DOI: 10.1016/j.jiph.2016.08.017
    BACKGROUND: Hospital Information Systems (HIS) can improve healthcare outcome quality, increase efficiency, and reduce errors. The government of Malaysia implemented HIS across the country to maximize the use of technology to improve healthcare delivery, however, little is known about the benefits and challenges of HIS adoption in each institution. This paper looks at the technology and people issues in adopting such systems.

    METHODS: The study used a case study approach, using an in-depth interview with multidisciplinary medical team members who were using the system on a daily basis. A thematic analysis using Atlas.ti was employed to understand the complex relations among themes and sub-themes to discover the patterns in the data. .

    RESULTS: Users found the new system increased the efficiency of workflows and saved time. They reported less redundancy of work and improved communication among medical team members. Data retrieval and storage were also mentioned as positive results of the new HIS system. Healthcare workers showed positive attitudes during training and throughout the learning process.

    CONCLUSIONS: From a technological perspective, it was found that medical workers using HIS has better access and data management compared to the previously used manual system. The human issues analysis reveals positive attitudes toward using HIS among the users especially from the physicians' side.
    Matched MeSH terms: Health Information Exchange*
  7. Zaidan BB, Haiqi A, Zaidan AA, Abdulnabi M, Kiah ML, Muzamel H
    J Med Syst, 2015 May;39(5):51.
    PMID: 25732083 DOI: 10.1007/s10916-015-0235-1
    This study focuses on the situation of health information exchange (HIE) in the context of a nationwide network. It aims to create a security framework that can be implemented to ensure the safe transmission of health information across the boundaries of care providers in Malaysia and other countries. First, a critique of the major elements of nationwide health information networks is presented from the perspective of security, along with such topics as the importance of HIE, issues, and main approaches. Second, a systematic evaluation is conducted on the security solutions that can be utilized in the proposed nationwide network. Finally, a secure framework for health information transmission is proposed within a central cloud-based model, which is compatible with the Malaysian telehealth strategy. The outcome of this analysis indicates that a complete security framework for a global structure of HIE is yet to be defined and implemented. Our proposed framework represents such an endeavor and suggests specific techniques to achieve this goal.
    Matched MeSH terms: Health Information Exchange*
  8. Alanazi HO, Zaidan AA, Zaidan BB, Kiah ML, Al-Bakri SH
    J Med Syst, 2015 Jan;39(1):165.
    PMID: 25481568 DOI: 10.1007/s10916-014-0165-3
    This study has two objectives. First, it aims to develop a system with a highly secured approach to transmitting electronic medical records (EMRs), and second, it aims to identify entities that transmit private patient information without permission. The NTRU and the Advanced Encryption Standard (AES) cryptosystems are secured encryption methods. The AES is a tested technology that has already been utilized in several systems to secure sensitive data. The United States government has been using AES since June 2003 to protect sensitive and essential information. Meanwhile, NTRU protects sensitive data against attacks through the use of quantum computers, which can break the RSA cryptosystem and elliptic curve cryptography algorithms. A hybrid of AES and NTRU is developed in this work to improve EMR security. The proposed hybrid cryptography technique is implemented to secure the data transmission process of EMRs. The proposed security solution can provide protection for over 40 years and is resistant to quantum computers. Moreover, the technique provides the necessary evidence required by law to identify disclosure or misuse of patient records. The proposed solution can effectively secure EMR transmission and protect patient rights. It also identifies the source responsible for disclosing confidential patient records. The proposed hybrid technique for securing data managed by institutional websites must be improved in the future.
    Matched MeSH terms: Health Information Exchange*
  9. Yau WC, Phan RC
    J Med Syst, 2013 Dec;37(6):9993.
    PMID: 24194093 DOI: 10.1007/s10916-013-9993-9
    Many authentication schemes have been proposed for telecare medicine information systems (TMIS) to ensure the privacy, integrity, and availability of patient records. These schemes are crucial for TMIS systems because otherwise patients' medical records become susceptible to tampering thus hampering diagnosis or private medical conditions of patients could be disclosed to parties who do not have a right to access such information. Very recently, Hao et al. proposed a chaotic map-based authentication scheme for telecare medicine information systems in a recent issue of Journal of Medical Systems. They claimed that the authentication scheme can withstand various attacks and it is secure to be used in TMIS. In this paper, we show that this authentication scheme is vulnerable to key-compromise impersonation attacks, off-line password guessing attacks upon compromising of a smart card, and parallel session attacks. We also exploit weaknesses in the password change phase of the scheme to mount a denial-of-service attack. Our results show that this scheme cannot be used to provide security in a telecare medicine information system.
    Matched MeSH terms: Health Information Exchange/standards*
  10. Jayabalan M, O'Daniel T
    J Med Syst, 2016 Dec;40(12):261.
    PMID: 27722981
    This study presents a systematic literature review of access control for electronic health record systems to protect patient's privacy. Articles from 2006 to 2016 were extracted from the ACM Digital Library, IEEE Xplore Digital Library, Science Direct, MEDLINE, and MetaPress using broad eligibility criteria, and chosen for inclusion based on analysis of ISO22600. Cryptographic standards and methods were left outside the scope of this review. Three broad classes of models are being actively investigated and developed: access control for electronic health records, access control for interoperability, and access control for risk analysis. Traditional role-based access control models are extended with spatial, temporal, probabilistic, dynamic, and semantic aspects to capture contextual information and provide granular access control. Maintenance of audit trails and facilities for overriding normal roles to allow full access in emergency cases are common features. Access privilege frameworks utilizing ontology-based knowledge representation for defining the rules have attracted considerable interest, due to the higher level of abstraction that makes it possible to model domain knowledge and validate access requests efficiently.
    Matched MeSH terms: Health Information Exchange*
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