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Background: The complicated nature of cloud computing encompassing internet-based technologies and service models for delivering IT applications, processing capability, storage, and memory space brings along challenging problems. Some issues such as information security, privacy, and legal aspects of cloud computing may become challenging while cross passing with another complex domain like healthcare., Objectives: The present study was conducted to report the results of a systematic literature review on the legal aspects of health cloud., Method: The original English papers published in Pub Med, Scopus, Web of Science, and IEEE Digital Library databases were extracted, among which1582 were related to the legal aspects of health cloud environment and were selected using predefined search strings., Conclusion: Through the review process, effective factors in relation to a health cloud legal framework were identified and accordingly, a proper design was developed for this domain. Next, the identified factors were confirmed and adjusted by mapping the contents of the selected papers to different categories and subcategories under the proposed framework. Five Main categories like the issues related to the compliance, data protection, Identity Credential Access Management (ICAM), ownership, and quality of service were selected as the basic pillars in the proposed framework. Finally, 22 papers were selected, among which 19 were mapped to the compliance issues, 18 the issues related to "Data protection" were addressed, and 14 "Identity Credential Access Management (ICAM)" was discussed. Fifteen Papers were mapped to "Data ownership" and "Quality of service" categories. Some papers were found to present some solutions in all the mentioned areas; however, most of them have addressed only a few issues., (Copyright © 2019 Elsevier B.V. All rights reserved.)

The value of using population data to answer important questions for individual and societal benefit has never been greater. Governments and research funders world-wide are recognizing this potential and making major investments in data-intensive initiatives. However, there are challenges to overcome so that safe, socially-acceptable data sharing can be achieved. This paper outlines the field of population data science, the International Population Data Linkage Network (IPDLN), and their roles in advancing data-intensive research. We provide an overview of core concepts and major challenges for data-intensive research, with a particular focus on ethical, legal, and societal implications (ELSI). Using international case studies, we show how challenges can be addressed and lessons learned in advancing the safe, socially-acceptable use of population data for public benefit. Based on the case studies, we discuss the common ELSI principles in operation, we illustrate examples of a data scrutiny panel and a consumer panel, and we propose a set of ELSI-based recommendations to inform new and developing data-intensive initiatives.We conclude that although there are many ELSI issues to be overcome, there has never been a better time or more potential to leverage the benefits of population data for public benefit. A variety of initiatives, with different operating models, have pioneered the way in addressing many challenges. However, the work is not static, as the ELSI environment is constantly evolving, thus requiring continual mutual learning and improvement via the IPDLN and beyond.

The Affordable Care Act mandates that public health data be made available for community agency use. Having access to such data allows community agencies to tailor interventions, evaluations, and funding requests more effectively. This study, jointly undertaken by Syracuse University faculty and students with the New York State Perinatal Association, sought to understand community agencies' access to requests for governmental data, as well as to identify areas for improving data access. Results from this survey of administrators from 43 agencies in New York State found that only one-half of their requests for data were successful. Difficulties in obtaining access to needed data included fiscal and staffing constraints of the state-level agencies that house the data, as well as possible overinterpretation of confidentiality policies. In addition, some of community agency respondents reported that their staff lacked skills in data analysis and would benefit from training in epidemiology and quantitative evaluation.

This final rule implements requirements under Section 105 of the Medicare Access and CHIP Reauthorization Act of 2015 that expand how qualified entities may use and disclose data under the qualified entity program to the extent consistent with applicable program requirements and other applicable laws, including information, privacy, security and disclosure laws. This rule also explains how qualified entities may create non-public analyses and provide or sell such analyses to authorized users, as well as how qualified entities may provide or sell combined data, or provide Medicare claims data alone at no cost, to certain authorized users. In addition, this rule implements certain privacy and security requirements, and imposes assessments on qualified entities if the qualified entity or the authorized user violates the terms of a data use agreement required by the qualified entity program.

Since the necessity of confirming records to ensure appropriate accuracy management for clinical laborato- ry tests was initially specified in the Good Clinical Practice (GCP) in 2011, it has been mandatory for clinical trial sponsors to confirm such management in the relevant medical institutions. In 2007, the Department of Clinical Laboratory and the Department of Blood Transfusion at Okayama Uni- versity Hospital acquired the ISO 15189 certification as the international standard for clinical laboratory tests. In 2015, they, including the Physiological Test Room, renewed this certification. Record documents to ensure appropriate accuracy management are stored in the Department of Clinical Laboratory for a fixed period. Subsequently, to be inspected by regulatory authorities, such as the PMDA, they are continuously stored in the Department of Clinical Research of New Drugs and Therapeutics for a long period. [Review].

This final rule will extend enhanced funding for Medicaid eligibility systems as part of a state's mechanized claims processing system, and will update conditions and standards for such systems, including adding to and updating current Medicaid Management Information Systems (MMIS) conditions and standards. These changes will allow states to improve customer service and support the dynamic nature of Medicaid eligibility, enrollment, and delivery systems.

Our study is the first to look at mobile device use for child sexual exploitation material (CSEM) consumption, and at the global impact of deterrence efforts by search providers. We used data from Google, Bing, and Yandex to assess how web searches for CSEM are being conducted, both at present and historically. Our findings show that the blocking efforts by Google and Microsoft have resulted in a 67% drop in the past year in web-based searches for CSEM. Additionally, our findings show that mobile devices are a substantial platform for web-based consumption of CSEM, with tablets and smartphones representing 32% of all queries associated with CSEM conducted on Bing. Further, our findings show that a major search engine not located in the United States, Yandex, did not undertake blocking efforts similar to those implemented by Google and Microsoft and has seen no commensurate drop in CSEM searches and continues to profit from ad revenue on these queries. While the efforts by Google and Microsoft have had a deterrence effect in the United States, searchers from Russia and other locations where child pornography possession is not criminalized have continued to use these services. Additionally, the same lax enforcement environment has allowed searchers from the United States to utilize Yandex with little fear of detection or referral to United States law enforcement from the Russian authorities., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Photography and electronic media are indispensable tools for dental education and clinical practice. Although previous research has focused on privacy issues and general strategies to protect patient privacy when sharing clinical photographs for educational purposes, there are no published recommendations for developing a functional, privacy-compliant institutional framework for the capture, storage, transfer, and use of clinical photographs and other electronic media. The aims of this study were to research patient rights relating to electronic media and propose a framework for the use of patient media in education and clinical care. After a review of the relevant literature and consultation with the University of Washington's director of privacy and compliance and assistant attorney general, the researchers developed a privacy-compliant framework to ensure appropriate capture, storage, transfer, and use of clinical photography and electronic media. A four-part framework was created to guide the use of patient media that reflects considerations of patient autonomy and privacy, informed consent, capture and storage of media, and its transfer, use, and display. The best practices proposed for capture, storage, transfer, and use of clinical photographs and electronic media adhere to the health care code of ethics (based on patient autonomy, nonmaleficence, beneficence, justice, and veracity), which is most effectively upheld by a practical framework designed to protect patients and limit institutional liability. Educators have the opportunity and duty to convey these principles to students who will become the next generation of dentists, researchers, and educators.

Background: In Australia research projects proposing the use of linked data require approval by a Human Research Ethics Committee (HREC). A sound evaluation of the ethical issues involved requires understanding of the basic mechanics of data linkage, the associated benefits and risks, and the legal context in which it occurs. The rapidly increasing number of research projects utilising linked data in Australia has led to an urgent need for enhanced capacity of HRECs to review research applications involving this emerging research methodology. The training described in this article was designed to respond to an identified need among the data linkage units in the Australian Population Health Research Network (PHRN) and HREC members in Australia., Methods: Five one-day face to face workshops were delivered in the study period to a total of 98 participants. Participants in the workshops represented all six categories of HREC membership composition listed in the National Health and Medical Research Centres' (NHMRC) National Statement on Ethical Conduct in Human Research. Participants were assessed at three time points, prior to the training (T1), immediately after the training (T2) and 8 to 17 months after the training (T3)., Results: Ninety participants completed the pre and post questionnaires; 58 of them completed the deferred questionnaire. Participants reported significant improvements in levels of knowledge, understanding and skills in each of the eight areas evaluated. The training was beneficial for those with prior experience in the area of ethics and data linkage as well as those with no prior exposure., Conclusions: Our preliminary work in this area demonstrates that the provision of intensive face to face ethics training in data linkage is feasible and has a significant impact on participant's confidence in reviewing HREC applications.

Healthcare-related bioinformatics databases are increasingly offering the possibility to maintain, organize, and distribute DNA sequencing data. Different national and international institutions are currently hosting such databases that offer researchers website platforms where they can obtain sequencing data on which they can perform different types of analysis. Until recently, this process remained mostly one-dimensional, with most analysis concentrated on a limited amount of data. However, newer genome sequencing technology is producing a huge amount of data that current computer facilities are unable to handle. An alternative approach has been to start adopting cloud computing services for combining the information embedded in genomic and model system biology data, patient healthcare records, and clinical trials' data. In this new technological paradigm, researchers use virtual space and computing power from existing commercial or not-for-profit cloud service providers to access, store, and analyze data via different application programming interfaces. Cloud services are an alternative to the need of larger data storage; however, they raise different ethical, legal, and social issues. The purpose of this Commentary is to summarize how cloud computing can contribute to bioinformatics-based drug discovery and to highlight some of the outstanding legal, ethical, and social issues that are inherent in the use of cloud services., (© 2014 Wiley Periodicals, Inc.)

Quality assurance for planned radiation exposure situations (e.g. Digital Radiography, Computed Tomography or Radio Fluoroscopic studies) requires the application of examination-specific scans protocols. These are tailored to patient age or size, body region and clinical indication for ensuring that the dose applied to each patient is as low as reasonably achievable for the clinical purpose of the image acquisition (ALARA principle). The European legal framework--2013/59/EURATOM--points that health authorities will be more pervasive on inspecting the dosimetry applied to patients. This paper discusses these legal alterations and presents an interoperable distributed system for dose monitoring, which is compliant with legal procedures and the IHE Radiation Exposure Monitoring profile (REM). The system combines the most representative stakeholders affected and directly interested in the patient radiological protection: patients, radiologists, practitioners, health authorities, and ethics committee. The system is capable of gathering, in real-time, dose information applied to the patient and storing it in a regional or national wide dose registry. The paper addresses which information should such systems hold and which should be accessed, from each stakeholder perspective. Furthermore, the system may detect irregular dose patterns, which could indicate dose abuses, and signal those findings to the appropriate stakeholders.

Teleassistance is defined by the help provided through a telemedicine network by a medical practitioner to one other medical practitioner faced to a difficult case. One of the main limiting factors of its development is the fear of the practitioners to be involved in a litigation. In such a situation, the main issue is to determine as quick and as certain as possible if the damage is in relation with the tort of negligence and the liabilities of each involved physician. After a brief summary of the legal context, we present a protocol combining joint watermarking-encryption and a third party to enforce exchange traceability and therefore to bring valuable electronic evidence in case of teleassistance litigations.

We report the outcomes of BioMed Central's public consultation on implementing open data-compliant licensing in peer-reviewed open access journals. Respondents (42) to the 2012 consultation were six to one in favor (29 in support; 5 against; 8 abstentions) of changing our authors' default open access copyright license agreement, to introduce the Creative Commons CC0 public domain waiver for data published in BioMed Central's journals. We summarize the different questions we received in response to the consultation and our responses to them - matters such as citation, plagiarism, patient privacy, and commercial use were raised. In light of the support for open data in our journals we outline our plans to implement, in September 2013, a combined Creative Commons Attribution license for published articles (papers) and Creative Commons CC0 waiver for published data.

According to § 23 paragraph 4 of the German Infection Prevention Act (IfSG; July 2011), hospitals and clinics for ambulatory surgery are obliged to establish a continuous monitoring system of antibiotic consumption. This is aimed at contributing to an optimization of antibiotic prescription practices in order to confine the development and spread of resistant pathogens. The general requirements (restricted to hospitals) on the method and extent of data collection are provided by the national public health institution after discussion with representatives of various professional societies (Robert Koch-Institut, Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 59, 2013). The article aims to clarify these specifications and to provide background details. In agreement with national and European surveillance systems, the Anatomical Therapeutic Chemical (ATC)/Defined Daily Dose (DDD) classification system recommended by the WHO should be used as reference standard. Antibiotic consumption should be expressed as the number of DDDs per 100 patient days and per 100 admissions. The categories of antimicrobials and hospital organizational units to be monitored and the time intervals in which analyses should be conducted are determined. Furthermore, various approaches of data assessment are described.

Regulatory administrative database systems within the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) are essential to supporting its core mission, as a regulatory agency. Such systems are used within FDA to manage information and processes surrounding the processing, review, and tracking of investigational and marketed product submissions. This is an area of increasing interest in the pharmaceutical industry and has been a topic at trade association conferences (Buckley 2012). Such databases in CBER are complex, not for the type or relevance of the data to any particular scientific discipline but because of the variety of regulatory submission types and processes the systems support using the data. Commonalities among different data domains of CBER's regulatory administrative databases are discussed. These commonalities have evolved enough to constitute real database convergence and provide a valuable asset for business process intelligence. Balancing review workload across staff, exploring areas of risk in review capacity, process improvement, and presenting a clear and comprehensive landscape of review obligations are just some of the opportunities of such intelligence. This convergence has been occurring in the presence of usual forces that tend to drive information technology (IT) systems development toward separate stovepipes and data silos. CBER has achieved a significant level of convergence through a gradual process, using a clear goal, agreed upon development practices, and transparency of database objects, rather than through a single, discrete project or IT vendor solution. This approach offers a path forward for FDA systems toward a unified database.

Objectives: The aim of this paper is to summarize concerns with the de-identification standard and methodologies established under the Health Insurance Portability and Accountability Act (HIPAA) regulations, and report some potential policies to address those concerns that were discussed at a recent workshop attended by industry, consumer, academic and research stakeholders., Target Audience: The target audience includes researchers, industry stakeholders, policy makers and consumer advocates concerned about preserving the ability to use HIPAA de-identified data for a range of important secondary uses., Scope: HIPAA sets forth methodologies for de-identifying health data; once such data are de-identified, they are no longer subject to HIPAA regulations and can be used for any purpose. Concerns have been raised about the sufficiency of HIPAA de-identification methodologies, the lack of legal accountability for unauthorized re-identification of de-identified data, and insufficient public transparency about de-identified data uses. Although there is little published evidence of the re-identification of properly de-identified datasets, such concerns appear to be increasing. This article discusses policy proposals intended to address de-identification concerns while maintaining de-identification as an effective tool for protecting privacy and preserving the ability to leverage health data for secondary purposes.

Pursuant to federal statutes and to laws in all fifty states, the United States government has assembled a database containing the DNA profiles of over eleven million citizens. Without judicial authorization, the government searches each of these profiles one-hundred thousand times every day, seeking to link database subjects to crimes they are not suspected of committing. Yet, courts and scholars that have addressed DNA databasing have focused their attention almost exclusively on the constitutionality of the government's seizure of the biological samples from which the profiles are generated. This Note fills a gap in the scholarship by examining the Fourth Amendment problems that arise when the government searches its vast DNA database. This Note argues that each attempt to match two DNA profiles constitutes a Fourth Amendment search because each attempted match infringes upon database subjects' expectations of privacy in their biological relationships and physical movements. The Note further argues that database searches are unreasonable as they are currently conducted, and it suggests an adaptation of computer-search procedures to remedy the constitutional deficiency.

Background: De-identification is a common way to protect patient privacy when disclosing clinical data for secondary purposes, such as research. One type of attack that de-identification protects against is linking the disclosed patient data with public and semi-public registries. Uniqueness is a commonly used measure of re-identification risk under this attack. If uniqueness can be measured accurately then the risk from this kind of attack can be managed. In practice, it is often not possible to measure uniqueness directly, therefore it must be estimated., Methods: We evaluated the accuracy of uniqueness estimators on clinically relevant data sets. Four candidate estimators were identified because they were evaluated in the past and found to have good accuracy or because they were new and not evaluated comparatively before: the Zayatz estimator, slide negative binomial estimator, Pitman's estimator, and mu-argus. A Monte Carlo simulation was performed to evaluate the uniqueness estimators on six clinically relevant data sets. We varied the sampling fraction and the uniqueness in the population (the value being estimated). The median relative error and inter-quartile range of the uniqueness estimates was measured across 1000 runs., Results: There was no single estimator that performed well across all of the conditions. We developed a decision rule which selected between the Pitman, slide negative binomial and Zayatz estimators depending on the sampling fraction and the difference between estimates. This decision rule had the best consistent median relative error across multiple conditions and data sets., Conclusion: This study identified an accurate decision rule that can be used by health privacy researchers and disclosure control professionals to estimate uniqueness in clinical data sets. The decision rule provides a reliable way to measure re-identification risk.

European laws on privacy and data security are not explicit about the storage and processing of genetic data. Especially whole-genome data is identifying and contains a lot of personal information. Is processing of such data allowed in computing grids? To find out, we looked at legal precedents in related fields, current literature, and interviews with legal experts. We found that processing of genetic data is only allowed on distributed systems with specific security measures, both technical and organizational. Informed consent, although important, offers no substitute for such requirements.

Fast-paced IT advances have made it increasingly possible and useful for firms to collect data on their customers on an unprecedented scale. One downside of this is that firms can experience negative publicity and financial damage if their data are breached. This is particularly the case in the medical sector, where we find empirical evidence that increased digitization of patient data is associated with more data breaches. The encryption of customer data is often presented as a potential solution, because encryption acts as a disincentive for potential malicious hackers, and can minimize the risk of breached data being put to malicious use. However, encryption both requires careful data management policies to be successful and does not ward off the insider threat. Indeed, we find no empirical evidence of a decrease in publicized instances of data loss associated with the use of encryption. Instead, there are actually increases in the cases of publicized data loss due to internal fraud or loss of computer equipment.

This final rule will revise Medicaid regulations for Mechanized Claims Processing and Information Retrieval Systems. We are also modifying our regulations so that the enhanced Federal financial participation (FFP) is available for design, development and installation or enhancement of eligibility determination systems until December 31, 2015. This final rule also imposes certain defined standards and conditions in terms of timeliness, accuracy, efficiency, and integrity for mechanized claims processing and information retrieval systems in order to receive enhanced FFP.

The Internet has grown into a world of its own, and its ethereal space now offers capabilities that could aid physicians in their duties in numerous ways. In recent years software functions have moved from the individual's local hardware to a central server that operates from a remote location. This centralization is called cloud computing. Privacy laws that speak to the protection of patient confidentiality are complex and often difficult to understand in the context of an ever-growing cloud-based technology. This article is a review of the legal background of protected health records, as well as cloud technology and physician applications. An attempt is made to integrate both concepts and examine Health Insurance Portability and Accountability Act (HIPAA) compliance for each of the examples discussed. The legal regulations that may inform care and standards of practice are reviewed, and the difficulties that arise in assessment and monitoring of the current situation are analyzed. For forensic psychiatrists who may be asked to provide expert opinions regarding malpractice situations pertaining to confidentiality standards, it is important to become acquainted with the new digital language from which these questions may arise.

Purpose: Health Insurance Portability and Accountability Act implementation in the USA caused waves in the medical world about documentation storage, flow and access. Protecting patients from information falling into the wrong hands is admirable, but the Act has influenced more than just documentation; it has slowed the research process and complicated basic US medical care. This article aims to discuss Health Insurance Portability and Accountability Act's effects on documentation and patient care and future US healthcare options., Design/methodology/approach: A chronological approach is used to lay out the Act's effects. Using process flow maps, the pre- and post-Act environment is analyzed to discover differences in the two processes. Then a critique of the new environment leads to future movement recommendations by the US government and the healthcare industry., Findings: True to the US government's track record, by the time the Act was passed, it was already outdated in terms of IT management capabilities. In addition to trying to comply with these outdated practices, the Act's wording is so vague that hospital staff are not sure with what they are even complying. The Act could be improved with some simple changes to wording and updating., Research Limitations/implications: This article attempts to take a massive problem with far reaching implications, drill down to the key issues and make managerial recommendations based on findings. This provides a more detailed problem view that can only be understood at a high level owing to its complexity. Importantly, the key issues developed in the article support US government reform for legislation, which is not an easy task. There were studies available on the Act's cost to patients, hospitals, clinics and general costs in the USA. However, all the research was site specific and easily contradicted by other sources. Additionally, source reliability was questionable at best, as publications came from specific hospitals and clinics., Practical Implications: Throughout the study two themes were clear--the Act's outdated nature and vague wording. The more research that was done, the more confusing the information began to get, it seems even experts have a hard time understating and complying with the Act. One thing is clear. The Act is confusing and outdated. Because the problem is so large and fragmented, people are not sure where to start fixing the predicament. Arming US hospitals, clinics and doctors with basic knowledge can give them a common springboard to start changing the current environment., Originality/value: It is clear that the problem is large and confusing. Consolidating research results seems a valuable tool to help understand what is wrong with US healthcare. This article makes a case that updating and improving the directive's ambiguous nature helps create a less frustrating US healthcare system.

Since the mid-1990s most EU Member States have established a national forensic DNA database. These mass repositories of DNA profiles enable the police to identify DNA stains which are found at crime scenes and are invaluable in criminal investigation. Governments have always brushed aside privacy objections by stressing that the stored DNA profiles do not contain sensitive genetic information on the included individuals and that they reside under the statutory privacy protection regulations. However, it has been generally overlooked that the police also store the DNA samples from which the DNA profiles are derived. Although these DNA samples are actually a potential source of genetic information, they have so far scarcely been the subject of discussion. In this article we will show that both European and national regulations offer inadequate protection to completely prevent function creep, that is, the use of these forensic DNA samples for purposes beyond those envisaged at the time of collection.