Announcing the Journal of the Medical Library Association's data sharing policy.

As librarians are generally advocates of open access and data sharing, it is a bit surprising that peer-reviewed journals in the field of librarianship have been slow to adopt data sharing policies. Starting October 1, 2019, the Journal of the Medical Library Association (JMLA) is taking a step forward and implementing a firm data sharing policy to increase the rigor and reproducibility of published research, enable data reuse, and promote open science. This editorial explains the data sharing policy, describes how compliance with the policy will fit into the journal's workflow, and provides further guidance for preparing for data sharing.

Legal framework for health cloud: A systematic review.

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.

Population data science: advancing the safe use of population data for public benefit.

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.

Community health agency administrators' access to public health data for program planning, evaluation, and grant preparation.

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.

Medicare Program: Expanding Uses of Medicare Data by Qualified Entities. Final rule.

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.

[Associations with Clinical Trials].

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].

Medicaid Program; Mechanized Claims Processing and Information Retrieval Systems (90/10). Final rule.

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.

An evaluation of a data linkage training workshop for research ethics committees.

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.

Considerations for use of dental photography and electronic media in dental education and clinical practice.

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.

Web-based child pornography: The global impact of deterrence efforts and its consumption on mobile platforms.

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.

Opportunities and challenges provided by cloud repositories for bioinformatics-enabled drug discovery.

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.

Screening radiation exposure for quality assurance.

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.