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.

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].

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.

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.

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.

[Surveillance of antibiotic consumption : clarification of the "definition of data on the nature and extent of antibiotic consumption in hospitals according to § 23 paragraph 4 sentence 2 of the IfSG"]. / Antibiotika-Verbrauchs-Surveillance : Ausführungen und Erläuterungen zur Bekanntmachung "Festlegung der Daten zu Art und Umfang des Antibiotika-Verbrauchs in Krankenhäusern nach § 23 Abs. 4 Satz 2 IfSG"

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.

DNA profiles, computer searches, and the Fourth Amendment.

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.

Estimating the re-identification risk of clinical data sets.

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.

Legal constraints on genetic data processing in European grids.

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.

Medicaid program; federal funding for Medicaid eligibility determination and enrollment activities. Final rule.

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.

HIPAA's effects on US healthcare.

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.

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.

Introduction to the mining of clinical data.

The increasing volume of medical data online, including laboratory data, represents a substantial resource that can provide a foundation for improved understanding of disease presentation, response to therapy, and health care delivery processes. Data mining supports these goals by providing a set of techniques designed to discover similarities and relationships between data elements in large data sets. Currently, medical data have several characteristics that increase the difficulty of applying these techniques, although there have been notable medical data mining successes. Future developments in integrated medical data repositories, standardized data representation, and guidelines for the appropriate research use of medical data will decrease the barriers to mining projects.

The retention of forensic DNA samples: a socio-ethical evaluation of current practices in the EU.

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.