The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods.

Hazard assessment, based on new approach methods (NAM), requires the use of batteries of assays, where individual tests may be contributed by different laboratories. A unified strategy for such collaborative testing is presented. It details all procedures required to allow test information to be usable for integrated hazard assessment, strategic project decisions and/or for regulatory purposes. The EU-ToxRisk project developed a strategy to provide regulatorily valid data, and exemplified this using a panel of > 20 assays (with > 50 individual endpoints), each exposed to 19 well-known test compounds (e.g. rotenone, colchicine, mercury, paracetamol, rifampicine, paraquat, taxol). Examples of strategy implementation are provided for all aspects required to ensure data validity: (i) documentation of test methods in a publicly accessible database; (ii) deposition of standard operating procedures (SOP) at the European Union DB-ALM repository; (iii) test readiness scoring accoding to defined criteria; (iv) disclosure of the pipeline for data processing; (v) link of uncertainty measures and metadata to the data; (vi) definition of test chemicals, their handling and their behavior in test media; (vii) specification of the test purpose and overall evaluation plans. Moreover, data generation was exemplified by providing results from 25 reporter assays. A complete evaluation of the entire test battery will be described elsewhere. A major learning from the retrospective analysis of this large testing project was the need for thorough definitions of the above strategy aspects, ideally in form of a study pre-registration, to allow adequate interpretation of the data and to ensure overall scientific/toxicological validity.

Safeguarding the future of genomic research in South Africa: Broad consent and the Protection of Personal Information Act No. 4 of 2013.

Genomic research has been identified in South Africa (SA) as important in developing a strong bio-economy that has the potential to improve human health, drive job creation and offer potential solutions to the disease burden harboured by low- and middle-income countries. Central to the success of genomic research is the wide sharing of biological samples and data, but the true value of data can only be unlocked if there are laws and policies in place that foster the legal and ethical sharing of genomic data. The introduction and entry into force of SA's Protection of Personal Information Act (POPIA) No. 4 of 2013 is to be welcomed, but the wording of POPIA as it pertains to consent for the processing of personal information for research purposes has sparked a debate about the legal status of broad consent. We argue that a purposive interpretation of the legislation would permit broad consent for the processing of personal information for research. Although there are ongoing debates surrounding the ethical use of broad consent in Africa, the objective of this article is not to engage with the ethics of broad consent itself, but rather to focus on the legal status of broad consent for genomic data sharing under POPIA.

Review of a medical illustration department's data processing system to confirm general data protection regulation (GDPR) compliance.

This article reviews the clinical photography and video data processing and storage arrangements of the Medical Illustration Department (MID) at the Queen Elizabeth Hospital Birmingham National Health Service (NHS) Foundation Trust (QEHB), part of the University Hospitals Birmingham (UHB) NHS Foundation Trust umbrella group. This review suggests that the department's current workflow and technical processing solution satisfies the requirements of the general data protection regulation (GDPR). At the time of writing, there were no additional financial costs or technical skills required for implementing GDPR regulations but this could change in future data processing systems. There are significant potential costs for non-compliance with GDPR. Brexit is unlikely to have any effect on complying with GDPR requirements. The GDPR gives the public the right to access information and be informed of how and why it is processed. It is recommended that improved administrative processing capability to accommodate this requirement should be included in future data processing designs. At the QEHB informed consent for use of photographs and videos is currently adequate to satisfy the common law of confidence.

[Required Framework for the Collection of Real-life Data: An Example from University Eye Hospital Munich]. / Rahmenbedingungen zur Sammlung von "Real-Life"-Daten am Beispiel der Augenklinik der Universität München.

Background The importance of evaluating real-life data is constantly increasing. Currently available computer systems better allow for analyses of data, as more and more data is available in a digital form. Before a project for real-life data analyses is started, technical considerations and staff, legal, and data protection procedures need to be addressed. In this manuscript, experiences made at the University Eye Hospital in Munich will be shared. Materials and Methods Legal requirements, as found in laws and guidelines governing documentation and data privacy, are highlighted. Technical requirements for information technology infrastructure and software are defined. A survey conducted by the German Ophthalmological Society, among German eye hospitals investigating the current state of digitalization, was conducted. Also, staff requirements are outlined. Results A database comprising results of 330,801 patients was set up. It includes all diagnoses, procedures, clinical findings and results from diagnostic devices. This database was approved by the local data protection officer. In less than half of German eye hospitals (n = 21) that participated in the survey (n = 54), a complete electronic documentation is done. Fourteen institutions are completely paper-based, and the remainder of the hospitals used a mixed system. Conclusion In this work, we examined the framework that is required to develop a comprehensive database containing real-life data from clinics. In future, these databases will become increasingly important as more and more innovation are made in decision support systems. The base for this is comprehensive and well-curated databases.

Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs. Final rule.

The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.

Comprehensive Child Welfare Information System. Final rule.

This final rule replaces the Statewide and Tribal Automated Child Welfare Information Systems (S/TACWIS) rule with the Comprehensive Child Welfare Information System (CCWIS) rule. The rule also makes conforming amendments in rules in related requirements. This rule will assist title IV-E agencies in developing information management systems that leverage new innovations and technology in order to better serve children and families. More specifically, this final rule supports the use of cost-effective, innovative technologies to automate the collection of high-quality case management data and to promote its analysis, distribution, and use by workers, supervisors, administrators, researchers, and policy makers.

Improve Tracking of Workplace Injuries and Illnesses. Final rule.

OSHA is issuing a final rule to revise its Recording and Reporting Occupational Injuries and Illnesses regulation. The final rule requires employers in certain industries to electronically submit to OSHA injury and illness data that employers are already required to keep under existing OSHA regulations. The frequency and content of these establishment-specific submissions is set out in the final rule and is dependent on the size and industry of the employer. OSHA intends to post the data from these submissions on a publicly accessible Web site. OSHA does not intend to post any information on the Web site that could be used to identify individual employees. The final rule also amends OSHA's recordkeeping regulation to update requirements on how employers inform employees to report work-related injuries and illnesses to their employer. The final rule requires employers to inform employees of their right to report work-related injuries and illnesses free from retaliation; clarifies the existing implicit requirement that an employer's procedure for reporting work-related injuries and illnesses must be reasonable and not deter or discourage employees from reporting; and incorporates the existing statutory prohibition on retaliating against employees for reporting work-related injuries or illnesses. The final rule also amends OSHA's existing recordkeeping regulation to clarify the rights of employees and their representatives to access the injury and illness records.

Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Implementation of Electronic Benefit Transfer-Related Provisions. Final rule.

This final rule considers public comments submitted in response to the proposed rule published February 28, 2013 and implements the provisions set forth in the Healthy, Hunger-Free Kids Act of 2010 related to electronic benefit transfer (EBT) for the WIC Program (also referred to herein as ``the Program''). The HHFKA amended provisions of the Child Nutrition Act of 1966 (CNA) and was enacted on December 13, 2010. EBT provisions of the HHFKA and other EBT implementation requirements included in this final rule are: A definition of EBT; a mandate that all WIC State agencies implement EBT delivery method by October 1, 2020; system management and reporting requirements; revisions to current provisions that prohibit imposition of costs on vendors; a requirement for the Secretary of Agriculture to establish minimum lane equipage standards; a requirement for the Secretary of Agriculture to establish technical standards and operating rules; and a requirement that State agencies use the National Universal Product Code (NUPC) database.

Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments. Final rule.

The Drug Enforcement Administration is updating its regulations for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals, and its regulations relating to reports required for domestic transactions in listed chemicals, gamma-hydroxybutyric acid, and tableting and encapsulating machines. In accordance with Executive Order 13563, the Drug Enforcement Administration has reviewed its import and export regulations and reporting requirements for domestic transactions in listed chemicals (and gamma-hydroxybutyric acid) and tableting and encapsulating machines, and evaluated them for clarity, consistency, continued accuracy, and effectiveness. The amendments clarify certain policies and reflect current procedures and technological advancements. The amendments also allow for the implementation, as applicable to tableting and encapsulating machines, controlled substances, and listed chemicals, of the President's Executive Order 13659 on streamlining the export/import process and requiring the government-wide utilization of the International Trade Data System (ITDS). This rule additionally contains amendments that implement recent changes to the Controlled Substances Import and Export Act (CSIEA) for reexportation of controlled substances among members of the European Economic Area made by the Improving Regulatory Transparency for New Medical Therapies Act. The rule also includes additional substantive and technical and stylistic amendments.

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.

Standard claims and appeals forms. Final rule.

The Department of Veterans Affairs (VA) amends its adjudication regulations and the appeals regulations and rules of practice of the Board of Veterans' Appeals (Board) to require that all claims governed by VA's adjudication regulations be filed on standard forms prescribed by the Secretary, regardless of the type of claim or posture in which the claim arises. This rulemaking also eliminates the constructive receipt of VA reports of hospitalization or examination and other medical records as informal claims for increase or to reopen while retaining the retroactive effective date assignment for awards for claims for increase which are filed on a standard form within 1 year of such hospitalization, examination, or treatment. This final rule also implements the concept of an intent to file a claim for benefits, which operates similarly to the current informal claim process, but requires that the submission establishing a claimant's effective date of benefits must be received in one of three specified formats. Finally, these amendments will provide that VA will accept an expression of dissatisfaction or disagreement with an adjudicative determination by the agency of original jurisdiction(AOJ) as a Notice of Disagreement (NOD) only if it is submitted on a standardized form provided by VA for the purpose of appealing the decision, in cases where such a form is provided. Although a standardized NOD form will only initially be provided in connection with decisions on compensation claims, VA may require a standard NOD form for any type of claim for VA benefits if, in the future, it develops and provides a standardized NOD form for a particular benefit. The purpose of these amendments is to improve the quality and timeliness of the processing of veterans' claims for benefits by standardizing the claims and appeals processes through the use of forms.

Electronic substitutions for SSA-538. Final rules.

This final rule adopts, without change, the final rule with request for comments we published in the Federal Register (76 FR 41685) on July 15, 2011. We are revising our regulations to reflect our use of electronic case processing at the initial and reconsideration levels of our administrative review process. We are not changing the requirement that State agency medical and psychological consultants must affirm the accuracy and completeness of their findings of fact and discussion of the supporting evidence, only the manner in which they may provide the required findings and affirmation. This revision will improve our efficiency by increasing our use of electronic resources.

Postmarketing safety reports for human drug and biological products; electronic submission requirements. Final rule.

The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.

Obtaining evidence beyond the current "special arrangement sources." Interim final rule with request for comments.

We are amending our regulations to state that we will obtain evidence from any appropriate source. Our current regulations provide that we will obtain information from "special arrangement sources'' for those infrequent situations when we are in a better position than our State agency partners to obtain evidence. Due to improved evidence collection through our increased use of health information technology (health IT), we are obtaining evidence electronically with increasing frequency. We expect that, over time, the electronic exchange of medical records will become our primary means for obtaining medical evidence. As we increase our use of health IT, the designation of "special arrangement sources'' will no longer adequately describe from whom we collect evidence.

Medical device reporting: electronic submission requirements. Final rule.

The Food and Drug Administration (FDA) is revising its postmarket medical device reporting regulation and making technical corrections. This final rule requires device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the Agency in an electronic format that FDA can process, review, and archive. Mandatory electronic reporting will improve the Agency's process for collecting and analyzing postmarket medical device adverse event information. Electronic reporting is also available to user facilities, but this rule permits user facilities to continue to submit written reports to FDA. This final rule also identifies changes to the content of required MDRs to reflect reprocessor information collected on the Form FDA 3500A as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

Unique device identification system. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.