This specification covers requirements for the disclosure of specific characteristics of screw-type adjustable clamps that are designed for the gradual permanent occlusion of carotid arteries. These devices consist of an implantable portion and an externally projecting removable screwdriver. The manufacturer shall disclose the generic names of the materials used in the manufacture of the clamp, the advance ratio, pressure plate induced laceration of vessel, and slip resistance of the clamp.1.1 This specification covers requirements for the disclosure of specific characteristics of screw-type adjustable clamps that are designed for the gradual permanent occlusion of carotid arteries. These devices consist of an implantable portion and an externally projecting removable screwdriver (see Fig. 1).1.2 The following precautionary caveat pertains only to the test method portion, Section 5, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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4.1 Data that document health services in health care organizations are business records and shall be archived to a secondary but retrievable medium, and readily accessible, such as data that would be archived in a server or cloud storage. Audit data shall be retained for as long as the medical record is maintained, and may not be destroyed before the medical record may legally be destroyed, and in any event, for at least 10 years or for two years after the legal age of majority, unless a longer period of record retention is prescribed by state, federal or other law or regulation.4.2 The purpose of audit data and disclosure logs is to document and maintain a permanent, trustworthy, and immutable record of all authorized and unauthorized activities of any nature whatsoever and disclosure of confidential health information {except exclusions per federal and state law [21 CFR 11 Subpart B(e)]}. This further facilitates the purpose that patients, healthcare providers, organizations, and others can obtain a verifiable, self-authenticating record documenting all activities with respect to that record. The process of information disclosure and auditing shall also conform, where relevant, with the Privacy Act of 1974 (3).4.3 Audit reports designed for system access provide a precise capability for healthcare providers, organizations, patients, patient representatives, and advocates to see who has accessed and/or manipulated patient information. Because of the significant risk of medical information manipulation in computing environments by authorized and unauthorized users, the audit report is an important management tool to monitor access and any such manipulation retrospectively. In addition, the access and disclosure logs become powerful support documents for disciplinary and legal actions. Moreover, audit reports are essential components to comprehensive security programs in healthcare and vital for the privacy rights of the individual. A patient has a right to know who has accessed their patient information and what occurred during such access. Access by any means (viewing or any other action) regarding the patient record and/or audit log or the data contained therein by attorneys, risk management, or similar individuals or entities are not privileged actions and must also be fully transparent and disclosed.4.4 Healthcare providers and organizations are accountable for managing the disclosure of health information in a way that meets legal, regulatory, accreditation, and licensing requirements and growing patient expectations for accountable privacy practices. Basic audit data procedures shall be applied, manually if necessary, to paper patient record systems to the extent necessary to protect patient privacy and to allow authentication of the paper record.4.5 Medical records with integrity and trustworthiness are essential to promote safe and appropriate healthcare, billing, research, and quality control initiatives and are protective of all individuals involved in healthcare delivery and receipt. Consumer fears about confidentiality of health information and legal initiatives underscore disclosure practices. Technology exists to incorporate audit functions in health information systems. Institutions are accountable for implementing comprehensive confidentiality, security, and patient information audit programs that combine social elements, management, and technology.4.6 This specification also responds to the need for a standard addressing privacy and confidentiality as noted in Public Law 104–191 (2), or the Health Insurance Portability and Accountability Act of 1996, and the need for a self-authenticating record that will verify accuracy and integrity.AbstractThis specification describes the security requirements involved in the development and implementation of audit and disclosure logs used in health information systems. It specifies how to design an access audit log to record all access to patient identifiable information maintained in computer systems, and includes principles for developing policies, procedures, and functions of health information logs to document all disclosure of confidential health care information to external users for use in manual and computer systems. This specification provides for two main purposes, namely: to define the nature, role, and function of system access audit logs and their use in health information systems as a technical and procedural tool to help provide security oversight; and to identify principles for establishing a permanent record of disclosure of health information to external users and the data to be recorded in maintaining it.1.1 This specification is for the development and implementation of secure audit data and logs for electronically stored health information. It specifies how to design the audit log to record all activities impacting a medical record, for example, creating a new record, entering data into a record, changing or deleting an existing record, and all additional user access data (for example, identification, location, and date and time) to patient-identifiable information maintained in computer systems. Such audit logs shall track not only data entry and modifications, but also simple access and viewing of the patient record, and whether any modifications are made during that access. This specification also includes principles for developing policies, procedures, and functions of health information logs to document all actions regarding identifiable health information for use in both manually entered (paper record) and computer systems.1.2 The first purpose of this specification is to define the nature, purpose, and function of system access audit logs and their use in health information systems as a technical and procedural tool to help provide privacy and security oversight and produce a self-authenticating record that would, when maintained together with its audit logs, speak to and confirm its own integrity and accuracy of the medical and other data within the record. Moreover, in concert with organizational confidentiality and security policies and procedures, permanent audit logs can clearly identify all system application users who accessed and acted on patient identifiable information or both, and identify the location of the user, identify patient information accessed, and maintain a permanent record of actions taken by the user. Accomplishing the purpose of creating a trustworthy record thus requires the use of secure, automatic, computer-generated, time-stamped audit logs, which shall be used to independently record the identity of the user as well as the date, time, and location of user access, and also record all entries and actions that create, change, or delete electronic records or other patient information. Full transparency of modifications or deletions or both is mandatory. For example, record changes shall not obscure previously recorded information. Such audit data and documentation shall be retained for a period at least as long as that required for the subject paper and electronic records (together, “records”), including any time period required by evidence preservation or litigation hold requirements and applicable state or applicable federal laws pertaining to the subject records. In no event shall the audit data or medical records in hard copy or electronic format be destroyed in advance of that date prescribed by state, federal or other law or regulation, when such records may be legally destroyed; and in any case, not before ten years or, in the case of a minor child, before two years after that child’s eighteenth birthday. If such records are for any reason maintained beyond this minimum requirement, then the audit logs, and the data contained therein, must be maintained as long as the records are maintained. Audit logs and healthcare information shall be provided when specifically requested by authorized healthcare providers; the patient, his personal representative, advocate, and/or designee; researchers; quality control personnel; and organizational managers or administrators or both; and other persons authorized to have access to patient records or patient-identifiable information or both in any form.1.3 In the absence of computerized logs, audit log principles can be implemented manually in the paper patient record environment with respect to permanently monitoring paper patient record access, data entry, and data modification. Where the paper patient record and the computer-based patient record coexist in parallel, security oversight and access and data management shall address both environments with the underlying and unifying principle being transparency regarding the identity of the individual accessing or acting upon data in the record or both; the location of the individual when doing so; the time and date of such actions/entries; and clear visibility of modifications such as addenda, deletions, error corrections, and late entries.1.4 The second purpose of this specification is to identify principles for establishing a permanent record of disclosure of health information to external users and the data to be recorded in maintaining it. Security management of health information requires a comprehensive framework that incorporates both mandates and criteria for disclosing patient health information found in federal and state laws and rules and regulations and ethical statements of professional conduct. Accountability for such a framework shall be established through a set of standard principles that are applicable to all healthcare settings and health information systems.1.5 The creation and preservation of logs used to audit and oversee health information access, actions made upon health information, and disclosure of health information are the responsibility of each healthcare provider, organization, data intermediary, data warehouse, clinical data repository, third-party payer, agency, organization, or corporation that maintains or provides or has access to individually identifiable data. Such logs are specified in and support policy on information access monitoring and are tied to disciplinary sanctions that satisfy legal, regulatory, accreditation, institutional mandates, civil remedies by the patient or patient’s family, and are also tied to authentication of medical data and a patient’s right to obtain a complete, accurate, and transparent set of medical data and metadata (for example, audit logs).1.6 When non-patient-specific healthcare data is sought (for example, analyses of aggregate patient data for internal or external reviews, research, or subsidies), healthcare providers and organizations need to also prescribe access requirements for such aggregate data and approve query tools that allow complete auditing capability or design data repositories that, in an active query, can limit inclusion of data in end-product aggregate form that reveals potential keys to identifiable data. In other words, endproduct aggregate-patient data shall not contain patient-identifying data or elements that, through analysis, can be used to identify individuals through inferences. For example, fields such as birth date, sex, race, or relevant demographics, and medical records numbers, or combinations thereof, are analyzed together for research purposes, using software that matches data elements across databases, thereby allowing identification of specific patients through inferencing, while preserving patient privacy. Audit data and logs can be designed to work with such applications, if the query functions are part of a defined retrieval application, but the end-product data is safeguarded to protect patient identity from release. This specification applies to the disclosure or transfer of health information (records) whether as individual files or in batches.1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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This specification covers the requirements for specific characteristics and appropriate test requirements for, and disclosure of self-closing aneurysm clips that are intended for permanent implantation. Miniatures of "microclips" that are not intended for the obliteration of aneurysms are excluded from this specification.1.1 This specification covers requirements for the specific characteristics of self-closing aneurysm clips that are intended for permanent implantation. Appropriate test requirements are also included.1.2 Since all of the properties that contribute to aneurysm clip performance may not be known, this specification is intended to reflect the state of our knowledge to date.1.3 Miniatures of "microclips" that are not intended for the obliteration of aneurysms are excluded from this specification.

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4.1 Significance—This guide provides additional guidance to preparers of environmental disclosures; these materials are needed to address changing audience needs, the increased regulatory and accounting complexity around environmental matters, and the emergence of a variety of long-term trends and factors, including but not limited to:4.1.1 Number and scope of domestic, and foreign environmental laws and their implementing regulations;4.1.2 Number and scope of treaties, as well as the implementing laws and regulations; parties in these treaties include multilateral organizations and indigenous peoples;4.1.3 Judicial decisions clarifying the impact of laws, regulations, and treaties;4.1.4 Costs of compliance with environmental regulations;4.1.5 Number of known chemical compounds (see Chemical Abstracts Service REGISTRYSM, which contains over 193 million unique organic and inorganic substances);4.1.6 Cost and accuracy of soil, sediment, air, soil vapor, surface water and groundwater testing equipment and procedures;4.1.7 Knowledge about benefits and effects of chemical compounds on human health, ecological receptors, and the environment;4.1.8 Number and efficacy of remedial technologies;4.1.9 Experience with assessing and remediating environmental conditions;4.1.10 Assumptions regarding impacts of environmental conditions, through modeling and other forecasting tools;4.1.11 Number of environmental, social and governance (ESG) metrics and their pace of adoption;4.1.12 Frequency and financial impact of counterparty failure; and4.1.13 Development of comparable accounting standards by other authorities; and4.1.14 Investor interest in the impact of these trends and factors on their investments.4.2 Uses—This guide is intended for use on a voluntary basis by a reporting entity that provides financial and qualitative disclosure regarding environmental liabilities. Disclosure is integrated with preceding elements of financial statements, namely recognition, measurement, and presentation of environmental liabilities, as noted in Fig. 1. (Full explanation of this framework can be found in FASB Concepts Statement 8, September 2010.) With the long-term trends and factors in 4.1, the issuers of environmental disclosures have found it useful to regularly report material environmental topics to the public through filings to the Securities and Exchange Commission (SEC), Form 10-K or 20-F.NOTE 1: Many of these trends and factors, as well as the changes to GAAP, have occurred gradually. For example, users of this guide will likely be aware that chemicals that were not regulated or considered contamination yesterday may be deemed so tomorrow.4.2.1 Typical environmental disclosures to the public include, but are not limited to:FIG. 1 FASB Conceptual Framework4.2.1.1 Book value of current environmental liabilities, such as asset retirement obligations, pollution remediation obligations, and natural resource damage claims;4.2.1.2 Book value of product liability costs (for example, recalls) and other litigation related to human health and the environment;4.2.1.3 Counts of projects or legal matters, especially over time, which provide a metric to track if the rate of liability settlements align with or vary from the rate of incoming liabilities;4.2.1.4 Indirect costs such as project and legal services to oversee liabilities, and guarantees on the long-term performance of counterparties;4.2.1.5 Costs and income associated with contracts and commitments, such as purchase and sale agreements, insurance contracts, and merger transactions;4.2.1.6 Voluntary costs to comply with environmental laws, regulations and treaties;4.2.1.7 Contingencies and non-financial metrics related to the above items; and4.2.1.8 Note to financial statements confirming that a booked environmental liability conforms to the accounting definition of a liability, namely that a loss has been incurred which will result in future spending that is both probable and reasonably estimable. See E3123 for further detail.4.2.2 The degree and type of disclosure depends on the scope and objective of the financial statements. Such statements may not always be audited or prepared for the public domain.4.2.3 For example, users of this guide may need to make non-public disclosures for the benefit of investors, prospective asset purchasers, lenders, regulators, insurers, tax authorities, key customers, and joint venture partners.4.2.4 Users of this guide should be aware that shareholder concerns, contractual obligations, financial assurance requirements, court decisions, and regulatory directives may affect their flexibility in the use of this guide.4.2.5 Some larger entities may publish their environmental, social and governance (ESG) metrics to communicate company policies, progress in meeting emission goals, sustainability of individual products and services, and the impact of subsidies and taxes. The user should note that ESG metrics are not a part of generally-accepted accounting principles. ESG metrics may lack comparability (see Fig. 1 above) from industry to industry, and sometimes company to company. While these ESG metrics constitute a form of environmental disclosure, they are excluded from this Guide. These metrics are published by several organizations, including the Sustainability Accounting Standards Board. See Guide E2718 for further information.4.3 Principles: The following principles are an integral part of this Guide and are intended to be referred to in resolving ambiguities or disputes regarding the interpretation of disclosures regarding environmental liabilities.4.3.1 Faithful representation—to be useful to the decisions of those receiving environmental disclosures, the information provided must be reliable and trusted. Users of this Guide should note the “Enhancing Qualitative Characteristics” in Fig. 1:(a) disclosures should be comparable with similar disclosures from competing or peer entities; the use of non-standard measurements or terminology should be avoided(b) disclosures should be verifiable through cost accounting and auditing specialists(c) disclosures should consist of timely information, reflecting an entity’s quarterly financial reporting to its officers(d) disclosures should be understandable through using the common reporting terminology in GAAP; for example, an entity should not describe asset retirement obligations (ASC 410-20 and GASB 83) with entity-specific project labels.4.3.2 Continuous Improvement—just as environmental liabilities generally accrue across time and with strategic transactions, any entity should disclose gradual improvements in addressing environmental matters as the scope and scale of issues evolve. A newly-formed entity may find no reason to disclose hypothetical losses or describe risks which have not occurred; however, an entity with 100 years of operations may find it essential to disclose an historical review of brands, facilities and waste disposal practices.4.3.3 Transparency—entities will find it useful to supplement financial disclosures with performance metrics, including but not limited to:4.3.3.1 Number of properties awaiting reuse and/or sale because of environmental contamination concerns, including those with AULs (see Guide E2091)4.3.3.2 Number of sites successfully completing regulator-directed remediation; portion of the liability portfolio in either early or final stages of regulator-directed remediation4.3.3.3 Relevance of emerging contaminants to current and historical production4.3.3.4 Relevance of climate adaptation expenses to future operations4.3.3.5 Relevance of pending court cases4.3.3.6 Limitations to reliably calculating current liabilities4.3.3.7 Comprehensive impact of long-term trends of booked liabilities – generally available by combining a decade or more of historical disclosures – to avoid the impression of “remediation theater” where environmental reserves are booked and expended roughly equally without any sense of progress or achievement in addressing contamination.4.3.4 Uncertainty Not Eliminated—Although a reporting entity, as of the time when its financial statements are prepared, may hold a certain position with regard to the existence and extent of its environmental liabilities, there remains uncertainty with regard to the final resolution of factual, technological, regulatory, legislative, and judicial matters, which could affect its valuation of environmental liabilities. Under the constraints of preparation cost and materiality (noted in Fig. 1), users needing reliable information may experience additional limitations, such as unaudited cost projections, draft scientific findings, or the bounds of attorney-client privilege. Users may encounter decisions identified as uncertainties and observe liabilities priced solely through the costs to implement potential remedial strategies; information on cognitive biases in valuing environmental costs and liabilities may be found in Guide E2137.4.3.5 Disclosure Dependent on Circumstances—Not every environmental liability warrants the same level of detail in its disclosure. Disclosure will be guided by the scope and objective of the financial statement, and accordingly, by the materiality of the environmental liability and the level of information available.4.3.6 Comparison with Subsequent Disclosures—Subsequent disclosures that convey different information regarding the extent or magnitude of the reporting entity's exposures should not be construed as indicating the initial disclosures were inappropriate or incorrect. Disclosures shall be evaluated on the reasonableness of judgments and inquiries made at the time and under the circumstances in which they were made. Subsequent disclosures should not be considered valid standards to judge the appropriateness of any prior disclosure based on hindsight, new information, use of developing analytical techniques, or other factors. However, information on trends may be of value to a user of financial statements.4.3.7 Not Exhaustive—Appropriate disclosure does not necessarily mean an exhaustive disclosure; discretion and professional judgment are used by estimators, auditors, and the reporting entity's management in setting limits on the preparation cost, materiality, and volume of information worth disclosing as environmental liabilities.NOTE 2: For each entity, there is a tradeoff between displaying detailed information and identifying reliable and accurate insights that are useful to user decisions.4.3.8 Assessment of Risk—As the reporting entity becomes aware of an environmental liability, the condition or issue should be evaluated to assess the actual or potential risk to human health and environment and resources. The degree of risk is evaluated in context of the current regulatory environment, an understanding of the specifics of the condition or issue, potential future uses, and asset retirement obligations.4.3.9 Improved Capital Stewardship—Disclosure, along with the preceding steps of recognition, measurement, and presentation, provides context for environmental liabilities and may improve the defensible allocation of capital to resolving those liabilities as efficiently as possible. Over time, an entity may find it valuable or even essential to demonstrate leadership in cost efficiency for understanding, controlling, preventing, and reducing environmental liabilities. The need for intermittent internal presentations may transform into the need for regular public disclosures as an entity acquires environmentally impaired assets or other environmental liabilities. An entity may prefer to make the ongoing investment in competent and continuous data collection and interpretation to draw internal managerial attention toward measuring and ensuring progress in discharging the liabilities as efficiently as possible.1.1 Purpose—The purpose of this guide is to provide a series of options or instructions consistent with good commercial and customary practice in the United States for environmental liability disclosures accompanying audited and unaudited financial statements. This guide is consistent with Generally Accepted Accounting Principles (GAAP)2 issued by Financial Accounting Standards Board (FASB), as well as related statements, rules, regulations, and/or procedures issued by Government Accounting Standards Board (GASB), Public Company Accounting Oversight Board (PCAOB), Securities and Exchange Commission (SEC), and Federal Accounting Standards Advisory Board (FASAB). This guide is intended to be consistent with national and multinational issuers of accounting standards and practices, including International Accounting Standards Board (IASB).1.2 Objectives—The objectives of this guide are to:1.2.1 Identify the common terminology used in environmental disclosures,1.2.2 Explain the need for environmental disclosures,1.2.3 Define the conditions warranting disclosure, and1.2.4 Illustrate the report formats and content typically used in environmental disclosures.1.3 History of development of this guide—In 1993-1994, a group of insurance companies approached ASTM to request a best practice environmental cost estimation and disclosure standard, as they were experiencing high environmental remediation and asbestos claims from policyholders that were reporting no material liabilities in their annual reports. At the same time, asbestos and environmental liabilities were triggering bankruptcy more frequently, again with little prior disclosure by companies other than boilerplate legal language that costs were too uncertain or not estimable, or that such costs would not be material. Research by the ASTM standard working committee at the time found such shortcomings as (a) rarely attempting to identify a full portfolio of potential liabilities, (b) dividing liabilities into separate sites or claims to avoid aggregated material outcomes that would require disclosure, and (c) relying on “known minimum costs” or “no estimate” to forecast liabilities. This disclosure standard (E2173), initially developed over a seven-year period with its first approval in 2001, was created to cure these shortcomings by providing guidance for best practice disclosure, including aggregation of liabilities before conducting a materiality test, as well as disclosure of the major assumptions and evaluations underlying the disclosure. The companion referenced cost estimation standard (E2137, which was split into a separate standard due to its broader applicability beyond disclosure purposes) provided guidance on a hierarchy of cost estimation methodologies that explicitly address uncertainty and recommend alternative methodologies. Both E2137 and E2173 have been revised over time to reference and incorporate applicable elements of new accounting standards and regulations, consider applicable case law, and incorporate new best-practice examples and years of additional experience with cost estimation and disclosure.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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