Procedures for disclosure or production of information under the Freedom of Information Act; amendments--Consumer Product Safety Commission. Final Rule

The Electronic Freedom of Information Act Amendments of 1996, which amend the Freedom of Information Act, are designed to make government documents more accessible to the public in electronic form. The amendments are also intended to expedite and streamline the process by which agencies disclose information generally. In this notice, the Commission amends its Freedom of Information Act regulations to comply with the requirements of the new statute.     

Release of information from Department of Veterans Affairs records--VA. Proposed rule

This document proposes to amend Department of Veterans Affairs (VA) regulations governing the confidentiality and release of VA records subject to the Privacy Act, the Freedom of Information Act (FOIA) (including the Electronic Freedom of Information Act Amendments of 1996), and the veterans' records confidentiality statute. The proposed rule sets forth a mechanism for the public to obtain information from the VA. The proposed rule is intended to maximize public availability of VA records to the extent permitted by law and considerations such a personal privacy or law enforcement. Essentially these provisions consist of restatements of statute, interpretations of statute, interpretations of case law, interpretations of Executive Orders, and clarification. The proposed amendments also would implement the Electronic Freedom of Information Act Amendments of 1996, court decisions and Executive Branch guidance issued since the regulations were originally published. Further, this document proposes to delegate authority to the Assistant General Counsel for Professional Staff Group IV for making final Departmental decisions on appeals under the Freedom of Information Act, the Privacy Act, and 38 U.S.C. 5701 and 5705. This would simplify decision making by allowing the highest level individual with direct responsibility for decision making to issue decisions.     

Medicaid program; MMIS system performance review revisions--HCFA. Final notice

This notice revises the system performance review standards, procedures and methodologies previously published in the Federal Register on June 30, 1981 (46 FR 33653) that we have used to evaluate State Medicaid Management Information Systems. These revisions are intended to improve the economy, effectiveness and efficiency of the Medicaid program.     

The ICO and artificial intelligence: The role of fairness in the GDPR framework

The year 2017 has seen many EU and UK legislative initiatives and proposals to consider and address the impact of artificial intelligence on society, covering questions of liability, legal personality and other ethical and legal issues, including in the context of data processing. In March 2017, the Information Commissioner's Office (UK) updated its big data guidance to address the development of artificial intelligence and machine learning, and to provide (GDPR), which will apply from 25 May 2018.This paper situates the ICO's guidance in the context of wider legal and ethical considerations and provides a critique of the position adopted by the ICO. On the ICO's analysis, the key challenge for artificial intelligence processing personal data is in establishing that such processing is fair. This shift reflects the potential for artificial intelligence to have negative social consequences (whether intended or unintended) that are not otherwise addressed by the GDPR. The question of ‘fairness’ is an important one, to address the imbalance between big data organisations and individual data subjects, with a number of ethical and social impacts that need to be evaluated.     

The Extension of the Criminal Law to Protecting Confidential Commercial Information: Comments on the Issues and the Cyber-Context

Confidential commercial information is an increasingly valuable commodity and commercial resource which may be inadequately protected by the traditional approach of English criminal law against misappropriation. This paper reviews the nature of the problem and some of the relevant legal issues. Notwithstanding that a global reform of the law in this area is probably not on the cards, the position advocated here is that the direct application of the criminal law is indeed an appropriate vehicle through which to deter the misappropriation of confidential commercial information. However, the scope of any new law must be carefully circumscribed - if it is drawn too wide, the law runs the danger of acting outside of the articulated rationale for criminal liability and endangering other legitimate interests (particularly in the cyberspace context). If it is drawn too narrow, any new law may very well prove ineffective. It is suggested that there are a number of difficulties, both doctrinal and practical, that must be resolved prior to enacting new legislation in this area. Some observations are presented upon the more critical issues for those interested in the implications of law reform in this area for cyberspace.     

Gender differences in intended escalatory tendencies among marital partners

This study addresses the intended escalatory tendency in eight hypothetical situations in which the provocator's identity (partner or stranger, male or female) and the provocation form (verbal or physical aggression) were manipulated. The research question is "how does the identity of the provocator and the form of his or her provocation affect the participant's intended escalation level, and does the gender of the participant affect differences in intended escalation level?" The research sample consisted of 208 Israeli couples. The main finding is that women's intended response to their male partner is more escalatory than men's intended response to their female partner. Results also show that women's escalation is the most severe to partner provocation and the least severe to male strangers' provocation. Men's escalation is the most severe to provocation by male strangers and the least severe to their partner's provocation. Findings indicate that men's intention to escalate decreases as their partner's provocation becomes more severe. The severity of provocation has little effect on women's inten-tion to escalate. Such results are consistent with social role theory and sexual selection theory that maintain that status enhancement is more important for men than for women, and is more important for men than risk reduction is, whereas the opposite is true for women.     

A Formal Model of Legal Argumentation

Abstract . The paper gives a formal reconstruction of some fundamental patterns of legal reasoning, intended to reconcile symbolic logic and argumentation theory. Legal norms are represented as unidirectional inference rules which can be combined into arguments. The value of each argument (its qualification as justified, defensible, or defeated) is determined by the importance of the rules it contains. Applicability arguments, intended to contest or support the applicability of norms, preference arguments, purporting to establish preference relations among norms, and interpretative arguments are also formalised. All those argument types are connected in a unitary model, which relates legal reasoning to the indeterminacy of legal systems, intended as the possibility to develop incompatible defensible arguments. The model is applied to permissive norms and normative hierarchies, and is implemented in a Prolog program.     

个人信息流通利用的制度基础——以信息识别性为视角

《个人信息保护法》以信息主体同意为基础,构筑了个人控制的个人信息直接利用制度,但其是否为流通利用提供了通道仍存疑问。信息因其识别性能的差异,可区分为直接标识符、间接标识符和准标识符,三者给个人权益带来的危害风险不同。《个人信息保护法》规定的匿名化和去标识化本质上是针对特定数据集中信息识别风险的制度安排,能消除因信息本身识别性产生的风险,而很难消除基于识别分析的识别性产生的风险。因此,缺失针对“基于识别分析的识别性产生的风险”的措施,现行关于匿名化和去标识化的规范均不能支撑个人信息流通利用。去标识化需要改造成为“去直接标识符+识别控制”的受控去标识化制度,在防控个人信息识别风险的前提下,为个人信息流通利用提供制度保障,以最大化实现个人信息的社会价值。     

Medical devices; Medical Device Data Systems. Final rule

The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices. An MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements.     

Coroners' autopsies: quality concerns in the United Kingdom

Safety in health care has increasingly become a key focus of health care providers. Data on "patient outcomes" and evidence-based clinical decision-making have led to real changes in health care policy and care provision. Specialist groups such as the National Patient Safety Agency which operates the National Confidential Enquiry into Patient Outcome and Death (NCEPOD) in the United Kingdom are reliant on good information in order to identify factors that lead to poor patient care. In a recent study the NCEPOD reviewed the quality of coroners' autopsy reports on which they rely for much of their core data. The study found that just over half of the reports (52%) were considered satisfactory by the reviewers, 19% were good and 4% were excellent. However, over a quarter of autopsies were marked as poor or of an unacceptable standard. While analysing the factors associated with poor-quality autopsies, comments and recommendations were made with regard to the processes of death investigation and the degree to which the coroner's death investigation meets the needs of health care services.     

The NHS Information Revolution: ‘Choice of Control’ to ‘Choice’ and ‘Control’

This paper provides a novel and critical analysis of the necessary and important balance between ‘individual privacy’ and ‘collective transparency’. We suggest that the onset of the Information Revolution has created a dilemma for the National Health Service (NHS) in terms of how it addresses its obligation to use information to improve best practice in healthcare for society (‘collective transparency’) whilst also keeping sensitive personal information confidential (‘individual privacy’). There is clearly a need to consider both whether the NHS is balancing this critically important informational relationship and whether its approach is fit for purpose. We argue that the NHS's ‘proxy-individual’ information guardian role could inadvertently mask individuals' intended roles, effectively circumventing autonomy-based laws by limiting the power of individuals to be autonomous. In this article we have identified three issues – first the prevailing ‘Mindset’ (the ‘M’) of ‘privacy’, which is viewed as individualistic, resulting in an overpowering concept of confidentiality; second, the quality and control of Information (the first ‘I’); and third, the concept of innovation (the second ‘i’), which is being used as a ‘solution’ rather than a vehicle for transparency. Indeed, transparency is our target of ‘best practice,’ and we suggest that individual privacy and collective transparency are best embedded within a complementary privacy framework that offers a better fit than the current split of control between the roles of the NHS and the roles of the individual. It is suggested that when facilitated by transparency, ‘control’ and ‘privacy’ form a continuum, aligning through the desire for choice. Therefore, the choice of control could facilitate control and choice. Together, they could replace the concept of privacy by empowering ‘informed patients’ to support the NHS's ‘No decision about me, without me’ pledge.     

Becoming an Informant

Though widely acknowledged as vital to law enforcement, social scientists have largely ignored the practice of confidential informing. The extant literature on the topic is primarily comprised of experientially based practical guides to informant management and a handful of field studies drawing information from informants in the study of other undercover practices. This study features data obtained from in‐depth interviews with eighty‐four former informants drawn from five southern states identified through a purposive‐snowball sampling strategy. Informant accounts suggest that the practice of confidential informing is an institutionalized component of a general narcotics enforcement pattern characterized by duplicity and social control irony. Confidential informant work is observed as a moral career entailing deviant identity maintenance through neutralizations and insider perspective. Narratives confirmed a motivational typology accounting for role assumption and informant–agent dynamics and orient discussion around practice and research implications.     

The Freedom of Information Act 1966–2006: A Retrospective on the Rise of Privacy Protection Over the Public Interest in Knowing What the Government's Up To

The tension between an individual's right to privacy and the public's right to obtain government-held information represents a conflict between two vital democratic values. The solution to resolving this tension lies in striking an appropriate balance between a person's need to be let alone and society's need to be informed. The crafters of the Freedom of Information Act (FOIA) intended to set such a balance when they created two privacy exemptions to the statute. In instances when the government refuses to release a record on privacy grounds, then a requester may turn to the courts to interpret what the law instructs. Consequently, the judiciary has significantly shaped the contours of the FOIA over the years. This article examines whether the Supreme Court's current FOIA-related privacy framework comports with the FOIA as reflected in its legislative history.     

Revisions to labeling requirements for blood and blood components, including source plasma. Final rule

The Food and Drug Administration (FDA) is revising the labeling requirements for blood and blood components intended for use in transfusion or for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling and circulars of information. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a replacement for the ``ABC Codabar' system for the labeling of blood and blood components. FDA is taking this action as a part of its efforts to comprehensively review and, as necessary, revise its regulations, policies, guidances, and procedures related to the regulation of blood and blood components. This final rule is intended to help ensure the continued safety of the blood supply and facilitate consistency in labeling.     

Paradigm intention

Antony Duff's recent account of intended action has aroused considerable interest, particularly amongst English commentators, as an attempt to provide criteria that might be utilised by a judge or legislator. While Duff's analysis is instructive, and although it may be desirable to find conditions capturing the central notion of intention in action, this paper demonstrates that the specific conditions proposed by Duff are unsatisfactory. They require extensive modification in order to circumvent a number of difficulties presented here.     

Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing final regulations defining the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body. The regulations also establish criteria for determining when a statement about a dietary supplement is a claim to diagnose, cure, mitigate, treat, or prevent disease. This action is intended to clarify the types of claims that may be made for dietary supplements without prior review by FDA and the types of claims that require prior authorization as health claims or prior approval as drug claims.     

个人信息权的体系化解释——兼论《个人信息保护法》的公法属性

《个人信息保护法》是数字时代个人信息保护的基本法。它采取了将个人信息权作为新兴公法权利的思路,确立了完整的个人信息权利保护体系,在个人信息保护问题上和《民法典》一起形成了公私法共同协力的进路。《个人信息保护法》以权利束的方式规定了个人信息主体的知情权、决定权、查阅权、复制权、更正权、删除权、可携带权和信息权利救济权等。《个人信息保护法》从立法依据、权利体系、条文设计和规制措施上都体现出鲜明的公法属性,这也可以从基本权利的双重面向和个人信息国家保护义务得到理论上的证成。这部法律是数字时代公法秩序的基石,它对公法边界的形塑仍需通过其实施来确立。     

Fault-lines in community treatment order legislation

This article discusses the major tension points in the legislation that authorises involuntary outpatient treatment for mental disorder in six British Commonwealth jurisdictions. Particular attention is paid to the role of competence (or capacity) principles in the ruling legal criteria, to the precise powers of community treatment conferred, and to the potential impact of the legislation on clinicians' liability concerns. It is argued that the conferral on clinicians of a power to administer 'forced medication' in community settings is not required to promote active use of involuntary outpatient care, and that such a power should not be provided. The article concludes with discussion of the reasons why community treatment orders are used more frequently in some jurisdictions than others.