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.

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.

Immunization information systems: a decade of progress in law and policy.

This article reports on a study of laws, regulations, and policies governing Immunization Information Systems (IIS, also known as "immunization registries") in states and selected urban areas of the United States. The study included a search of relevant statutes, administrative codes and published attorney general opinions/findings, an online questionnaire completed by immunization program managers and/or their staff, and follow-up telephone interviews.The legal/regulatory framework for IIS has changed considerably since 2000, largely in ways that improve IIS' ability to perform their public health functions while continuing to maintain strict confidentiality and privacy controls. Nevertheless, the exchange of immunization data and other health information between care providers and public health and between entities in different jurisdictions remains difficult due in part to ongoing regulatory diversity.To continue to be leaders in health information exchange and facilitate immunization of children and adults, IIS will need to address the challenges presented by the interplay of federal and state legislation, regulations, and policies and continue to move toward standardized data collection and sharing necessary for interoperable systems.

An education in contrast: state-by-state assessment of school immunization records requirements.

OBJECTIVES: We reviewed the complexities of school-related immunization policies, their relation to immunization information systems (IIS) and immunization registries, and the historical context to better understand this convoluted policy system. METHODS: We used legal databases (Lexis-Nexis and Westlaw) to identify school immunization records policies for 50 states, 5 cities, and the District of Columbia (Centers for Disease Control and Prevention "grantees"). The original search took place from May to September 2010 (cross-referenced in July 2013 with the list on http://www.immunize.org/laws ). We describe the requirements, agreement with IIS policies, and penalties for policy violations. RESULTS: We found a complex web of public health, medical, and education-directed policies, which complicates immunization data sharing. Most (79%) require records of immunizations for children to attend school or for a child-care institution licensure, but only a few (11%) require coordination between IIS and schools or child-care facilities. CONCLUSIONS: To realize the full benefit of IIS investment, including improved immunization and school health program efficiencies, IIS and school immunization records policies must be better coordinated. States with well-integrated policies may serve as models for effective harmonization.

Health information privacy and health information technology in the US correctional setting.

Electronic health records and electronic health information exchange are essential to improving quality of care, reducing medical errors and health disparities, and advancing the delivery of patient-centered medical care. In the US correctional setting, these goals are critical because of the high numbers of Americans affected, yet the use of health information technology is quite limited. In this article, I describe the legal environment surrounding health information sharing in corrections by focusing on 2 key federal privacy laws: the Health Insurance Portability and Accountability Act of 1996 and the federal Confidentiality of Alcohol and Drug Abuse Patient Records laws. In addition, I review stakeholder concerns and describe possible ways forward that enable electronic exchange while ensuring protection of inmate information and legal compliance.

The meaningful use regulations in information technology: what do they mean for quality improvement in hospitals?

If provider organizations are serious about improving quality and efficiency, they must advance their electronic health record capabilities far beyond just meeting the U.S. federal regulations.

State systems Advance Planning Document (APD) process. Final rule.

The Advance Planning Document (APD) process governs the procedure by which States obtain approval for Federal financial participation in the cost of acquiring automated data processing equipment and services. This final rule reduces the submission requirements for lower-risk information technology (IT) projects and procurements and increases oversight over higher-risk IT projects and procurements by making technical changes, conforming changes and substantive revisions in the documentation required to be submitted by States, counties, and territories for approval of their Information Technology plans and acquisition documents.

Health IT the road so far.

As healthcare financial executives plan their health IT investments, they should evaluate not only the technology, but also the governance model. Hospitals need health-centric collaboration of stakeholders and a sustainable business model to ensure the success of their IT investment. The whole enterprise of health IT should be about improving the health delivery system and reducing its cost.

What you heed to know about meaningful use.

The final rule on meaningful use of electronic health records has brought both relief and anxiety to hospitals. This foldout section offers some guidance.

Privacy impact assessment in the design of transnational public health information systems: the BIRO project.

OBJECTIVES: To foster the development of a privacy-protective, sustainable cross-border information system in the framework of a European public health project. MATERIALS AND METHODS: A targeted privacy impact assessment was implemented to identify the best architecture for a European information system for diabetes directly tapping into clinical registries. Four steps were used to provide input to software designers and developers: a structured literature search, analysis of data flow scenarios or options, creation of an ad hoc questionnaire and conduction of a Delphi procedure. RESULTS: The literature search identified a core set of relevant papers on privacy (n = 11). Technicians envisaged three candidate system architectures, with associated data flows, to source an information flow questionnaire that was submitted to the Delphi panel for the selection of the best architecture. A detailed scheme envisaging an "aggregation by group of patients" was finally chosen, based upon the exchange of finely tuned summary tables. CONCLUSIONS: Public health information systems should be carefully engineered only after a clear strategy for privacy protection has been planned, to avoid breaching current regulations and future concerns and to optimise the development of statistical routines. The BIRO (Best Information Through Regional Outcomes) project delivers a specific method of privacy impact assessment that can be conveniently used in similar situations across Europe.

[Setting up a national information system for prevention]. / La costruzione di un sistema informativo nazionale per la prevenzione.

BACKGROUND: The recent law (D.lgs n. 81/2008) redesigned all the Italian regulations regarding safety and health at work. It redesigned rules that up to now were contained in laws that were introduce over a period of over nearly sixty years, with due review and extension. METHODS AND RESULTS: Article 8 of the law is dedicated specifically to a national information system for the prevention at the workplace (called SINP), created "with the aim of supplying useful data in order to guide, programme, to plan, and assess the effectiveness of actions taken for the prevention of injuries and occupational diseases... and to provide guidance in matters of inspection". It is important to emphasize that the course followed to define the SINP is due to the joint efforts that INAIL, ISPESL, the Regions and the independent Provinces started in 2002, by agreeing to a protocol, with the common aim of creating an integrated information system for prevention in the workplace. CONCLUSIONS: At present data are available on a national scale and they are useful in order to acquire more detailed knowledge of the area in question (on enterprises, accidents, occupational diseases) and in order to define intervention priorities, to plan and program activities and verify the results.

Adopting electronic medical records: what do the new federal incentives mean to your individual physician practice?

Under President Obama's American Recovery and Reinvestment Act of 2009, the federal government is offering incentives to physicians to adopt electronic health records. The goal is to improve quality of care and constrain costs. Higher incentive payments are available for those physicians who act quickly to meet the government's standards. Physicians who practice in "health professional shortage areas" and who serve mainly Medicaid recipients may qualify for additional incentives. Although compliance is "voluntary, "physicians who have not met the standards by 2015 will face reductions in their Medicare reimbursements unless they can show a significant hardship. Physicians can get started by contacting hospitals with which they are affiliated and professional associations to find out what vendors are being used in their service area. Agreements for electronic health records should be reviewed carefully to ensure that physicians' interests are protected.

Exemption of certain systems of records under the Privacy Act. Final rule.

This final rule exempts four systems of records (SORs) from subsections (c)(3), (d)(1) through (d)(4), (e)(4)(G) and (H), and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2): The Automated Survey Processing Environment (ASPEN) Complaint/ Incidents Tracking System (ACTS), HHS/CMS, System No. 09-70-0565; the Health Insurance Portability and Accountability Act (HIPAA) Information Tracking System (HITS), HHS/CMS, System No. 09-70-0544; the Organ Procurement Organizations System (OPOS), HHS/CMS, System No. 09-70- 0575; and the Fraud Investigation Database (FID), HHS/CMS, System No. 09-70-0527.

eHealth services and Directive on Electronic Commerce 2000/31/EC.

We often restrict the analysis of eHealth services to a concept of privacy. In this article, we'll demonstrate that other legislation can apply to those services as Directive 2000/31/EC on Ecommerce. By creating telematic networks or infrastructure, eHealth services are offering information services. But what are the consequences with such concept? What are the duties and rights for the actors of the network(s)? We'll try to answer to some questions, even if it won't be exhaustive.

2008 HIMSS analytics report: security of patient data.

This report, released in April 2008, summarizes findings from a survey of senior executives from healthcare organizations across the United States on how their organizations are dealing with an environment in which the need to secure patient data is ever becoming an increasingly greater priority. The survey was conducted by HIMSS Analytics, Chicago, IL (http://www.himssanalytics.org/), a company which collects and analyzes healthcare organization data relating to IT processes and environments. The report was funded by Kroll Fraud Solutions, Nashville, TN (www. krollfraudsolutions.com), a provider of data protection and identity theft response services. Excerpts from the report are reprinted with permission. To download the entire report, go to: http//www.krollfraudsolutions.corr/about-kroll/HIMSS-Patient-Data-Security-Study.aspx

Progress in governance of converging technologies integrated from the nanoscale.

It is expected that convergence of nanotechnology, modern biology, the digital revolution, and cognitive sciences will bring about tremendous improvements in transformative tools, generate new products and services, enable human personal abilities and social achievements, and in time reshape societal relationships. This article focuses on the progress made in governance of such converging, emerging technologies that are integrated with more traditional technologies. The proposed framework for governance calls for several key functions: supporting the transformative impact; advancing responsible development that includes health, safety, and ethical concerns; encouraging national and global partnerships; and commitment to long-term planning with effects on human development. Principles of good governance include participation of all those involved or affected by the new technologies, transparency, participant responsibility, and effective strategic planning. Introduction and management of converging technologies must be done with respect for immediate concerns (such as information technology privacy, access to medical advancements, and addressing toxicity of new nanomaterials) and longer-term concerns (such as human development and concern for human integrity, dignity, and welfare). Four levels of governance of converging technologies have been identified: (a) adapting existing regulations and organizations; (b) establishing new programs, regulations, and organizations specifically to handle converging technologies; (c) national policies and institutional capacity building; and (d) international agreements and partnerships.